Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000107426
Ethics application status
Approved
Date submitted
15/01/2025
Date registered
30/01/2025
Date last updated
30/01/2025
Date data sharing statement initially provided
30/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the impact of an 8-week outpatient memory clinic program for people living with dementia and their care partner: a pilot study.
Scientific title
Evaluating the impact of an 8-week outpatient memory clinic program for people living with dementia and their care partner: a pilot study.
Secondary ID [1] 307299 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12625000014459 is the pilot study evaluating an earlier model of the outpatient memory clinic.

Health condition
Health condition(s) or problem(s) studied:
Dementia 326941 0
Condition category
Condition code
Neurological 324126 324126 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The clinic consists of a clinic room, meeting room, activity space and gym area. The programs will be designed to meet the needs of the clients following an initial clinical interview with a nurse practitioner (NP) or registered nurse (RN). The clinical interview determine the person’s goals, likes and focus areas (such as balance, strength, socialisation, quality of life etc.) to assist in allocating them to the clinics various programs (as described below).
• Programs will consist of the following face-to-face sessions held at the clinic:
Carer support group delivered by a mental health RN in the meeting room (RN) (60 minutes, every month). The carer support group focuses on topics such as carer stress, grief, dementia, transitions of care. The conversation is directed by the carers and facilitated by the mental health RN.
• Group yoga delivered by a trainer yoga instructor and RN in the gym area (30 minutes). The yoga is a low intensity class, with the instructor modifying the exercises to suit individual participant.
• Group and individual exercise interventions delivered by an exercise physiologist in the gym area (30- 60 minutes). The exercise sessions range from low to medium intensity (based on the individual). Exercises ranges from body weight exercises, resistance bands, treadmill, exercise bike, weights. The exercises are modified to suit individual participants
• Group and individual EnhaneMind sessions (60 to 180 minutes), deliver by an NP and RN in the activity room. EnhanceMind is a comprehensive program designed to provide tailored support and stimulation for people with dementia. The program integrates the benefits of cognitive exercises (such as brain games) with artistic expression and social interaction. Materials for these sessions include painting, clay, craft, drawing material, puzzles, legos, and games. The EnhanceMind sessions are designed and tailored weekly by the NP and RN to match the abilities and interests of the individual participants.
• As required appointment with a NP or RN to discuss health and wellbeing issues (30-90 minutes) held in the clinic room as requested by the participants

Participants will attend the clinic weekly, for one to four hours, for eight weeks. Participants can choose how long they spend in the clinic each week. Session attendance (including length of time at each session) will be recorded for all participants.
Intervention code [1] 323977 0
Behaviour
Intervention code [2] 323976 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340364 0
Engagement and Independence of the person living with dementia (measured as a composite primary outcome). Measured using the Engagement and Independence in Dementia Questionnaire (EID-Q).
Timepoint [1] 340364 0
T0: within two weeks prior to the 8-week program starting T1: within two weeks of completing the 8-week program
Secondary outcome [1] 443869 0
Depression (for both the person living with dementia and their care partner. Measured using the Depression Anxiety Stress Scale (DASS) 21
Timepoint [1] 443869 0
T0: within two weeks prior to the 8-week program starting T1: within two weeks of completing the 8-week program
Secondary outcome [2] 443867 0
Quality of life for the care partner. Measured using the EuroQoL-5D-5L (self reported).
Timepoint [2] 443867 0
T0: within two weeks prior to the 8-week program starting T1: within two weeks of completing the 8-week program
Secondary outcome [3] 444205 0
Stress (for both the person living with dementia and their care partner. Measured using the Depression Anxiety Stress Scale (DASS) 21
Timepoint [3] 444205 0
T0: within two weeks prior to the 8-week program starting T1: within two weeks of completing the 8-week program
Secondary outcome [4] 443868 0
Cognition of the person living with dementia. Measured using Mini-Addenbrookes Cognitive Examination (mini-ACE) III.
Timepoint [4] 443868 0
T0: within two weeks prior to the 8-week program starting T1: within two weeks of completing the 8-week program
Secondary outcome [5] 443870 0
Care giver burden of the care partner. Measured using the Zarit Burden Interview (ZBI).
Timepoint [5] 443870 0
T0: within two weeks prior to the 8-week program starting T1: within two weeks of completing the 8-week program
Secondary outcome [6] 443866 0
Quality of life for the person living with dementia. Measured using the EuroQoL-5D-5L (self or proxy reported).
Timepoint [6] 443866 0
T0: within two weeks prior to the 8-week program starting T1: within two weeks of completing the 8-week program
Secondary outcome [7] 444204 0
Anxiety (for both the person living with dementia and their care partner. Measured using the Depression Anxiety Stress Scale (DASS) 21
Timepoint [7] 444204 0
T0: within two weeks prior to the 8-week program starting T1: within two weeks of completing the 8-week program

Eligibility
Key inclusion criteria
Eligible participants must meet the following inclusion criteria:
(1) Person living with dementia:
• Over the age of 18 years old
• Clinical-confirmed diagnosis of dementia
• Able to read and understand English
• Living in the community (not residential aged care)
• Able to verbalise
• Able to provide written informed consent (Capacity for consent will be determined by process consent or have a person responsible who provides consent on their behalf.

Or
(2) Primary care partner of a person-living with dementia:
• Over the age of 18 years old
• Able to read and understand English
A care partner is defined as a family member or friend of the person living with dementia who provides emotional support, assistance with activities of daily living, and may advocate for this person in a health setting.
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 sessions due to disruptive behaviours and/or wandering behaviour, or severely impaired hearing or vision.

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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2025
Actual
Date of last participant enrolment
Anticipated
2/12/2025
Actual
Date of last data collection
Anticipated
3/02/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311591 0
University
Name [1] 311591 0
University of Wollongong
Country [1] 311591 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Country
Australia
Secondary sponsor category [1] 320559 0
Individual
Name [1] 320559 0
Kelly Marriott-Statham (University of Wollongong)
Address [1] 320559 0
Country [1] 320559 0
Australia
Secondary sponsor category [2] 313030 0
Individual
Name [2] 313030 0
Amy Montgomery (University of Wollongong)
Address [2] 313030 0
Country [2] 313030 0
Australia
Other collaborator category [1] 283362 0
Individual
Name [1] 283362 0
Rebekkah Middleton (University of Wollongong)
Address [1] 283362 0
Country [1] 283362 0
Australia
Other collaborator category [2] 283361 0
Individual
Name [2] 283361 0
Luke Molloy (University of Wollongong)
Address [2] 283361 0
Country [2] 283361 0
Australia
Other collaborator category [3] 283363 0
Individual
Name [3] 283363 0
Nathan D'Cunha (University of Canberra)
Address [3] 283363 0
Country [3] 283363 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311040 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 311040 0
Ethics committee country [1] 311040 0
Australia
Date submitted for ethics approval [1] 311040 0
05/04/2024
Approval date [1] 311040 0
10/04/2024
Ethics approval number [1] 311040 0
2022/082

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

Contacts
Principal investigator
Name 119782 0
Dr Amy Montgomery
Address 119782 0
University of Wollongong, Northfields Ave, Wollongong, NSW, 2522
Country 119782 0
Australia
Phone 119782 0
+610287636487
Fax 119782 0
Email 119782 0
[email protected]
Contact person for public queries
Name 119783 0
Kelly Marriott-Statham
Address 119783 0
University of Wollongong, Northfields Ave, Wollongong, NSW, 2522
Country 119783 0
Australia
Phone 119783 0
+610242392173
Fax 119783 0
Email 119783 0
[email protected]
Contact person for scientific queries
Name 119784 0
Amy Montgomery
Address 119784 0
University of Wollongong, Northfields Ave, Wollongong, NSW, 2522
Country 119784 0
Australia
Phone 119784 0
+610287636487
Fax 119784 0
Email 119784 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.