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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]

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

Condition category

Condition code

Mental Health

Other mental health disorders

Neurological

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]

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]

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]