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

NCT03800082 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2021-07-28

No results posted yet for this study

Summary

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).

Conditions

  • Pain
  • Cardiac Ischemia
  • Women
  • Pain, Chronic

Interventions

BEHAVIORAL

at heart (changed from HEARTPA♀N during usability testing)

An integrated smartphone and web-based intervention (at heart) 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 intervention for participants randomized to the treatment group will consist of regular use of a progressive WebApp that is managed by a Chatbot named 'Holly', in addition to usual care, for a period of 3 months.

Sponsors & Collaborators

  • University of Toronto

    lead OTHER

Principal Investigators

  • Monica Parry, PhD · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03800082 on ClinicalTrials.gov