Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001522707
Ethics application status
Approved
Date submitted
16/01/2022
Date registered
7/12/2022
Date last updated
7/12/2022
Date data sharing statement initially provided
7/12/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Post-diagnostic support program for people with dementia and carers
Scientific title
Evaluation of the effect of a multi-component post-diagnostic support program on quality of life in people living with dementia and their carers
Secondary ID [1] 306017 0
Nil
Universal Trial Number (UTN)
U1111-1272-0817
Trial acronym
SPICE (Sustainable Personalised Interventions for Cognition, Care, and Engagement)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 324896 0
Condition category
Condition code
Neurological 322333 322333 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Sustainable Personalised Interventions for Cognition, Care, and Engagement (SPICE) Program aims to address the need for post diagnostic support for people newly diagnosed with dementia and their carers. The intervention will be delivered by allied health professionals across two, 2.5 hour visits to the University of Canberra Hospital twice per week, and individual appointments for the nutrition assessment and COPE program. The intervention includes twelve weeks of active and practical support including:
1. Physical activity (2/week for 1 hour): Participants engage in strength, mobility and aerobic exercises selected and tailored to their abilities. The circuit involves a personalised approach to physical activity in a group setting as the person with dementia (and their carer if they chose to participate) perform targeted balance, lower and upper limb strength, dual tasking, and cardiovascular fitness exercises. Some exercises also focus on maintaining bone strength and density through high-impact actions.
2. Cognitive Stimulation Therapy (2/week for 1 hour): An evidence-based non-medical therapy group intervention that is designed to encourage cognitive activity through a series of themed activities. The themes include storytelling, word games, and reminiscence.
3. Social, Emotional, and Resilience Education and Capacity Building program (1/week for one hour): Carers participate in a psychoeducational group intervention. This aims to provide actionable information to improve the quality of life for both the carer and the person with dementia as well as improve the self-efficacy of the carer through mindfulness practices. The program is delivered by a team of clinicians from clinical psychology, neuropsychology, social work, speech pathology, pharmacy, and occupational therapy. The intervention is designed based on previous literature and resources are provided by each clinician with respect to their area of focus each week.
4. Nutrition assessment and consultation (3 appointments in first 6 weeks; 1 hour long appointment, and 2 30 minute appointments): Nutrition evaluation and dietary advice for the person with dementia is provided and delivered by the University of Canberra Dietetics Clinic. This consists of a nutritional evaluation, nutritional counselling, and a nutritional review session. One counselling session is conducted online to discuss foods already in the home.
5. Care of People with Dementia in their Environments (COPE) program (1/week * 10 appointments for 1 hour): The COPE program is a structured intervention that involves 10 sessions scheduled in the participant’s home, delivered by a COPE-trained occupational therapist. These focus on identifying meaningful engagement opportunities as well as further supporting carers to implement strategies for managing identified care challenges. This component aims to improve both carer and the person with dementia’s functional capacity, engagement, and quality of life.

Attendance to each intervention component is tracked across the study.
Intervention code [1] 322622 0
Rehabilitation
Intervention code [2] 322675 0
Treatment: Other
Intervention code [3] 322676 0
Lifestyle
Comparator / control treatment
Participants are enrolled in the study on a first come first served basis until each group is fully allocated. Of the four groups, the second and fourth groups will be in the waiting-list, waiting 12 weeks before the intervention commences. There are no distinguishing traits between groups aside from the time of enrolment.
Control group
Active

Outcomes
Primary outcome [1] 330136 0
Quality of life. The primary outcome will be change in the DEMQOL (Dementia Health-related Quality of Life). The 28-item questionnaire is designed for people with dementia (DEMQOL) (Smith, Lamping et al. 2005). The DEMQOL is a self-reported, interviewer-assessed questionnaire that inquires about the person with dementia’s feelings, memory, and everyday life activities from the last week.
Timepoint [1] 330136 0
Intervention group:
T1 = Baseline/Pre-intervention
T2 = Post-intervention at week 12
T3 = Follow-up at week 24 (Primary endpoint)

Waiting-list group:
T0 = Baseline
T1 = Pre-intervention at week 12
T2 = Post-intervention at week 24
T3 = Follow-up at week 36 (Primary endpoint)
Secondary outcome [1] 404999 0
Cognitive function. The Addenbrooke’s Cognitive Examination (ACE-III) will be used to evaluate cognitive function at baseline, post-intervention and follow-up. The ACE-III is a screening measure used by CHS that includes tests of attention, orientation, memory, language, visual perception and visuospatial skills (Hodges and Larner 2017, So, Foxe et al. 2018).
Timepoint [1] 404999 0
Intervention group:
T1 = Baseline/Pre-intervention
T2 = Post-intervention at week 12
T3 = Follow-up at week 24

Waiting-list group:
T0 = Baseline
T1 = Pre-intervention at week 12
T2 = Post-intervention at week 24
T3 = Follow-up at week 36
Secondary outcome [2] 405000 0
Physical measure 1 (Timed Up & Go). It requires participants to stand from a seated position, walk 3 metres, turn, walk back, and sit down again. Time taken to complete the task is recorded.
Timepoint [2] 405000 0
Intervention group:
T1 = Baseline/Pre-intervention
T2 = Post-intervention at week 12
T3 = Follow-up at week 24

Waiting-list group:
T0 = Baseline
T1 = Pre-intervention at week 12
T2 = Post-intervention at week 24
T3 = Follow-up at week 36
Secondary outcome [3] 405001 0
Physical measure 2 (10 metre walk test). The 10 Metre Walk Test assesses walking speed in metres per second over 10 metres.
Timepoint [3] 405001 0
Intervention group:
T1 = Baseline/Pre-intervention
T2 = Post-intervention at week 12
T3 = Follow-up at week 24

Waiting-list group:
T0 = Baseline
T1 = Pre-intervention at week 12
T2 = Post-intervention at week 24
T3 = Follow-up at week 36
Secondary outcome [4] 405004 0
Physical measure 3 (30 second sit to stand). The 30 Second Sit to Stand test evaluates lower limb strength, speed and coordination. It measures the time taken to complete five sit to stand’s as fast as possible from a standard height chair (43 cm).
Timepoint [4] 405004 0
Intervention group:
T1 = Baseline/Pre-intervention
T2 = Post-intervention at week 12
T3 = Follow-up at week 24

Waiting-list group:
T0 = Baseline
T1 = Pre-intervention at week 12
T2 = Post-intervention at week 24
T3 = Follow-up at week 36
Secondary outcome [5] 405005 0
Physical measure 4 (Hand grip strength). A handgrip strength test using a Dynamometer will be undertaken by participants (Smedlay’s Dynamo Meter (100kg), Tokyo, Japan).
Timepoint [5] 405005 0
Intervention group:
T1 = Baseline/Pre-intervention
T2 = Post-intervention at week 12
T3 = Follow-up at week 24

Waiting-list group:
T0 = Baseline
T1 = Pre-intervention at week 12
T2 = Post-intervention at week 24
T3 = Follow-up at week 36
Secondary outcome [6] 405006 0
Functional ability. The 12-item World Health Organization Disability Assessment Schedule (WHODAS) is a global measure of disability and functioning (Ustün, Chatterji et al. 2010).
Timepoint [6] 405006 0
Intervention group:
T1 = Baseline/Pre-intervention
T2 = Post-intervention at week 12
T3 = Follow-up at week 24

Waiting-list group:
T0 = Baseline
T1 = Pre-intervention at week 12
T2 = Post-intervention at week 24
T3 = Follow-up at week 36
Secondary outcome [7] 405007 0
Neuropsychiatric symptoms. Neuropsychiatric symptoms will be assessed using the neuropsychiatric inventory (NPI) which is a structured validated informant interview (Cummings, Mega et al. 1994).
Timepoint [7] 405007 0
Intervention group:
T1 = Baseline/Pre-intervention
T2 = Post-intervention at week 12
T3 = Follow-up at week 24

Waiting-list group:
T0 = Baseline
T1 = Pre-intervention at week 12
T2 = Post-intervention at week 24
T3 = Follow-up at week 36
Secondary outcome [8] 405008 0
Quality of Life. The DEMQOL-Proxy is a 31-item, validated quality of life interviewer-administered questionnaire answered by the carer (Brown, Page et al. 2019) which is used to complement the DEMQOL..
Timepoint [8] 405008 0
Intervention group:
T1 = Baseline/Pre-intervention
T2 = Post-intervention at week 12
T3 = Follow-up at week 24

Waiting-list group:
T0 = Baseline
T1 = Pre-intervention at week 12
T2 = Post-intervention at week 24
T3 = Follow-up at week 36
Secondary outcome [9] 405009 0
Quality of life (carer). The C-DEMQOL measures the quality of life of carers of people with dementia (Brown, Page et al. 2019).
Timepoint [9] 405009 0
Intervention group:
T1 = Baseline/Pre-intervention
T2 = Post-intervention at week 12
T3 = Follow-up at week 24

Waiting-list group:
T0 = Baseline
T1 = Pre-intervention at week 12
T2 = Post-intervention at week 24
T3 = Follow-up at week 36
Secondary outcome [10] 416455 0
Carer well-being will be measured through the Perceived Change Index, a 13-item validated questionnaire that focuses on the carer’s self-reported change in the ability to cope and emotional state [Gillan et al., 2006]. A higher score in this questionnaire indicates an improved sense of well-being.
Timepoint [10] 416455 0
Intervention group:
T1 = Baseline/Pre-intervention
T2 = Post-intervention at week 12
T3 = Follow-up at week 24

Waiting-list group:
T0 = Baseline
T1 = Pre-intervention at week 12
T2 = Post-intervention at week 24
T3 = Follow-up at week 36

Eligibility
Key inclusion criteria
Eligible participants will be people with dementia (all forms) and their carer (as nominated by the person with dementia). Participants will be living independently in the community and will be recruited from within the ACT. People with dementia will be required to participate with a carer. The carer may be male or female, must be aged over 18 years, and providing ongoing support to the person with dementia. Potential participants will be screened using the Clinical Dementia Rating scale (CDR). Participants with mild to moderate scores of between 0.5 and 2 will be eligible to participate. Participants need to be willing to attend for greater than 10 weeks (i,e. do not have a holiday planned).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with dementia may be excluded if they are unable to engage in, or requires 1:1 support for group participation due to disruptive behaviours and/or wandering behaviour, or severely impaired hearing or vision. Participants with a CDR score of 0 and 3 will be excluded. People with dementia who do not have a carer or support person willing to participate in required program components will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Baseline demographic and cluster descriptive statistics will be summarised between the intervention and wait-list control groups. Categorical data will be summarised using frequency statistics and visualisation. Continuous and other numerical data will be visually explored and summarised using sample descriptive statistics, selected as appropriate based on apparent distributions.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/09/2022
Date of last participant enrolment
Anticipated
28/07/2023
Actual
Date of last data collection
Anticipated
27/04/2024
Actual
Sample size
Target
24
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 21487 0
The University of Canberra Hospital: Specialist Centre for Rehabilitation, Recovery and Research - Bruce
Recruitment postcode(s) [1] 36394 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 310359 0
University
Name [1] 310359 0
University of Canberra
Country [1] 310359 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
University of Canberra, University Drive, Bruce, ACT, 2617
Country
Australia
Secondary sponsor category [1] 311496 0
Government body
Name [1] 311496 0
Canberra Health Services
Address [1] 311496 0
University of Canberra Hospital, 20 Guraguma St, Bruce, ACT, 2617
Country [1] 311496 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310015 0
ACT Health
Ethics committee address [1] 310015 0
Ethics committee country [1] 310015 0
Australia
Date submitted for ethics approval [1] 310015 0
12/01/2022
Approval date [1] 310015 0
16/06/2022
Ethics approval number [1] 310015 0

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

Contacts
Principal investigator
Name 116186 0
Dr Nathan M D'Cunha
Address 116186 0
University of Canberra, University Drive, Bruce, ACT, 2617
Country 116186 0
Australia
Phone 116186 0
+61262068585
Fax 116186 0
Email 116186 0
[email protected]
Contact person for public queries
Name 116187 0
Nathan M D'Cunha
Address 116187 0
University of Canberra, University Drive, Bruce, ACT, 2617
Country 116187 0
Australia
Phone 116187 0
+61262068585
Fax 116187 0
Email 116187 0
[email protected]
Contact person for scientific queries
Name 116188 0
Nathan M D'Cunha
Address 116188 0
University of Canberra, University Drive, Bruce, ACT, 2617
Country 116188 0
Australia
Phone 116188 0
+61262068585
Fax 116188 0
Email 116188 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.