Trial Outcomes & Findings for Innovative Care of Older Adults With Chronic Heart Failure: A Comparative Effectiveness Clinical Trial (I-COACH) (NCT NCT04304833)
NCT ID: NCT04304833
Last Updated: 2024-10-10
Results Overview
self care scores on a scale range from 70 to 100, mean (SD). The SCHFI uses a Likert-type scale, with responses ranging from 1 (never) to 5 (always). The SCHFI also includes scales for self-care management and self-care confidence. Higher scores on the SCHFI indicate better self-care. A score of less than 70 on any of the subscales is considered inadequate self-care.
TERMINATED
NA
26 participants
Change from Baseline, 3 months, and 6 months
2024-10-10
Participant Flow
Participants enrolled and assessed in the study are HF patients. Caregivers were not enrolled.
Participant milestones
| Measure |
Provider-Based Care Model Arm
Non-connected home vital sign equipment will be given to patients in this group. The patients in the group will be instructed to record their daily readings on a paper log provided by the research team. These monitoring devices will not transmit readings to a centralized location and no one will be alerted to out-of-range readings or compliance with taking daily vital sign measures. At the front page of the log, normal ranges will be described with brief instructions about what participants/caregivers should do if their readings are out-of-range. Logs will be collected at baseline, 3-months and 6-months.
Provider-Based Care Model Arm: The PI will be supplementing standard care by providing and training each patient in the use of an analog (not internet connected) vital sign kit for 6 months: weight scale, blood pressure cuff, pulse oximeter. A Log for recording their vital sign measures.
|
mHealth Model Arm
Connected home vital sign equipment (mHealth) will be given to patients in this group. The patients will be instructed to take their daily readings, which will automatically be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse (RN) Call Center will be automatically alerted and the event will be triaged. Daily measures and medical follow-up from the measures will be counted and collected at baseline, 3-months, and 6-months.
mHealth Model Arm: The PI will provide each patient with weight scale, blood pressure cuff, \& pulse oximeter kit connected to a Bluetooth-paired Android Health Tablet for 6 months. Daily vital sign readings will be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse Call Center will be automatically alerted and triaged.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
14
|
|
Overall Study
COMPLETED
|
8
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Provider-Based Care Model Arm
Non-connected home vital sign equipment will be given to patients in this group. The patients in the group will be instructed to record their daily readings on a paper log provided by the research team. These monitoring devices will not transmit readings to a centralized location and no one will be alerted to out-of-range readings or compliance with taking daily vital sign measures. At the front page of the log, normal ranges will be described with brief instructions about what participants/caregivers should do if their readings are out-of-range. Logs will be collected at baseline, 3-months and 6-months.
Provider-Based Care Model Arm: The PI will be supplementing standard care by providing and training each patient in the use of an analog (not internet connected) vital sign kit for 6 months: weight scale, blood pressure cuff, pulse oximeter. A Log for recording their vital sign measures.
|
mHealth Model Arm
Connected home vital sign equipment (mHealth) will be given to patients in this group. The patients will be instructed to take their daily readings, which will automatically be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse (RN) Call Center will be automatically alerted and the event will be triaged. Daily measures and medical follow-up from the measures will be counted and collected at baseline, 3-months, and 6-months.
mHealth Model Arm: The PI will provide each patient with weight scale, blood pressure cuff, \& pulse oximeter kit connected to a Bluetooth-paired Android Health Tablet for 6 months. Daily vital sign readings will be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse Call Center will be automatically alerted and triaged.
|
|---|---|---|
|
Overall Study
Due to the pandemic in person visits were not allowed
|
4
|
2
|
Baseline Characteristics
We had participants withdraw from the study.
Baseline characteristics by cohort
| Measure |
Provider-Based Care Model Arm
n=12 Participants
Non-connected home vital sign equipment will be given to patients in this group. The patients in the group will be instructed to record their daily readings on a paper log provided by the research team. These monitoring devices will not transmit readings to a centralized location and no one will be alerted to out-of-range readings or compliance with taking daily vital sign measures. At the front page of the log, normal ranges will be described with brief instructions about what participants/caregivers should do if their readings are out-of-range. Logs will be collected at baseline, 3-months and 6-months.
Provider-Based Care Model Arm: The PI will be supplementing standard care by providing and training each patient in the use of an analog (not internet connected) vital sign kit for 6 months: weight scale, blood pressure cuff, pulse oximeter. A Log for recording their vital sign measures.
|
mHealth Model Arm
n=14 Participants
Connected home vital sign equipment (mHealth) will be given to patients in this group. The patients will be instructed to take their daily readings, which will automatically be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse (RN) Call Center will be automatically alerted and the event will be triaged. Daily measures and medical follow-up from the measures will be counted and collected at baseline, 3-months, and 6-months.
mHealth Model Arm: The PI will provide each patient with weight scale, blood pressure cuff, \& pulse oximeter kit connected to a Bluetooth-paired Android Health Tablet for 6 months. Daily vital sign readings will be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse Call Center will be automatically alerted and triaged.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 6.48 • n=12 Participants
|
64.67 years
STANDARD_DEVIATION 8.89 • n=14 Participants
|
63.60 years
STANDARD_DEVIATION 7.73 • n=26 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=4 Participants • We had participants withdraw from the study.
|
1 Participants
n=6 Participants • We had participants withdraw from the study.
|
4 Participants
n=10 Participants • We had participants withdraw from the study.
|
|
Sex: Female, Male
Male
|
1 Participants
n=4 Participants • We had participants withdraw from the study.
|
5 Participants
n=6 Participants • We had participants withdraw from the study.
|
6 Participants
n=10 Participants • We had participants withdraw from the study.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
0 Participants
n=6 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
0 Participants
n=10 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
0 Participants
n=6 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
0 Participants
n=10 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
0 Participants
n=6 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
0 Participants
n=10 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=4 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
4 Participants
n=6 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
6 Participants
n=10 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
|
Race (NIH/OMB)
White
|
2 Participants
n=4 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
2 Participants
n=6 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
4 Participants
n=10 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
0 Participants
n=6 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
0 Participants
n=10 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
0 Participants
n=6 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
0 Participants
n=10 Participants • Due to the COVID-19 pandemic our study was drastically impacted and our participant pool was decreased.
|
PRIMARY outcome
Timeframe: Change from Baseline, 3 months, and 6 monthsPopulation: The study was terminated by mutual agreement by the funding agency and UAMS due to circumstances of the pandemic which made it impossible to recruit patients in the hospital and their caregivers were not allowed in the hospital setting.
self care scores on a scale range from 70 to 100, mean (SD). The SCHFI uses a Likert-type scale, with responses ranging from 1 (never) to 5 (always). The SCHFI also includes scales for self-care management and self-care confidence. Higher scores on the SCHFI indicate better self-care. A score of less than 70 on any of the subscales is considered inadequate self-care.
Outcome measures
| Measure |
Provider-Based Care Model Arm
n=8 Participants
Non-connected home vital sign equipment will be given to patients in this group. The patients in the group will be instructed to record their daily readings on a paper log provided by the research team. These monitoring devices will not transmit readings to a centralized location and no one will be alerted to out-of-range readings or compliance with taking daily vital sign measures. At the front page of the log, normal ranges will be described with brief instructions about what participants/caregivers should do if their readings are out-of-range. Logs will be collected at baseline, 3-months and 6-months.
Provider-Based Care Model Arm: The PI will be supplementing standard care by providing and training each patient in the use of an analog (not internet connected) vital sign kit for 6 months: weight scale, blood pressure cuff, pulse oximeter. A Log for recording their vital sign measures.
|
mHealth Model Arm
n=12 Participants
Connected home vital sign equipment (mHealth) will be given to patients in this group. The patients will be instructed to take their daily readings, which will automatically be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse (RN) Call Center will be automatically alerted and the event will be triaged. Daily measures and medical follow-up from the measures will be counted and collected at baseline, 3-months, and 6-months.
mHealth Model Arm: The PI will provide each patient with weight scale, blood pressure cuff, \& pulse oximeter kit connected to a Bluetooth-paired Android Health Tablet for 6 months. Daily vital sign readings will be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse Call Center will be automatically alerted and triaged.
|
|---|---|---|
|
Self-Care of Heart Failure Maintenance Scale (SCHFI)
3 Month
|
80.00 score on a scale
Standard Deviation 8.72
|
99 score on a scale
Standard Deviation 1.41
|
|
Self-Care of Heart Failure Maintenance Scale (SCHFI)
6 Month
|
83.50 score on a scale
Standard Deviation 3.42
|
74.67 score on a scale
Standard Deviation 21.39
|
|
Self-Care of Heart Failure Maintenance Scale (SCHFI)
Baseline
|
75.50 score on a scale
Standard Deviation 14.55
|
83.67 score on a scale
Standard Deviation 13.41
|
SECONDARY outcome
Timeframe: Change from Baseline, 3 months, and 6 monthssubscale of questionnaire that measures anxiety. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/max range is 39.1-82.7
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline, 3 months, and 6 monthssubscale of questionnaire that measures depression. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 38.4-80.3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline, 3 months, and 6 monthssubscale of questionnaire that measures fatigue. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 33.4-76.8
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline, 3 months, and 6 monthssubscale of questionnaire that measures pain. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 41.1-76.3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline, 3 months, and 6 monthssubscale of questionnaire that measures physical function. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 21.6-58.7
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline, 3 months, and 6 monthssubscale of questionnaire that measures sleep disturbance. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population Min/Max Range 31.7-76.1
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline, 3 months, and 6 monthssubscale of questionnaire that measures the ability to participate in social roles and activities . Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max Range 26.7-65
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline, 3 months, and 6 monthssubscale of questionnaire that measures pain intensite. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 0-10
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline, 3 months, and 6 monthsquestionnaire assesses psychological impact/health distress
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsquestionnaire to assess quality of life. Scoring for the MLHFQ ranges from 0 to 105, the higher the score the more affected, over the past 4 months, the individual is by their heart failure.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 6 monthsquestionnaire to Assess caregiver perception of burden. Scoring of the Zarit Burden Interview ranges from 0-88, the higher the score, the more severe the burden on the caregiver.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 6 monthsquestionnaire to Assess caregiver health
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 3 months and 6 monthsquestionnaire to Assess patient's satisfaction with care received
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 3 months and 6 monthsnumber of medical treatment visits
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months and 6 monthsdeath
Outcome measures
Outcome data not reported
Adverse Events
Provider-Based Care Model Arm
mHealth Model Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place