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Trial registered on ANZCTR


Registration number
ACTRN12625000014459
Ethics application status
Approved
Date submitted
18/11/2024
Date registered
10/01/2025
Date last updated
10/01/2025
Date data sharing statement initially provided
10/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the impact of a nurse practitioner-led outpatient memory clinic for people living with dementia and their carers/families: a feasibility and pilot study.
Scientific title
Evaluating the impact of a nurse practitioner-led outpatient memory clinic for people living with dementia and their carers/families: a feasibility and pilot study.
Secondary ID [1] 313401 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 335774 0
Condition category
Condition code
Neurological 332335 332335 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Enhance is a nurse practitioner (NP)-led multidisciplinary clinic with the aim of supporting independence, wellbeing and function of people living with dementia. Both people living with dementia and their carers/ families will be able to clients at the clinic. The clinic is aiming to offer person-centred and individual care. Currently, most programs supporting people living with dementia and their carers/ families usually have a one-size fits all approach and rarely take into consideration the individual needs of the clients. 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 the NP. 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 registered nurse 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 registered nurse,
• 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 art therapy delivered by an NP and RN in the activity room (60 minutes). The art therapy includes painting, clay, craft and drawing materials,
• Group and individual cognitive stimulation delivered by an NP and RN in the activity room (60-120 minutes). The cognitive stimulation therapy includes activities such as puzzles, Lego and, games,
• 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,
• As required appointment with the nurse practitioner to discuss health and wellbeing issues (30-90 minutes) held in the clinic room as requested by the participants
The NP will design cognitive rehabilitation and cognitive simulation programs tailored to match the cognitive abilities of the individual. Participants will attend the clinic weekly, for 1-2 hours, for up to 12-months. Participants are free to choose which sessions they attend and how often they would like to attend during the 12-month period.
Intervention code [1] 329975 0
Treatment: Other
Comparator / control treatment
Nil comparator or control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339902 0
Depression, Anxiety and Stress (for both the person living with dementia and their main carer). This is a composite primary outcome.
Timepoint [1] 339902 0
At baseline and then every 3 months for a duration of 12 months.
T0 Baseline
T1 3-months
T2 6-months
T3 9-months
T4 12- months
Primary outcome [2] 339903 0
Clinic attendance
Timepoint [2] 339903 0
At each clinic attendance over the 12 month intervention period
Secondary outcome [1] 441876 0
Cognitive Impairment (person living with dementia only)
Timepoint [1] 441876 0
At baseline and then every 3 months for a duration of 12 months.
T0 Baseline
T1 3-months
T2 6-months
T3 9-months
T4 12- months
Secondary outcome [2] 441877 0
Quality of Life of the person living with dementia
Timepoint [2] 441877 0
At baseline and then every 3 months for a duration of 12 months.
T0 Baseline
T1 3-months
T2 6-months
T3 9-months
T4 12- months
Secondary outcome [3] 441878 0
Care giver burden (for the main carer only)
Timepoint [3] 441878 0
At baseline and then every 3 months for a duration of 12 months.
T0 Baseline
T1 3-months
T2 6-months
T3 9-months
T4 12- months
Secondary outcome [4] 441879 0
Activities of Daily Living of the person living with dementia
Timepoint [4] 441879 0
At baseline and then every 3 months for a duration of 12 months.
T0 Baseline
T1 3-months
T2 6-months
T3 9-months
T4 12- months
Secondary outcome [5] 442888 0
Quality of Life of the main carer
Timepoint [5] 442888 0
At baseline and then every 3 months for a duration of 12 months.
T0 Baseline
T1 3-months
T2 6-months
T3 9-months
T4 12- months

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 carer or family member of a person-living with dementia:
• Over the age of 18 years old
• Able to read and understand English
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317841 0
Commercial sector/Industry
Name [1] 317841 0
Illawarra Health and Medical Research Institute (IHMRI)
Country [1] 317841 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Country
Australia
Secondary sponsor category [1] 320171 0
None
Name [1] 320171 0
Address [1] 320171 0
Country [1] 320171 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316524 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 316524 0
[email protected]
Ethics committee country [1] 316524 0
Australia
Date submitted for ethics approval [1] 316524 0
17/03/2022
Approval date [1] 316524 0
04/05/2022
Ethics approval number [1] 316524 0
2022/082

Summary
Brief summary
Nurse practitioner (NP)-led memory clinics have the potential to be complementary models to help address the growing care for those living with dementia and their carers/ families. However, to date there is limited research evaluating the benefit of NP-led memory clinics. This research study will be a prospective cohort pilot design to evaluate a nurse practitioner-led memory clinic, Enhance. Enhance is a NP-led multidisciplinary clinic with the aim of supporting independence, wellbeing and function of people living with dementia. Both people living with dementia and their main carer will be able to clients at the clinic. Currently, most programs supporting people living with dementia and their main carer usually have a one-size fits all approach and rarely take into consideration the individual needs of the clients. The programs will be designed to meet the needs of the clients. Programs will consist of support groups, yoga, art therapy, cognitive simulation and exercise interventions. The NP will design cognitive rehabilitation and cognitive simulation programs tailored to match the cognitive abilities of the individual/ group
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138154 0
Dr Amy Montgomery
Address 138154 0
University of Wollongong, Northfields Ave, Wollongong, NSW, 2522
Country 138154 0
Australia
Phone 138154 0
+610287636487
Fax 138154 0
Email 138154 0
[email protected]
Contact person for public queries
Name 138155 0
Amy Montgomery
Address 138155 0
University of Wollongong, Northfields Ave, Wollongong, NSW, 2522
Country 138155 0
Australia
Phone 138155 0
+610287636487
Fax 138155 0
Email 138155 0
[email protected]
Contact person for scientific queries
Name 138156 0
Amy Montgomery
Address 138156 0
University of Wollongong, Northfields Ave, Wollongong, NSW, 2522
Country 138156 0
Australia
Phone 138156 0
+610287636487
Fax 138156 0
Email 138156 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.