Home Administered Pre-surgical Psychological Intervention for Knee OA
Research type
Research Study
Full title
Home Administered Pre-surgical Psychological Intervention for Knee Osteoarthritis: A single blind feasibility randomised controlled trial
IRAS ID
136311
Contact name
Roshan Nair
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Research summary
This feasibility study will enable us to plan for a Phase III Randomised Control Trial (RCT) to evaluate the effectiveness of a pre-surgical psychological intervention based on Cognitive Behavioural therapy (CBT). The aim is to improve post-surgical outcomes for patients undergoing knee replacement surgery for osteoarthritis (OA), including reducing inpatient stays and readmissions. If the intervention is effective, patients may experience reduced distress, more confidence in carrying out daily activities and improved quality of life, placing less reliance on health services and reducing the burden on the NHS. The aim is to evaluate the suitability of recruitment, assessment methods and intervention and enable us to calculate the number of people we will need for a definitive study. Potential participants will be those with knee OA, over the age of 18, listed for knee replacement surgery, with high levels of distress. They will be recruited from the knee surgery pathway. Participants, after initial assessments, will complete baseline measures before being randomly allocated to receive the intervention plus usual care or usual care alone. Up to ten sessions of one hour of the intervention will be offered on an individual basis by a clinical psychologist at a hospital clinic or in participant’s own home, if preferred. Control group participants will receive usual care. The same assessments will be repeated 4 and 6 months after randomisation by all participants. Feedback interviews with some participants will be conducted by patient-partners or RA to assess what parts of the intervention were helpful or unhelpful, the acceptability of randomisation, the experience of being in a control group, and the appropriateness of the measures used. We will examine the feasibility and acceptability of patient-partners conducting the interviews, by also interviewing patient-partners.
Participants will be in the study for approximately 8 months and the study will last 2 years.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
14/EM/0099
Date of REC Opinion
20 Mar 2014
REC opinion
Favourable Opinion