Contact information
Type
Scientific
Primary contact
Dr Nefyn Williams
ORCID ID
Contact details
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
+44(0)1978 727 430
williamsnh@cf.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SPON381-07
Study information
Scientific title
Developing an active management booklet for hip and knee pain: an interventional single centre randomised controlled trial
Acronym
AIDA
Study hypothesis
Evidence-based booklet for older patients with hip or knee pain encourages physical activity and promoting autonomy.
Ethics approval
North East Wales Research Ethics Committee approved on 28th February 2008 (ref: 08/WNo03/5)
Study design
Interventional randomised controlled single-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
20/01/2009
Overall trial end date
30/06/2009
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200 patients in total from four practices, 100 with hip pain, 100 with knee pain
Participant 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.
Recruitment start date
20/01/2009
Recruitment end date
30/06/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Primary Care and Public Health
Wrexham
LL13 7YP
United Kingdom
Sponsor information
Organisation
Cardiff University (UK)
Sponsor details
Newport Road
Cardiff
CF24 0DE
United Kingdom
AmoakwaEN@cardiff.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Wales Office of Research and Development for Health and Social Care (WORD) (UK) (ref: 06/2/234)
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
1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19732415
2. 2011 feasibility study results in http://www.ncbi.nlm.nih.gov/pubmed/21801537
Publication citations
-
Protocol
Williams NH, Amoakwa E, Burton K, Hendry M, Belcher J, Lewis R, Hood K, Jones J, Bennett P, Edwards RT, Neal RD, Andrew G, Wilkinson C, Activity Increase Despite Arthritis (AIDA): design of a Phase II randomised controlled trial evaluating an active management booklet for hip and knee osteoarthritis [ISRCTN24554946]., BMC Fam Pract, 2009, 10, 62, doi: 10.1186/1471-2296-10-62.
-
Feasibility study results
Williams NH, Amoakwa E, Belcher J, Edwards RT, Hassani H, Hendry M, Burton K, Lewis R, Hood K, Jones J, Bennett P, Linck P, Neal RD, Wilkinson C, Activity Increase Despite Arthritis (AÏDA): phase II randomised controlled trial of an active management booklet for hip and knee osteoarthritis in primary care., Br J Gen Pract, 2011, 61, 589, e452-8, doi: 10.3399/bjgp11X588411.