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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03149510
• Other study ID #: HUM00123222
• Status: Completed
• Phase: N/A
• Start date: March 6, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: April 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Mobile Application
Participants will use the mobile application daily to assess heart failure symptoms.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minnesota Living with Heart Failure Questionnaire (MLHFQ)	MLHFQ is a quality of life questionnaire for heart failure.	Change from Baseline MLHFQ at Week 12
Secondary	Self-Care Heart Failure Index (SCHFI)	SCHFI is a survey of heart failure patient self-management.	Change from Baseline SCHFI at Week 12
Secondary	Hospitalizations	Admission to the hospital while enrolled in the trial.	Over 12 weeks
Secondary	Mortality	Death while enrolled in the trial.	Over 12 weeks

External Links

•   University of Michigan Center for Health Communications Research