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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.
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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.
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Secondary ID [1]
307299
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
ACTRN12625000014459 is the pilot study evaluating an earlier model of the outpatient memory clinic.
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Health condition
Health condition(s) or problem(s) studied:
Dementia
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Condition category
Condition code
Neurological
324126
324126
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0
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Dementias
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
323977
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Behaviour
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Intervention code [2]
323976
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Treatment: Other
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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).
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Assessment method [1]
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Timepoint [1]
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T0: within two weeks prior to the 8-week program starting T1: within two weeks of completing the 8-week program
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Secondary outcome [1]
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Depression (for both the person living with dementia and their care partner. Measured using the Depression Anxiety Stress Scale (DASS) 21
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Assessment method [1]
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Timepoint [1]
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T0: within two weeks prior to the 8-week program starting T1: within two weeks of completing the 8-week program
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Secondary outcome [2]
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Quality of life for the care partner. Measured using the EuroQoL-5D-5L (self reported).
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Assessment method [2]
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Timepoint [2]
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T0: within two weeks prior to the 8-week program starting T1: within two weeks of completing the 8-week program
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Secondary outcome [3]
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Stress (for both the person living with dementia and their care partner. Measured using the Depression Anxiety Stress Scale (DASS) 21
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Assessment method [3]
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Timepoint [3]
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T0: within two weeks prior to the 8-week program starting T1: within two weeks of completing the 8-week program
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Secondary outcome [4]
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Cognition of the person living with dementia. Measured using Mini-Addenbrookes Cognitive Examination (mini-ACE) III.
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Assessment method [4]
443868
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Timepoint [4]
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T0: within two weeks prior to the 8-week program starting T1: within two weeks of completing the 8-week program
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Secondary outcome [5]
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Care giver burden of the care partner. Measured using the Zarit Burden Interview (ZBI).
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Assessment method [5]
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Timepoint [5]
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T0: within two weeks prior to the 8-week program starting T1: within two weeks of completing the 8-week program
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Secondary outcome [6]
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Quality of life for the person living with dementia. Measured using the EuroQoL-5D-5L (self or proxy reported).
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Assessment method [6]
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Timepoint [6]
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T0: within two weeks prior to the 8-week program starting T1: within two weeks of completing the 8-week program
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Secondary outcome [7]
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Anxiety (for both the person living with dementia and their care partner. Measured using the Depression Anxiety Stress Scale (DASS) 21
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Assessment method [7]
444204
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Timepoint [7]
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T0: within two weeks prior to the 8-week program starting T1: within two weeks of completing the 8-week program
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
4/02/2025
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Actual
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Date of last participant enrolment
Anticipated
2/12/2025
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Actual
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Date of last data collection
Anticipated
3/02/2026
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Wollongong
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Wollongong
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Address
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Kelly Marriott-Statham (University of Wollongong)
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Address [1]
320559
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Country [1]
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Australia
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Secondary sponsor category [2]
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Individual
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Name [2]
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Amy Montgomery (University of Wollongong)
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Address [2]
313030
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Country [2]
313030
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Australia
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Other collaborator category [1]
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Individual
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Name [1]
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Rebekkah Middleton (University of Wollongong)
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Address [1]
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Country [1]
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Australia
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Other collaborator category [2]
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Individual
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Name [2]
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Luke Molloy (University of Wollongong)
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Address [2]
283361
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Country [2]
283361
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Australia
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Other collaborator category [3]
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Individual
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Name [3]
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Nathan D'Cunha (University of Canberra)
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Address [3]
283363
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Country [3]
283363
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Wollongong Human Research Ethics Committee
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Ethics committee address [1]
311040
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uow-humanethics@uow.edu.au
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Ethics committee country [1]
311040
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Australia
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Date submitted for ethics approval [1]
311040
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05/04/2024
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Approval date [1]
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10/04/2024
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Ethics approval number [1]
311040
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2022/082
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Summary
Brief summary
Nurse-led memory clinics have the potential to be complementary models to help address the growing care for those living with dementia and their care partners. However, to date there is limited research evaluating the benefit of nurse-led memory clinics. This research will be a pilot study to evaluate a nurse-led memory clinic, Enhance. Enhance is a nurse-led multidisciplinary clinic with the aim of supporting independence, wellbeing and function of people living with dementia. Both people living with dementia and their care partner will be able to clients at the clinic.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Amy Montgomery
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Address
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University of Wollongong, Northfields Ave, Wollongong, NSW, 2522
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Country
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Australia
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Phone
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+610287636487
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Kelly Marriott-Statham
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Address
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University of Wollongong, Northfields Ave, Wollongong, NSW, 2522
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Country
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Australia
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Phone
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+610242392173
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Amy Montgomery
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Address
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University of Wollongong, Northfields Ave, Wollongong, NSW, 2522
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Country
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Australia
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Phone
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+610287636487
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Fax
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Email
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[email protected]
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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.
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