Recruiting

Observational Study

Sponsor:

University of Toronto

Code:

NCT03800082

Conditions

Pain

Cardiac Ischemia

Women

Pain, Chronic

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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

Study ID

NCT03800082

Start date

Aug 1, 2021

Status verified date

Jul, 2021

Completion date

Aug 31, 2022

Anticipated

Primary completion date

Aug 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control

Participants allocated to the control group will receive the usual care and supports provided to women with cardiac pain, including usual clinic appointments and follow-up.

experimental: Treatment

Participants allocated to the treatment group will also learn how to use the progressive WebApp intervention. The intervention will be delivered on restricted password-protected applications that will permit tracking of adherence (number of logins to app and website using Google Analytics). Participants will be encouraged to log-in regularly to the progressive WebApp (via automated alerts) over the 3-month period to complete a Heart and/or Wellness Check. A Chatbot named 'Holly' will assist women with log-in and maintaining health and wellness. Participants will be directed to the PC for technical problems.

Interventions

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.

Primary outcome measure

  • Feasibility (recruitment, retention, engagement) [ Time Frame: 3 months ]
  • Feasibility (acceptability, satisfaction) [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

Monica Parry

Recruiting

Toronto, Ontario, Canada, M5T 1P8

Contacts

More Information

Sponsor

University of Toronto

Last update posted

Jul 28, 2021

Last verified

Jul, 2021

Keywords

  • Women, Self-Management, Cardiac Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2021-07-28.