NCT02344342

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 2, 2017

Completed
Last Updated

May 2, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

January 16, 2015

Results QC Date

October 4, 2016

Last Update Submit

March 21, 2017

Conditions

Heart Failure

Keywords

telemonitoring

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Self Care for Heart Failure Index Score

    180 day follow up

  • Minnesota Living With Heart Failure Questionnaire

    180 day follow up

  • Days to Hospitalization or Death (if it Occurs Within 180 Days)

    180 days

Study Arms (2)

Health Buddy Web Management system

EXPERIMENTAL

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

Device: TelemonitoringOther: Flexible Diuretic Regimen

Flexible Diuretic Regimen

EXPERIMENTAL

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

Device: TelemonitoringOther: Flexible Diuretic Regimen

Interventions

TelemonitoringDEVICE

The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.

Also known as: Bosch Health Buddy Web Management System
Flexible Diuretic RegimenHealth Buddy Web Management system
Flexible Diuretic RegimenOTHER

Patients will have a prescribed diuretic regimen specified by specific weight ranges.

Flexible Diuretic RegimenHealth Buddy Web Management system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Limitations and Caveats

Early termination leading to a small number of subjects analyzed. We have enrolled a total of 51 patients when our target was to enroll 400 patients.

Results Point of Contact

Title
Todd Koelling, MD
Organization
University of Michgan Health Systems
tkoellin@med.umich.edu
734-936-5265

Study Officials

  • Todd M Koelling, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine, Director of Heart Failure Program

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 22, 2015

Study Start

February 1, 2015

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

May 2, 2017

Results First Posted

May 2, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)