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Trial registered on ANZCTR


Registration number
ACTRN12622000269730
Ethics application status
Approved
Date submitted
12/07/2021
Date registered
14/02/2022
Date last updated
14/02/2022
Date data sharing statement initially provided
14/02/2022
Date results provided
14/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Digital Memory Album on Psychosocial Wellbeing among People with Dementia Living in Community – A Single Blind Randomised Controlled Trial
Scientific title
Digital Memory Album on Psychosocial Wellbeing among People with Dementia Living in Community – A Single Blind Randomised Controlled Trial
Secondary ID [1] 301122 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
DMA
Digital Memory Album
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 317221 0
Cognitive Impairment 317222 0
Condition category
Condition code
Neurological 315362 315362 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BRIEF NAME: Digital Memory Album (DMA) Project
The feasibility of applying information and communication technology (ICT) to facilitate reminiscence work for people with dementia (PWD) and its potential to induce psychosocial benefits is well documented. Multimedia appears to be the earliest form of technology used to support reminiscence work. Tangible prompts like photographs, familiar items from the past or music which serve as stimuli for remote memories during reminiscence process are exported into the multimedia system and further enriched with visual and auditory enhancement. This multimedia can be displayed to a person with dementia using DMA as a platform.

WHY: The effect of traditional reminiscence work or therapy either in a group setting or individual setting never lasted more than 5 weeks. This is due to the lack of a tangible platform to display the reminiscence package such life story book so on. Previous research has indicated a person with dementia prefers digital life story book or paper based life story book. This is mainly because due to the incorporation of multimedia effects such as favourite music, songs, video clips, the narration of life story and many other digital effects only possible via ICT based reminiscence work. However, research still lacking in establishing a feasible platform to display digital life story book and its effects. Therefore current research aims to examine the effects of having DMA among older adults with Dementia.

WHAT:
This is an intervention which mainly focuses on the effect of developing digital memory album (DMA) and having DMA on psychological well being among older adults with dementia living in the community.
Group 1: Intervention Group
People in the intervention group received 8 individual sessions of life review process weekly leading to the construction of their own personalised digital life story (DLS) displayed in a Digital Life Story Album (DMA). The life review process was conducted according to the Life Review and Experiencing Form (LREF).
The LREF used to develop participants' DLS contain multiple segment or themes in chronological order and usually conducted in 8 separate sessions;
a. Introduction (opening session)
b. Childhood
c. Adolescence
d. Family & Home
e. Adulthood
f. summary session,

After 8 initial sessions, the personalised DLS developed through life review process is uploaded and displayed in a digital memory album (DMA) at participant's home for 6 weeks. This DMA contains participants life story in chronological order with their pictures, movie clips, background music, tangible items e.g. work id, certificates etc.

Digital Memory Album (DMA) is a 15 inch screen digital photo frame with remote control, motion sensor, built in sound system, USB memory storage and two auto-play looped sections which separate photo from the video.

Control Group (Active);
Received usual care in the community.

WHO PROVIDED:
A post graduate with a qualification in Community Health Sciences and received 6 months of training at geriatrics health services.
HOW:
The intervention was executed in an individual face to face session.
WHERE:
In a selected participants' home around Kuala Lumpur and other areas in Klang Valley in Peninsular Malaysia. Participants were selected based on examination and diagnosis outcome from Memory Clinicals at Government hospitals. Each Memory Clinics has an expert in cognitive disorders such as a geriatrician or psychogeriatrician.
WHEN AND HOW MUCH;
This intervention was carried out for over a period of 3 months and 2 weeks for each participant.
First 2 months (week 1 to week 8), life review process intervention phase and the next 6 weeks (week 9 to week 14) is a phase whereby participants viewed their own digital life story in a DMA.
The intervention consisted of 8 weekly sessions of the individual life review process and another 6 weeks to watch DMA.
Time: 60 to 90 minutes is the time duration of each session of the 8 weekly life review sessions
Intervention adherence monitoring: using logbook and session attendance checklist.
TAILORING:
(i) The life review session has been adjusted according to participants' interest and availability of personal items e.g. photos, music and etc. If participants lacked in personalised items to suit the theme of the session, a generic item or pictures was used to facilitate the recalling process (ii) Interventionist acted a secretary or editor and participant as a director of their own life story movie.

MODIFICATION: N/A
Intervention code [1] 317455 0
Rehabilitation
Intervention code [2] 317456 0
Behaviour
Intervention code [3] 317457 0
Treatment: Other
Comparator / control treatment
Active Control Group: Receiving usual care in the community

Usual care in this study is the participants living in community, received community care; family and social support, regular health care visits, medical examination and treatments.
Control group
Active

Outcomes
Primary outcome [1] 323914 0
Quality of Life-Alzheimer’s Disease (QOL-AD) (Logsdon, Gibbons, McCurry, & Teri, 2002)
Timepoint [1] 323914 0
Baseline, at 8 weeks (at the end of intervention, primary endpoint) and at 14 weeks (follow-up from baseline)
Primary outcome [2] 323915 0
Addenbrooke’s Cognitive Examination III (ACE-III) (Hsieh, Schubert, Hoon, Mioshi, & Hodges, 2013)
Timepoint [2] 323915 0
Baseline, at 8 weeks (at the end of intervention, primary endpoint) and at 14 weeks (follow-up from baseline)
Primary outcome [3] 323916 0
Geriatric Depression Scale-Short Form (GDS-15) (Yesavage & Sheikh, 1986)
Timepoint [3] 323916 0
Baseline, at 8 weeks (at the end of intervention, primary endpoint) and at 14 weeks (follow-up from baseline)
Secondary outcome [1] 383322 0
Person with Dementia (Patients) - reported Quality of Carer-Patient Relationship (QCPR) (Spruytte, Van Audenhove, Lammertyn, & Storms, 2002)
Timepoint [1] 383322 0
Baseline, at 8 weeks (at the end of intervention) and at 14 weeks (follow-up from baseline)
Secondary outcome [2] 383323 0
Person with Dementia (Patients) - reported Perceived Stress Scale, (PSS) (Cohen, Kamarck, & Mermelstein, 1983)
Timepoint [2] 383323 0
Baseline, at 8 weeks (at the end of intervention) and at 14 weeks (follow-up from baseline)
Secondary outcome [3] 403117 0
Carer - reported Quality of Carer-Patient Relationship (QCPR) (Spruytte, Van Audenhove, Lammertyn, & Storms, 2002)
Timepoint [3] 403117 0
Baseline, at 8 weeks (at the end of intervention) and at 14 weeks (follow-up from baseline)
Secondary outcome [4] 403118 0
Carer - reported Perceived Stress Scale, (PSS) (Cohen, Kamarck, & Mermelstein, 1983)
Timepoint [4] 403118 0
Baseline, at 8 weeks (at the end of intervention) and at 14 weeks (follow-up from baseline)
Secondary outcome [5] 403119 0
Person with Dementia (Patients)- Feedback using a set of open-ended semi structured questions adapted from Subramaniam & Woods (2014) to get feedback on patients experiences taking part in development of Digital Life Story through life review process.
Timepoint [5] 403119 0
at 8 weeks (at the end of intervention)
Secondary outcome [6] 403120 0
Person with Dementia (Patients)- Feedback using a set of open-ended semi structured questions adapted from Subramaniam & Woods (2014) to get feedback on patients' view about benefit and experiences in having and using DMA .
Timepoint [6] 403120 0
at 14 weeks (follow-up from baseline)
Secondary outcome [7] 403121 0
Carer- Feedback using a set of open-ended semi structured questions adapted from Subramaniam & Woods (2014) to get feedback on carers' view and experiences about person with dementia taking part in the development of Digital Life Story through life review process.
Timepoint [7] 403121 0
at 8 weeks (at the end of intervention)
Secondary outcome [8] 403122 0
Carer- Feedback using a set of open-ended semi structured questions adapted from Subramaniam & Woods (2014) to get feedback on carers' view about benefit and experiences in having and using DMA for person with dementia .
Timepoint [8] 403122 0
at 14 weeks (follow-up from baseline)

Eligibility
Key inclusion criteria
• Participants aged 60 years old and above, ambulatory and community dwelling with a diagnosis of dementia according to DSM-5 by a psychogeriatrician.
• The rating of the Clinical Dementia Rating (Hughes et al., 1982) should be stage 1 (mild) or stage 2 (moderate).
• Participants should have sufficient abilities to speak, write and read in Malay language.
• Participants and relatives (caregivers) were willing to participate and consent for the study.
• Participants must have a relative, close friend, or care staff member who is willing to participate in tasks which require an informant perspective and give necessary additional life history of participant.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants were excluded from the study if they had a history of psychosis based on medical record, presence of psychiatric diagnosis (based on DSM-5) other than dementia (major neurocognitive disorders), severe physical condition or uncorrected sensory problem e.g. vision or hearing and severe dementia.

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 by minimisation (Altman & Bland, 2005) using sealed envelope.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation methods such as Minimisation
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
Baseline demographic variables differences between the two groups were assessed with chi-square test or Fisher’s exact test for categorical data and independent sample t-test for continuous variables. Repeated Measures ANOVA was used to examine the difference changes (pattern) between groups (time x group interaction). Post hoc analyses using paired t-tests with Bonferroni adjustment were used to compare the changes at each time level. The level of statistical significance was set at p<0.05. All analyses were computed using the SPSS 23.0.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/09/2015
Date of last participant enrolment
Anticipated
Actual
12/09/2019
Date of last data collection
Anticipated
Actual
27/12/2019
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 22572 0
Malaysia
State/province [1] 22572 0
W/P Kuala Lumpur
Country [2] 22573 0
Malaysia
State/province [2] 22573 0
Selangor

Funding & Sponsors
Funding source category [1] 305566 0
University
Name [1] 305566 0
Universiti Kebangsaan Malaysia
Country [1] 305566 0
Malaysia
Primary sponsor type
University
Name
University Kebangsaan Malaysia
Address
Universiti Kebangsaan Malaysia, 43600 UKM, Bangi Selangor
Country
Malaysia
Secondary sponsor category [1] 305975 0
None
Name [1] 305975 0
Address [1] 305975 0
Country [1] 305975 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305871 0
Research Ethics Commitee Unversity Kebangsaan Malaysia (RECUKM)
Ethics committee address [1] 305871 0
Ethics committee country [1] 305871 0
Malaysia
Date submitted for ethics approval [1] 305871 0
Approval date [1] 305871 0
14/05/2014
Ethics approval number [1] 305871 0

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

Contacts
Principal investigator
Name 101882 0
Dr Ponnusamy Subramaniam
Address 101882 0
Centre for Healthy Aging and Wellness
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country 101882 0
Malaysia
Phone 101882 0
+60326878185
Fax 101882 0
Email 101882 0
ponnusaami@ukm.edu.my
Contact person for public queries
Name 101883 0
Ponnusamy Subramaniam
Address 101883 0
Centre for Healthy Aging and Wellness
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country 101883 0
Malaysia
Phone 101883 0
+60326878185
Fax 101883 0
Email 101883 0
ponnusaami@ukm.edu.my
Contact person for scientific queries
Name 101884 0
Ponnusamy Subramaniam
Address 101884 0
Centre for Healthy Aging and Wellness
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country 101884 0
Malaysia
Phone 101884 0
+60326878185
Fax 101884 0
Email 101884 0
ponnusaami@ukm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Raw data; de-identified participant data will be shared which is participant data of published results only.

When will data be available (start and end dates)?
Immediately following publication and ending 5 years following main results publication.
Available to whom?
Raw de-identified participant data will be shared to researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Data available for analyses to achieve the primary and secondary research objective. Also for meta-analysis for other researchers.
How or where can data be obtained?
Data need to request with clear purpose and depend on approvals by Principal Investigator.
Data can be requested via email from PI (ponnusaami@ukm.edu.my)


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.