Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000264381
Ethics application status
Approved
Date submitted
17/02/2017
Date registered
21/02/2017
Date last updated
21/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Volunteering and Health Study: Does volunteering in the community benefit older adults' cognitive functioning?
Scientific title
Volunteering and Health Study: The impact of community-based volunteering on older adults' cognitive functioning
Secondary ID [1] 291165 0
Nil known
Universal Trial Number (UTN)
U1111-1192-9493
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive functioning 302031 0
Condition category
Condition code
Neurological 301668 301668 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial will be conducted in Dunedin, New Zealand. Participants in the intervention group will be asked to:

1. Register with a local volunteering agency within 3 weeks of their baseline testing session. The researcher will provide specific details on how to do so via a 10-minute consultation at the end of the baseline testing session. During that consultation, the researcher will provide and talk through a booklet listing all relevant volunteering organisations, the types of volunteering they offer, and their contact details.

2. Engage in at least 2 hours of formal volunteering each week for 6 months. Formal volunteering is defined as unpaid, non-compulsory work that is done through an organisation, and for the benefit of people outside the participant’s household. It does not include caregiving for friends or family members (International Labour Organization, 2011). Aside from that definition, there are no restrictions on the type of volunteering participants can engage in.

3. Self-manage their engagement in volunteering (with the help of the organisation they've signed up with) and record their volunteering hours and type via self-complete weekly diaries.
Intervention code [1] 297160 0
Prevention
Intervention code [2] 297161 0
Lifestyle
Comparator / control treatment
Participants in the control group will continue their usual lifestyle, but at the completion of the 6-month trial will be encouraged to sign up with volunteering agencies if they wish.
Control group
Active

Outcomes
Primary outcome [1] 301065 0
Global cognitive functioning, as assessed by scores on the Montreal Cognitive Assessment (MOCA; Nasreddine et al., 2005).
Timepoint [1] 301065 0
Baseline (pre-intervention) and follow-up (6 months after baseline)
Primary outcome [2] 301161 0
Inhibitory control, as assessed by performance on three computer-based reaction time tests (Flanker arrows, Simon, and Anti keypress). Standardised z-scores will be calculated for each test and then averaged to create a composite measure of inhibitory control.
Timepoint [2] 301161 0
Baseline (pre-intervention) and follow-up (6 months after baseline)
Primary outcome [3] 301162 0
Task switching ability, as assessed by performance on a computer-based reaction time task (Pro/Anti keypress).
Timepoint [3] 301162 0
Baseline (pre-intervention) and follow-up (6 months after baseline)
Secondary outcome [1] 331630 0
Depressive symptoms, as assessed by scores on the Centre for Epidemiologic Studies Depression scale (Radloff, 1977).
Timepoint [1] 331630 0
Baseline (pre-intervention) and follow-up (6 months after baseline)
Secondary outcome [2] 331895 0
Self esteem, as assessed by scores on the Rosenberg Self Esteem Scale (Rosenberg, 1965).
Timepoint [2] 331895 0
Baseline (pre-intervention) and follow-up (6 months after baseline)
Secondary outcome [3] 331896 0
Quality of Life, as assessed by the Older People's Quality of Life Scale - Brief Version (Bowling et al., 2013).
Timepoint [3] 331896 0
Baseline (pre-intervention) and follow-up (6 months after baseline)
Secondary outcome [4] 331898 0
Working memory, as assessed by performance on a computer-based reaction time task (2-back continuous performance task).

Note: This is a primary outcome
Timepoint [4] 331898 0
Baseline (pre-intervention) and follow-up (6 months after baseline)

Eligibility
Key inclusion criteria
1. Aged between 65 and 75 years
2. Retired (not in part- or full-time paid employment) for at least 6 months
3. Have volunteered less often than once a month in the past year
Minimum age
65 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Diagnosis of dementia or other neurological conditions
2. Insufficient mobility to get around independently
3. Do not have normal or corrected-to-normal vision

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will not be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation. The factors to be balanced across groups through minimisation are age, gender, education, and Montreal Cognitive Assessment score.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 8669 0
New Zealand
State/province [1] 8669 0
Otago

Funding & Sponsors
Funding source category [1] 295606 0
Other Collaborative groups
Name [1] 295606 0
Brain Research New Zealand (BRNZ)
Country [1] 295606 0
New Zealand
Primary sponsor type
Individual
Name
Dr Liana Machado
Address
Psychology Department
University of Otago
William James Building
275 Leith Walk
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 294475 0
Individual
Name [1] 294475 0
Hayley Guiney
Address [1] 294475 0
Psychology Department
University of Otago
William James Building
275 Leith Walk
Dunedin 9016
Country [1] 294475 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296925 0
University of Otago Human Ethics Committee
Ethics committee address [1] 296925 0
Ethics committee country [1] 296925 0
New Zealand
Date submitted for ethics approval [1] 296925 0
Approval date [1] 296925 0
17/11/2016
Ethics approval number [1] 296925 0
16/150

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

Contacts
Principal investigator
Name 72450 0
Dr Liana Machado
Address 72450 0
Department of Psychology
University of Otago
William James Building
275 Leith Walk
Dunedin 9016
Country 72450 0
New Zealand
Phone 72450 0
+6434797622
Fax 72450 0
Email 72450 0
[email protected]
Contact person for public queries
Name 72451 0
Hayley Guiney
Address 72451 0
Department of Psychology
University of Otago
William James Building
275 Leith Walk
Dunedin 9016
Country 72451 0
New Zealand
Phone 72451 0
+6434794077
Fax 72451 0
Email 72451 0
[email protected]
Contact person for scientific queries
Name 72452 0
Hayley Guiney
Address 72452 0
Department of Psychology
University of Otago
William James Building
275 Leith Walk
Dunedin 9016
Country 72452 0
New Zealand
Phone 72452 0
+6434794077
Fax 72452 0
Email 72452 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.