Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Application | Experimental | Participants will be using a mobile application, activity monitor and scale. |
|
| Control Group | No Intervention | Participants will receive standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Application | Behavioral | Participants will use the mobile application daily to assess heart failure symptoms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) | MLHFQ is a quality of life questionnaire for heart failure. | Change from Baseline MLHFQ at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Care Heart Failure Index (SCHFI) | SCHFI is a survey of heart failure patient self-management. | Change from Baseline SCHFI at Week 12 |
| Hospitalizations | Admission to the hospital while enrolled in the trial. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Todd M Koelling, MD | University of Michigan Heart Failure Program | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109-2054 | United States | ||
| University of Michigan Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25654615 | Background | 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. | |
| 25379983 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Over 12 weeks |
| Mortality | Death while enrolled in the trial. | Over 12 weeks |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| 34878990 | Derived | 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. |