Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000502831
Ethics application status
Approved
Date submitted
15/02/2021
Date registered
29/04/2021
Date last updated
14/06/2023
Date data sharing statement initially provided
29/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Choices: The effect of co-designed community programs on healthy lifestyle choices for people with chronic conditions.
Scientific title
Healthy Choices: The effect of co-designed community programs on healthy lifestyle choices for people with chronic conditions - A randomised and controlled pragmatic trial.
Secondary ID [1] 303467 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes type 2 321158 0
Chronic respiratory diseases 321159 0
Chronic cardiovascular disease 321160 0
Chronic kidney disease 321161 0
Chronic musculo-skeletal disorders 321162 0
Chronic pain 321163 0
Cancer survivors 321164 0
Chronic mental health disorders 321165 0
Diabetes type 1 321654 0
Condition category
Condition code
Public Health 318600 318600 0 0
Health promotion/education
Cancer 318959 318959 0 0
Any cancer
Cardiovascular 318960 318960 0 0
Other cardiovascular diseases
Mental Health 318961 318961 0 0
Other mental health disorders
Metabolic and Endocrine 318962 318962 0 0
Diabetes
Musculoskeletal 318963 318963 0 0
Other muscular and skeletal disorders
Neurological 318964 318964 0 0
Other neurological disorders
Renal and Urogenital 318965 318965 0 0
Other renal and urogenital disorders
Respiratory 318966 318966 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Program has 4 components and runs as a three-month module (which can be repeated as necessary for longer term goals). The principles of self-management will form the basis of the first two components and these will be reiterated throughout the service pathway where participants:
• gain knowledge of their condition
• follow a management plan, based on identified wellbeing goals, as agreed with health team
• actively share in decision-making with the health team
• monitor and manage signs and symptoms of their condition
• manage the impact of the condition on their physical, emotional and social life
• adopt lifestyles that promote health
• have confidence, access and ability to use support services.

1. Education Package and sessions – specific to the individual’s chronic disease/s
We will use a comprehensive education package (paper-based and online) detailing the implications of the targeted chronic disease/s and potential risk management strategies – for group presentations and for individual reference. This includes descriptions of any necessary medical monitoring of health factors as well as lifestyle changes and is consistent with current national guidelines for the prevention and management of chronic disease. The resources were initially constructed with the support of postgraduate Design students at UniSA and staff trained in Chronic Disease Self-Management (Flinders Program). These sessions will be offered individually or in groups using the online and paper-based resources, supported by the student/s and their supervisor. From our pilot work, they usually need to occur over 1-3 hour long sessions – this will be tailored.
Specific delivery:
a) the frequency of sessions will be once per week
b) the mode and location/setting where the intervention takes place will initially be face-to-face at the clinic, and then negotiated subsequently to continue at the clinic or face-to-face at participant's home, or via a TeleHealth platform. The location and mode will be recorded for each session.
c) the number of sessions delivered will be decided between the student, participant and supervisor based on expressed need for coaching and monitoring. This will be recorded with reasons.
d) University of South Australia health students will deliver the sessions under supervision.

2. Individual Health Coaching
2.1 Motivational interview with identification of strategies to promote and support identified behaviour change – focus on health behaviours.
The initial session will identify needs and establish future assistance/requirements using motivational interviewing processes. This will allow participants to use the LS7 metrics to identify which aspects of their lifestyle they wish to address, or which particular health targets they are having difficulty achieving. For example, one participant may have high cholesterol levels and wish to have assistance to adapt their diet to Mediterranean guidelines, while another may struggle to control their diabetes and have a desire to undergo regular exercise to improve their blood sugar levels.
Participants will be offered a tool kit of tailored supports for behaviour change to help them achieve their health and lifestyle goals by monitoring and reminding them about those goals in decision-making situations. Specific examples of behaviour change techniques can take the form of: shaping and cues (pre-designed shopping lists that have more room for vegetables and fruits than for snacks); antecedents (stickers on the food containers attracting attention to healthier food groups); outcome expectancies (a key ring which reminds participants of the benefits of walking when possible instead of taking the car).
2.2. Ongoing health coaching with new/reviewed strategies, liaison and Health Diary
The health coaches will follow-up the adherence to the identified strategies above via coaching check-ups. This will be the opportunity to re-evaluate participants’ scores and provide valuable feedback for behaviour change. This process will also be facilitated by the use of a personal Health Diary – an individually held portfolio of information and recording sheets for the participant to keep a monthly record of advice, goals, monitoring activities (e.g. diet habits, levels of physical activity, BP results from the GP, health service utilisation and so forth). The check-ups will occur with decreasing regularity – commencing with weekly - and reducing by negotiation, perhaps interspersed with telephone/on-line check-ups. There will also be ongoing liaison with the treating GP for medical checks (check veracity of self-reports) and to encourage use of the Health Diary as a tool of communication between the participant, students/staff and the GP or other health providers. All health and diary resources have been developed specifically for the study and have been piloted.
Specific delivery:
a) the approximate duration of each session will be 1 hour,
b) the duration of time between the initial session and subsequent ongoing health coaching sessions is anticipated to be weekly and will continue as negotiated.
c) University students will deliver the coaching under supervision.
d) The expected frequency of GP medical checks is at minimum on entry to the study, at 3 months, 6 months and 12 months.
e) The telephone/online check-ups will occur as for the education sessions - minimum of weekly but as negotiated and recorded by the student/supervisor and individual participant.

3. Individual and group sessions with targeted disciplines - referral and attendance will be recorded but will be bespoke to each individual participant.
In this aspect of the service the participant and their health coach will have identified and coordinated more specific sessions as required. All activities will be goal-based and monitored. For example:
3.1 Dietitian/nutrition consultations – to establish dietary intake and goals/modifications. This could expand from individual consultations with UniSA Nutrition students and supervisors (or Academic and community-based Dietitians if required) to include pop-up cooking classes or support in shopping choices and budgets. All plans will be based on evidence and personal preference and could span specific dietary targets (reducing salt) or individualised diet plans through to dietary patterns such as the Mediterranean diet or Intermittent Energy Restriction.
3.2 Physical activity – this may require investigation of local opportunities, personal preference, barriers and accessibility. Participants can be referred to existing local programs such as cardiac rehabilitation, gyms or walking groups or specific programs and groups can be established by UniSA Exercise Physiology students as pop-ups in the Program. Again evidence-based plans could range from specific targeted exercise programs (e.g. high intensity) through to lifestyle activities like gardening or walking the dog.
3.3 Liaison with the relevant General Practitioner (GP) and Pharmacy for the routine medical monitoring of identified risk factors including: scheduled BP, cholesterol, other blood-work, diabetic control, management of co-morbidities.
3.4 Miscellaneous consultations – for example referring to sleep counselling; smoking cessation (community programs); stress management; pain management; hydrotherapy; other UniSA clinics – physiotherapy, podiatry, occupational therapy, psychology, social work.

4. Health Buddy
The participant will be encouraged to identify a ‘health buddy’ to attend sessions with them and to support them in their identified goals and strategies. This method has been trialled successfully in Scandinavian countries and serves two purposes – a friendly peer supporter to be there between formal coaching sessions and snowballing knowledge about health and wellbeing to the broader community.

These components run concurrently and in some cases in parallel if reinforcement or reiteration is needed. The individualisation will be ongoing as each session builds on the previous in a co-design approach. All sessions will be monitored by a supervisor in real time, all session times/mode and location will be logged and adherence recorded (via attendance software). Fidelity checks will be run by videoing at least one session per participant (ethics approval obtained) and the advisory group will evaluate these videos for accuracy regarding motivational interviewing, participation and engagement.
Intervention code [1] 319756 0
Behaviour
Intervention code [2] 320036 0
Lifestyle
Intervention code [3] 320037 0
Prevention
Comparator / control treatment
1. Wait list control - usual care offered after the 3 month wait list period.
Usual care is defined as care which is routinely available for chronic condition management in the primary care health system in Australia and subject to MBS and PBS payment.
2. A further comparison for longer term health and behavior change will occur between the intervention group/s and a matched cohort identified from the North West Adelaide Health Study (NWAHS - 20 year chronic conditions cohort) database who have not received the intervention (only usual care). The matching will be using age and gender (post-code/area already matched). The NWAHS provides an invaluable insight into the state of health of people in the north-western suburbs of Adelaide over a 20-year period. The details of the cohort study are described elsewhere(1,2) but in brief used a telephone survey to recruit over 4000 community dwelling participants aged 18 year and over between 1999-2003 (Stage 1). Each participant undertook the telephone survey, questionnaire and attended a clinic-based assessment. Further data collection occurred as Stage 2 in 2004-6; Stage 3 in 2008-10, plus an extensive questionnaire in 2015.
1. Grant JF, Chittleborough CR, Taylor AW, Dal Grande E, Wilson D, Phillips PJ, Adams RJ, Cheek J, Price K, Gill T, Ruffin RE; North West Adelaide Health Study Team 2006. The North West Adelaide Health Study: detailed methods and baseline segmentation of a cohort for selected chronic diseases. Epidemiol Perspect Innov. 12; 3:4.
2. Grant JF, Taylor AW, Ruffin RE, Wilson DH, Phillips PJ, Adams RJ, Price K; 2009. Cohort Profile: The North West Adelaide Health Study (NWAHS). Int J Epidemiol. 6:1479-86.
Control group
Active

Outcomes
Primary outcome [1] 326560 0
Life’s Simple 7 Factors and scoring system adapted for Healthy Choices: Scored using a matrix of Ideal, Intermediate or Poor with points allocated as below. Note to achieve the score out of 10 the BP/cholesterol/fasting glucose scores are combined as one average.
American Heart Association. 2010 https://www.heart.org/en/healthy-living/healthy-lifestyle/my-life-check--lifes-simple-7
1. Smoking: Never or given up over 1 year ago (2pts) ;Former smoker or given up within 1 year (1 pt); Current (0pts)
2. Healthy diet score: adheres to guidelines for vegetables/fruit/low sodium etc (2 pts; sometimes adheres (1pt), rarely (0 pts).
3. Physical activity: 4 bouts per week of intense physical activity sufficient to work up a sweat (2pts),1 to 3 bouts per week of intense physical activity sufficient to work up a sweat (1pt), No intense physical activity sufficient to work up a sweat (0pts).
4. Body mass index (measured by stadiometer and scales): less than 25 kg/m2 (2pts), 25 to 29.9 kg/m2 (1 pt), 30 kg/m2 or more (0pts).
5. Blood pressure (Sphygmometer): less than 120/less than 80 mm Hg untreated (2pts), SBP 120 to 139 or DBP 80 to 89 mm Hg or treated to ideal level (1pt), SBP 140 (or more) or DBP 90 mm Hg (or more) (0pts).
6. Total cholesterol (blood test): less than 5.18 mmol/L (less than 200 mg/dL) untreated (2pts), 5.18 to 6.19 mmol/L (200 to 239 mg/dL) or treated to ideal level (1pt), 6.20 mmol/L or more (240 mg/dL or more) (0pts).
7. Fasting glucose (blood test): less than 5.55 mmol/L (less than100 mg/dL) untreated (2pts), 5.55 to 6.94 mmol/L (100 to 125 mg/dL) or treated to ideal level (1pt), 6.95 mmol/L or more (126 mg/dL or more) (0pts).

Medical measures will be conducted in liaison with local GP. Note further data may be gained such as physical activity levels monitored with accelerometry and the Australian Activity Survey and dietary information may be supplemented with a Food Frequency Questionnaire (for example).
Timepoint [1] 326560 0
Baseline, 12 weeks post-intervention commencement (primary endpoint), 12 months post-intervention commencement.
Secondary outcome [1] 391867 0
EQ 5D 5L: five dimensions of quality of life (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) evaluated using 5 levels.
Timepoint [1] 391867 0
baseline, 12 weeks post-intervention commencement, 12 months post-intervention commencement
Secondary outcome [2] 391868 0
Patient Activation Measure (PAM) – 13 item assessment that encompasses self-efficacy, readiness to change, taking-action, self-management, care navigation.
Timepoint [2] 391868 0
baseline, 12 weeks post-intervention commencement, 12 months post-intervention commencement
Secondary outcome [3] 391869 0
Pharmaceutical and Medical Benefits Scheme/Schedule (PBS and MBS) data for linkage - health care utilization and program costs - composite measure for economic analysis.
Timepoint [3] 391869 0
baseline and 12 months
Secondary outcome [4] 391870 0
Australian Hospital Patient Experience Question Set© – participant experience and satisfaction.
Timepoint [4] 391870 0
12 weeks post-intervention commencement and 12 months post-intervention commencement
Secondary outcome [5] 392999 0
EQ VAS
Timepoint [5] 392999 0
baseline, 12 weeks post-intervention commencement, 12 months post-intervention commencement

Eligibility
Key inclusion criteria
People with chronic conditions (which have an evidence-base of benefit from improved health behaviours, including primary and secondary prevention): referred from TQEH medical outpatients, emergency department, pre-surgery clinics; local primary care practices (general practice and allied health) and NWAHS database. Diagnosis of at least one chronic condition (diabetes I or II; respiratory, cardiovascular, kidney disease; chronic mental or musculoskeletal disorders; chronic pain; cancer survivors); able to participate in the Program – face-to-face sessions or internet-based (adequate language, cognition and physical access).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
Independent allocator, located separately from the trial operations
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomised assignation
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
Presentation of results will follow the CONSORT statement guidelines, starting with a flowchart of participants in each group through the trial. Descriptive statistics will then be presented for each group with no formal statistical testing for group differences. Primary statistical analysis will be by way of linear mixed effects models, with the Time*Group interaction coefficient determining any treatment effect. The primary analysis will be by intention to treat using the stated outcome measures. Although many of the outcome measures are likely highly skewed, linear mixed effects models are well known for their robustness against departures from normality. Multiple imputation might be considered, depending upon the quantity of missing data and reasons for them. The 12 months comparison with the NWAHS participants will be undertaken by pairwise matching this trial’s Intervention group participants by propensity score with the NWAHS cohort study database. Clustered multivariable linear regression will be the primary statistical model, with clustering by matched pair.
A best practice method will be used to undertake a cost utility analysis of the intervention (Healthy Choice Program) with quality of life as measured and valued by the secondary outcome measure EQ-5D-5L. Resource use associated with the development and implementation of the Healthy Choice Program (including staff/health professionals time spent developing and administering the program, consumables, online resources development and others) will be carefully documented, measured and valued. An informed consent will be sought from the two groups (intervention group and matched cohort from the NWAHS) for data linkage to access data on the frequency and duration of hospital in-patient admissions, outpatient visits, emergency department presentations, and PBS and MBS utilisation over a period of 12 months after the end of the first intervention period.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
1/07/2021
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
420
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18725 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 33168 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 307883 0
Government body
Name [1] 307883 0
Department of Health
Country [1] 307883 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
University of South Australia: Allied Health and Human Performance
City East, GPO Box 2471, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 308593 0
Hospital
Name [1] 308593 0
The Queen Elizabeth Hospital
Address [1] 308593 0
28 Woodville Rd, Woodville, SA 5011
Country [1] 308593 0
Australia
Other collaborator category [1] 281655 0
Government body
Name [1] 281655 0
Charles Sturt Council
Address [1] 281655 0
72 Woodville Rd, Woodville, SA 5011
Country [1] 281655 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307883 0
UniSA HREC
Ethics committee address [1] 307883 0
University of South Australia
City East, GPO Box 2471, Adelaide SA 5001
Ethics committee country [1] 307883 0
Australia
Date submitted for ethics approval [1] 307883 0
24/12/2020
Approval date [1] 307883 0
25/12/2020
Ethics approval number [1] 307883 0
203566

Summary
Brief summary
This study will investigate the effect of co-designed community programs on health lifestyle choices for people with chronic conditions, including cancer survivors.

Who is it for?
You may be eligible to join this study if you are aged 18 and above, have been referred from The Queen Elizabeth Hospital medical outpatients, emergency department, pre-surgery clinics; local primary care practices (general practice and allied health), community services or self-referred and have at least one diagnosed chronic condition (diabetes I or II; respiratory, cardiovascular, kidney disease; chronic mental or musculoskeletal disorders; chronic pain; cancer survivors).

Study details
Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive the ‘Healthy Choices’ program over 3 months. Participants in the other group will receive 'usual care' as care which is routinely available for management of their chronic condition and be offered the ‘Healthy Choices’ program after a 3 month waiting period.

Participants will learn about their conditions, set health and well-being goals and receive support to achieve these using a 'health coach' who helps them navigate through various resources and services in the wider community. The ‘Healthy Choices’ program involves education package sessions specific to participants’ chronic disease, individual health coaching, and individual and group sessions with targeted disciplines. The participant will also be encouraged to identify a ‘health buddy’ to attend sessions with them and to support them in their identified goals and strategies. These components run concurrently and in some cases in parallel if reinforcement or reiteration is needed.

Effectiveness of the intervention will be assessed using Life’s Simple 7 Factors to determine changes in health and lifestyle factors over 12 months.

It is hoped that this research project will provide evidence of how best to support people in the community to improve their health and wellbeing when faced with chronic conditions.
Trial website
TBA
Trial related presentations / publications
TBA
Public notes
TBA

Contacts
Principal investigator
Name 108810 0
Prof Susan Hillier
Address 108810 0
University of South Australia: Allied Health and Human Performance
C8-54 North Tce, City East, GPO Box 2471, Adelaide SA 5001
Country 108810 0
Australia
Phone 108810 0
+61 0419034578
Fax 108810 0
nil
Email 108810 0
susan.hillier@unisa.edu.au
Contact person for public queries
Name 108811 0
Prof Susan Hillier
Address 108811 0
University of South Australia: Allied Health and Human Performance
C8-54 North Tce, City East, GPO Box 2471, Adelaide SA 5001
Country 108811 0
Australia
Phone 108811 0
+61 0419034578
Fax 108811 0
nil
Email 108811 0
susan.hillier@unisa.edu.au
Contact person for scientific queries
Name 108812 0
Prof Susan Hillier
Address 108812 0
University of South Australia: Allied Health and Human Performance
C8-54 North Tce, City East, GPO Box 2471, Adelaide SA 5001
Country 108812 0
Australia
Phone 108812 0
+61 0419034578
Fax 108812 0
nil
Email 108812 0
susan.hillier@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.