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

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ClinicalTrials.gov Identifier: NCT03149510
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Todd M Koelling, MD, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Mobile Application Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Patient-centered Mobile Intervention to Promote Self-management and Improve Patient Outcomes in Chronic Heart Failure
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149510


Contacts
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Contact: Judith Grossi 734-232-6367 jgrossi@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109-2054
Contact: Judy Grossi       jgrossi@med.umich.edu   
Sub-Investigator: Michael P Dorsch, PharmD, MS         
University of Michigan Health System Active, not recruiting
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Todd M Koelling, MD University of Michigan Heart Failure Program

Additional Information:
Publications:
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Responsible Party: Todd M Koelling, MD, Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT03149510     History of Changes
Other Study ID Numbers: HUM00123222
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Todd M Koelling, MD, University of Michigan:
mobile application
mHealth

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases