Background: Decreased sexual activity and sexual problems are common among people with cardiovascular disease, negatively impacting quality of life, psychological wellbeing and relationship satisfaction. Recent American Heart Association and European Society of Cardiology guidelines recommend sexual counselling as an important component of cardiac rehabilitation and detail how this should be provided.
Aim: To finalise and pilot the CHARMS sexual counselling intervention trial for sexual problems among patients with cardiovascular disease in advance of full scale evaluation in a cluster randomised controlled trial.
Specifically, we will:
Finalise the CHARMS intervention components and data collection tools
Assess the feasibility and acceptability of study procedures (centre and patient recruitment, data collection methods, follow up, fidelity assessment) and intervention (content and delivery)
Pilot data collection tools (process and outcome evaluation)
Estimate recruitment, retention and follow up rates, as well as baseline and variance levels of the trial primary outcome variable for an Irish sample, to facilitate sample size calculation for the main trial
Estimate timeframe and resources required for main trial
Method: We will finalise the CHARMS intervention components.
We will pilot this intervention in 2 cardiac rehabilitation centres in Ireland. Data will be collected at time 1 (baseline) and time 2 (6 month follow up) from staff (estimated 6 in each centre) and patients & partners (n=29 of each in each centre).
Quantitative data will be collected on (1) recruitment and retention rates (2) details on delivery of, and participation in the CHARMS intervention, (3) trial treatment fidelity and (4) data collection.
To assess intervention feasibility, qualitative interviews will be conducted with cardiac rehabilitation staff (n=6) and patients (n=20) & partners (n=6) to understand better the experience of participating in the intervention.
The final intervention and RCT protocol will be developed based on findings from this pilot study.
