Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000334505
Ethics application status
Approved
Date submitted
9/02/2024
Date registered
26/03/2024
Date last updated
26/03/2024
Date data sharing statement initially provided
26/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing the effectiveness of the Flinders Program in supporting self-management when applied to a group education program for adults with chronic conditions.
Scientific title
Applying the Flinders Program to support self-management in people with chronic conditions in a group setting: a feasibility study.
Secondary ID [1] 311346 0
None.
Universal Trial Number (UTN)
U1111-1304-0838
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Conditions (any) 332622 0
arthritis 333008 0
diabetes 333009 0
lung disorders and disease 333010 0
renal / kidney disease 333011 0
chronic pain 333012 0
chronic fatigue 333013 0
asthma 333014 0
cancer 333015 0
cardiovascular / heart disease 333016 0
Condition category
Condition code
Public Health 329326 329326 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Take Control - Live Well is a group education program consisting of 3 weekly 2-2.5 hour sessions and 1 session after 3 months of completing session 3. The program is run either face-to-face or online (i.e. no hybrid programs). Facilitators provide information on self-management principles (as per the Flinders Program for self-management of chronic conditions) and how these can incorporated into the participants' healthcare and lives. Group discussion is highly encouraged in the groups to support peer-to-peer learning. At the end of the first 2 sessions, activities are worked through which include setting up a plan for behaviour change over the following week which are then reflected on in the subsequent week's session. After the third session, participants write their own Flinders Program Care Plan which outlines a plan to reach their 6-9 month SMART goal (also set in the third session). Participant attendance will be recorded using Canberra Health Service's Digital Health Record as per usual care. Attendance and 'drop-out' rates will be analysed during data analysis.
This is a single centre feasibility/acceptability study using a mixed methods approach (both quantitative and qualitative measures).
As per usual care, trained facilitators will run the “Take Control – Live Well” program either online or face-to-face from March to November 2024. Facilitators are either allied health or nursing professionals working in the Community Care Program at Canberra Health Services who have completed training in the Flinders Program and Take Control - Live Well program delivery. Participants will self-select into the study and, after informed consent is received, be invited to complete anonymous surveys prior to starting the program, after 3-weeks, after the 3-month session and after 6-months. Interviews will be carried out by the principal investigator after the 3-month session.
Intervention code [1] 327800 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337182 0
Self-management competency.
Timepoint [1] 337182 0
Baseline (completed in session 1 prior to commencement session delivery), 3-weeks (at the end of the third session), 3-months (completed at the end the 3-month session) and 6-months after the third session.
Primary outcome [2] 337183 0
Feasibility
Timepoint [2] 337183 0
End of intervention period.
Secondary outcome [1] 430994 0
Quality of life
Timepoint [1] 430994 0
Baseline (completed in session 1 prior to commencement session delivery), 3-weeks (at the end of the third session), 3-months (completed at the end the 3-month session) and 6-months after the third session.
Secondary outcome [2] 430995 0
Confidence
Timepoint [2] 430995 0
Baseline (completed in session 1 prior to commencement session delivery), 3-weeks (at the end of the third session), 3-months (completed at the end the 3-month session) and 6-months after the third session.
Secondary outcome [3] 430996 0
Program acceptability.
Timepoint [3] 430996 0
Feeback surveys done at 3-weeks (at the end of the third session), 3-months (completed at the end the 3-month session) and 6-months after the third session.
Secondary outcome [4] 432097 0
Program acceptability.
Timepoint [4] 432097 0
Interviews will be done with 5 consenting participants after completing their 3-month session.
Secondary outcome [5] 432098 0
Quality of Life
Timepoint [5] 432098 0
Baseline (completed in session 1 prior to commencement session delivery), 3-weeks (at the end of the third session), 3-months (completed at the end the 3-month session) and 6-months after the third session.

Eligibility
Key inclusion criteria
- are an adult (18 years of age or older)
- are a resident of the Australian Capital Territory
- have at least one chronic condition (any condition lasting 3 months or more)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Deemed unsuitable for group programs or situations (for example, an uncontrolled mental health condition exhibiting in disruptive behaviours).

Study design
Purpose of the study
Educational / counselling / training
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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data analysis will be conducted in collaboration with academic staff from Flinders University (Prof. Malcolm Battersby and Dr David Smith). Feasibility data will be analysed and presented descriptively. Descriptive statistics will be used to summarise the screening, eligibility, consent, adverse events, retention, completion and missing data, intervention adherence rates, and sample representativeness and recruitment bias. All pre- and post-intervention analyses will include all available data using linear mixed models to explore differences in PIH, R-Outcomes and WSAS scores before and after program completion, at 3-months and at 6-months. Effect sizes (Cohen’s d) will be calculated for within-group changes.

For interview transcript analysis, theoretical thematic analysis (i.e. explicitly analyst-driven underpinned by self-management theory) at a semantic level (i.e. interpreted in context of existing evidence-base), will be used as outlined by Braun and Clarke (Braun & Clarke, 2006) to identify themes. MS Word will be used in this analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/03/2024
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
52
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 315602 0
Hospital
Name [1] 315602 0
Canberra Health Services Allied Health Research Support Grant
Country [1] 315602 0
Australia
Primary sponsor type
Hospital
Name
Canberra Health Services
Address
Country
Australia
Secondary sponsor category [1] 317814 0
None
Name [1] 317814 0
Address [1] 317814 0
Country [1] 317814 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314490 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 314490 0
https://health.act.gov.au/act-health-system/research-data-and-publications/research/research-ethics-and-governance
Ethics committee country [1] 314490 0
Australia
Date submitted for ethics approval [1] 314490 0
22/12/2023
Approval date [1] 314490 0
17/01/2024
Ethics approval number [1] 314490 0
2024.LRE.00007

Summary
Brief summary
The Take Control - Live Well program is a self-management program for adults living with at least one chronic condition. We have based the program on the Flinders Program which was designed for use in one-on-on consultations. This study is to explore the effectiveness of applying the Flinders Program to a group program setting in providing self-management support for adults living with chronic conditions. We hypothesise that the Flinders Program will be feasible and effective in a group setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131770 0
Ms Chelsea Hillenaar
Address 131770 0
Canberra Health Services, City Community Health Centre, Level 2, 1 Moore Street, Canberra ACT 2601
Country 131770 0
Australia
Phone 131770 0
+61251241581
Fax 131770 0
Email 131770 0
chelsea.hillenaar@act.gov.au
Contact person for public queries
Name 131771 0
Chelsea Hillenaar
Address 131771 0
Canberra Health Services, City Community Health Centre, Level 2, 1 Moore Street, Canberra ACT 2601
Country 131771 0
Australia
Phone 131771 0
+61251241581
Fax 131771 0
Email 131771 0
chelsea.hillenaar@act.gov.au
Contact person for scientific queries
Name 131772 0
Chelsea Hillenaar
Address 131772 0
Canberra Health Services, City Community Health Centre, Level 2, 1 Moore Street, Canberra ACT 2601
Country 131772 0
Australia
Phone 131772 0
+61251241581
Fax 131772 0
Email 131772 0
chelsea.hillenaar@act.gov.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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21604Informed consent form    387178-(Uploaded-09-02-2024-11-16-50)-Study-related document.docx
21605Ethical approval    387178-(Uploaded-09-02-2024-11-17-08)-Study-related document.pdf
21606Study protocol    387178-(Uploaded-09-02-2024-11-17-51)-Study-related document.doc



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.