Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000296730
Ethics application status
Approved
Date submitted
11/03/2013
Date registered
18/03/2013
Date last updated
19/01/2022
Date data sharing statement initially provided
19/01/2022
Date results provided
19/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Having more fun: Increasing enjoyable activities to improve mood in nursing home residents with Alzheimer’s disease: A pilot study.
Scientific title
Having more fun: Increasing enjoyable activities to treat depression in nursing home residents with Alzheimer's disease: A pilot study.
Secondary ID [1] 282076 0
Nil
Universal Trial Number (UTN)
U1111-1140-2349
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 288566 0
Alzheimer's disease 288567 0
Condition category
Condition code
Mental Health 288899 288899 0 0
Depression
Neurological 288900 288900 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an 8-week trial of activity scheduling to improve symptoms of depression in nursing home residents with Alzheimer's disease. The intervention has two important components: (A) participants will work individually with a therapist (once per week for approximately 30-40 minutes) to identify enjoyable activities that are feasible and practical within the nursing home environment and the resident’s abilities, and develop an individually tailored plan to increase the availability and frequency of those events. Enjoyable activities are defined simply as activities the resident reports he or she would enjoy doing or enjoy doing more of and may be as simple as wearing a favourite piece of clothing, watching a TV show or going on an outing.
(B) Involvement of facility staff - The therapist will simultaneously work with facility staff (particularly activities staff) to implement the enjoyable activities and educate them about depression in the nursing home context. One three hour training session regarding depression in older people will be conducted immediately prior to commencement of the intervention. In addition, one staff member (ideally an activities staff member) will be nominated to be actively involved as a co-therapist for each participant who will be asked to support and encourage him/her to achieve their planned enjoyable activity each week. The therapist will liase with the co-therapist weekly (5-10 minutes will be all that is required) to inform them of the planned enjoyable activities for each participant for the following week and to identify any potential barriers to their implementation and identify possible solutions.
The trial will be conducted in 2 residential aged care facilities sequentially. Residents in facility A will receive the intervention for 8 weeks while residents in facility B receive treatment as usual. At the end of 8 weeks, residents in facility B will receive the intervention for 8 weeks while residents in facility A receive treatment as usual. There will be no wash-out period.
Intervention code [1] 286674 0
Behaviour
Intervention code [2] 286718 0
Treatment: Other
Comparator / control treatment
Treatment as usual. Participants in the control group will continue to engage in all activities provided by the residential care facility in which they live but will receive no input from research staff for the control period.
Control group
Active

Outcomes
Primary outcome [1] 289030 0
Depression (as measured by the Geriatric Depression Scale (12R))
Timepoint [1] 289030 0
Week 8 (following intervention)
Primary outcome [2] 289031 0
Quality of life (as measured by the Quality of Life - Alzheimer's Disease - Nursing Home version)
Timepoint [2] 289031 0
Week 8 (following intervention)
Secondary outcome [1] 301606 0
Agitation (as measured by the Cohen-Mansfield Agitation Inventory - short form)
Timepoint [1] 301606 0
Week 8 (following intervention)

Eligibility
Key inclusion criteria
Participants must have a diagnosis of mild to moderate probable Alzheimer's Disease (AD), or Vascular Dementia (VAD) mixed AD/VAD;
Participants must have evidence of symptoms of depression as measured by the Geriatric Depression Scale (12R);
Participants must reside in a Residential Aged Care facility
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Profound deafness;
Severe dementia (MMSE scores <10);
Non-english speaking;

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)
Participants from 2 residential care facilities in Queensland will participate in the study. Participants from facility A will receive the intervention first while participants in facility B will receive treatment as usual. A cross-over design will be used and following 8 weeks of the intervention, the intervention will be implemented in Facility B while participants in Facility A receive treatment as usual. There is no wash-out period. The Research Assistant responsible for recruiting participants into the study will be a different person to the perosn who will be acting as the therapist for the study and will be unaware regarding group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation of the two facilities: A and B will depend on the toss of a coin.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Differences in groups will be assessed by comparing outcomes following the intervention (weeks 8 and 16) with baseline values.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/05/2013
Actual
31/10/2013
Date of last participant enrolment
Anticipated
31/01/2014
Actual
25/02/2014
Date of last data collection
Anticipated
Actual
31/03/2014
Sample size
Target
20
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 286854 0
Charities/Societies/Foundations
Name [1] 286854 0
JR & JR Wicking Trust & Mason Foundation (one source)
Country [1] 286854 0
Australia
Primary sponsor type
Individual
Name
Catherine Travers
Address
Room 612, N Block
Queensland University of technology
Victoria Park Rd.,
Kelvin Grove Qld 4059
Country
Australia
Secondary sponsor category [1] 285643 0
Individual
Name [1] 285643 0
Associate Professor Deb Parker
Address [1] 285643 0
UQ Blue Care Research & Practice Development Centre
Sylvan Rd.,
Toowong Qld 4066
Country [1] 285643 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288916 0
Queensland University of Technology
Ethics committee address [1] 288916 0
Ethics committee country [1] 288916 0
Australia
Date submitted for ethics approval [1] 288916 0
20/03/2013
Approval date [1] 288916 0
22/04/2013
Ethics approval number [1] 288916 0
1300000340

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

Contacts
Principal investigator
Name 38322 0
Dr Catherine Travers
Address 38322 0
Room 612, N Block
QUT
Victoria Park Rd.,
Kelvin Grove Qld 4059
Country 38322 0
Australia
Phone 38322 0
+61 07 3138 3882
Fax 38322 0
Email 38322 0
[email protected]
Contact person for public queries
Name 38323 0
Catherine Travers
Address 38323 0
Room 612, N Block
QUT
Victoria Park Rd.,
Kelvin Grove Qld 4059
Country 38323 0
Australia
Phone 38323 0
+61 07 3138 3882
Fax 38323 0
Email 38323 0
[email protected]
Contact person for scientific queries
Name 38324 0
Catherine Travers
Address 38324 0
Room 612, N Block
QUT
Victoria Park Rd.,
Kelvin Grove Qld 4059
Country 38324 0
Australia
Phone 38324 0
+61 07 3138 3882
Fax 38324 0
Email 38324 0
[email protected]

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?

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.