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Development and Usability Testing of a Progressive WebApp for Women With Heart Disease

Unknown statusNot applicableNCT03800082
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

The overall goal of this program of research is to develop and systematically evaluate an integrated smartphone and web-based intervention (at heart \[formerly called HEARTPA♀N\]) to provide evidence-informed symptom triage and self-management support to reduce pain and increase health-related quality of life (HRQoL) in women with heart disease. The investigators will use the individual and family self-management theory, mobile device functionality and the pervasive information architecture of mHealth interventions, and follow the sequential phased approach recommended by the Medical Research Council (MRC) to develop at heart (progressive WebApp). Funding was received from the Canadian Institutes of Health Research to develop the architecture and conduct usability testing (Phase 2, complete) to ensure it is easy to use, efficient and satisfying to operate. In Phase 3 (current proposal), feasibility in terms of implementation (accrual rates, acceptability and level of engagement) and initial estimation of effectiveness outcomes (estimates of magnitude of effect) will be evaluated in a pilot randomized controlled trial (RCT). The Phase 3 pilot study will enable the investigators to refine the prototype, inform the methodology, and calculate the sample size for a larger multi-site RCT (Phase 4, future work).

Study details

Official title
Development and Usability Testing of a Progressive WebApp for Women With Heart Disease
Conditions
Interventions
  • Behavioral: at heart (changed from HEARTPA♀N during usability testing)
Sponsor
University of Toronto
Start date
2021-08-01
Primary completion
2022-08-31
Sex
Female
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Canada
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * women greater than 18 years of age with obstructive and non-obstructive CAD pain, post PCI/cardiac surgery pain lasting greater than 3 months * women will be required to speak and read English Exclusion Criteria: * severe cognitive impairment assessed using the Six-Item Screener * major co-morbid medical or psychiatric illness that could preclude their ability to participate

Canadian sites (1)

FacilityCityProvince
Monica ParryTorontoOntario

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03800082