University of Michigan Advanced Heart Failure Tele-Monitoring and Flexible Diuretic Project (Manifold-HF)

March 21, 2017 updated by: Todd M Koelling, MD, University of Michigan

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Days Hospitalized or Dead in the 180 Day Follow up Period
Time Frame: 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.
180 days (6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self Care for Heart Failure Index Score
Time Frame: 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.
180 day follow up
Minnesota Living With Heart Failure Questionnaire
Time Frame: 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),
180 day follow up
Days to Hospitalization or Death (if it Occurs Within 180 Days)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 16, 2015

First Posted (Estimate)

January 22, 2015

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00091053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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