Development and Usability Testing of HEARTPA♀N (HEARTPA♀N)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03800082|
Recruitment Status : Not yet recruiting
First Posted : January 11, 2019
Last Update Posted : January 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain Cardiac Ischemia Women Pain, Chronic||Behavioral: HEARTPA♀N||Not Applicable|
Phase 3 (Study 3): Pilot Randomized Controlled Trial of the HEARTPA♀N Intervention.
The HEARTPA♀N 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 cardiac pain. The investigators will undertake a process and preliminary effect evaluation of the HEARTPA♀N intervention for women with cardiac pain, as guided by the MRC framework. The primary objective is to determine the feasibility of implementing an RCT of the HEARTPA♀N 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 HEARTPA♀N 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 HEARTPA♀N, 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. HEARTPA♀N 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A two group parallel single blind pilot RCT.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||It is not possible to blind the participants to group allocation due to the specific nature of the HEARTPA♀N intervention; however, a data analyst at the University of Toronto's Faculty of Nursing who is blinded to treatment allocation will conduct the analysis ensuring neutrality of the outcome assessment.|
|Primary Purpose:||Supportive Care|
|Official Title:||Development and Usability Testing of HEARTPA♀N: An Integrated Smartphone and Web-Based Intervention for Women With Cardiac Pain|
|Estimated Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2021|
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.
Participants allocated to the treatment group will also learn how to use the HEARTPA♀N 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 to the pain diary app daily (via automated alerts) over the 3-month period to complete pain diary entries and develop and track their goals related to their pain, activities, sleep, emotions and medications. Participants will be directed to the PC for technical problems.
An integrated smartphone and web-based intervention (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 cardiac pain. The intervention for participants randomized to the treatment group will consist of daily use of the HEARTPA♀N app, in addition to usual care, for a period of 3 months.
- Feasibility (recruitment, retention, engagement) [ Time Frame: 3 months ]A process evaluation will be used to assess the feasibility of the implementation of the intervention. The PC will track any issues or difficulties encountered during trial implementation, such as problems using the app. Engagement will be assessed using Google Analytics, which will track patterns of app and website usage. Engagement with the app diary will be defined as 100% with daily entries for 3 months. Engagement with goal setting will be defined as 100% when 12 goals are identified over the 3-month period. Criteria for implementation success: recruitment rates > 70%, retention > 85%, minimal technical difficulties reported by < 10%, engagement > 80%, and minimal missed responses. Prevalence of refusal, retention, engagement and technical difficulties reported will be calculated with their 95% confidence intervals.
- Feasibility (acceptability, satisfaction) [ Time Frame: 3 months ]The investigators will also assess acceptability and satisfaction in all participants in the intervention group using a modified Acceptability e-Scale (AES). The modified AES includes 9 items, each with a 5-point Likert response. Higher scores represent better acceptability/satisfaction. Responses are summed and averaged. Criteria for implementation success: AES mean summary score > 4.
- Pain (Brief Pain Inventory) [ Time Frame: 3 months ]A preliminary efficacy evaluation will also be undertaken focusing on the outcomes of pain. Pain will be measured using the Brief Pain Inventory-Short Form (BPI-SF), which rates pain severity and the degree to which pain interferes with mood, sleep, and other physical activities such as work, social activity and relations with others. We will investigate the variability and sensitivity to change for pain (T2-T1). We will calculate the number of participants who report clinically meaningful decreases in pain, which has been defined for the BPI-SF as a two-point difference in worst pain. Variability will be estimated using the mean/median scores and standard deviation, in each group separately, at pre and post-test.
- Health-related quality of life (HRQOL) [ Time Frame: 3 months ]A preliminary efficacy evaluation will also be undertaken focusing on the outcomes of HRQOL. HRQOL will be measured using the SF-36v2TM, which contains 36 items and yields a score for each of the 8 domains of health: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role emotional), and mental health. We will investigate the variability and sensitivity to change for HRQOL (T2-T1). Sensitivity to change will be assessed by determining the number of participants who had a clinically meaningful increase in HRQOL: ≥ 15 points in physical functioning, general health and mental health; ≥ 16.7 in role emotional functioning; ≥ 18.5 points in role physical functioning and vitality; ≥ 20 points in bodily pain; and ≥ 25 points in social functioning.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800082
|Contact: Monica Parry, PhDfirstname.lastname@example.org|
|Contact: Myra Leyden, MAemail@example.com|
|Principal Investigator:||Monica Parry, PhD||University of Toronto|