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21 May 2012
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| [ Print-friendly version ] |
| A pilot randomised controlled trial of occupational therapy to optimise recovery for patients undergoing primary total hip replacement for osteoarthritis |
| ISRCTN | ISRCTN38381590 |
| ClinicalTrials.gov identifier | |
| Public title | A pilot randomised controlled trial of occupational therapy to optimise recovery for patients undergoing primary total hip replacement for osteoarthritis |
| Scientific title | |
| Acronym | PROOF THR |
| Serial number at source | 11294 |
| Study hypothesis | Occupational therapy will optimise recovery for patients undergoing primary total hip replacement for osteoarthritis |
| Lay summary | Not provided at time of registration |
| Ethics approval | First MREC, 22 June 2011, ref: 77739 |
| Study design | Randomised interventional trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Musculoskeletal, All Diseases |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/02/2012 |
| Anticipated end date | 31/01/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | Planned Sample Size: 60. UK Sample Size: 60. |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | NIHR Programme Grants for Applied Research (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Catherine Sackley |
| Address |
Primary Care Clinical Sciences
School of Health and Population Sciences Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 2TT |
| Country | United Kingdom |
| c.m.sackley@bham.ac.uk | |
| Sponsor | University of Birmingham (UK) |
| Address |
Department of Primary Care & General Practice
Primary Care Clinical Sciences Building School of Health and Population Sciences Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 2TT |
| Country | United Kingdom |
| Tel | +44 (0)121 414 3344 |
| Fax | +44 (0)121 414 3971 |
| Sponsor website: | http://www.birmingham.ac.uk/ |
| Date applied | 06/02/2012 |
| Last edited | 07/02/2012 |
| Date ISRCTN assigned | 06/02/2012 |
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| © 2012 ISRCTN unless otherwise stated. | |
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