Condition category
Musculoskeletal Diseases
Date applied
18/05/2009
Date assigned
02/07/2009
Last edited
19/10/2011
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

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

http://www.cardiff.ac.uk

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

  1. 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.

  2. 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.

Additional files

Editorial Notes