Activity Increase Despite Arthritis: developing and evaluating an active management booklet for hip and knee pain

ISRCTN ISRCTN24554946
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

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
Email williamsnh@cf.ac.uk

Study information

Study designInterventional randomised controlled single-centre study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDeveloping an active management booklet for hip and knee pain: an interventional single centre randomised controlled trial
Study acronymAIDA
Study objectivesEvidence-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) studiedOsteoarthritis of hip and knee
InterventionParticipants 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 typeOther
Primary outcome measure1. 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 measures1. 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 date20/01/2009
Completion date30/06/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants200 patients in total from four practices, 100 with hip pain, 100 with knee pain
Key inclusion criteria1. 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 criteria1. 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 enrolment20/01/2009
Date of final enrolment30/06/2009

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

Department of Primary Care and Public Health
Wrexham
LL13 7YP
United Kingdom

Sponsor information

Cardiff University (UK)
University/education

Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom

Email AmoakwaEN@cardiff.ac.uk
Website http://www.cardiff.ac.uk
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 04/09/2009 Yes No
Results article feasibility study results 01/08/2011 Yes No