Trial Outcomes & Findings for A Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure (NCT NCT04755816)

Last Updated: 2024-09-19

Results Overview

Time to all-cause mortality (ACM), time to heart failure hospital readmission (HFHR), and decline in quality of life will be analyzed using the Finkelstein-Schoenfeld method. The method combines these three endpoints in a hierarchical fashion using ACM first, HRHR second, and change in HRQOL third. The method pairs every participant receiving the diet intervention with every participant not receiving the diet intervention within each stratum. Within each pairing, a +1 is assigned to the "better" participant, -1 to the "worse" participant, and 0 if they are "tied". The comparison begins with ACM. Tied pairings are then compared using HFHR. Any remaining tied pairings are compared using change in HRQOL. A 'Win' represents a participant doing better within each pairing (receiving +1) based on the hierarchical comparison. The reported unit is the total "wins" for each intervention group from performing such a hierarchical comparison across all strata.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

62 participants

Primary outcome timeframe

12 weeks

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group Standard heart failure educational information. Educational content: Standard heart failure educational information and a daily symptom survey.	Dietary Sodium Intervention The dietary sodium intervention facilitates lower sodium choices using tailored push notifications. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content.	Clinical Worsening Intervention The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.	Dietary Sodium and Clinical Worsening Full access to all content in the control, dietary sodium, and clinical worsening interventions. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.
Overall Study STARTED	12	20	12	18
Overall Study COMPLETED	12	20	12	18
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=12 Participants Standard heart failure educational information. Educational content: Standard heart failure educational information and a daily symptom survey.	Dietary Sodium Intervention n=20 Participants The dietary sodium intervention facilitates lower sodium choices using tailored push notifications. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content.	Clinical Worsening Intervention n=12 Participants The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.	Dietary Sodium and Clinical Worsening n=18 Participants Full access to all content in the control, dietary sodium, and clinical worsening interventions. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.	Total n=62 Participants Total of all reporting groups
Race (NIH/OMB) Black or African American	7 Participants n=99 Participants	13 Participants n=107 Participants	7 Participants n=206 Participants	7 Participants n=7 Participants	34 Participants n=31 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=99 Participants	16 Participants n=107 Participants	10 Participants n=206 Participants	12 Participants n=7 Participants	46 Participants n=31 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants	4 Participants n=107 Participants	2 Participants n=206 Participants	6 Participants n=7 Participants	16 Participants n=31 Participants
Age, Continuous	56.8 years STANDARD_DEVIATION 13.04 • n=99 Participants	54.1 years STANDARD_DEVIATION 15.6 • n=107 Participants	54 years STANDARD_DEVIATION 11.53 • n=206 Participants	54.8 years STANDARD_DEVIATION 16.6 • n=7 Participants	54.8 years STANDARD_DEVIATION 14.44 • n=31 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	7 Participants n=107 Participants	4 Participants n=206 Participants	6 Participants n=7 Participants	20 Participants n=31 Participants
Sex: Female, Male Male	9 Participants n=99 Participants	13 Participants n=107 Participants	8 Participants n=206 Participants	12 Participants n=7 Participants	42 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=99 Participants	19 Participants n=107 Participants	12 Participants n=206 Participants	18 Participants n=7 Participants	60 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	1 Participants n=31 Participants
Race (NIH/OMB) White	4 Participants n=99 Participants	6 Participants n=107 Participants	5 Participants n=206 Participants	10 Participants n=7 Participants	25 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Subjects randomized to the Dietary intervention only (n=20) + those randomized to both interventions (n=18) vs Subjects randomized to the Clinical Worsening intervention only (n=12) + those randomized to Neither intervention (n=12)

Outcome measures

Outcome measures
Measure	Dietary Sodium Intervention n=38 Participants The sodium dietary intervention provides the user with tailored messages to assist with making dietary choices based on sodium content when they arrive at a grocery store or a restaurant. This includes group B and D.	No Dietary Sodium Intervention n=24 Participants Access to all content in the control, and clinical worsening interventions. This includes group A and C.	Clinical Worsening Intervention The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.	Dietary Sodium and Clinical Worsening Full access to all content in the control, dietary sodium, and clinical worsening interventions. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.
Hierarchical Combination ("Win Ratio") of Time to All-cause Mortality, Time to Heart Failure Hospital Readmission, and Decline in Health-related Quality of Life (HRQOL) [ Time Frame: Baseline up to Week 12 ] Time to All-Cause Death	0 Total number of wins	0 Total number of wins	—	—
Hierarchical Combination ("Win Ratio") of Time to All-cause Mortality, Time to Heart Failure Hospital Readmission, and Decline in Health-related Quality of Life (HRQOL) [ Time Frame: Baseline up to Week 12 ] Time to Heart-Failure Readmission	136 Total number of wins	156 Total number of wins	—	—
Hierarchical Combination ("Win Ratio") of Time to All-cause Mortality, Time to Heart Failure Hospital Readmission, and Decline in Health-related Quality of Life (HRQOL) [ Time Frame: Baseline up to Week 12 ] Change in MLHFQ from Baseline to 12 Weeks	146 Total number of wins	63 Total number of wins	—	—
Hierarchical Combination ("Win Ratio") of Time to All-cause Mortality, Time to Heart Failure Hospital Readmission, and Decline in Health-related Quality of Life (HRQOL) [ Time Frame: Baseline up to Week 12 ] Overall (across 3 outcomes)	282 Total number of wins	219 Total number of wins	—	—

PRIMARY outcome

Timeframe: 12 weeks

Population: Subjects randomized to the Clinical Worsening intervention only (n=12) + those randomized to both interventions (n=18) vs Subjects randomized to the Dietary intervention only (n=20) + those randomized to Neither intervention (n=12)

Time to all-cause mortality (ACM), time to heart failure hospital readmission (HFHR), and decline in quality of life will be analyzed using the Finkelstein-Schoenfeld method. The method combines these three endpoints in a hierarchical fashion using ACM first, HRHR second, and change in HRQOL third. The method pairs every participant receiving the clinical worsening intervention with every participant not receiving the clinical worsening intervention within each stratum. Within each pairing, a +1 is assigned to the "better" participant, -1 to the "worse" participant, and 0 if they are "tied". The comparison begins with ACM. Tied pairings are then compared using HFHR. Any remaining tied pairings are compared using change in HRQOL. A 'Win' represents a participant doing better within each pairing (receiving +1) based on the hierarchical comparison. The reported unit is the total "wins" for each intervention group from performing such a hierarchical comparison across all strata.

Outcome measures

Outcome measures
Measure	Dietary Sodium Intervention n=30 Participants The sodium dietary intervention provides the user with tailored messages to assist with making dietary choices based on sodium content when they arrive at a grocery store or a restaurant. This includes group B and D.	No Dietary Sodium Intervention n=32 Participants Access to all content in the control, and clinical worsening interventions. This includes group A and C.	Clinical Worsening Intervention The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.	Dietary Sodium and Clinical Worsening Full access to all content in the control, dietary sodium, and clinical worsening interventions. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.
Hierarchical Combination ("Win Ratio") of Time to All-cause Mortality, Time to Heart Failure Hospital Readmission, and Decline in Health-related Quality of Life (HRQOL) [ Time Frame: Baseline up to Week 12 ] Time to All-Cause Death	0 Total number of wins	0 Total number of wins	—	—
Hierarchical Combination ("Win Ratio") of Time to All-cause Mortality, Time to Heart Failure Hospital Readmission, and Decline in Health-related Quality of Life (HRQOL) [ Time Frame: Baseline up to Week 12 ] Time to Heart-Failure Readmission	136 Total number of wins	156 Total number of wins	—	—
Hierarchical Combination ("Win Ratio") of Time to All-cause Mortality, Time to Heart Failure Hospital Readmission, and Decline in Health-related Quality of Life (HRQOL) [ Time Frame: Baseline up to Week 12 ] Change in MLHFQ from Baseline to 12 Weeks	146 Total number of wins	63 Total number of wins	—	—
Hierarchical Combination ("Win Ratio") of Time to All-cause Mortality, Time to Heart Failure Hospital Readmission, and Decline in Health-related Quality of Life (HRQOL) [ Time Frame: Baseline up to Week 12 ] Overall (across 3 outcomes)	282 Total number of wins	219 Total number of wins	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: no deaths in the study and this outcome could not be assessed

Time to all-cause mortality will be analyzed up to week 12.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Time to first heart-failure related hospitalization will be analyzed up to week 12.

Outcome measures

Outcome measures
Measure	Dietary Sodium Intervention n=38 Participants The sodium dietary intervention provides the user with tailored messages to assist with making dietary choices based on sodium content when they arrive at a grocery store or a restaurant. This includes group B and D.	No Dietary Sodium Intervention n=24 Participants Access to all content in the control, and clinical worsening interventions. This includes group A and C.	Clinical Worsening Intervention The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.	Dietary Sodium and Clinical Worsening Full access to all content in the control, dietary sodium, and clinical worsening interventions. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.
Heart Failure-related Hospitalizations [ Time Frame: Baseline up to Week 12 ]	43.4285714 Days since randomization Standard Deviation 24.4871200	48.5000000 Days since randomization Standard Deviation 19.3649167	—	—

SECONDARY outcome

Timeframe: 12 weeks

Change from baseline to week 12 in health-related quality of life as measured by the Minnesota Living with Heart Failure Questionnaire.

Outcome measures

Outcome measures
Measure	Dietary Sodium Intervention n=27 Participants The sodium dietary intervention provides the user with tailored messages to assist with making dietary choices based on sodium content when they arrive at a grocery store or a restaurant. This includes group B and D.	No Dietary Sodium Intervention n=12 Participants Access to all content in the control, and clinical worsening interventions. This includes group A and C.	Clinical Worsening Intervention The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.	Dietary Sodium and Clinical Worsening Full access to all content in the control, dietary sodium, and clinical worsening interventions. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.
Change From Baseline in Health-related Quality of Life [ Time Frame: Baseline up to Week 12 ]	-39.70 Points on MLHFQ scale Standard Deviation 33.908	-24.33 Points on MLHFQ scale Standard Deviation 24.828	—	—

SECONDARY outcome

Timeframe: 12 weeks

Time to first heart-failure related hospitalization will be analyzed up to week 12.

Outcome measures

Outcome measures
Measure	Dietary Sodium Intervention n=30 Participants The sodium dietary intervention provides the user with tailored messages to assist with making dietary choices based on sodium content when they arrive at a grocery store or a restaurant. This includes group B and D.	No Dietary Sodium Intervention n=32 Participants Access to all content in the control, and clinical worsening interventions. This includes group A and C.	Clinical Worsening Intervention The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.	Dietary Sodium and Clinical Worsening Full access to all content in the control, dietary sodium, and clinical worsening interventions. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.
Heart Failure-related Hospitalizations [ Time Frame: Baseline up to Week 12 ]	53.7500000 Days since randomization Standard Deviation 14.4308697	40.4285714 Days since randomization Standard Deviation 24.8720535	—	—

SECONDARY outcome

Timeframe: 12 Weeks

Change from baseline to week 12 in health-related quality of life as measured by the Minnesota Living with Heart Failure Questionnaire.

Outcome measures

Outcome measures
Measure	Dietary Sodium Intervention n=17 Participants The sodium dietary intervention provides the user with tailored messages to assist with making dietary choices based on sodium content when they arrive at a grocery store or a restaurant. This includes group B and D.	No Dietary Sodium Intervention n=22 Participants Access to all content in the control, and clinical worsening interventions. This includes group A and C.	Clinical Worsening Intervention The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.	Dietary Sodium and Clinical Worsening Full access to all content in the control, dietary sodium, and clinical worsening interventions. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.
Change From Baseline in Health-related Quality of Life [ Time Frame: Baseline up to Week 12 ]	-42.29 Points on MLHFQ scale Standard Deviation 28.169	-29.32 Points on MLHFQ scale Standard Deviation 34.036	—	—

Adverse Events

Control Group

Serious events: 5 serious events

Other events: 3 other events

Deaths: 0 deaths

Dietary Sodium Intervention

Serious events: 9 serious events

Other events: 4 other events

Deaths: 0 deaths

Clinical Worsening Intervention

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Dietary Sodium and Clinical Worsening

Serious events: 6 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Control Group n=12 participants at risk Standard heart failure educational information. Educational content: Standard heart failure educational information and a daily symptom survey.	Dietary Sodium Intervention n=20 participants at risk The dietary sodium intervention facilitates lower sodium choices using tailored push notifications. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content.	Clinical Worsening Intervention n=12 participants at risk The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.	Dietary Sodium and Clinical Worsening n=18 participants at risk Full access to all content in the control, dietary sodium, and clinical worsening interventions. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.
Blood and lymphatic system disorders Inpatient hospitalization or prolongation of existing hospitalization	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	5.0% 1/20 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/18 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.
Cardiac disorders Inpatient hospitalization or prolongation of existing hospitalization	16.7% 2/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	25.0% 5/20 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	16.7% 2/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	5.6% 1/18 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.
Endocrine disorders Inpatient hospitalization or prolongation of existing hospitalization	8.3% 1/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	5.0% 1/20 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/18 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.
Gastrointestinal disorders Inpatient hospitalization or prolongation of existing hospitalization	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/20 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	8.3% 1/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/18 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.
Infections and infestations Inpatient hospitalization or prolongation of existing hospitalization	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	5.0% 1/20 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/18 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.
Injury, poisoning and procedural complications Inpatient hospitalization or prolongation of existing hospitalization	8.3% 1/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/20 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/18 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.
Musculoskeletal and connective tissue disorders Inpatient hospitalization or prolongation of existing hospitalization	16.7% 2/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/20 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	5.6% 1/18 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.
Investigations Inpatient hospitalization or prolongation of existing hospitalization	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/20 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	5.6% 1/18 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.
Psychiatric disorders Inpatient hospitalization or prolongation of existing hospitalization	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	5.0% 1/20 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/18 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.
Renal and urinary disorders Inpatient hospitalization or prolongation of existing hospitalization	8.3% 1/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/20 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	11.1% 2/18 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.
Respiratory, thoracic and mediastinal disorders Inpatient hospitalization or prolongation of existing hospitalization	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	5.0% 1/20 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	16.7% 2/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/18 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.
Cardiac disorders Life Threatening	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/20 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	5.6% 1/18 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.
Respiratory, thoracic and mediastinal disorders Other	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	5.0% 1/20 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/18 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.

Other adverse events

Other adverse events
Measure	Control Group n=12 participants at risk Standard heart failure educational information. Educational content: Standard heart failure educational information and a daily symptom survey.	Dietary Sodium Intervention n=20 participants at risk The dietary sodium intervention facilitates lower sodium choices using tailored push notifications. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content.	Clinical Worsening Intervention n=12 participants at risk The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.	Dietary Sodium and Clinical Worsening n=18 participants at risk Full access to all content in the control, dietary sodium, and clinical worsening interventions. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content. Clinical worsening intervention: The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.
Renal and urinary disorders Hyperkalemia (Potassium > 6.0 meq/dl or requiring change in therapy)	8.3% 1/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/20 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/18 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.
Cardiac disorders Symptomatic bradycardia	8.3% 1/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/20 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/18 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.
Blood and lymphatic system disorders Symptomatic hypotension	8.3% 1/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	5.0% 1/20 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	16.7% 2/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	0.00% 0/18 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.
Renal and urinary disorders Worsening renal function (increase in creatinine by 0.5 mg/dl from last visit or requiring change in	0.00% 0/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	15.0% 3/20 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	8.3% 1/12 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.	11.1% 2/18 • The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline. The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.

Additional Information

Dr. MICHAEL DORSCH

University of Michigan College of Pharmacy

Phone: 734/647-1452

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place