Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000228684
Ethics application status
Approved
Date submitted
16/02/2023
Date registered
3/03/2023
Date last updated
8/09/2024
Date data sharing statement initially provided
3/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
CONNECT 50+ Healthy ageing for midlife and beyond using community health programs: a feasibility trial
Scientific title
Evaluating the efficacy of CONNECT 50+ a community healthy ageing program for recently hospitalised older people with chronic disease: a feasibility trial
Secondary ID [1] 309005 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
age related physical impairments 329041 0
physical inactivity 329042 0
social isolation 329043 0
functional immobility 329044 0
reduced health related quality of life 329045 0
chronic disease 329047 0
post hospitalisation deconditioning 329048 0
Condition category
Condition code
Public Health 326027 326027 0 0
Other public health
Physical Medicine / Rehabilitation 326028 326028 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CONNECT 50+ is a pragmatic exercise and wellness program delivered from Connect Victoria Park Community Hub, and consists of:
a. Evidenced-based strength and balance exercise in groups of up to 15 people supervised by a trained personal trainer one hour, twice per week for 12 weeks. Examples of strength and balance exercises are sit-to-stand repetitions for 15 seconds, 1/4 squats and lunges, timed unsupported standing with feet apart then together then on foam, with and without upper limb support. The intensity will be low-moderate, assessed using BORG RPE scale. Attendance will be monitored weekly using session attendance lists.
b. Completion of a weekly wellness activity that the participant chooses from a schedule that draw on local hub events (such as dancing, singing, meditation, book club, bush-walking), content encompasses domains of wellness to address participants’ interests. This will be planned prior to commencement of the 12-week program and monitored weekly using session attendance lists.
c. Workbook designed for the study that includes information about self-management of health, principles and benefits of healthy ageing and wellness, and cues to action. Participants will be guided through the workbook prior to commencement of the program for approximately 1-hour, including explanation of scheduled events that represent domains of wellness (physical, social, intellectual, vocational, spiritual, emotional, environmental), then supported to plan a weekly timetable of wellness activities tailored to their interests that they would complete over the 12-weeks.
d. Participants will be asked to wear a study-supplied smartwatch that logs their physical via the accompanying app activity monitor app via a website or a smartphone app (android and iOS compatible). The app will collect data over a period of 12 weeks, and monitored weekly by a research officer who will contact participants and support them to use the smartwatch consistently to gather weekly step-count data.
Intervention code [1] 325447 0
Behaviour
Comparator / control treatment
Control group receive components c) Workbook and d) smartwatch activity monitor app (supplied).
Control group
Active

Outcomes
Primary outcome [1] 333881 0
Recruitment rate is a composite outcome measured according to proportion of screened patients converted to recruitment at hospital and through GP practices (2 practices chosen), time to recruit n=60, cost and productivity of each recruitment route. These will be measured using audit of trial of records and telephone follow-up with participants. Barriers to recruitment and changes made to recruitment procedure will be based on these.
Timepoint [1] 333881 0
Upon conclusion of the study
Primary outcome [2] 333887 0
Retention rates including number of participants who remain or drop-out, and characteristics of these; flow of participants, barriers to participation will be measured using audit of trial records, and telephone follow-up with participants.
Timepoint [2] 333887 0
Upon conclusion of the study
Primary outcome [3] 333966 0
Composite primary outcome: Acceptability and suitability of the intervention and trial procedures assessed by study-specific questionnaire.
Timepoint [3] 333966 0
Upon conclusion of the study
Secondary outcome [1] 418623 0
Physical function, measured using Gait speed
Timepoint [1] 418623 0
At baseline (T1) and 12-week follow-up (T2: after completion of 12-week intervention)
Secondary outcome [2] 418626 0
Qualitative feedback of the intervention from participants to understand impact of the intervention, including on their physical function as an indicator for efficacy of the intervention to achieve successful self-management and recovery will be gathered using a study-specific online questionnaire.
Timepoint [2] 418626 0
Upon conclusion of the study
Secondary outcome [3] 418659 0
Qualitative feedback from staff (group leaders) regarding acceptability of the intervention from a delivery perspective will be gathered using semi-structured phone interviews once the intervention is completed for all participants.
Timepoint [3] 418659 0
Upon conclusion of the study
Secondary outcome [4] 418883 0
Daily physical activity (steps per day using the app data) will be reported by participants using the smartwatch
Timepoint [4] 418883 0
On a weekly basis for 12 week intervention.
Secondary outcome [5] 418886 0
Balance, measured using Timed up and Go (TUG) test
Timepoint [5] 418886 0
At baseline (T1) and 12-week follow-up (T2: after completion of 12-week intervention)
Secondary outcome [6] 418887 0
Wellness, measured using perceived wellness survey (Adams T, Bezner J, Steinhardt M. (1997). The conceptualization and measurement of perceived wellness: Integrating balance across and within dimensions. American Journal of Health Promotion 11(3): 208-218. doi:10.4278/0890-1171-11.3.208)
Timepoint [6] 418887 0
At baseline (T1) and 12-week follow-up (T2: after completion of 12-week intervention)
Secondary outcome [7] 418888 0
Health-related Quality of life, measured using EQ5D-5L instrument
Timepoint [7] 418888 0
At baseline (T1) and 12-week follow-up (T2: after completion of 12-week intervention)

Eligibility
Key inclusion criteria
- Aged 50 years or over, medical hospital admission >3 days within the past 3 months; able to ambulate with or without an aid
- Provide written informed consent
- Presence of at least one chronic health condition confirmed by a GP at the time of recruitment.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Impaired cognitive capacity (score less than 7/10 using Abbreviated Mental Test Score); limited English language proficiency to be able to understand instructions and provide consent i.e. if participants are unable to fully understand the aims and requirements of the study they will not be enrolled.

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 randomisation process will be conducted through a secure online database (RedCap) management services by a chief investigator (CI) not involved in recruitment or data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a feasibility trial, and the data will inform sample size calculation for a future large RCT. The trial will determine if the target sample size of n=60 is feasible to be recruited within 12 weeks and then followed up after 12 weeks to allow completion of the pilot trial. The targeted number is also enough to provide preliminary results about feasibility and safety of the program to then optimise it for people recently hospitalised with chronic disease. It should be noted that the trial is not powered for significant changes in the secondary measures of physical function.

Data for the feasibility and safety components of the trial will be analysed using descriptive statistics (mean, standard deviation and percentages), proportion of participants approached to participate who did not commence the program, percentage of participants who complete the intervention, overall percentage of sessions attended, number of participants who drop-out, any serious adverse effects that occur during the trial, including falls, requiring medical attention will be reported. Differences in proportions between control and intervention groups will be analysed using chi-squared test.

An acceptable level for feasibility of the program will be based on 60% adherence for the prescribed number of exercise and wellness sessions at completion of the 12-week program, with retention of 85% of the sample (15% estimated drop-out). To determine effectiveness, physical function secondary outcomes will be analysed using generalised linear mixed models to compare differences within and between groups over time (pre/post). A post-hoc analysis will be completed using the group differences to determine the required sample size for a future adequately powered trial using these outcomes. All statistical analyses will be conducted using Stata v17 (StataCorp, College Station, TX). Interview transcripts and observational data such as field notes will be analysed using thematic analysis.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
16/03/2023
Actual
2/05/2023
Date of last participant enrolment
Anticipated
Actual
30/01/2024
Date of last data collection
Anticipated
Actual
23/04/2024
Sample size
Target
60
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 24060 0
Bentley Health Service - Bentley
Recruitment postcode(s) [1] 39563 0
6102 - Bentley
Recruitment postcode(s) [2] 39564 0
6102 - Bentley South
Recruitment postcode(s) [3] 39565 0
6100 - Victoria Park
Recruitment postcode(s) [4] 39566 0
6104 - Belmont

Funding & Sponsors
Funding source category [1] 313218 0
Charities/Societies/Foundations
Name [1] 313218 0
Royal Perth Hospital Research Foundation, Springboard Plus Grant
Country [1] 313218 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Hwy
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 314946 0
None
Name [1] 314946 0
Address [1] 314946 0
Country [1] 314946 0
Other collaborator category [1] 282556 0
Other
Name [1] 282556 0
Connect Victoria Park
Address [1] 282556 0
5 Mackie Street
Victoria Park WA 6100
Country [1] 282556 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312448 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 312448 0
Ethics committee country [1] 312448 0
Australia
Date submitted for ethics approval [1] 312448 0
01/11/2022
Approval date [1] 312448 0
12/12/2022
Ethics approval number [1] 312448 0
RGS0000005715
Ethics committee name [2] 312455 0
The University of Western Australia Human Research Ethics Office
Ethics committee address [2] 312455 0
Ethics committee country [2] 312455 0
Australia
Date submitted for ethics approval [2] 312455 0
02/02/2023
Approval date [2] 312455 0
09/02/2023
Ethics approval number [2] 312455 0
2023/ET000084 Springboard Plus Promoting healthy ageing for recently hospitalised older people by implementing community health programs

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

Contacts
Principal investigator
Name 124706 0
Prof Anne-Marie Hill
Address 124706 0
The University of Western Australia
35 Stirling Highway, Crawley WA 6009
Country 124706 0
Australia
Phone 124706 0
+61 08 9224 4514
Fax 124706 0
Email 124706 0
[email protected]
Contact person for public queries
Name 124707 0
Anne-Marie Hill
Address 124707 0
The University of Western Australia
35 Stirling Highway, Crawley WA 6009
Country 124707 0
Australia
Phone 124707 0
+61 08 9224 4514
Fax 124707 0
Email 124707 0
[email protected]
Contact person for scientific queries
Name 124708 0
Professor Anne-Marie Hill
Address 124708 0
The University of Western Australia
35 Stirling Highway, Crawley WA 6009
Country 124708 0
Australia
Phone 124708 0
+61 08 9224 4514
Fax 124708 0
Email 124708 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?
In line with the National Health and Medical Research Council's Open Access Policy, de-identified data and underlying published results will be made available.
When will data be available (start and end dates)?
At the time of publication as per open access guidelines and available for 5 years after publication (July 2024 - July 2029)
Available to whom?
De-identified database may be made available upon request to the CPI with evidence that the requesting researcher has complied with ethics requirements in maintaining privacy of data, and the data request is consistent with the aims of their approved proposal.
Available for what types of analyses?
Only to achieve the aims of the approved proposal.
How or where can data be obtained?
Access subject to approvals by the Chief Investigator Professor Anne-Marie Hill ([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
No additional documents have been identified.