Heart Failure
Conditions
Keywords
telemonitoring
Brief summary
The proposed project is a 2x2 factorial designed study aimed at assessing the impact of 1) a home tele-monitoring system and 2) a flexible diuretic regimen among high risk heart failure patients in the University of Michigan Health System (UMHS).
Detailed description
The proposed project is a 2x2 factorial designed study aimed at assessing the impact of 1) a home tele-monitoring system and 2) a flexible diuretic regimen among high risk heart failure patients in the University of Michigan Health System (UMHS). The first intervention consists of the use of a home monitoring tool utilizing a tablet interface. The device facilitates collection of heart failure patient self-care information, including weight, blood pressure, heart rate and heart failure symptoms. This information is collected and stored on a secured server provided by the vendor, and can be viewed by the physician and nursing team. The second intervention is a flexible diuretic regimen strategy. This intervention will be applied in an independent randomized fashion. The flexible regimen will be prescribed by the patient's physician. The two interventions will be applied to heart failure patients treated at the University of Michigan. A total of 400 patients will be enrolled into the study.
Interventions
DEVICETelemonitoring
The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
OTHERFlexible Diuretic Regimen
Patients will have a prescribed diuretic regimen specified by specific weight ranges.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. University of Michigan patients hospitalized for the treatment of heart failure, within the past 30 days. 2. Patients must be receiving an oral loop diuretic on their home regimen or have received intravenous loop diuretic during the index hospitalization at the time of enrollment. 3. Patients must have an assessment of left ventricular function within the previous 2 years. 4. Patients must have LVEF ≤ 40%, or LVEF \>40 with evidence of left atrial enlargement (LA dimension \> 40 mm), BNP \> 200 ng/ml or PCW \> 18 mmHg.
Exclusion criteria
* Prisoners * Residents of long term nursing facilities * Enrollment into a hospice program * Receiving dialysis * Patients with dementia * Patients with dGFR less than 20ml/min. * Patients being worked up for heart surgery. * Patients being worked up for heart transplant. * Patients being evaluated for revascularization. * Patients being evaluated for heart valve intervention. * Patients with primary pulmonary hypertension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Hospitalized or Dead in the 180 Day Follow up Period | 180 days (6 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self Care for Heart Failure Index Score | 180 day follow up | 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. |
| Minnesota Living With Heart Failure Questionnaire | 180 day follow up | 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), |
| Days to Hospitalization or Death (if it Occurs Within 180 Days) | 180 days | 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. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Health Buddy Yes and Flexible Diuretic Yes Telemonitoring: Yes
Flexible Diuretic Yes | 13 |
| Health Buddy Yes and Flexible Diuretic No Telemonitoring: Yes
Flexible Diuretic No | 11 |
| Health Buddy No and Flexible Diuretic Yes Telemonitoring: No
Flexible Diuretic Yes | 14 |
| Health Buddy No and Flexible Diuretic No Telemonitoring: No
Flexible Diuretic No | 13 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Industry partner dropped out | 11 | 9 | 14 | 10 |
Baseline characteristics
| Characteristic | Health Buddy Yes and Flexible Diuretic No | Health Buddy No and Flexible Diuretic Yes | Health Buddy Yes and Flexible Diuretic Yes | Health Buddy No and Flexible Diuretic No | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 3 Participants | 5 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 10 Participants | 10 Participants | 8 Participants | 36 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants | 3 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 8 Participants | 11 Participants | 7 Participants | 10 Participants | 36 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 4 Participants | 3 Participants | 14 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 9 Participants | 10 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 13 | 1 / 11 | 2 / 14 | 1 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 11 | 0 / 14 | 0 / 13 |
| serious Total, serious adverse events | 5 / 13 | 4 / 11 | 7 / 14 | 6 / 13 |
Outcome results
Primary
Number of Days Hospitalized or Dead in the 180 Day Follow up Period
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Health Buddy Yes and Flexible Diuretic Yes | Number of Days Hospitalized or Dead in the 180 Day Follow up Period | 5 Days |
| Health Buddy Yes and Flexible Diuretic No | Number of Days Hospitalized or Dead in the 180 Day Follow up Period | 23 Days |
| Health Buddy No and Flexible Diuretic No | Number of Days Hospitalized or Dead in the 180 Day Follow up Period | 0 Days |
Secondary
Days to Hospitalization or Death (if it Occurs Within 180 Days)
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.
Time frame: 180 days
Population: All participants who completed 180 days or died prior to 180 days (all who completed study and all listed in all cause mortality)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Health Buddy Yes and Flexible Diuretic Yes | Days to Hospitalization or Death (if it Occurs Within 180 Days) | 107 days till hospitalization |
| Health Buddy Yes and Flexible Diuretic No | Days to Hospitalization or Death (if it Occurs Within 180 Days) | 155 days till hospitalization |
| Health Buddy No and Flexible Diuretic Yes | Days to Hospitalization or Death (if it Occurs Within 180 Days) | 102 days till hospitalization |
| Health Buddy No and Flexible Diuretic No | Days to Hospitalization or Death (if it Occurs Within 180 Days) | 122 days till hospitalization |
Secondary
Minnesota Living With Heart Failure Questionnaire
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),
Time frame: 180 day follow up
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Health Buddy Yes and Flexible Diuretic Yes | Minnesota Living With Heart Failure Questionnaire | 49 units on a scale |
| Health Buddy Yes and Flexible Diuretic No | Minnesota Living With Heart Failure Questionnaire | 22 units on a scale |
| Health Buddy No and Flexible Diuretic No | Minnesota Living With Heart Failure Questionnaire | 74 units on a scale |
Secondary
Self Care for Heart Failure Index Score
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.
Time frame: 180 day follow up
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Health Buddy Yes and Flexible Diuretic Yes | Self Care for Heart Failure Index Score | 83 units on a scale |
| Health Buddy Yes and Flexible Diuretic No | Self Care for Heart Failure Index Score | 71 units on a scale |
| Health Buddy No and Flexible Diuretic No | Self Care for Heart Failure Index Score | 80 units on a scale |