Cardiac surgery Surgery
Conditions
Interventions
All participants receive the prehabilitation programme alongside their usual NHS care. The study does not test a formal hypothesis or whether the programme is effective
instead, it focuses on whether it is practical to deliver the programme in the NHS and whether a future randomised controlled trial is feasible.
The study includes two sequential feasibility studies
Sponsors
Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Adults (aged >=18 years) 2. Accepted for cardiac surgery
Exclusion criteria
Exclusion criteria: 1. Patients undergoing cardiac transplantation 2. Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment and retention feasibility measured as the proportion of screened eligible patients recruited to the study and the proportion of recruited participants completing study follow-up, using study screening, recruitment and follow-up records recorded in the REDCap study database, throughout recruitment and at three months after surgery 2. Implementation fidelity and patient engagement measured as the proportion of participants adhering to the prehabilitation intervention and the proportion recording at least two agreed prehabilitation goals and achieving those goals within the My Heart Surgery workbook, using participant workbook records and intervention delivery and follow-up records recorded in the REDCap study database, throughout the intervention period and at completion of the intervention (pre-surgery) 3. Acceptability and feasibility of intervention delivery in different settings measured as the acceptability and feasibility of delivering the intervention across outpatient and inpatient settings from the perspectives of participants and healthcare professionals, using semi-structured qualitative interviews with patients, healthcare professionals and trained intervention providers, during and following intervention delivery 4. Barriers and facilitators to implementation measured as patient-, healthcare professional- and organisation-level barriers and facilitators to implementing the intervention, using semi-structured qualitative interviews with patients, healthcare professionals and trained intervention providers, during and following intervention delivery 5. Feasibility of collecting quality-of-life, healthcare resource-use and cost data to inform a future definitive randomised controlled trial measured as the completeness and feasibility of collecting health-related quality-of-life, healthcare resource-use and cost data, using the SF-36v2, EQ-5D-5L, Hospital Anxiety and Depression Scale (HADS), Duke Activity Status Index (DASI), Modular Resource U | — |
Countries
England, United Kingdom
Contacts
Public ContactFit4HeartOp Study Team
Outcome results
None listed