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
Protocol serial number	11294
Sponsor	University of Birmingham (UK)
Funder	NIHR Programme Grants for Applied Research (UK)

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

Primary Care Clinical Sciences
School of Health and Population Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	c.m.sackley@bham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised interventional trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(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.
Key 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
Completion date	31/01/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

University of Birmingham

Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes