Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000527460
Ethics application status
Approved
Date submitted
4/04/2025
Date registered
26/05/2025
Date last updated
26/05/2025
Date data sharing statement initially provided
26/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Sustainable Personalised Intervention for Care Cognition and Engagement (SPICE) at Home for people with mild to moderate dementia
Scientific title
Hybrid type 1 implementation effectiveness study exploring Sustainable Personalised Interventions for Care Cognition and Engagement (SPICE) at Home for people with mild to moderate dementia on occupational performance in the home environment
Secondary ID [1] 313757 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 336357 0
Condition category
Condition code
Neurological 332892 332892 0 0
Dementias
Neurological 332893 332893 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SPICE at Home is a complex intervention designed to support people with mild to moderate dementia and their care partners through personalised, goal-directed interventions. The Occupational Therapist will use the Canadian Occupational Performance Measure (COPM) to identify priority goals and guide the development of the intervention. If indicated, participants will receive an assessment from a Physiotherapist to incorporate physical components into their goals. The initial consultation will be 1-2 hours and aims to gather the information required to design a personalised intervention. The Occupational Therapist and as needed, Physiotherapist, will collaborate to develop a personalised intervention plan, which will be referred to the Allied Health Assistant for implementation. The Occupational Therapist will break down overarching goals into smaller, achievable goals for each session, considering safety risks and individual goals. The six sessions will be scheduled over up to 12 weeks, depending on the participant's goals and appropriate intensity. Each session will be up to 90 minutes in duration and will be adaptable based on the pre-prepared goals and interventions. Each session will commence with a standardised cognitive stimulation exercise for the purpose of familiarity.
Each session will aim to consolidate and build upon the previous sessions. A resource pack, created by the Allied Health Assistant, will be provided to the participants at the completion of the intervention. This pack will include step-by-step guides with pictures, person-specific instructions, and visual cues to promote ongoing maintenance of the goals achieved during the intervention.
Fidelity to the intervention will be achieved through the development of a manual with a guide around the structure for each session for the Allied Health Assistant, Occupational Therapist, and Physiotherapist to be guided by.
Activities that are related to occupational performance will be developed by the occupational therapist.
Examples of activities that may be included are as follows:
- Self-care activities (E.g., engaging in gardening, or putting on music and dancing to it)
- Leisure activities (E.g., engaging in a board game or forest bathing)
- Productivity activities (E.g., folding and putting away laundry)
- Social engagement (E.g., planning and attending a coffee catch-up with a friend)
- Physical activity (E.g., going for a planned walk or exercise routine)
- Meaningful occupation (E.g., helping prepare a shopping list for a meal)
- Cognitive activity (E.g., engaging in completion of a puzzle or developing a journal of the person’s life)
Activities that are related to mobility and exercise will be developed by the physiotherapist where identified as being related to one of the person's goals or when clinically necessary.
All activities will be delivered by the allied health assistant with clinical supervision and guidance from the occupational therapist and/or physiotherapist.
The sessions will be delivered over a minimum period of 6 weeks and a maximum period of 12 weeks. The decision for delivery over 6 or 12 weeks will be person-centred and driven by the participant and not dependent on the actual activity.
Intervention code [1] 330412 0
Treatment: Other
Intervention code [2] 330413 0
Rehabilitation
Intervention code [3] 330414 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340524 0
Occupational performance within the participant’s home environment
Timepoint [1] 340524 0
Baseline, post-intervention (within one week of final session), 6 months post-intervention completion, and 12 months post-intervention completion.
Secondary outcome [1] 444344 0
Independence and engagement
Timepoint [1] 444344 0
Baseline, post-intervention (within one week of final session), 6 months post-intervention completion, and 12 months post-intervention completion.
Secondary outcome [2] 445075 0
Service use
Timepoint [2] 445075 0
Baseline, post-intervention (within one week of final session), 6 months post-intervention completion, and 12 months post-intervention completion.
Secondary outcome [3] 445076 0
Hospitalisations
Timepoint [3] 445076 0
Baseline, post-intervention (within one week of final session), 6 months post-intervention completion, and 12 months post-intervention completion.
Secondary outcome [4] 445077 0
Falls
Timepoint [4] 445077 0
Baseline, post-intervention (within one week of final session), 6 months post-intervention completion, and 12 months post-intervention completion.
Secondary outcome [5] 445078 0
Quality of life
Timepoint [5] 445078 0
Baseline, post-intervention (within one week of final session), 6 months post-intervention completion, and 12 months post-intervention completion.
Secondary outcome [6] 445090 0
Satisfaction with the intervention.
Timepoint [6] 445090 0
Post intervention (within one week of final session).
Secondary outcome [7] 445091 0
Physical performance.
Timepoint [7] 445091 0
Baseline, post-intervention (within one week of final session), 6 months post-intervention completion, and 12 months post-intervention completion.

Eligibility
Key inclusion criteria
- Able to consent to participation
- Dementia diagnosis (any type) by a health professional
- A rating of 0.5-2 on the Clinical Dementia Rating Scale (CDR)
- People with a CDR of 2 will be required to be supported by a care partner or supporter who will be present at each session
- Be willing, interested, and able to participate in six sessions and consent to home visits
- ACT resident
- Participants must be experiencing challenges relating to living with dementia in the community, including:
• Living alone, socially isolated, or without support of a family member or care partner and/or
• With a care partner or family members who are experiencing challenges supporting the person to be engaged in their home and/or
• Do not currently have reliable transport to access health or community services
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Not able to consent
- No formal dementia diagnosis (any type)
- CDR score of 0 or 3
- Significant changed behaviours and unable to engage with allied health professionals
- Non-ACT resident
- Already accessing and satisfied with community supports (e.g., have a support/case worker in place, social support for respite, attend day respite regularly)

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
30/12/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 318211 0
Government body
Name [1] 318211 0
ACT Health Research and Innovation Fund
Country [1] 318211 0
Australia
Primary sponsor type
Hospital
Name
University of Canberra Hospital
Address
Country
Australia
Secondary sponsor category [1] 320722 0
University
Name [1] 320722 0
University of Canberra
Address [1] 320722 0
Country [1] 320722 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316860 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 316860 0
Ethics committee country [1] 316860 0
Australia
Date submitted for ethics approval [1] 316860 0
05/02/2025
Approval date [1] 316860 0
07/05/2025
Ethics approval number [1] 316860 0

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

Contacts
Principal investigator
Name 139230 0
Ms Clare Stephenson
Address 139230 0
University of Canberra 20 Guraguma St Bruce ACT 2617
Country 139230 0
Australia
Phone 139230 0
+61 262068585
Fax 139230 0
Email 139230 0
[email protected]
Contact person for public queries
Name 139231 0
Nathan D'Cunha
Address 139231 0
University of Canberra 20 Guraguma St Bruce ACT 2617
Country 139231 0
Australia
Phone 139231 0
+61 262068585
Fax 139231 0
Email 139231 0
[email protected]
Contact person for scientific queries
Name 139232 0
Nathan D'Cunha
Address 139232 0
University of Canberra 20 Guraguma St Bruce ACT 2617
Country 139232 0
Australia
Phone 139232 0
+61 262068585
Fax 139232 0
Email 139232 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.