Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001187730
Ethics application status
Approved
Date submitted
29/07/2022
Date registered
6/09/2022
Date last updated
8/09/2022
Date data sharing statement initially provided
6/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A very brief intervention for physical activity behaviour change in cardiac rehabilitation: the ‘Measure It!’ effectiveness-implementation trial
Scientific title
Is physical activity measurement on 5 occasions over 24-weeks more effective than 2 occasions in improving accelerometer daily minutes of moderate-to-vigorous physical activity in insufficiently active adult cardiac rehabilitation attendees with heart disease?
Secondary ID [1] 307683 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12616000566437 was conducted as a pilot study of the intervention in healthy adults and has informed the intervention in the current record.

Health condition
Health condition(s) or problem(s) studied:
coronary heart disease 327221 0
physical inactivity 327222 0
Condition category
Condition code
Cardiovascular 324357 324357 0 0
Coronary heart disease
Public Health 324358 324358 0 0
Health promotion/education
Physical Medicine / Rehabilitation 324610 324610 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical activity measurement (PAM) intervention: ‘Measure It!’ includes a self-report and objective measure of physical activity plus physical activity advice provided by their cardiac rehabilitation clinician. Patients will be asked about their current level of physical activity using the Physical Activity Vital Sign (On average how many days per week do you engage in moderate or greater physical activity?; On average how many minutes per day do you engage in activity at this level?), taking less than 30 seconds to complete. Patients will also be asked to provide the average number of steps/day they completed in the last week according to their wearable activity tracker or smartphone app. The physical activity guidelines will be very briefly discussed (2 minutes) at each measurement. An example of the very brief physical activity advice provided is ‘moderate intensity physical activity means you should be able to talk in full sentences but not sing’, or ‘any activity is better than none’. Patients will be encouraged to safely increase their physical activity levels during the 24-week intervention period aiming to progress towards the Australian Physical Activity and Sedentary Behaviour Guidelines for Adults, that is, accumulate 150 to 300 minutes of moderate intensity physical activity or 75 to 150 minutes of vigorous intensity physical activity or a combination of both each week. The ‘Measure It!’ intervention will be delivered face-to-face at baseline (5-PAM), 6 (5-PAM, end-cardiac rehabilitation program) and 24-weeks (5-PAM) but may be delivered via telehealth at 12 (5-PAM) and 18-weeks (5-PAM) depending on the site-specific cardiac rehabilitation model. The number of times the intervention is delivered to each patient will be recorded. From our pilot study (ACTRN12616000566437) in a healthy adult population, the total time required for measuring physical activity and provision of brief advice was less than 5 minutes, classifying this as a very brief intervention.
Intervention code [1] 324156 0
Rehabilitation
Intervention code [2] 324157 0
Prevention
Intervention code [3] 324158 0
Lifestyle
Comparator / control treatment
The comparator group will receive 2 physical activity measurements face-to-face over 24-weeks (2-PAM: baseline and 24-weeks) compared to 5 physical activity measurements (5-PAM) over 24-weeks in the intervention group. The intervention for the comparator group is the same as the intervention group but at a lower frequency over the 24-week period. The number of times the intervention is delivered to each patient in the 2-PAM will be recorded.
Control group
Active

Outcomes
Primary outcome [1] 332158 0
Physical activity levels: A triaxial commercial accelerometer (ActiGraph GT3X, Fort Walton Beach, FL) will be used to objectively assess physical activity. Patients will be asked to wear the accelerometer on their right hip, while awake, for 7-consecutive days at baseline and 24-weeks as an outcome measure only, returning the accelerometer via mail in the reply-paid post pak provided. All data will be downloaded, screened and categorised according to commonly used algorithms in this population to determine time spent in different physical activity intensities.
Timepoint [1] 332158 0
For a 7-day period at baseline and 24-weeks post-commencement of intervention.
Secondary outcome [1] 412417 0
Health-related quality of life: The Assessment of Quality of Life (AQoL)-6D is a self-administered health-related quality of life questionnaire. It has 20 items, takes 2-3 minutes to complete, and has six dimensions - independent living, mental health, coping, relationships, pain, senses, and provides an overall multi-attribute utility score.
Timepoint [1] 412417 0
Baseline and 24-weeks post-commencement of intervention.
Secondary outcome [2] 412418 0
Body mass index: Body mass index (kg/m2) will be calculated using a calibrated set of scales and a stadiometer (ht).
Timepoint [2] 412418 0
Baseline and 24-weeks post-commencement of intervention.
Secondary outcome [3] 412419 0
Waist circumference: Waist circumference will be measured in centimetres using a stretch-resistant tape measure. The waist circumference will be recorded as the midpoint between the lower margin of the lowest palpable rib and the top of the iliac crest. The measure will be repeated twice.
Timepoint [3] 412419 0
Baseline and 24-weeks post-commencement of intervention.
Secondary outcome [4] 412420 0
Cardiac rehabilitation clinicians physical activity promotion survey: Cardiac rehabilitation clinicians will be asked to complete an online survey which includes questions about their physical activity promotion practices, perceived role in physical activity promotion, barriers to promotion, feasibility of different strategies, knowledge of the physical activity guidelines and personal physical activity levels using a validated survey.
Timepoint [4] 412420 0
Baseline and 18-months post-commencement of intervention.
Secondary outcome [5] 412424 0
Costs (healthcare perspective): Healthcare resource use will include trial-intervention resource use (e.g. cardiac rehabilitation clinician’s time) and non-trial healthcare use which may be impacted (e.g. hospital visits via an audit of hospital records; Medicare and PBS items from Services Australia, where patients have consented to access), costed using actual costs accrued where available or market rate estimates.
Timepoint [5] 412424 0
24-weeks post-commencement of intervention.
Secondary outcome [6] 413464 0
Acceptability of the Intervention: Patients and cardiac rehabilitation clinicians will be asked about the acceptability of the intervention using the Acceptability of Intervention Measure (AIM), a valid and reliable scale, which will be electronically-administered following an interview with consenting patients and cardiac rehabilitation clinicians.
Timepoint [6] 413464 0
Patients: 24-weeks post-commencement of intervention.
Cardiac rehabilitation clinicians: 18-months post-commencement of intervention.
Secondary outcome [7] 413465 0
Implementation outcome (acceptability, appropriateness, adoption, sustainability and feasibility): Semi-structured interviews will be conducted with patients and treating cardiac rehabilitation clinicians. The Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF) will be used to understand how the physical activity intervention works to change individual behaviour and multilevel factors that influence implementation success or failure. Interviews will be led by an experienced qualitative researcher post-intervention. All interviews will be audio-recorded and professionally transcribed. The implementation outcome is a composite measure of acceptability, appropriateness, adoption, sustainability and feasibility.
Timepoint [7] 413465 0
Patients: 24-weeks post-commencement of intervention.
Cardiac rehabilitation clinicians: 18-months post-commencement of intervention.

Eligibility
Key inclusion criteria
Eligible patients must:
• be 18+ years old
• be enrolled in a hospital-based phase II cardiac rehabilitation program
• have stable coronary heart disease and be receiving optimal medical treatment ± revascularisation (eg, coronary artery bypass graft surgery, percutaneous coronary intervention), or have had a myocardial infarction
• have a wearable activity tracker OR smartphone (step tracker app) OR computer/tablet
• be insufficiently active (<150 mins of self-reported moderate-to-vigorous physical activity/wk),
• have no serious medical conditions or functional impairments that could limit participation in moderate intensity physical activity,
• have adequate English language and cognitive skills to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have New York Heart Association class II-IV symptoms of heart failure (or documented signs and symptoms of chronic heart failure, with ejection fraction < 45%), uncontrolled arrhythmias, severe chronic obstructive pulmonary disease, uncontrolled hypertension, symptomatic peripheral artery disease, unstable angina, uncontrolled diabetes, or are unable to wear an accelerometer due to disability, for example, if they are confined to a wheelchair.

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)
After patient baseline measures have been completed, the investigator will be contacted via telephone or email by the assessing cardiac rehabilitation clinician to reveal random allocation to one of two groups (1:1 ratio): 5 physical activity measurements (5-PAM) or 2 physical activity measurements (2-PAM) in total over 24-weeks.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An investigator in a remote location and not involved in recruitment or assessments will use a computer to generate a random number sequence which is consecutively numbered. Randomisation will occur at an individual patient level.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
Analyses will be carried out following the intention-to-treat principle. Linear (for continuous outcome data) and generalised linear (for binary and count outcome data) fixed-effects models will be used for between group comparisons at 24-weeks and interactions analyses adjusting for baseline measures as well as demographic characteristics, such as gender, and other potential covariates, such as cardiac rehabilitation program. All analyses will be conducted using either SPSS or STATA. Significance level will be set at p<0.05.

Incremental cost-effectiveness ratios (ICER) of cost (healthcare perspective) per Quality Adjusted Life Year (from AQoL-6D) gained (24-week time horizon, consistent with primary analysis) will be estimated for the between group comparison using patient level trial data, that is, ICER (5 vs 2-PAM) = [(Cost5-PAM)-(Cost2-PAM)] / [(Effect5-PAM-Effect2-PAM)]. Bootstrap resampling will be used to derive 95% confidence intervals (costs and effects) and 95% confidence ellipse (ICER). Probabilistic extrapolation modelling (stochastic, following modelling guidelines informed by best available evidence including trial (e.g. measures of disease risk) and published literature) will extend these estimates to a (secondary) time-horizon of 5-years. Cost-effectiveness acceptability curves will be prepared. We will assess the sensitivity of results to variation in measured resource use, effectiveness, time-horizon, discounting and unit costs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/10/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
190
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 22895 0
The Sydney Private Hospital - Ashfield
Recruitment hospital [2] 22896 0
Delmar Private Hospital - Dee Why
Recruitment hospital [3] 22897 0
National Capital Private Hospital - Garran
Recruitment hospital [4] 22898 0
Calvary Public Hospital ACT - Bruce
Recruitment postcode(s) [1] 38201 0
2131 - Ashfield
Recruitment postcode(s) [2] 38202 0
2099 - Dee Why
Recruitment postcode(s) [3] 38203 0
2605 - Garran
Recruitment postcode(s) [4] 38204 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 311952 0
Self funded/Unfunded
Name [1] 311952 0
Country [1] 311952 0
Primary sponsor type
Individual
Name
A/Prof Nicole Freene
Address
University of Canberra, University Drive, Bruce, ACT, 2617
Country
Australia
Secondary sponsor category [1] 313439 0
Individual
Name [1] 313439 0
Prof Rachel Davey
Address [1] 313439 0
University of Canberra, University Drive, Bruce, ACT, 2617
Country [1] 313439 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311384 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 311384 0
Ethics committee country [1] 311384 0
Australia
Date submitted for ethics approval [1] 311384 0
06/07/2022
Approval date [1] 311384 0
18/08/2022
Ethics approval number [1] 311384 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120906 0
A/Prof Nicole Freene
Address 120906 0
University of Canberra, University Drive, Bruce, ACT, 2617
Country 120906 0
Australia
Phone 120906 0
+61262015550
Fax 120906 0
Email 120906 0
[email protected]
Contact person for public queries
Name 120907 0
Nicole Freene
Address 120907 0
University of Canberra, University Drive, Bruce, ACT, 2617
Country 120907 0
Australia
Phone 120907 0
+61262015550
Fax 120907 0
Email 120907 0
[email protected]
Contact person for scientific queries
Name 120908 0
Nicole Freene
Address 120908 0
University of Canberra, University Drive, Bruce, ACT, 2617
Country 120908 0
Australia
Phone 120908 0
+61262015550
Fax 120908 0
Email 120908 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Physical activity levels, body mass index, waist circumference, Health-related quality of life, and socio-demographic variables (eg: age, gender).
When will data be available (start and end dates)?
2025 - 2030. This data will be available for 5 years.
Available to whom?
Researchers interested in a cardiac rehabilitation and physcial activity.
Available for what types of analyses?
Statistical.
How or where can data be obtained?
De-identified data for this trial will be available upon request by emailing the principal investigator: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseVery brief intervention for physical activity behaviour change in cardiac rehabilitation: protocol for the 'Measure It!' effectiveness-implementation hybrid trial.2023https://dx.doi.org/10.1136/bmjopen-2023-072630
N.B. These documents automatically identified may not have been verified by the study sponsor.