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OpenTrials
Completed

NCT Number: NCT03149510

The Effects of Self-monitoring With a Mobile Application in 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile application

Behavioral

Participants will use the mobile application daily to assess heart failure symptoms.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Hospitalizations

    Time frame: Over 12 weeks

    Admission to the hospital while enrolled in the trial.

  3. Mortality

    Time frame: Over 12 weeks

    Death while enrolled in the trial.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 11, 2017
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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