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

Primary Purpose

Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemonitoring
Flexible Diuretic Regimen
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring telemonitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Health Buddy Web Management system

Flexible Diuretic Regimen

Arm Description

Patients randomized to the telemonitoring intervention will be assigned to use the Bosch Health Buddy Web management system.

Patients randomized into the Flexible Diuretic Regimen intervention will have a diuretic regimen specified by specific weight ranges.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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),
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.

Full Information

First Posted
January 16, 2015
Last Updated
March 21, 2017
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02344342
Brief Title
University of Michigan Advanced Heart Failure Tele-Monitoring and Flexible Diuretic Project
Acronym
Manifold-HF
Official Title
Michigan Advanced Heart Failure TelemoNItoring and FLexible Diuretic Trial - MANIFOLD-HF
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
The industry sponsor has discontinued the product under evaluation in the study.
Study Start Date
February 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
telemonitoring

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health Buddy Web Management system
Arm Type
Experimental
Arm Description
Patients randomized to the telemonitoring intervention will be assigned to use the Bosch Health Buddy Web management system.
Arm Title
Flexible Diuretic Regimen
Arm Type
Experimental
Arm Description
Patients randomized into the Flexible Diuretic Regimen intervention will have a diuretic regimen specified by specific weight ranges.
Intervention Type
Device
Intervention Name(s)
Telemonitoring
Other Intervention Name(s)
Bosch Health Buddy Web Management System
Intervention Description
The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Intervention Type
Other
Intervention Name(s)
Flexible Diuretic Regimen
Intervention Description
Patients will have a prescribed diuretic regimen specified by specific weight ranges.
Primary Outcome Measure Information:
Title
Number of Days Hospitalized or Dead in the 180 Day Follow up Period
Description
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)
Secondary Outcome Measure Information:
Title
Self Care for Heart Failure Index Score
Description
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
Title
Minnesota Living With Heart Failure Questionnaire
Description
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
Title
Days to Hospitalization or Death (if it Occurs Within 180 Days)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd M Koelling, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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