Heart failure patients and healthcare professionals involved in the clinical care pathway of heart failure. Circulatory System Heart failure
Conditions
Interventions
Current interventions as of 27/02/2024:
Phase 3: A multi-centre study will be conducted to determine the acceptability and feasibility of the BeActive-HF intervention. The BeActive-HF intervention wa
Sponsors
Teesside University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Heart failure patients: 1.1. Adults aged =18 years 1.2. Confirmed diagnosis of HF (reduced or preserved) 1.3. Actively involved in the HF care pathway and have no contraindications to physical activity Healthcare professionals: 2.1. HCPs who are directly involved in the care pathway of HF patients, including but not limited to; cardiac nurses, cardiology consultants and physiotherapists.
Exclusion criteria
Exclusion criteria: HF patients: contraindications to physical activity as advised by a healthcare professional; receiving an intervention to improve lifestyle such as increasing physical activity levels or increase exercise capacity. (added 28/04/2023) Healthcare professions: No exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 27/02/2024: Feasibility data will be collected on the number of HCPs who attend and complete the training, attrition rate and the number of times the intervention was used with adults with HF. Patient adherence will be measured by recording the number and percentage of intervention sessions each patient participant received. Participant (adults with HF and HCPs) retention rates will be measured using the number of participants that are still participating in the study at the end of the study period divided by the number of participants at the start of the study period. The attrition rate will be calculated by dividing ‘the number of participants who dropped out’ by ‘the total number of participants enrolled for the study period’. Reasons for patient attrition will be recorded (i.e. patient chose to drop out, patient death, etc.). Qualitative data collection: At 8 months post-training, HCPs will be invited to participate in a semi-structured interview to explore their views on the intervention content and experience of delivering the intervention to patients, including issues associated with sustainability of the intervention. During the 8-month post-participation period, semi-structured interviews with adults with HF will explore their views on the form and content of the intervention, including their experience of receiving and enacting the intervention in their daily lives. Fidelity: All training will be video recorded to enable assessment of fidelity of training delivery in ‘real-time’. Fidelity will be assessed via a checklist to determine the intervention components delivered, for example, whether the training facilitators satisfactorily deliver key behaviour change techniques. In addition, where possible, the delivery of the intervention to adults with HF will be audio recorded to assess the fidelity of HCP delivery. _____ Previous primary outcome measure as of 28/04/2023 to 27/02/2024: Feasibility will be assessed t | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 27/02/2024: Data will be collected from adults with HF at baseline and follow-up periods (6- and 12-months). Data collected will consist of socio-demographics; health-related quality of life (the Minnesota Living with Heart Failure Questionnaire, MLHFQ); and physical activity behaviour (Actigraph GT3X). Device wear time will be recorded, along with the number of active minutes spent in light, moderate and vigorous activity, and steps per day. Adults with HF will be asked to wear the device for eight consecutive days (24-hour monitoring). HCP participants: Age, sex, time in role, role description, and any previous training in physical activity promotion will be collected from HCPs. The COM-B-SEQv1 will be administered to HCPs before attending training and post-training. A training evaluation form will be provided post-training to explore whether the training met its objectives and was considered useful to HCPs in terms of providing them with the required knowledge and skills to deliver the BeActive-HF intervention during routine clinical care appointments. Referrals to cardiac rehabilitation: Longitudinal data from each study site will be collected on referrals to, and attendance at cardiac rehabilitation. Monthly referral and attendance to cardiac rehabilitation will be observed from each participating site (NHS Trusts) to assess whether referral and uptake rates to cardiac rehabilitation have increased since the introduction of the BeActive-HF intervention. Where feasible, data on unique patient attendance at cardiac rehabilitation will be collected and analysed using time series methods. The time series results will be triangulated with the findings emerging from the patients’ and HCPs’ interviews to inform the optimisation of BeActive-HF ahead of a larger-scale follow-up evaluation. _____ Previous secondary outcome measures as of 28/04/2023 to 27/02/2024: Participants with HF: Physical activity levels at baseline, 6-m | — |
Countries
England, United Kingdom
Outcome results
None listed