ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621000825853

Ethics application status

Approved

Date submitted

12/04/2021

Date registered

28/06/2021

Date last updated

27/05/2024

Date data sharing statement initially provided

28/06/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

CanaCare, Person-centred care planning for adults in an interdisciplinary team.

Scientific title

CanaCare: Person-centred care planning in an interdisciplinary team.
The effect of person-centred care planning by an interdisciplinary team on the happiness of healthy adults.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Mental health

Condition category

Condition code

Mental Health

Addiction

Mental Health

Anxiety

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Person-centred care planning in an interdisciplinary team.
Participants will be accompanied by a support person from the Cana Communities volunteer
pool to the University of Sydney study site.
Participants will initially meet/talk to Professor Maria Fiatarone Singh [study physician] to
identify their primary goals/reasons for wanting to take part in the research program.
Depending on what the participants identify as their primary (life) goal or aspiration/s, the
physical and medical history assessment will focus on areas relevant to their goals.
Participants will then meet with one or more allied health practitioners for additional
assessments to be completed. The interdisciplinary team will consist of accredited dietitians,
accredited exercise physiologists, registered psychologists, registered
physiotherapists and pharmacists. If a social work intervention is required, the participant will be referred to the external Cana or Justice Health Team.
Assessments may include questionnaires, structured interviews, counselling sessions, body composition testing, nutritional assessments, fitness assessments and drug reviews. Participants will also be screened for cognitive imapairment using the ACI-ACE program screening tool and subsequently referred to appropriate clinicians if warranted.
A case conference will be held with all health practitioners involved in the participants’ care.
Subsequently, a case conference will be held with the team and the participants, with their
support person present to discuss their assessments and how they relate to their goals.
Through discussions with the participant, initial components of the Wellness program will be
made. This may include exercise, dietary changes, mental health strategies such as
mindfulness, meditation or cognitive behavioural therapy. The care provided by CanaCare will be in addition to the usual supports provided by Cana Communities for effective reintegration into work, housing support and social relationship building.
The Wellness program may take place across different sites including the University of
Sydney Camperdown campus, Cana Communities sites around Sydney, Cana Farm in
Orchard Hills and via the secure online platform. Programs may be supervised or
unsupervised as appropriate, and will be interdisciplinary in nature. Where relevant, the
study physician may make referrals to the participant’s general practitioner, a psychiatrist or
specialist.
Each participant will be linked with a Cana Communities volunteer from the community who
will be his/her primary coordinator of care, depending on the most important or urgent goal
or wellness need identified. This person will be responsible for follow-up by telephone on a
weekly basis initially, to assist with the adoption of the Wellness program elements and to measure adherence and any issues arising from the intervention.
Mode of delivery of primary interventions includes machine based strength/weightlifting and aerobic based exercises under guidance of Accredited Exercise Physiologists. The progressive resistance training component time duration will be consistent throughout the duration of the trial. The anticipated time spent per session including warm up will be 60 minutes, three times a week.
Progressive-resistance training: Week 1 of the intervention will include familiarisation and gradual increase in target intensity from 50, 60, 70% 1RM in each successive session. From the first session of week 2, training intensity will be set at 80% 1RM and progressed by a projected gain in strength of 3% 1RM each session, used in conjunction with Borg RPE Scale to maintain intensity at 80% 1RM. At the start of every 7th session, 1RM will be re-tested and target weight at 80% 1RM will be recalculated based on the new 1RM. Total training volume is 24 repetitions per exercise, set initially at 3 sets of 8 repetitions. However, as intensity is most important, sets and repetitions may be manipulated such that prescribed intensity is adhered to and the total volume remains 24 repetitions per exercise. Five pneumatic resistance machines will be used and exercises will be completed in the following order; leg press, seated row, knee extension, chest press and knee flexion. Participants will be instructed to contract concentrically ‘as fast as possible’ and then 3-4 seconds of control through the eccentric phase. There will be 20-30 seconds of rest between repetitions and 3-5 minutes rest between sets to allow sufficient recovery of anaerobic metabolism.

Aerobic interval training: The Aerobic training component time duration will be consistent throughout the duration of the trial. The anticipated time spent per session including warm up will be 30 minutes, three times a week. Interval training will employ the 4x4 method. The protocol consists of 8 minutes of warm up working up to 70% peak heart rate (HRpeak), followed by four 4-minute intervals at a target of 85-95% HRpeak, separated by 3 minutes of active recovery at ~70% HRpeak. During each of the 4-minute intervals, participants will progress from 70-80% HRpeak over the first 2-minutes, to that target intensity of 85-95% HRpeak for the final 2-minutes of each interval. Following the last interval, the participant will cool down to a slow walk with no gradient for a minimum of 5 minutes, or until breathlessness has ceased. Week 1 will serve as a familiarisation period, where the time spend at the target intensity will be increased from 30, 60, 90sec. Training will take place on a treadmill/bicycle ergometer, at a self-selected brisk walking or running speed, with incline adjusted for intensity. Heart rate and oxygen saturation will be continuously monitored throughout each session and rate of perceived exertion [RPE] will be recorded in the last 15 seconds of every minute of training.
The nutritional support and education intervention will be under supervision of Accredited practicing Dietitian and includes shopping, food planning, preparation and cooking. The anticipated time spent in the nutritional support component of the trial will be 2 times per month for approximately 60 mins per session.
The Meditation and mindfulness component of the intervention will be instructed by members of CanaCare team. The anticipated time spent in meditation will initially begin in week one for 10 mins and increase in volume to 20 mins in week 10 and beyond. The mindfulness intervention will consist of 1) body scan and awareness type guided meditation, 2) mind training utilising breath focused relaxation and distraction techniques. Time spent in meditation will increase in volume the further the participant proceeds through the trial.
The interventional component will proceed for 6 months in total with participants engaging with Canacare Clinicians 2-3 times/week either in person or via on line platform.
Follow-up will be planned for 1 month, 3 months and 6 months to re-evaluate and re-set
goals (either in-person or online).

Intervention code [1]

Lifestyle

Intervention code [2]

Behaviour

Comparator / control treatment

Nil controls

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Happiness, As measured by
The Oxford Happiness Questionaire (OHQ).

Timepoint [1]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [1]

Depression as measured by
Patient Health Questionnaire-9 (PHQ-9).

Timepoint [1]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [2]

Anxiety as measured by
Generalised Anxiety Disorder 7-Item (GAD-7)

Timepoint [2]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [3]

Quality of Life as measured by
Short Form 36 Health Survey Questionnaire (SF-36)

Timepoint [3]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [4]

Physical Activity Levels measured by
Paffenbarger Physical Activity Questionnaire

Timepoint [4]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [5]

Aerobic Capacity measured by
Maximal aerobic capacity (VO2peak) Graded treadmill/bicycle ergometer test to voluntary fatigue with indirect calorimetry.

Timepoint [5]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [6]

Nutrition assessment as measured by
The Short Form Food Frequency Questionnaire (SFFFQ)

Timepoint [6]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [7]

Self-efficacy assessment as measured by
Ewart’s Self Efficacy Scale.

Timepoint [7]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [8]

Sleep Quality measured by
Pittsburgh Sleep Quality Index (PSQI)

Timepoint [8]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [9]

Cognitive Function as measured by
Montreal Cognitive Assessment (MoCA) score

Timepoint [9]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [10]

Haemodynamic Measures Blood pressure, resting and orthostatic, Using digital and manual blood pressure monitors.

Timepoint [10]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [11]

Alcohol/drug use related Outcomes
As measured by AUDIT-C

Timepoint [11]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [12]

Metabolic assessment as measured by
The Australian Type 2 Diabetes Risk Assessment Tool (AUSRISK)

Timepoint [12]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [13]

Muscular Strength as measured by
One Repetition Maximum (1RM) Seated leg press.

Timepoint [13]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [14]

Muscular Strength as measured by
One Repetition Maximum (1RM) Unilateral knee extension.

Timepoint [14]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [15]

Muscular Strength as measured by
One Repetition Maximum (1RM) Chest press,

Timepoint [15]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [16]

Muscular Strength as measured by
One Repetition Maximum (1RM) Seated row.

Timepoint [16]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [17]

Muscular Strength as measured by
One Repetition Maximum (1RM) Knee Flexion.

Timepoint [17]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [18]

Bone density in the lumbar spine and hip measured by
Dual-energy X-ray absorptiometry (DXA)

Timepoint [18]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [19]

Anthropometry as measured by
Waist circumfrence (cm) by tape measure.

Timepoint [19]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [20]

Anthropometry as measured by
Height (cm) by stadiometer.

Timepoint [20]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [21]

Anthropometry as measured by
Weight (kg) by didital scales.

Timepoint [21]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [22]

A weekly participant journal of thoughts and feelings associated with the experience of the program is encouraged by both USyd researchers and Cana staff. Captured information with be processed utilising the qualitative analysis program Nvivo. Participants can choose whether they submit their own journal for research purposes or completely decline participating in the journal assessment protocol.

Timepoint [22]

Weekly for 26 weeks post enrolment.

Secondary outcome [23]

Post-traumatic Stress Disorder Symptom Scale.
Interview for DSM-5 (PSS-I-5)

Timepoint [23]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [24]

Mindfulness as measured by,
Mindfulness Attention Awareness Scale

Timepoint [24]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [25]

Experiential Avoidance as measured by
Acceptance and Action Questionnaire (AAQ)

Timepoint [25]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [26]

Nutrititional assessment as measured by
The CanaCare Dietary Questionnaire

Timepoint [26]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [27]

Body Composition.
Whole body and regional lean tissue measured by
Dual-energy X-ray absorptiometry (DXA)

Timepoint [27]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [28]

Body Composition.
Whole body and regional adipose tissue measured by
Dual-energy X-ray absorptiometry (DXA)

Timepoint [28]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [29]

Anthropometry as measured by
Upper-arm circumference (cm) by tape measure.

Timepoint [29]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [30]

Anthropometry as measured by
Calf circumference (cm) by tape measure.

Timepoint [30]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [31]

Adverse events will be monitored through the administration of a weekly questionnaire and a
reporting of events throughout the study period. If participants report any adverse events,
these will be reported to the University of Sydney HREC. These will be reported even if they
may be unrelated to the intervention. This will be adjudicated by the study physician.

Timepoint [31]

Weekly for 26 weeks post enrolment.

Secondary outcome [32]

Adherence of Progressive resistance training throughout the intervention will be monitored by,
1. Percent of prescribed exercise sessions attended.
2. Adherence to prescribed exercise intensity and average percent of peak strength used in training loads during resistance training.

Timepoint [32]

Weekly for 26 weeks post enrolment.

Secondary outcome [33]

Adherence of Aerobic interval training throughout the intervention will be monitored by,
1. Percent of prescribed exercise sessions attended.
2. Adherence to prescribed exercise intensity.
3. Average percent of peak heart rate during last two minutes of each bout interval training.

Timepoint [33]

Weekly for 26 weeks post enrolment.

Secondary outcome [34]

Adherence of Nutritional component throughout the intervention will be monitored by,
Percent of nutritional education activities attended/completed.

Timepoint [34]

Weekly for 26 weeks post enrolment.

Secondary outcome [35]

Adherence of mindfulness/meditation component throughout the intervention will be monitored by,
Number of mindfulness/meditation sessions attended.

Timepoint [35]

Weekly for 26 weeks post enrolment.

Secondary outcome [36]

Adherence to the journaling component for qualitative analysis throughout the intervention will be monitored by,
Number of journal entries completed.

Timepoint [36]

Weekly for 26 weeks post enrolment.

Secondary outcome [37]

Attention Deficit Hyperactivity Disorder (ADHD) as measured by,
The Adult ADHD Self-report Scale/Screener.

Timepoint [37]

Pre intervention, 1 month, 3 months and 6 months.

Secondary outcome [38]

Sustained Attention as measured by the Conners Continuous Performance Test - 3rd Edition.

Timepoint [38]

Secondary outcome [39]

Sustained Attention as measured by the Conners Continuous Performance Test - 3rd Edition.

Timepoint [39]

Pre-intervention, 6 months.

Eligibility

Key inclusion criteria

We will recruit individuals aged 18 years and over who express interest in the CanaCare
study.
Link to Cana Communites below,
https://www.cana.org.au/
Recruitment notes Canacare will recruit men and women who have had any interaction with Cana Communities. This may be via provision of services, general inquiries or individuals who have been identified as suitable for the CanaCare Clinic study by Cana Communities staff and volunteers.

Minimum age

18 Years

Maximum age

90 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Participants who present with active suicidal ideation, active psychosis, delirium, acute
withdrawal, current uncontrolled substance misuse or unstable cardiovascular or other disease will be referred for appropriate treatment, and may be eligible to enrol in the study upon completion of appropriate treatment.

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

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

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

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

6-month translational study.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Our sample size calculation is based on a pilot randomised controlled trial in a non-clinical
adult population, who were randomly allocated to one of two positive psychology
interventions. Effect size and sample size estimates based on the changes in the Oxford
Happiness Questionnaire.
Sample size estimates were based on within-group changes in the Oxford Happiness
Questionnaire, with a critical alpha of 0.05, and a power of 0.8, using a two-tailed t-test.
Based on the data above, we would require 57 participants to detect a significant change in
the Oxford Happiness Questionnaire. As we are recruiting a marginalised population, it is
possible that the effect size following the intervention will be larger, and therefore we believe this reflects a conservative sample size estimate.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/07/2021

Actual

22/06/2022

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Sydney,

Address [1]

University of Sydney,
Susan Wakil Building D18
CamperDown, NSW.
2006

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

.University of Sydney,
Susan Wakil Building D18
CamperDown, NSW.
2006

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of New south Wales

Address [1]

High Street, Kensington New South Wales 2052

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney Human Research Ethics committee

Ethics committee address [1]

160 Missenden Road, Newtown New South Wales 2042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/03/2021

Approval date [1]

01/04/2021

Ethics approval number [1]

Summary

Brief summary

CanaCare is a clinical trial incorporating a multi disciplinary team with interventions that utilise structured physical activty under the guidance of an Exercise physiologist, a nutritional educational intervention with a registered Dietitian, and a mindfulness/meditation component.
The participants are anyone involved in Cana communities, a non government organaisation that supports members of our community that experience mental health issues, substance use disorders or any other social marginalisation. The primary outcome measurement is a happiness/quality of lfe scale measured at numerous timepoints up to six months. (The Oxford Happiness Questionnaire).
Public Hypothesis.
The primary aim of the CanaCare program is to utilise a person-centred approach to care
planning and delivery, provided in collaboration with an interdisciplinary team with the overall aim of improving the health and wellness for all participants.

Trial website

Trial related presentations / publications

Public notes

Financial notes. The CanaCare program will be provided on an entirely voluntary basis to participants by health care professionals and other volunteers, and will be assisted by students who are completing HDR degrees or undergraduate/postgraduate placement hours for USYD degrees. The study is also partially supported by" the Seed Funding Scheme: Mental Health, Drug and Alcohol Comorbidity” from the University of Sydney and University of New South Wales.

Contacts

Principal investigator

Name

Prof Maria Fiatarone Singh.

Address

University of Sydney,
Susan Wakil Building D18
CamperDown, NSW. 2006

Country

Australia

Phone

+61 2 9351 9755

Fax

[email protected]

Contact person for public queries

Name

Dr Yorgi Mavros

Address

University of Sydney
Susan Wakil Building D18
Camperdown, NSW. 2006

Country

Australia

Phone

+61 2 9351 9279

Fax

[email protected]

Contact person for scientific queries

Name

Prof Maria Fiatarone Singh.

Address

University of Sydney,
Susan Wakil Building D18
CamperDown, NSW. 2006

Country

Australia

Phone

+61 2 9351 9755

Fax

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

De identified Data will be kept in secure Usyd server.
Will not be publically available.

What supporting documents are/will be available?

Doc. No.	Type	Attachment
11260	Study protocol	377937-(Uploaded-02-04-2021-15-58-51)-Study-related document.pdf
11261	Informed consent form	377937-(Uploaded-02-04-2021-14-55-50)-Study-related document.pdf
11339	Ethical approval	377937-(Uploaded-10-04-2021-08-31-53)-Study-related document.pdf

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.

Trial Review

Documents added manually

Documents added automatically