Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001360505
Ethics application status
Approved
Date submitted
10/12/2015
Date registered
15/12/2015
Date last updated
13/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Independent community participation for people with intellectual disability transitioning from open employment into retirement
Scientific title
The transition from open employment to retirement for workers with intellectual disability: Phase 2 -Keeping Active to increase social contacts, time spent in mainstream community activities, and knowledge of recreation options.
Secondary ID [1] 288122 0
Nil
Universal Trial Number (UTN)
U1111-1177-0390
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intellectual Disability 296997 0
Condition category
Condition code
Mental Health 297249 297249 0 0
Learning disabilities
Human Genetics and Inherited Disorders 297250 297250 0 0
Down's syndrome

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The pilot program intervention is an individually tailored program delivered by Jobsupport’s (collaborating organisation) Vocational Training Officers and based on interests and needs of each participant. The program called Keeping Active has 3 elements:
A. Providing information in appropriate formats to older workers and their advocates on the range of mainstream recreation options/ retirement activities available (Getting informed).
B. Creating social opportunities for people to connect with people who they see as their peers (Keeping Connected).
C. Provide support to participate in an ongoing mainstream recreation or volunteering opportunity matched to the individual’s interests and capacity, utilising systematic training and support strategies of the DES to maximise independence and inclusion (Keeping Busy).

Skills training based on individual need including training on public transport and the use of technology to connect with the community is inherent in each of the 3 elements. The ‘Getting Informed’ and ‘Keeping Connected’ elements of the program will be delivered in a combination of individual and small group activities. The ‘Keeping Busy’ component will be delivered individually.

The program has a 13-week initial intervention phase with weekly program sessions of individually determined duration (depending on need) and then an ongoing support phase that continues until the participant chooses to leave the program or the program funding ends (pilot program currently funded until June 2017). Vocational Training Officers will deliver both the intervention phase and the ongoing support phase. The participant’s advocate/support person is not required to attend intervention program sessions.

Participation in the program will be monitored through participants’ weekly logs and program staff timesheets.
Intervention code [1] 293431 0
Lifestyle
Intervention code [2] 293445 0
Behaviour
Comparator / control treatment
The control group will be a wait-list control group. Participants in the control group will receive the same pre and post measures as those in the intervention group but will be placed on a 13-week waiting list while the intervention group receive their program. While on the wait-list the control group will receive their usual program with the employment support service.
Control group
Active

Outcomes
Primary outcome [1] 296833 0
Social contacts including face-to-face, over the phone or through the use of technology over the period of a week as recorded on activity calendars. Social contacts will exclude family, people the person lives with and contact related to service delivery i.e. paid support workers.
Timepoint [1] 296833 0
Baseline, weekly during initial intervention phase (weeks 1 -13), during follow up maintenance program at 26 weeks, 52 weeks, 6 months after program end.
Primary outcome [2] 296834 0
Time spent in mainstream community activities (other than work) without being accompanied by family member or paid staff member as recorded on activity calendars. . Mainstream community activities include activities (e.g., social groups, sporting activities, volunteering) undertaken away from home by members of the general community. Activities primarily intended primarily or solely for groups of people with disability are excluded from this definition of mainstream community activities.
Timepoint [2] 296834 0
Baseline, weekly during initial intervention phase (weeks 1 -13), during follow up maintenance program at 26 weeks, 52 weeks, 6 months after program end.
Primary outcome [3] 296835 0
Knowledge of recreation options measured through asking participants to list the activities organisations they know of that adults can go to when not at work.
Timepoint [3] 296835 0
Baseline, post initial intervention phase (13 weeks), 26 weeks, 52 weeks after intervention commencement, 6 months after program end.
Secondary outcome [1] 319483 0
Costs of delivering program per participant compared to available government funding for comparable programs.
Staff wages costs are based on time allocated to specific program activity and to participant specific activity. Hours multiplied by the staff member’s wage can be used in analysing individual and average program costs. Wages costs that are not client specific (e.g. administration activities, staff training, staff meeting and non-wage costs such as those relating to maintaining the office premises) are apportioned across programs.
Timepoint [1] 319483 0
End of pilot program June 2017
Secondary outcome [2] 319484 0
Scores on the Modified Worker Loneliness Questionnaire (MWLQ)
Timepoint [2] 319484 0
Baseline, post initial intervention phase (13 weeks)
Secondary outcome [3] 319485 0
Participants’ experience of participating in the program and expectations of retirement explored through qualitative analysis of file records.
The file to be analysed is the participant’s the Keeping Active program file.
Timepoint [3] 319485 0
Baseline, post initial intervention phase (13 weeks), 26 weeks, 52 weeks, end of program

Eligibility
Key inclusion criteria
The Keeping Active program is being delivered by Jobsupport’s (collaborating organisation) Vocational Training Officers. All people enrolled in the Keeping Active program who are willing to give written informed consent are eligible to participate in the study.

Eligibility for the program has been established by the Jobsupport Disability Employment Service (DES) operating the program and include
* Intellectual Disability (IQ<70)
* Aged 40 years or over
* Currently employed with support of the DES or have retired from a job supported by the DES service
* Assessed through the DES-ESS system as requiring ongoing support (high, moderate or flexible support) to maintain employment.
* Have a home advocate/support person such as a family member or accommodation support worker willing and able to assist in planning the participant’s individual program and in providing practical support at home where needed for the person with ID to participate in their program activities e.g. budgeting for activities.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People not enrolled in the Keeping Active program. (Note: wait-list control group members are enrolled in the Keeping Active program but wait three months before receiving the intervention).
People enrolled in the Keeping Active program who do not give written consent to participate in the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Envelopes contain slips showing either intervention or waitlist. All the envelopes are kept in a box and allocation occurs when the participant selects an envelope from the box at their enrolment meeting. This tangible method of randomisation has been chosen deliberately to help participants with intellectual disability understand the process of random allocation to groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures (participant selecting a sealed envelope)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There is expected to be 50 participants enrolled in the Keeping Active pilot program from a total eligible population of 100. The sample size of 40 has been chosen in recognition that it is likely that some people will choose not to participate in the study despite there being minimal difference in program procedures for those in the study and those who are not.
ANOVA will be used to compare the differences in outcomes between the 2 groups using a significance level of 0.05. If needed, individual participant characteristics related to outcomes will be used as covariates.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/12/2015
Actual
21/12/2015
Date of last participant enrolment
Anticipated
30/06/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 12411 0
2208 - Kingsgrove

Funding & Sponsors
Funding source category [1] 292534 0
Self funded/Unfunded
Name [1] 292534 0
NA
Country [1] 292534 0
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 291246 0
None
Name [1] 291246 0
NA
Address [1] 291246 0
NA
Country [1] 291246 0
Other collaborator category [1] 278730 0
Charities/Societies/Foundations
Name [1] 278730 0
Jobsupport
Address [1] 278730 0
Suite 201 1-5 Commercial Rd, Kingsgrove
P.O. Box 429 Kingsgrove NSW 1480
Country [1] 278730 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294007 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 294007 0
Ethics committee country [1] 294007 0
Australia
Date submitted for ethics approval [1] 294007 0
20/07/2015
Approval date [1] 294007 0
19/11/2015
Ethics approval number [1] 294007 0
2015/751

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

Contacts
Principal investigator
Name 62130 0
Prof Roger Stancliffe
Address 62130 0
THE UNIVERSITY OF SYDNEY
Faculty of Health Sciences
75 East Street (PO Box 170)
Lidcombe NSW 1825
Country 62130 0
Australia
Phone 62130 0
+61 2 93519984
Fax 62130 0
+61 2 93519197
Email 62130 0
[email protected]
Contact person for public queries
Name 62131 0
Roger Stancliffe
Address 62131 0
THE UNIVERSITY OF SYDNEY
Faculty of Health Sciences
75 East Street (PO Box 170)
Lidcombe NSW 1825
Country 62131 0
Australia
Phone 62131 0
+61 2 93519984
Fax 62131 0
+61 2 93519197
Email 62131 0
[email protected]
Contact person for scientific queries
Name 62132 0
Roger Stancliffe
Address 62132 0
THE UNIVERSITY OF SYDNEY
Faculty of Health Sciences
75 East Street (PO Box 170)
Lidcombe NSW 1825
Country 62132 0
Australia
Phone 62132 0
+61 2 93519984
Fax 62132 0
+61 2 93519197
Email 62132 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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