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Trial registered on ANZCTR


Registration number
ACTRN12618001269224
Ethics application status
Approved
Date submitted
24/05/2018
Date registered
27/07/2018
Date last updated
10/07/2019
Date data sharing statement initially provided
10/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Dementia-friendly book clubs in the care home: can quality of life be improved? A randomized clinical trial
Scientific title
An international, multicentre RCT to evaluate the use of adapted classical literature in book groups for people living with dementia at aged care facilities: can quality of life be improved?
Secondary ID [1] 292830 0
None
Universal Trial Number (UTN)
U1111-1217-4081
Trial acronym
Linked study record
ACTRN12617001417370 is a pilot for this study. this study is a full RCT, powered to find a clinically meaningful difference.

Health condition
Health condition(s) or problem(s) studied:
Dementia 308000 0
Condition category
Condition code
Mental Health 307036 307036 0 0
Other mental health disorders
Neurological 307911 307911 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dementia-friendly book clubs within residential aged care facility (RACF).
In week 1, all participants (intervention and control) will receive the baseline evaluation, and the intervention will begin. The Assessor will be blinded to treatment allocation, and will be either a Psychiatry Registrar or a Psychiatrist. Baseline evaluation includes the following measures: Quality of Life (Resident QoL-AD self-report and proxy); "Thriving"(how well the individual has adjusted to life at the RACF (TOPAS and TOPAS-proxy) ; Theory of Mind via the Eyes/Faces Test (EFT); Assessment of Cognitive Function (ACE-III); depression (GDS-SF); and any changes in behaviour (NPI).
During weeks 2 – 8, facility staff will conduct the book clubs (2/week, 45 mins each), and patient carers will provide support to the patients to encourage them to read the books between meetings, attend and participate in the book clubs. Selected parts of the book will be read and discussed at each session. The goal is not to improve memory, but rather to engage the participates and allow them to appreciate the tale and the language. The book club sessions are therefore not dependent on the participants having read the book beforehand, nor on them remembering anything about the book. All participants with dementia will have their own books to read. The books are dementia-friendly books, written by the researchers (Drs Rimkeit and Claridge, see www.dovetalepress.com) after initial research. One book will be read each week. The book clubs will involve reading these books, and discussing them with the participants. Only the participants with dementia will attend the book clubs.
In week 9, the final assessment, a repeat of the baseline assessment for all participants (intervention and control), will be done, again by a blinded assessor who is either a Psychiatrist or a Psychiatry Registrar.
Frequency of attendance at the book clubs will be noted for each participant by the book club facilitator.
Intervention code [1] 301319 0
Rehabilitation
Comparator / control treatment
Activities as usual at the RACF. This may vary from RACF to RACF, but as we will be using only Bupa facilities will probably be more consistent than if we just used two different facilities. Usual activities would normally include social gatherings (eg, "Happy Hour"), games, television, mild exercise classes etc
Control group
Active

Outcomes
Primary outcome [1] 306012 0
To determine the difference before and after the intervention in Quality of Life (using Resident QoL-AD-self and proxy) in our population, and whether or not the mean difference differs by intervention and control groups.
Timepoint [1] 306012 0
At baseline (before intervention) and 9 weeks post intervention.
Secondary outcome [1] 347303 0
To determine the difference before and after the intervention in "Thriving" (using TOPAS-self and proxy) in our population, and whether or not the difference differs between intervention and control groups.


Timepoint [1] 347303 0
At baseline (before intervention) and 9 weeks post intervention.
Secondary outcome [2] 347304 0
To determine the mean difference before and after intervention in "Theory of Mind" (using the Eyes/ Faces Test) in our population, and whether or not the difference differs between intervention and control groups.

Timepoint [2] 347304 0
At baseline (before intervention) and 9 weeks post intervention.
Secondary outcome [3] 347307 0
Geriatric Depression Scale - Short Form
Timepoint [3] 347307 0
At baseline (before intervention) and 9 weeks post intervention.
Secondary outcome [4] 347308 0
Addenbrooks Cognitive scale
Timepoint [4] 347308 0
At baseline (before intervention) and 9 weeks post intervention.
Secondary outcome [5] 347310 0
To determine the mean difference in changes in behaviour (measured by the Neuropsychiatric Inventory (NPI) in our population, and whether the differences differ between the intervention and control groups.

Timepoint [5] 347310 0
At baseline (before intervention) and 9 weeks post intervention.

Eligibility
Key inclusion criteria
Medical diagnosis of dementia
living in a rest home or hospital level care
adequate communication skills as measured on the InterRAI
No problems with verbal or physical abuse, No socially disruptive behaviour
provide consent
score between 36 and 82 on the Addenbrooks at baseline
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
co-morbidity which would preclude them from participating for 7 weeks

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)
allocation to intervention or control groups will be done centrally, by phone or email, using a random number generator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simplified randomization using computer software, within each site (RACF)/ stratum.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
pre-post design: outcomes are measured as changes pre to post intervention
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be done on an Intention-to-Treat basis. Intervention and control groups will be compared at baseline (using t tests or chi-squared tests as appropriate). Initial checks will determine whether or not the Resident QoL-AD is normally distributed. If so, ANCOVA (Analysis of Covariance) will be used to test whether the change in Resident QoL-AD was different between the intervention and control groups, adjusting for baseline characteristics (QoL-AD, TOPAS, EFT, Addenbrooke’s - III, GDS-SF, and NPI.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/07/2018
Actual
8/10/2018
Date of last participant enrolment
Anticipated
31/10/2019
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
260
Accrual to date
75
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment outside Australia
Country [1] 10504 0
New Zealand
State/province [1] 10504 0
All provinces in New Zealand
Country [2] 10505 0
United Kingdom
State/province [2] 10505 0

Funding & Sponsors
Funding source category [1] 297461 0
Government body
Name [1] 297461 0
Lotteries Grant, Internal Affairs, New Zealand
Country [1] 297461 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago, Wellington
PO Box 7343,
Wellington South 6242
New Zealand
Country
New Zealand
Secondary sponsor category [1] 296459 0
Commercial sector/Industry
Name [1] 296459 0
Bupa Care NZ
Address [1] 296459 0
Bupa New Zealand Support Office,
Level 4 1 Walton Leigh Avenue
Porirua, New Zealand, 5022
Country [1] 296459 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298567 0
Health and Disability Ethics Committee
Ethics committee address [1] 298567 0
Ethics committee country [1] 298567 0
New Zealand
Date submitted for ethics approval [1] 298567 0
29/03/2018
Approval date [1] 298567 0
21/05/2018
Ethics approval number [1] 298567 0
18/NTA/50

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2746 2746 0 0
/AnzctrAttachments/373609-RCT protocol 12 April 2018.docx (Protocol)

Contacts
Principal investigator
Name 77494 0
Dr Sally Rimkeit
Address 77494 0
Department of Psychological Medicine,
University of Otago, Wellington,
23a Mein St
Newtown, Wellington
New Zealand 6242
Country 77494 0
New Zealand
Phone 77494 0
+64 4410 8708 027
Fax 77494 0
Email 77494 0
Sally.Rimkeit@ccdhb.org.nz
Contact person for public queries
Name 77495 0
Sally Rimkeit
Address 77495 0
Department of Psychological Medicine,
University of Otago, Wellington,
23a Mein St
Newtown, Wellington
New Zealand 6242
Country 77495 0
New Zealand
Phone 77495 0
+64 4410 8708 027
Fax 77495 0
Email 77495 0
Sally.Rimkeit@ccdhb.org.nz
Contact person for scientific queries
Name 77496 0
Sally Rimkeit
Address 77496 0
Department of Psychological Medicine,
University of Otago, Wellington,
23a Mein St
Newtown, Wellington
New Zealand 6242
Country 77496 0
New Zealand
Phone 77496 0
+64 4410 8708 027
Fax 77496 0
Email 77496 0
Sally.Rimkeit@ccdhb.org.nz

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.