Clinical trial NCT03149510: The Effects of Self-monitoring With a Mobile Application in Heart Failure
Official title: A Patient-centered Mobile Intervention to Promote Self-management and Improve Patient Outcomes in Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: mobile application
mHealth
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 83
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Minnesota Living with Heart Failure Questionnaire (MLHFQ)
timeFrame: Change from Baseline MLHFQ at Week 12
Secondary outcomes:
measure: Self-Care Heart Failure Index (SCHFI)
timeFrame: Change from Baseline SCHFI at Week 12
measure: Hospitalizations
timeFrame: Over 12 weeks
measure: Mortality
timeFrame: Over 12 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan Heart Failure Program
name: Todd M Koelling, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dorsch MP, Farris KB, Bleske BE, Koelling TM. A web application for self-monitoring improves symptoms in chronic systolic heart failure. Telemed J E Health. 2015 Apr;21(4):267-70. doi: 10.1089/tmj.2014.0095. Epub 2015 Feb 5.
citation: Bleske BE, Dillman NO, Cornelius D, Ward JK, Burson SC, Diez HL, Pickworth KK, Bennett MS, Nicklas JM, Dorsch MP. Heart failure assessment at the community pharmacy level: a feasibility pilot study. J Am Pharm Assoc (2003). 2014 Nov-Dec;54(6):634-41. doi: 10.1331/JAPhA.2014.14039.
citation: Dorsch MP, Farris KB, Rowell BE, Hummel SL, Koelling TM. The Effects of the ManageHF4Life Mobile App on Patients With Chronic Heart Failure: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 7;9(12):e26185. doi: 10.2196/26185.