Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000568314
Ethics application status
Approved
Date submitted
19/04/2017
Date registered
24/04/2017
Date last updated
9/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of a brief reminiscence task on mood for older adults living in residential aged care.
Scientific title
The effects of a brief reminiscence task on mood for older adults living in residential aged care.
Secondary ID [1] 291684 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mood Disorders 302849 0
Condition category
Condition code
Mental Health 302331 302331 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 302332 302332 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study aims to investigate the impact that a brief instrumental reminiscence intervention has on mood, hopefulness and mastery for older adults living in residential aged care. Using a pre-test/post-test experimental design the study explores the impact that a reminiscence task has on mood, hopefulness and mastery using the following instruments:
- The Positive and Negative Affect Scale (PANAS) (Watson, Clark & Tellegan, 1988)
- Adult Hope Scale (AHS) (Snyder, et al. 1991)
- Pearlin Mastery Scale (Pearlin et al, 1981)
- Memories of Mastery Experiences Scale (Bhar, Brown & Beck 2007)

The research will be conducted face to face with individual participants using a standardise reminiscence script for the experimental condition and a current events script for the control condition. Both conditions will be conducted by the student investigators. Participants are asked general questions about their personal and family history. Such questions refer to participant’s work and schooling history, early family environment, and relationships with parents and siblings. The purpose of these questions is not to elicit comprehensive information about the participants’ history but rather to prime participants to think about their past, thus creating a psychological climate involving the recollection of memories. For participants in the intervention condition, these questions create a context for asking more specific questions about mastery related experiences (i.e., the mastery memory activation task). This discussion should take approximately 10 minutes.

The research will be conducted in residential aged care facilities in Victoria and the Australian Capital Territory.
Intervention code [1] 297772 0
Treatment: Other
Comparator / control treatment
The control condition involves talking about a current event and is delivered by the student investigators. Participants are asked general questions about current events, NOT related to their personal and family history. The questions will cover topics related to families, environment, education, work and children. The purpose of these questions is to provide an active control for the introductory questions in the reminiscence condition. This discussion should take approximately 10 minutes.
Control group
Active

Outcomes
Primary outcome [1] 301746 0
Change in mood as measured by the Positive and Negative Affect Scale (PANAS).
Timepoint [1] 301746 0
Change in mood after the intervention as compared to baseline.
Primary outcome [2] 301747 0
Change in hopefulness as measured by the Adult Hope Scale (AHS).
Timepoint [2] 301747 0
Change in hopefulness after the intervention as compared to baseline.
Primary outcome [3] 301748 0
Change in mastery as measured by the Pearlin Mastery Scale.
Timepoint [3] 301748 0
Change in mastery after the intervention as compared to baseline.
Secondary outcome [1] 333758 0
Memories of mastery experience as measured by the Memory of Mastery Experiences Scale (MOMS: Bhar, Brown, & Beck, 2007).
Timepoint [1] 333758 0
directly after the intervention

Eligibility
Key inclusion criteria
To be eligible for the study, participants must (a) be living in a residential aged care facility, (b) be at least 65 years old, (c) demonstrate adequate cognitive functioning (as indicated by a score of 24 or more on the Mini Mental Status Examination).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Potential participants who appear unable to participate in screening procedures, as assessed by the interviewer due to health, cognitive or language related limitations will not be eligible for participation.

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 envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomised table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2017
Actual
6/03/2017
Date of last participant enrolment
Anticipated
1/09/2017
Actual
16/10/2017
Date of last data collection
Anticipated
1/09/2017
Actual
16/10/2017
Sample size
Target
60
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
ACT,VIC

Funding & Sponsors
Funding source category [1] 296101 0
University
Name [1] 296101 0
Swinburne University of Technology
Country [1] 296101 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
John Street, Hawthorn Victoria 3122
Country
Australia
Secondary sponsor category [1] 295145 0
None
Name [1] 295145 0
Address [1] 295145 0
Country [1] 295145 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297356 0
Swinburne's Human Research Ethics Committee (SUHREC)
Ethics committee address [1] 297356 0
Ethics committee country [1] 297356 0
Australia
Date submitted for ethics approval [1] 297356 0
Approval date [1] 297356 0
23/01/2017
Ethics approval number [1] 297356 0
SHR Project 2016/185

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

Contacts
Principal investigator
Name 73794 0
A/Prof Sunil Bhar
Address 73794 0
Faculty of Health, Arts and Design, Swinburne University of Technology, Mail H24, Hawthorn VIC 3122
Country 73794 0
Australia
Phone 73794 0
6139214 8371
Fax 73794 0
Email 73794 0
[email protected]
Contact person for public queries
Name 73795 0
Jencie Castles
Address 73795 0
Faculty of Health, Arts and Design, Swinburne University of Technology, Mail H24, Hawthorn VIC 3122
Country 73795 0
Australia
Phone 73795 0
61433474231
Fax 73795 0
Email 73795 0
[email protected]
Contact person for scientific queries
Name 73796 0
Jencie Castles
Address 73796 0
John Street, Hawthorn Faculty of Health, Arts and Design, Swinburne University of Technology, Mail H24, Hawthorn VIC 3122
Country 73796 0
Australia
Phone 73796 0
61433474231
Fax 73796 0
Email 73796 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.