University of Michigan Advanced Heart Failure Tele-Monitoring and Flexible Diuretic Project

Study Overview
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Brief Summary
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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
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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.

Official Title
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Michigan Advanced Heart Failure TelemoNItoring and FLexible Diuretic Trial - MANIFOLD-HF

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Telemonitoring
* Other: Flexible Diuretic Regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: University of Michigan patients hospitalized for the treatment of heart failure, within the past 30 days. 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. Patients must have an assessment of left ventricular function within the previous 2 years. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Buddy Web Management system<br>Patients randomized to the telemonitoring intervention will be assigned to use the Bosch Health Buddy Web management system. | Device: Telemonitoring<br>* The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.<br>* Other names: Bosch Health Buddy Web Management System;Other: Flexible Diuretic Regimen<br>* Patients will have a prescribed diuretic regimen specified by specific weight ranges.<br>|
| Experimental: Flexible Diuretic Regimen<br>Patients randomized into the Flexible Diuretic Regimen intervention will have a diuretic regimen specified by specific weight ranges. | Device: Telemonitoring<br>* The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.<br>* Other names: Bosch Health Buddy Web Management System;Other: Flexible Diuretic Regimen<br>* Patients will have a prescribed diuretic regimen specified by specific weight ranges.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 180 days (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 180 day follow up | 
| 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), | 180 day follow up | 
| 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. | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemonitoring