A pilot randomised controlled trial of occupational therapy to optimise recovery for patients undergoing primary total hip replacement for osteoarthritis | Not Recruiting
A pilot randomised controlled trial of occupational therapy to optimise recovery for patients undergoing primary total hip replacement for osteoarthritis
PROOF THR
Trial Source

Health Conditions
  • Musculoskeletal, All Diseases
Not Recruiting
Recruitment Status
ISRCTN38381590
Primary Trial ID Number
Summary
Occupational therapy will optimise recovery for patients undergoing primary total hip replacement for osteoarthritis
Primary Outcome Measures
  • 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
Research Question
  • Occupational therapy will optimise recovery for patients undergoing primary total hip replacement for osteoarthritis
Design Type
Sorry, this information is not available
Ethics Approval
First MREC, 22/06/2011, ref: 77739
Publications
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25795459
Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
60
Participant 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
Participant 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
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
Design Details
Sorry, this information is not available
Study Design
Randomised interventional trial
Results Reporting
Sorry, this information is not available
Acronym
PROOF THR
Scientific Title
A pilot randomised controlled trial of occupational therapy to optimise recovery for patients undergoing primary total hip replacement for osteoarthritis
Secondary Trial Identifying Number
11294
Website
Sorry, this information is not available
Study Funded By
NIHR Programme Grants for Applied Research (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
University of Birmingham (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

01 Feb 2012

Recruitment End Date

31 Jan 2013

Trial End Date

31 Jan 2013

Date added to Registry

06 Feb 2012

Last Updated

28 Jul 2015