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
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Behavioral: Mobile Application||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- Hospitalizations [ Time Frame: Over 12 weeks ]Admission to the hospital while enrolled in the trial.
- Mortality [ Time Frame: Over 12 weeks ]Death while enrolled in the trial.
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
|Contact: Judith Grossiemail@example.com|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109-2054|
|Contact: Judy Grossi firstname.lastname@example.org|
|Sub-Investigator: Michael P Dorsch, PharmD, MS|
|University of Michigan Health System||Active, not recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Todd M Koelling, MD||University of Michigan Heart Failure Program|