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ISRCTN
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ISRCTN24554946
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ClinicalTrials.gov identifier
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Public title
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Activity Increase Despite Arthritis: developing and evaluating an active management booklet for hip and knee pain
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Scientific title
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Developing an active management booklet for hip and knee pain: an interventional single centre randomised controlled trial
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Acronym
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AIDA
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Serial number at source
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SPON381-07
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Study hypothesis
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Evidence-based booklet for older patients with hip or knee pain encourages physical activity and promoting autonomy.
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Ethics approval
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North East Wales Research Ethics Committee approved on 28th February 2008 (ref: 08/WNo03/5)
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Study design
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Interventional randomised controlled single-centre study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Osteoarthritis of hip and knee
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Participants - inclusion criteria
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1. Patients over 50 years old, either sex
2. Presenting in primary care with hip or knee pain within the last 12 months
Inclusion will not be dependent upon any diagnostic criteria for osteoarthritis, as these are inconsistently applied in primary care populations.
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Participants - exclusion criteria
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1. Inflammatory joint disease
2. Fractures
3. Arthroplasty referral
4. Prescription of potent opioid analgesia
Patients who have already participated in the focus groups and cognitive debriefing interviews will be excluded from the trial.
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Anticipated start date
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20/01/2009
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Anticipated end date
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30/06/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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200 patients in total from four practices, 100 with hip pain, 100 with knee pain
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Interventions
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Participants randomised to the intervention arm will receive new educational booklet. Participants randomised to the control arm will receive a patient information booklet about osteoarthritis produced by the Arthritis Research Campaign (ARC) at 1 month and 3 months follow-up.
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Primary outcome measure(s)
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1. Illness beliefs will be measured with the hip and knee pain beliefs questionnaire (HKBQ) measuring illness beliefs; score (1 = strongly disagree, 5 = strongly agree) at baseline, 1 month and 3 months follow-up
2. Treatment beliefs will be measured with a modified Exercise Attitude Questionnaire-18 (EAQ-18); score (1 = strongly disagree, 5 = strongly agree) at baseline, 1 month and 3 months follow-up
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Secondary outcome measure(s)
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1. Western Ontario McMaster University Arthritis Index (WOMAC) measuring pain, stiffness and difficulty performing daily activities; score (0 = no pain, no stiffness, no difficulty; 10 = extreme pain, extreme stiffness, extreme difficulty) at baseline, 1 month and 3 months follow up
2. Tampa Scale for Kinesiophobia measuring fear of movement/re-injury; score on 4 point likert scale from strongly disagree to strongly agree at baseline, 1 month and 3 months follow-up
3. 12-item short form health survey (SF-12) measuring health and well-being by indicating which statement best describes your health at baseline, 1 month and 3 month follow-up
4. EQ-5D, a measure of health utility by indicating which statement describe health state at baseline, 1 month and 3 months follow-up
5. Client Service Inventory (CSRI) asking about contact with health care services at 3 months follow-up
6. International Physical Activity Questionnaire (IPAQ), a measure of physical activity at baseline, 1 month and 3 months follow up
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Sources of funding
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Wales Office of Research and Development for Health and Social Care (WORD) (UK) (ref: 06/2/234)
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Trial website
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Publications
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2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19732415
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Contact name
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Dr
Nefyn
Williams
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Address
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Department of Primary Care and Public Health
Cardiff University
School of Medicine
North Wales Clinical School
Gwenfro Unit 6/7
Wrexham Technology Park
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City/town
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Wrexham
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Zip/Postcode
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LL13 7YP
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Country
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United Kingdom
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Tel
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+44(0)1978 727 430
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Email
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williamsnh@cf.ac.uk
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Sponsor
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Cardiff University (UK)
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Address
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Newport Road
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City/town
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Cardiff
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Zip/Postcode
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CF24 0DE
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Country
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United Kingdom
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Email
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AmoakwaEN@cardiff.ac.uk
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Sponsor website:
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http://www.cardiff.ac.uk
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Date applied
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18/05/2009
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Last edited
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08/12/2009
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Date ISRCTN assigned
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02/07/2009
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