A pilot randomised controlled trial of occupational therapy to optimise recovery for patients undergoing primary total hip replacement for osteoarthritis
| ISRCTN | ISRCTN38381590 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38381590 |
| Secondary identifying numbers | 11294 |
- Submission date
- 06/02/2012
- Registration date
- 06/02/2012
- Last edited
- 28/07/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Catherine Sackley
Scientific
Scientific
Primary Care Clinical Sciences
School of Health and Population Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
| c.m.sackley@bham.ac.uk |
Study information
| Study design | Randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A pilot randomised controlled trial of occupational therapy to optimise recovery for patients undergoing primary total hip replacement for osteoarthritis |
| Study acronym | PROOF THR |
| Study objectives | Occupational therapy will optimise recovery for patients undergoing primary total hip replacement for osteoarthritis |
| Ethics approval(s) | First MREC, 22/06/2011, ref: 77739 |
| Health condition(s) or problem(s) studied | Musculoskeletal, All Diseases |
| Intervention | A multi centre pilot RCT of a pre-surgery home based occupational intervention versus hospital based usual care. Sixty participants awaiting primary elective unilateral total hip replacement (THR) due to osteoarthritis, with no history of previous joint replacement, will be randomised centrally following baseline assessment by a computer generated block randomisation algorithm. The intervention group will receive a pre-surgery home visit by an occupational therapist (n=30) who will discuss expectations and anxieties, assess home safety, provide adaptive devices and education depending on identified needs. The control group will receive treatment as usual (TAU) (n=30). Randomisation will be stratified by surgery site and age (above or below 65 years). The outcome assessor will be blinded to group allocation. Pre-surgery Occupational Therapy (OT) Patients randomised to this arm of the study will be visited by an OT prior to surgery who will assess the individual needs of each participant and their home circumstances. The OT will deliver all the adaptive devices required by the participant and educate them in how they should be used. In addition, the OT will discuss the patients expectations, discuss any anxieties the person (or carer) may have, give explanations about the surgery, hospital stay and post operative rehabilitation as an I Followed up at 6 months As of 07/02/2012, this ISRCTN record has been updated to include description: 30 participants will be in the control group receiving routine NHS care (treatment as usual group). 30 participants will receive the bespoke OT intervention in their own homes prior to admission for THR surgery |
| Intervention type | Other |
| Primary outcome measure | Assess the feasibility of a full scale RCT measured at the end of study with respect to: 1. Recruitment procedures measured by identification and response rates, recruitment rates and establishment of site specific procedures 2. Appropriateness, responsiveness and acceptability of outcome measures measured by analysis of any missing data and completion rates 3. Fidelity of the intervention assessed by dropout rates, content of the intervention using an intervention log and acceptability of randomisation into the intervention/control. |
| Secondary outcome measures | 1. Pain 2. Functional activity 3. Societal participation Measured at 4, 12 and 26 weeks and physical activity levels at 12 weeks (using accelerometry). 4. Record resource use 5. Adverse events 6. Clinical effect size 7. Directionality of the outcome measure questionnaires Measured at the end of study 8. Health resource usage measured at 26 weeks 9. Pain 10. Functional activity 11. Societal participation The above outcomes will be measured using patient administered questionaires at 4, 12 and 26 weeks 12. Physical activity using accelerometery will be measured at 12 weeks |
| Overall study start date | 01/02/2012 |
| Completion date | 31/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60. UK Sample Size: 60. |
| Key inclusion criteria | 1. Patients accepted for surgery for primary THR following review in orthopaedic clinic 2. No previous lower limb joint replacement surgery 3. Osteoarthritis as the primary indication for surgery 4. No planned additional lower limb joint replacement surgery within 12 months 5. Unilateral surgery 6. Male & female participants 7. Lower Age Limit 55 years |
| Key exclusion criteria | 1. Patients with inflammatory arthritis 2. Patients whose existing comorbidities prevent them from participating in the proposed treatment intervention (such as stroke or amputation) 3. Patients who are unable to provide informed consent |
| Date of first enrolment | 01/02/2012 |
| Date of final enrolment | 31/01/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
University of Birmingham (UK)
Hospital/treatment centre
Hospital/treatment centre
Department of Primary Care & General Practice
Primary Care Clinical Sciences Building
School of Health and Population Sciences
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Website | http://www.birmingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
NIHR Programme Grants for Applied Research (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2016 | Yes | No |
