Activity Increase Despite Arthritis: developing and evaluating an active management booklet for hip and knee pain
ISRCTN | ISRCTN24554946 |
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DOI | https://doi.org/10.1186/ISRCTN24554946 |
Secondary identifying numbers | SPON381-07 |
- Submission date
- 18/05/2009
- Registration date
- 02/07/2009
- Last edited
- 19/10/2011
- 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
Dr Nefyn Williams
Scientific
Scientific
Department of Primary Care and Public Health
Cardiff University
School of Medicine
North Wales Clinical School
Gwenfro Unit 6/7
Wrexham Technology Park
Wrexham
LL13 7YP
United Kingdom
Phone | +44(0)1978 727 430 |
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williamsnh@cf.ac.uk |
Study information
Study design | Interventional randomised controlled single-centre study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Prevention |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Developing an active management booklet for hip and knee pain: an interventional single centre randomised controlled trial |
Study acronym | AIDA |
Study objectives | Evidence-based booklet for older patients with hip or knee pain encourages physical activity and promoting autonomy. |
Ethics approval(s) | North East Wales Research Ethics Committee approved on 28th February 2008 (ref: 08/WNo03/5) |
Health condition(s) or problem(s) studied | Osteoarthritis of hip and knee |
Intervention | 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. |
Intervention type | Other |
Primary outcome measure | 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 |
Secondary outcome measures | 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 |
Overall study start date | 20/01/2009 |
Completion date | 30/06/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 200 patients in total from four practices, 100 with hip pain, 100 with knee pain |
Key inclusion criteria | 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. |
Key exclusion criteria | 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. |
Date of first enrolment | 20/01/2009 |
Date of final enrolment | 30/06/2009 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Department of Primary Care and Public Health
Wrexham
LL13 7YP
United Kingdom
LL13 7YP
United Kingdom
Sponsor information
Cardiff University (UK)
University/education
University/education
Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom
AmoakwaEN@cardiff.ac.uk | |
Website | http://www.cardiff.ac.uk |
https://ror.org/03kk7td41 |
Funders
Funder type
Government
Wales Office of Research and Development for Health and Social Care (WORD) (UK) (ref: 06/2/234)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Protocol article | protocol | 04/09/2009 | Yes | No | |
Results article | feasibility study results | 01/08/2011 | Yes | No |