ADHERE study: Behaviour change SMS messages to promote longer term adherence to exercise for knee osteoarthritis
The University of MelbourneDataset description
Demographic, baseline and 24-week follow-up data from the ADHERE trial. 110 patients aged over 50 years, obese (BMI ≥ 30 kg/m2) with moderate to severe symptomatic radiographic medial knee osteoarthritis. Both groups were asked to complete a home exercise program unsupervised three times per week for 24 weeks and were randomly allocated to a behavior change theory-informed, automated, semi-interactive SMS intervention addressing exercise barriers and facilitators or to control (no SMS). Primary outcomes were self-reported home exercise adherence measures. All data presented in the results paper (J Med Internet Res. 2020;22(9):e21749) available in XLSX format.Date Information
Source Study
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12617001243303
Funding
Government body, National Health and Medical Research Council (NHMRC)
Scientific enquiries
Prof Kim L Bennell
Brief Summary
Knee osteoarthritis (OA) is a major public health problem. Exercise is recommended by all clinical guidelines for managing pain in knee OA, however, effects of exercise on pain and function outcomes are only modest. This may be due to poor exercise adherence amongst knee OA sufferers. There is evidence that the use of text messaging as a behaviour change adherence tool can be effective in the healthcare setting for a variety of conditions. To date the use of SMS messages as an adherence tool for .... Read more
Key Inclusion Criteria
Participants who complete a previous RCT (TARGET study, ACTRN 12617001013358) investigating the effect of two different exercise programs for people with medial knee osteoarthritis and obesity will be automatically enrolled into this trial. The inclusion criteria for the previous RCT are; I. aged 50 years and above; II. report knee pain on most days of the past month; III. suffered knee pain for 3 months or more; IV. report a minimum average overall pain score of 4 on an 11-point numeric rating .... Read more
Key Exclusion Criteria
The exclusion criteria are; I. Lateral joint space narrowing greater than or equal to medial joint space narrowing on x-ray; II. knee surgery/joint injection in past 6 months or planned surgery in the next 9 months; III. current or past (4 weeks) oral corticosteroids; IV. systemic arthritic conditions; V. past knee fracture or malignancy VI. past hip/knee joint replacement/tibial osteotomy; VII. other condition currently effecting lower limb function; VIII. participation in knee strengthening or .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 110
Min. age 50 Years
Max. age No limit
Sex Both males and females
Condition category Osteoarthritis
Condition code Musculoskeletal
Intervention
Intervention code Rehabilitation , Behaviour
Participants will be randomly allocated to either 1) SMS adherence intervention or 2) no adherence support control. Participants in both groups will be expected to continue their home exercise program prescribed to them in a previous study, the TARGET study (Trial Id: ACTRN12617001013358). Participants will complete their prescribed home exercise program 3 times/week for 24 weeks. Each home exercise session will take approximately 20 minutes. In addition participants in the SMS intervention will .... Read more
Comparison
Control group Active
Participants in the control intervention will be expected to complete a home exercise program for their knee osteoarthritis 3 times per week for 24 weeks with no SMS support during that period. Participants in the control intervention will also receive an optional exercise log book to use during the 24 week period.
Outcomes
Outcome: Self-reported number of exercise sessions in the last week (max 3) Timepoint: 24 weeks after baseline
Outcome: Exercise Adherence Rating Scale (EARS) Section BTimepoint: 24 weeks after baseline
Will the study consider sharing individual participant data?
Yes
Who can request access to individual participant data?
Data will be made available as required for specific, approved analyses by researchers. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.
Are there any conditions for requesting access to individual participant data?
-
What individual participant data might be shared?
Individual participant data not covered above
All data presented in the results paper (J Med Internet Res. 2020 Sep 28;22(9):e21749) available in XLSX format.
What types of analyses could be done with individual participant data?
The investigators endorse the concept of data sharing to advance medical science. All requests for data sharing will be reviewed by the Principal Investigator to ensure no conflict with any planned sub analyses and to ensure that the data are shared in an ethical and protected manner. Analyses aimed to improve treatment of knee osteoarthritis for non-commercial purposes are eligible.
Are there extra considerations when requesting access to individual participant data?
No
When can requests for individual data be made (start and end dates)?
From: 19-03-2020 to 19-03-2035 (a period of 15 years from publication)
To: -