Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001417370
Ethics application status
Approved
Date submitted
7/09/2017
Date registered
9/10/2017
Date last updated
9/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Reading for Pleasure: Participating in a dementia-friendly book club at a residential aged care facility.
Scientific title
Reading for Pleasure: A pilot study on the feasibility and utility of a dementia-friendly book club at a residential aged care facility..
Secondary ID [1] 292831 0
None
Universal Trial Number (UTN)
UTN 1111-1195-8508
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 304667 0
Condition category
Condition code
Mental Health 303983 303983 0 0
Other mental health disorders
Neurological 304183 304183 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. 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] 299079 0
Rehabilitation
Intervention code [2] 299211 0
Treatment: Other
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] 303319 0
Can the proposed patient population handle the burden of two full assessments. Each 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).
This will be assessed by the clinical assessors who will be aware of any discomfort, anxiety or tiring of the subjects during the assessments.
Timepoint [1] 303319 0
Baseline (week 1) and 9 weeks from baseline assessment
Primary outcome [2] 303494 0
Which parts of the assessments need to be removed from the study, and for which subjects.
This will be assessed by the clinical assessors who will be aware of any discomfort, anxiety or tiring of the subjects during the assessments.
Timepoint [2] 303494 0
baseline (week 1) and at 9 weeks post baseline
Primary outcome [3] 303495 0
Phenomenological analysis of the lived experience of persons with dementia participating in the book club. Analysed from recordings of book club sessions.
Timepoint [3] 303495 0
At time of book clubs: twice weekly, weeks 2 - 8.
Secondary outcome [1] 338622 0
To determine the size of any effect of the intervention on Quality of Life (using Resident QoL-AD-self and proxy) in our pilot population, by calculating the difference in QoL-AD pre- and post- intervention. Since the pilot will include only 18 to 20 dyads (of participants with dementia and carer participants), allocated to intervention and control arms, we will not have sufficient power to determine statistical significance. However, the pilot study will provide helpful information about the possible size and variability of any change in Quality of Life due to the intervention. This will be used to design the full RCT.
Timepoint [1] 338622 0
9 weeks from baseline assessment
Secondary outcome [2] 339068 0
To compare change in language with D-level scale and proportional density analysis, from a convenience sampling of participants, from the first to the last session of the book club intervention. Qualitative analysis of intra- and interclausal meaning relationships will also be carried out.
Timepoint [2] 339068 0
At the times of the book clubs, from recordings of them. twice weekly, weeks 2 through 8.
Secondary outcome [3] 339126 0
To determine the size of any effect of the intervention on "Thriving" (using TOPAS-self and proxy) in our pilot population, by calculating the difference in TOPAS-self pre and post- intervention. Since the pilot will include only 18 to 20 dyads (of participants with dementia and carer participants), allocated to intervention and control arms, we will not have sufficient power to determine statistical significance. However, the pilot study will provide helpful information about the possible size and variability of any change in TOPAS score due to the intervention. This will be used to design the full RCT.
Timepoint [3] 339126 0
baseline and 9 weeks
Secondary outcome [4] 339127 0
To determine the size of any effect of the intervention on "Theory of Mind" (using the Eyes/ Faces Test) in our pilot population, By calculating the difference in the EFT pre and post- intervention. Since the pilot will include only 18 to 20 dyads (of participants with dementia and carer participants), allocated to intervention and control arms, we will not have sufficient power to determine statistical significance. However, the pilot study will provide helpful information about the possible size and variability of any change in EFT score due to the intervention. This will be used to design the full RCT.
Timepoint [4] 339127 0
baseline and 9 weeks
Secondary outcome [5] 339128 0
To determine the size of any effect of the intervention on cognitive function (using Addenbrooks -III) in our pilot population, By calculating the difference in the ACE-III score pre and post- intervention. Since the pilot will include only 18 to 20 dyads (of participants with dementia and carer participants), allocated to intervention and control arms, we will not have sufficient power to determine statistical significance. Nor would we expect much change in cognitive function over the 7 weeks. However, the pilot study will provide helpful information about the possible size and variability of any change in ACE-III score due to the intervention. This will be used to design the full RCT.
Timepoint [5] 339128 0
baseline and at 9 weeks
Secondary outcome [6] 339129 0
To determine the size of any effect of the intervention on depression (using the GDS-SF scale) in our pilot population, by calculating the difference in GDS-SF pre and post- intervention. Since the pilot will include only 18 to 20 dyads (of participants with dementia and carer participants), allocated to intervention and control arms, we will not have sufficient power to determine statistical significance. However, the pilot study will provide helpful information about the possible size and variability of any change in GDS-SF score due to the intervention. This will be used to design the full RCT.
Timepoint [6] 339129 0
baseline and at 9 weeks
Secondary outcome [7] 339130 0
To determine the size of any effect of the intervention on changes in behaviour (measured by the NPI) in our pilot population, By calculating the difference in TOPAS-self pre and post- intervention. Since the pilot will include only 18 to 20 dyads (of participants with dementia and carer participants), allocated to intervention and control arms, we will not have sufficient power to determine statistical significance. However, the pilot study will provide helpful information about the possible size and variability of any change in NPI score due to the intervention. This will be used to design the full RCT.
Timepoint [7] 339130 0
baseline and at 9 weeks

Eligibility
Key inclusion criteria
Inclusion Criteria
1 All participants will have a medical diagnosis of Dementia, or will be a carer for someone diagnosed with dementia. In addition, the Bupa facility staff will attest that, in their latest InterRAI ( InterRAI Long-Term Care Facility (LTCF) Assessment Form Version 9.3, copyrighted), the participant with dementia has a recorded diagnosis of Alzheimer’s disease or Dementia other than Alzheimer’s (section I: Disease Diagnosis). Participants will be recruited as a dyad of carer and person with dementia (PWD).
2 Participants with dementia will be recruited from those living in rest home or hospital level care (with likely mild-moderate dementia) and those living in secure dementia units (likely moderate – severe dementia). Participants with dementia will reside at the Bupa Care Home. The Carer Participants can reside outside of the Care Home, in community, or at the Bupa Care Home.
3 Participants will be recruited by invitation by the facility manager, or his/her surrogate, with referral to a poster giving information about the book club.
4 All participants with dementia will score 0, 1 or 2 on all parts of Section D: Communication and vison of the InterRAI Long-Term Care Facility (LTCF) Assessment Form Version 9.3, copyrighted.
5 All participants with dementia will be recorded as NOT having any problems with verbal abuse, physical abuse or socially disruptive behaviour in their InterRAI (Section E.3, parts b, c, and d).
6 “With patient autonomy being a guiding principle in health care law, it is important that the test that sets the limit for capacity is at a level that allows most people to make their own decisions about treatment”. (Gunn, 1994)) . In consultation with HDEC, we have carefully designed our consent/assent process to respect this autonomy principle. As per The HDC Code of Health and Disability Services Consumers' Rights Regulation 1996, all participants will be deemed to have the capacity to give informed, written consent or assent (even if they have been deemed incompetent within PPPR legislation). This written consent/assent will be sought only after they have had time to fully read the Information Sheet, speak to family members (who have been provided with a Family Information Sheet and Carer Views on their Relative’s Participation in the study), and had an interview with the clinical researchers (Drs Rimkeit and Astika), so that their questions about the study are fully answered. In this consent/assent process, we will ensure that those who agree to participate do so because 1) it is their personal, informed choice to participate, and 2) they believe it is in their best interest to participate.
7 The carer-participant for each PWD will receive their own letter of information for the role they will play in the study and interview with the researchers, and will sign their own consent form.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
1. Potential participants with comorbidities which would preclude them from participating in the book club for seven weeks will be excluded; this will be assessed by the facility manager or his/her surrogate.
2. Potential participants who score 3 or 4 on any parts of Section D: Communication and vision of the InterRAI Long-Term Care Facility (LTCF) Assessment Form Version 9.1, copyrighted will be excluded from the trial.
3. All potential participants with dementia who are recorded as exhibiting any verbal abuse, physical abuse or socially disruptive behaviour in their InterRAI (Section E.3, parts b, c, or d) will be excluded from the study.

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)
central randomisation by phone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using a randomisation table generated by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assessing the burdens/ resource requirements: The participants will be required to meet with the blinded assessor in an initial interview at baseline and a week after completion of the seven-week trial. We anticipate that the assessment process, measuring Resident QoL-AD self-report, Thriving of Older Persons Assessment Scale (TOPAS), Faces Test for Theory of Mind, Addenbrookes’-III cognitive assessment, and the Geriatric Depression Scale Short Form (GDS –SF), will take approximately 1 hour. For the pilot, we will carefully consider whether this assessment process is too burdensome for the participants and whether it causes undue anxiety. We will not extend any one assessment session for longer than one hour to reduce strain on the PWD. This may mean that assessment sessions for the PWD takes place twice in one week, on separate days. In addition, we need to consider resource obligations for the blinded assessment, which will be undertaken as a Scholarly Project by a Psychiatric Registrar (Dr Kappagoda), supervised by psychogeriatrician and clinical investigator Dr Sally Rimkeit, and independently by Dr Rimkeit. Through the pilot RCT, we can evaluate whether blinded assessment is practical or achievable. It will also allow evaluation of time commitment involved in assessing selected participants at an RACF, requiring this assessment to take place in a in a relatively short space of time (preferably one week): we may find this is impractical. Importantly, the pilot study allows opportunity for review and feedback from our sponsor Bupa Care, who is providing staff resourcing for recruitment and facilitation of the book club intervention. Beth McDougall is the Dementia Care Advisor for Bupa and has agreed to work with facilities closely during the study to address any clinical issues that arise.
As anticipated for the full RCT, for the pilot study, we will require the recording of demographic factors on each participant, including, by proxy report, age, gender, marital status, nationality, ethnicity, Iwi if Maori, placement level in RACF (rest home, hospital or secure dementia unit), years of education, and estimated number of books read each year 10 years ago. Although we will not use these variables for the analysis of the pilot study, we will collect them so that we can describe our participants, and trial our data collection mechanisms.

Assessing Effect size and variance: The pilot RCT will provide data for refining protocol requirements for the full project. This includes estimates of mean and variance of the effect size, from which a sample size estimate can be made. The required sample size will be calculated for the primary outcome (Quality of Life), but the power available to test secondary outcomes will also be calculated.
The assessment tools for the pilot RCT, and proposed for the full RCT are:
A. Primary Assessment: The change in Quality of Life, as measured by the Resident QoL-AD-self and the Resident QoL-AD-proxy reports
B. Secondary Assessments are:
1) Change in “Thriving” (TOPAS self-report and TOPAS-proxy);
2) Change in Theory of Mind ability (Faces Test Theory of Mind);
3) Change in Cognitive functioning (Addenbrookes’ Cognitive examination, version III);
4) Change in mood (Geriatric Depression Scale-Short Form) ;
5) Change in behaviour (Neuropsychiatric Inventory);
Qualitative Analysis: The Pilot study will also enable us to complete the Qualitative evaluation of the book club experience, namely:
1. To use Interpretative Phenomenological Analysis to explore the lived experience of a convenience sampling of participants in the book clubs;
2. To compare change in language with D-level scale and proportional density analysis, from a convenience sampling of participants, from the first to the last session of the book club intervention. Qualitative analysis of intra- and interclausal meaning relationships will also be carried out.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/10/2017
Actual
Date of last participant enrolment
Anticipated
17/10/2017
Actual
Date of last data collection
Anticipated
21/12/2017
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 9181 0
New Zealand
State/province [1] 9181 0
Rotorua and Kapiti Coast

Funding & Sponsors
Funding source category [1] 297462 0
University
Name [1] 297462 0
University of Otago
Country [1] 297462 0
New Zealand
Funding source category [2] 297613 0
Commercial sector/Industry
Name [2] 297613 0
Bupa Care New Zealand Ltd
Country [2] 297613 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Bupa Care Services New Zealand Ltd
Address
Level 4, 1 Walton Leigh Ave, Porirua, 5022, New Zealand
Country
New Zealand
Secondary sponsor category [1] 296461 0
University
Name [1] 296461 0
University of Otago
Address [1] 296461 0
Dean's Department, PO Box 7343 Wellington South, 6242, New Zealand
Country [1] 296461 0
New Zealand
Other collaborator category [1] 279709 0
University
Name [1] 279709 0
IPU New Zealand
Address [1] 279709 0
IPU
57 Aokautere Drive, Manawatu, 4410 New Zealand
Country [1] 279709 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298568 0
HDEC Northern A
Ethics committee address [1] 298568 0
Ethics committee country [1] 298568 0
New Zealand
Date submitted for ethics approval [1] 298568 0
05/07/2017
Approval date [1] 298568 0
31/08/2017
Ethics approval number [1] 298568 0
17/NTA/133

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2025 2025 0 0
/AnzctrAttachments/373610-HDEC Letter 17NTA133_Approved FULL Application with non std conditions.pdf (Ethics approval)

Contacts
Principal investigator
Name 77498 0
Dr Dalice Sim
Address 77498 0
Dean's Department, University of Otago, Wellington, PO Box7343, Wellington, New Zealand 6242
Country 77498 0
New Zealand
Phone 77498 0
+6449186113
Fax 77498 0
Email 77498 0
[email protected]
Contact person for public queries
Name 77499 0
B Sally Rimkeit
Address 77499 0
Te Whare Ra Uta
Kenepuru Hospital,
16 Hospital Drive
Porirua 5022
New Zealand
Country 77499 0
New Zealand
Phone 77499 0
+64278014714
Fax 77499 0
Email 77499 0
[email protected]
Contact person for scientific queries
Name 77500 0
B Sally Rimkeit
Address 77500 0
Te Whare Ra Uta
Kenepuru Hospital,
16 Hospital Drive
Porirua 5022
New Zealand
Country 77500 0
New Zealand
Phone 77500 0
+64278014714
Fax 77500 0
Email 77500 0
[email protected]

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