The Effects of Self-monitoring With a Mobile Application in Heart Failure

April 1, 2020 updated by: Todd M Koelling, MD, University of Michigan

A Patient-centered Mobile Intervention to Promote Self-management and Improve Patient Outcomes in Chronic Heart Failure

In the United States, about 40 percent of heart failure (HF) patients are readmitted within 1-year following their first admission for HF and hospitalization accounts for approximately 70 percent of the costs of HF management. As a result, the management of HF patients is evolving from the traditional model of face-to-face follow-up visits toward a proactive real-time technological model of assisting patients with monitoring and self-management while in the community. The investigators plan to test the impact of a mobile application on clinical outcomes in HF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

HF patients with a reduced ejection fraction will be randomized to the mobile application versus placebo for 12 weeks. The mobile application will provide the participants with a reminder to perform self-monitoring, a health status indicator and heart failure education for self-management.

All participants will complete the Minnesota Living with Heart Failure Questionnaire and Self-Care Heart Failure Index. Hospital admissions and mortality will also be collected.

Study Type

Interventional

Enrollment (Actual)

83

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
      • Ann Arbor, Michigan, United States, 48109-2054
        • University of Michigan

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

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 45 years old or older
  • Left ventricular ejection fraction </= 40% or an LVEF > 40% (with left atrial size >40mm or BNP > 200 pg/ml or NT-proBNP > 800 pg/ml)
  • Admitted for acutely decompensated heart failure or recently discharged in the past 4 weeks.
  • Smartphone (iOS or Android) with home wifi

Exclusion Criteria:

  • Unstable coronary syndrome within 8 weeks (unstable angina, NSTEMI, STEMI)
  • Primary valvular heart disease
  • Known pericardial disease (Sarcoidosis, amyloidosis, rheumatoid arthritis, lupus)
  • Uncorrected thyroid disease
  • Advanced renal disease (dialysis or creatinine >4.0 mg/dL)
  • End-stage HF (hospice candidate, home milrinone or dobutamine)
  • Active cancer
  • Pulmonary fibrosis
  • Discharge to a setting other than home

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mobile Application
Participants will be using a mobile application, activity monitor and scale.
Behavioral: Mobile Application
Participants will use the mobile application daily to assess heart failure symptoms.
NO_INTERVENTION: Control Group
Participants will receive standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time Frame: Change from Baseline MLHFQ at Week 12
MLHFQ is a quality of life questionnaire for heart failure.
Change from Baseline MLHFQ at Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Care Heart Failure Index (SCHFI)
Time Frame: Change from Baseline SCHFI at Week 12
SCHFI is a survey of heart failure patient self-management.
Change from Baseline SCHFI at Week 12
Hospitalizations
Time Frame: Over 12 weeks
Admission to the hospital while enrolled in the trial.
Over 12 weeks
Mortality
Time Frame: Over 12 weeks
Death while enrolled in the trial.
Over 12 weeks

Collaborators and Investigators

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

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Todd M Koelling, MD, University of Michigan Heart Failure Program

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

March 6, 2017

Primary Completion (ACTUAL)

April 30, 2019

Study Completion (ACTUAL)

April 30, 2019

Study Registration Dates

First Submitted

April 20, 2017

First Submitted That Met QC Criteria

May 9, 2017

First Posted (ACTUAL)

May 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00123222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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