ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001243303

Ethics application status

Approved

Date submitted

22/08/2017

Date registered

25/08/2017

Date last updated

15/04/2024

Date data sharing statement initially provided

29/04/2019

Date results provided

15/10/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

ADHERE study: Behaviour change SMS messages to promote longer term adherence to exercise for knee osteoarthritis.

Scientific title

ADHERE study: The effect of adding a behaviour change, short message service (SMS) intervention to a home based exercise program on exercise adherence in knee osteoarthritis and obesity.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1186-3774

Trial acronym

Linked study record

Trial Id: ACTRN12617001013358

Health condition

Health condition(s) or problem(s) studied:

Osteoarthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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 receive text messages over the 24 week period aiming to facilitate adherence to the home exercise program. Message content has been developed drawing on behaviour change theory and will address common barriers and facilitators to exercise participation previously identified in the knee OA literature. The messaging system will be automated, personalized using first names and be semi-interactive.

Participants will receive approximately 4-5 messages per week initially, dependent on their level of home exercise participation. At the start of the program all participants will receive 2 facilitator to exercise messages per week and a text message asking home many times they completed their home exercise program in the previous week. Participants who complete their home exercise program less than 3 times in the previous week will receive additional messages to identify and address the possible barriers to their exercise participation. Message frequency will gradually reduce over the 24 weeks, so as to not become burdensome to participants.

Participants in both groups will receive an optional exercise log book to record their weekly exercise practice over the 24 week period.

Intervention code [1]

Rehabilitation

Intervention code [2]

Behaviour

Comparator / control treatment

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.

Control group

Active

Outcomes

Primary outcome [1]

Self-reported number of exercise sessions in the last week (max 3)

Timepoint [1]

24 weeks after baseline

Primary outcome [2]

Exercise Adherence Rating Scale (EARS) Section B

Timepoint [2]

24 weeks after baseline

Secondary outcome [1]

Average overall knee pain in the previous week on an 11-point numeric rating scale

Timepoint [1]

Baseline and 24 weeks after baseline

Secondary outcome [2]

Knee Injury and Osteoarthritis Outcome Score (KOOS).
Pain sub-scale

Timepoint [2]

Baseline and 24 weeks after baseline

Secondary outcome [3]

Health related quality of life - AQoL2

Timepoint [3]

Baseline and 24 weeks after baseline

Secondary outcome [4]

Global change overall rated on a 7 point numeric scale from much worse to much better.

Timepoint [4]

24 weeks

Secondary outcome [5]

Physical Activity scale for the elderly (PASE)

Timepoint [5]

Baseline and 24 weeks after baseline

Secondary outcome [6]

Arthritis self-efficacy scale

Timepoint [6]

Baseline and 24 weeks after baseline

Secondary outcome [7]

Brief fear of movement scale

Timepoint [7]

Baseline and 24 weeks after baseline

Secondary outcome [8]

Pain Catastrophising Scale

Timepoint [8]

Baseline and 24 weeks after baseline

Secondary outcome [9]

Self-rated adherence to the home exercise program.
Scored on an 11-point Likert scale (0 – strongly disagree to 10 – strongly agree).

Timepoint [9]

24 weeks after baseline

Secondary outcome [10]

Knee Injury and Osteoarthritis Outcome Score (KOOS).
Function in Daily Living sub-scale

Timepoint [10]

Baseline and 24 weeks after baseline

Secondary outcome [11]

Knee Injury and Osteoarthritis Outcome Score (KOOS).
Other symptoms sub-scale

Timepoint [11]

Baseline and 24 weeks after baseline

Secondary outcome [12]

Knee Injury and Osteoarthritis Outcome Score (KOOS).
Function in sport and recreation sub-scale

Timepoint [12]

Baseline and 24 weeks after baseline

Secondary outcome [13]

Knee Injury and Osteoarthritis Outcome Score (KOOS).
Knee related quality of life sub-scale

Timepoint [13]

Baseline and 24 weeks after baseline

Eligibility

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 scale over the previous week
V. demonstrate tibiofemoral osteophytes on x-ray
VI. obesity (BMI of 30 kg/m2 and over)
VII. have a mobile phone that has text messaging functionality and be happy to receive text message reminders if required during the study

Minimum age

50 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

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 neuromuscular exercise in past 6 months or planning to start exercise in next 9 months;
IX. unable to walk unaided.
X. unable to commit to study requirements (Unable to attend study appointments or complete study
outcomes)

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The person who determines if a participant is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the subject will be allocated.
Randomisation will be concealed in a password protected computer database.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

This study will utilise participants completing another clinical trial, the TARGET study (ACTRN 12617001013358).

Computer generated randomisation will be prepared by our study biostatistician and will be conducted by permuted blocks of varying sizes, stratified by;
- exercise group assigned in the TARGET RCT (1. weight bearing functional exercise or 2.non-weight bearing quadriceps strengthening) and;
- baseline home exercise adherence in the previous week (Scale 0-4 where 0-1 = lower adherence; 2-4=higher adherence.) (Note: baseline home exercise adherence refers to home exercise adherence in the previous week, taken from the final time point of the TARGET RCT).

The randomisation schedule will be computer generated, using random permuted blocks of varying sizes. To conceal allocation, the randomisation schedule will be accessed via a password-protected, computer program by a researcher not involved in participant recruitment or assessment.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample Size Calculation: Participants who complete the TARGET RCT will automatically and immediately be enrolled in the ADHERE RCT and randomised into one of two groups. Conservatively supposing that 102 participants (80% of the 128 TARGET enrolees) will be randomised into ADHERE, and that of those 102 participants, 80% will remain in ADHERE until week 24, this leaves 40 participants per group. With 40 participants per group, we will have 83% power to detect an effect size of 0.6 with two-sided significance level of 0.05, assuming a correlation between baseline home exercise adherence and home exercise adherence at 24 weeks of 0.4, including baseline home exercise adherence in the regression model as a covariate.

Statistical Analysis Plan: Analyses comparing the two groups will be performed by the statistician in a blinded fashion using all available data from all randomised participants. Demographic and baseline characteristics of participants at the time of randomisation in ADHERE will be summarised as appropriate (means and standard deviations for continuous variables that appear to be approximately normally distributed, medians and interquartile ranges for other continuous variables, counts and percentages for categorical variables) and will be inspected to assess baseline comparability of treatment groups. For continuous outcomes, differences in change will be compared between groups
using linear regression models adjusted for baseline levels of these outcomes and TARGET exercise group. Models for non-adherence outcomes will also contain a term for baseline home exercise adherence (a stratifying variable). Model assumptions will be assessed using standard diagnostic plots. For binary outcomes, differences between groups will be compared using relative risks, calculated from logistic regression models including terms for TARGET exercise group and baseline home exercise adherence. Should the amount of missing data for an outcome be such that imputation is required, multiple imputation will be conducted and the method reported.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/12/2017

Actual

19/12/2017

Date of last participant enrolment

Anticipated

9/10/2019

Actual

13/08/2019

Date of last data collection

Anticipated

9/04/2020

Actual

18/02/2020

Sample size

Target

102

Accrual to date

Final

110

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

L 1 16 MARCUS CLARKE Street, Canberra Australian Capital Territory 2601

Country [1]

Australia

Primary sponsor type

University

Name

The University of Melbourne

Address

1-100 Grattan Street, Melbourne, Victoria, 3010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne Behavioural & Social Sciences (BSS-HESC)

Ethics committee address [1]

University of Melbourne, Victoria, Australia, 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/05/2016

Approval date [1]

20/07/2016

Ethics approval number [1]

1544919

Summary

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 exercise has not been assessed in the knee OA population.
Our primary aim will therefore be to investigate the effects of adding a behaviour change embedded text message intervention, to a 6 month home based exercise program for knee osteoarthritis.
Participants who complete a previous RCT (ACTRN 12617001013358) will be randomly allocated to one of two groups:
i) SMS adherence intervention  - a home based exercise program completed three times weekly for 24 weeks PLUS an automated, semi-personalised, mobile phone text message intervention, embedded in behaviour change theory to promote adherence to the exercise program. 
ii) No adherence support control - a home based exercise program completed three times weekly for 24 weeks, independently with no adherence support.  
Primary outcomes are self-reported adherence measures and secondary outcomes include self-reported pain and function. The primary timepoint is 24 weeks.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Kim L Bennell

Address

L7 161 Barry Street, The University of Melbourne, Victoria, Australia, 3010

Country

Australia

Phone

+61 3 8344 4135

Fax

k.bennell@unimelb.edu.au

Contact person for public queries

Name

Sarah Schwartz

Address

L7 161 Barry Street, The University of Melbourne, Victoria, Australia, 3010

Country

Australia

Phone

+61 3 8344 8455

Fax

sarah.schwartz@unimelb.edu.au

Contact person for scientific queries

Name

Kim L Bennell

Address

L7 161 Barry Street, The University of Melbourne, Victoria, Australia, 3010

Country

Australia

Phone

+61 3 8344 9411

Fax

k.bennell@unimelb.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All data presented in the results paper (J Med Internet Res. 2020 Sep 28;22(9):e21749) available in XLSX format.

When will data be available (start and end dates)?

19-03-2020 to 19-03-2035 (a period of 15 years from publication)

Available to whom?

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.

Available for what types of analyses?

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.

How or where can data be obtained?

By emailing the Principal Investigator at k.lbennell@unimelb.edu.au. Data will be made available after review and approval by the Principal Investigator. Before any analysis, a signed Confidentiality Agreement and/or Data Sharing Agreement is required.

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details
13583	Study protocol	k.bennell@unimelb.edu.au
13584	Statistical analysis plan	k.bennell@unimelb.edu.au
13585	Clinical study report	k.bennell@unimelb.edu.au
13586	Analytic code	k.bennell@unimelb.edu.au
13587	Ethical approval	k.bennell@unimelb.edu.au
13588	Informed consent form	k.bennell@unimelb.edu.au
22198	Data dictionary		The Data Dictionary will be supplied with the de-i... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effect of a short message service (SMS) intervention on adherence to a physiotherapist-prescribed home exercise program for people with knee osteoarthritis and obesity: Protocol for the ADHERE randomised controlled trial.	2019	https://dx.doi.org/10.1186/s12891-019-2801-z

N.B. These documents automatically identified may not have been verified by the study sponsor.

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