Condition category
Musculoskeletal Diseases
Date applied
06/02/2012
Date assigned
06/02/2012
Last edited
28/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Catherine Sackley

ORCID ID

Contact details

Primary Care Clinical Sciences
School of Health and Population Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
c.m.sackley@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11294

Study information

Scientific title

A pilot randomised controlled trial of occupational therapy to optimise recovery for patients undergoing primary total hip replacement for osteoarthritis

Acronym

PROOF THR

Study hypothesis

Occupational therapy will optimise recovery for patients undergoing primary total hip replacement for osteoarthritis

Ethics approval

First MREC, 22/06/2011, ref: 77739

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

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

Overall trial start date

01/02/2012

Overall trial end date

31/01/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60. UK Sample Size: 60.

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

Recruitment start date

01/02/2012

Recruitment end date

31/01/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Department of Primary Care & General Practice
Primary Care Clinical Sciences Building
School of Health and Population Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.birmingham.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Programme Grants for Applied Research (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25795459

Publication citations

Additional files

Editorial Notes