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Behavioral Intervention
Intervention for Patient Activation (EmpowerMyCH Trial)
N/A
Waitlist Available
Led By Anushree Agarwal, MBBS, MAS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* have congenital heart disease
* 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 6, 12, and 24 months
Awards & highlights
Summary
The theory-informed digital health intervention, called as "Empower My Congenital Health (EmpowerMyCH)" aims to activate and engage ACHD patients in building confidence toward navigating the adult healthcare system. This tool is built after incorporating the theories of behavior change, gathering inputs from target patients in all stages of its design and implementation. The key features of the tool include a digital medical passport, updated congenital information, community support, and patient stories and advice. The investigators aim to test the acceptability, feasibility, efficacy, and effectiveness of the intervention.
Who is the study for?
This trial is for adults with congenital heart disease (CHD) who are interested in using a digital tool to help manage their condition. The tool aims to empower patients by providing resources and community support.
What is being tested?
The 'Empower My Congenital Health' digital intervention is being tested for its ability to help CHD patients navigate the healthcare system, increase confidence, and improve health behaviors through features like a medical passport and patient stories.
What are the potential side effects?
Since this is a digital empowerment tool, traditional physical side effects are not applicable. However, users may experience increased screen time or stress if technical issues arise.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 6, 12, and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 6, 12, and 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of the intervention components
Feasibility of the intervention
Recruitment rate
+1 moreSecondary study objectives
Euro-Quality of Life
Gothenburg Empowerment Scale (GES)
Patient activation measure (PAM)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
This is a digital (web and mobile-based) multicomponent patient engagement behavioral intervention. The intervention components include digital medical passport, health-specific updated information, credible resources, connections with the community, peer- and expert support and guidance, among others
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,856 Previous Clinical Trials
47,817,920 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,531 Previous Clinical Trials
15,243,282 Total Patients Enrolled
Anushree Agarwal, MBBS, MASPrincipal InvestigatorUniversity of California, San Francisco
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