Clinical trial NCT03800082: Development and Usability Testing of a Progressive WebApp for Women With Heart Disease
Official title: Development and Usability Testing of a Progressive WebApp for Women With Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Cardiac Ischemia
Women
Pain, Chronic
Keywords: Women, Self-Management, Cardiac Pain
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two group parallel single blind pilot RCT.
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: Phase 3 (Study 3): Pilot Randomized Controlled Trial of the at heart (formerly called HEARTPA♀N) Intervention.

The at heart intervention is the first of its kind; there are no previous trials of the efficacy of such an intervention to decrease pain and improve HRQoL in women with heart disease. The investigators will undertake a process and preliminary effect evaluation of the intervention for women with heart disease, as guided by the MRC framework. The primary objective is to determine the feasibility of implementing an RCT of the intervention. A process evaluation will be conducted to examine: 1) the feasibility of randomization, recruitment and retention, 2) acceptability and barriers to implementing the intervention (including the symptom triage algorithms), and 3) the extent of engagement with the intervention. The investigators will also undertake a preliminary efficacy evaluation of the primary outcomes. Based on the investigator's theorized mechanism of change, they hypothesize that the intervention will reduce pain and improve HRQoL (primary outcomes). The investigators will assess the variability and sensitivity to change for both outcomes. Prior to conducting a full scale RCT of a complex intervention, such as at heart, the MRC recommends that a pilot trial be performed. Results from this pilot trial will inform the success of a future RCT in three ways: 1) help determine sample size calculation for the full-scale trial, 2) test procedures (recruitment, randomization, follow-up), which will make up the design of the full-scale trial, and 3) test feasibility of implementing the intervention, particularly by estimating rates of recruitment and retention. Triage algorithms and self-management interventions will be developed using a strong theoretical framework, informed by needs assessments and a comprehensive integrated mixed methods systematic review, with preliminary acceptability and usability testing by end-users. The investigators anticipate minimal risk to safety but will track adverse events using the Adverse Event Form. Moreover, latest WebApp technologies have been integrated through the use of a Chatbot named 'Holly'.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility (recruitment, retention, engagement)
timeFrame: 3 months
measure: Feasibility (acceptability, satisfaction)
timeFrame: 3 months
Secondary outcomes:
measure: Pain (Brief Pain Inventory)
timeFrame: 3 months
measure: Health-related quality of life (HRQOL)
timeFrame: 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Monica Parry
state: Ontario
Study officials:
affiliation: University of Toronto
name: Monica Parry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parry M, Dhukai A, Clarke H, Bjornnes AK, Cafazzo JA, Cooper L, Harvey P, Katz J, Lalloo C, Leegaard M, Legare F, Lovas M, McFetridge-Durdle J, McGillion M, Norris C, Parente L, Patterson R, Pilote L, Pink L, Price J, Stinson J, Uddin A, Victor JC, Watt-Watson J, Auld C, Faubert C, Park D, Park M, Rickard B, DeBonis VS. Development and usability testing of HEARTPAfemale symbolN: protocol for a mixed methods strategy to develop an integrated smartphone and web-based intervention for women with cardiac pain. BMJ Open. 2020 Mar 9;10(3):e033092. doi: 10.1136/bmjopen-2019-033092.