Trial Outcomes & Findings for University of Michigan Advanced Heart Failure Tele-Monitoring and Flexible Diuretic Project (NCT NCT02344342)
NCT ID: NCT02344342
Last Updated: 2017-05-02
Results Overview
This is the total combined number of days that all participants in each arm were hospitalized or dead between day 1 and day 180. It is a method to combine the endpoints of death and hospitalization used in heart failure trials. Days hospitalized for all participants are added to days dead for all participants, per arm.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
180 days (6 months)
Results posted on
2017-05-02
Participant Flow
Patients were randomized to one of 4 study groups: Telemedicine intervention\_YES and Flexible Diuretic\_YES Telemedicine intervention\_YES and Flexible Diuretic\_NO Telemedicine intervention\_NO and Flexible Diuretic\_YES Telemedicine intervention\_NO and Flexible Diuretic\_NO
Participant milestones
| Measure |
Health Buddy Yes and Flexible Diuretic Yes
Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges.
|
Health Buddy Yes and Flexible Diuretic Regimen No
Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Flexible Diuretic Regimen: These patients will not be assigned to receive a flexible diuretic prescription
|
Health Buddy No and Flexible Diuretic Yes
Telemonitoring: These patients will not receive care with the Health Buddy Web intervention.
Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges.
|
Health Buddy No and Flexible Diuretic No
Telemonitoring: These patients will not be assigned to the Health Buddy Web intervention.
Flexible Diuretic Regimen: These patients will not be assigned to follow a flexible diuretic regimen.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
14
|
13
|
|
Overall Study
COMPLETED
|
2
|
2
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
14
|
10
|
Reasons for withdrawal
| Measure |
Health Buddy Yes and Flexible Diuretic Yes
Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges.
|
Health Buddy Yes and Flexible Diuretic Regimen No
Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Flexible Diuretic Regimen: These patients will not be assigned to receive a flexible diuretic prescription
|
Health Buddy No and Flexible Diuretic Yes
Telemonitoring: These patients will not receive care with the Health Buddy Web intervention.
Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges.
|
Health Buddy No and Flexible Diuretic No
Telemonitoring: These patients will not be assigned to the Health Buddy Web intervention.
Flexible Diuretic Regimen: These patients will not be assigned to follow a flexible diuretic regimen.
|
|---|---|---|---|---|
|
Overall Study
Industry partner dropped out
|
11
|
9
|
14
|
10
|
Baseline Characteristics
University of Michigan Advanced Heart Failure Tele-Monitoring and Flexible Diuretic Project
Baseline characteristics by cohort
| Measure |
Health Buddy Yes and Flexible Diuretic Yes
n=13 Participants
Telemonitoring: Yes
Flexible Diuretic Yes
|
Health Buddy Yes and Flexible Diuretic No
n=11 Participants
Telemonitoring: Yes
Flexible Diuretic No
|
Health Buddy No and Flexible Diuretic Yes
n=14 Participants
Telemonitoring: No
Flexible Diuretic Yes
|
Health Buddy No and Flexible Diuretic No
n=13 Participants
Telemonitoring: No
Flexible Diuretic No
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
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
|
|
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
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
36 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
37 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
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)
Native Hawaiian or Other Pacific Islander
|
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)
Black or African American
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
36 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
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 180 days (6 months)Population: The subjects included in this measure each completed the 180 follow up period or died within the 180 follow up period. Subjects that had less than 180 days of follow up at the time of study closure are excluded from this analysis.
This is the total combined number of days that all participants in each arm were hospitalized or dead between day 1 and day 180. It is a method to combine the endpoints of death and hospitalization used in heart failure trials. Days hospitalized for all participants are added to days dead for all participants, per arm.
Outcome measures
| Measure |
Health Buddy Yes and Flexible Diuretic Yes
n=2 Participants
Telemonitoring: Yes
Flexible Diuretic Yes
|
Health Buddy Yes and Flexible Diuretic No
n=2 Participants
Telemonitoring: Yes
Flexible Diuretic No
|
Health Buddy No and Flexible Diuretic Yes
Telemonitoring: No
Flexible Diuretic Yes
|
Health Buddy No and Flexible Diuretic No
n=3 Participants
Telemonitoring: No
Flexible Diuretic No
|
|---|---|---|---|---|
|
Number of Days Hospitalized or Dead in the 180 Day Follow up Period
|
5 Days
|
23 Days
|
—
|
0 Days
|
SECONDARY outcome
Timeframe: 180 day follow upPopulation: Two participants completed the study but did not answer all of the questions on this questionnaire, and therefore they are not included in the report for this secondary end point. The subjects included completed the 180 follow up period. Subjects that had less than 180 days of follow up at the time of study closure are excluded from this analysis.
The self care for heart failure index score ranges from 22 to 88 where 22 is the lowest score meaning cares for oneself least well and 88 means one is most confident or able to care for oneself properly.
Outcome measures
| Measure |
Health Buddy Yes and Flexible Diuretic Yes
n=1 Participants
Telemonitoring: Yes
Flexible Diuretic Yes
|
Health Buddy Yes and Flexible Diuretic No
n=2 Participants
Telemonitoring: Yes
Flexible Diuretic No
|
Health Buddy No and Flexible Diuretic Yes
Telemonitoring: No
Flexible Diuretic Yes
|
Health Buddy No and Flexible Diuretic No
n=2 Participants
Telemonitoring: No
Flexible Diuretic No
|
|---|---|---|---|---|
|
Self Care for Heart Failure Index Score
|
83 units on a scale
For a single participant, there is no range beyond the value of that individual.
|
71 units on a scale
Interval 59.0 to 84.0
|
—
|
80 units on a scale
Interval 78.0 to 81.0
|
SECONDARY outcome
Timeframe: 180 day follow upPopulation: 2 patients completed the study, whose answers were not coded into the analysis for the questionnaire, therefore they are not included in the report for this secondary end point. The subjects included completed the 180 follow up period. Subjects that had less than 180 days of follow up at the time of study closure are excluded from this analysis.
It provides a total score (range 0-105, where 0 is best quality of life up to 105 as worst Health Related Quality of Life),
Outcome measures
| Measure |
Health Buddy Yes and Flexible Diuretic Yes
n=1 Participants
Telemonitoring: Yes
Flexible Diuretic Yes
|
Health Buddy Yes and Flexible Diuretic No
n=2 Participants
Telemonitoring: Yes
Flexible Diuretic No
|
Health Buddy No and Flexible Diuretic Yes
Telemonitoring: No
Flexible Diuretic Yes
|
Health Buddy No and Flexible Diuretic No
n=2 Participants
Telemonitoring: No
Flexible Diuretic No
|
|---|---|---|---|---|
|
Minnesota Living With Heart Failure Questionnaire
|
49 units on a scale
Because there is only a single participant's data presented, there is no range beyond that individual's data.
|
22 units on a scale
Interval 15.0 to 29.0
|
—
|
74 units on a scale
Interval 62.0 to 87.0
|
SECONDARY outcome
Timeframe: 180 daysPopulation: All participants who completed 180 days or died prior to 180 days (all who completed study and all listed in all cause mortality)
Time to Hospitalization (if participant was hospitalized and did not die) or death whichever came first. In fact all participants who died in the follow up period were hospitalized first, so actual data reported below also represents time to hospitalization for all participants.
Outcome measures
| Measure |
Health Buddy Yes and Flexible Diuretic Yes
n=3 Participants
Telemonitoring: Yes
Flexible Diuretic Yes
|
Health Buddy Yes and Flexible Diuretic No
n=3 Participants
Telemonitoring: Yes
Flexible Diuretic No
|
Health Buddy No and Flexible Diuretic Yes
n=2 Participants
Telemonitoring: No
Flexible Diuretic Yes
|
Health Buddy No and Flexible Diuretic No
n=4 Participants
Telemonitoring: No
Flexible Diuretic No
|
|---|---|---|---|---|
|
Days to Hospitalization or Death (if it Occurs Within 180 Days)
|
107 days till hospitalization
Interval 62.0 to 152.0
|
155 days till hospitalization
Interval 114.0 to 195.0
|
102 days till hospitalization
Interval 70.0 to 134.0
|
122 days till hospitalization
Interval 83.0 to 161.0
|
Adverse Events
Health Buddy Web YES/Flexible Diuretic YES
Serious events: 5 serious events
Other events: 0 other events
Deaths: 1 deaths
Health Buddy Web YES /Flexible Diuretic NO
Serious events: 4 serious events
Other events: 0 other events
Deaths: 1 deaths
Health Buddy Web NO/Flexible Diuretic YES
Serious events: 7 serious events
Other events: 0 other events
Deaths: 2 deaths
Health Buddy Web NO /Flexible Diuretic NO
Serious events: 6 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Health Buddy Web YES/Flexible Diuretic YES
n=13 participants at risk
Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges.
|
Health Buddy Web YES /Flexible Diuretic NO
n=11 participants at risk
Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Flexible Diuretic Regimen: These patients will not be assigned to receive a flexible diuretic prescription
|
Health Buddy Web NO/Flexible Diuretic YES
n=14 participants at risk
Telemonitoring: These patients will not receive care with the Health Buddy Web intervention.
Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges.
|
Health Buddy Web NO /Flexible Diuretic NO
n=13 participants at risk
Telemonitoring: These patients will not be assigned to the Health Buddy Web intervention.
Flexible Diuretic Regimen: These patients will not be assigned to follow a flexible diuretic regimen.
|
|---|---|---|---|---|
|
Cardiac disorders
Congestive heart failure,
|
7.7%
1/13 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
0.00%
0/11 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
7.1%
1/14 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
0.00%
0/13 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
|
Nervous system disorders
Occipital stroke
|
0.00%
0/13 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
0.00%
0/11 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
0.00%
0/14 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
7.7%
1/13 • Number of events 1 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
|
Cardiac disorders
Hospitalization
|
30.8%
4/13 • Number of events 4 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
27.3%
3/11 • Number of events 3 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
35.7%
5/14 • Number of events 5 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
38.5%
5/13 • Number of events 5 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
|
Cardiac disorders
ventricular tachycardia/ventricular fibrillation
|
0.00%
0/13 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
9.1%
1/11 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
0.00%
0/14 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
0.00%
0/13 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
|
Cardiac disorders
Death
|
0.00%
0/13 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
0.00%
0/11 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
7.1%
1/14 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
0.00%
0/13 • 180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place