Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000235505
Ethics application status
Approved
Date submitted
22/01/2024
Date registered
11/03/2024
Date last updated
11/03/2024
Date data sharing statement initially provided
11/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Integrated care for people living with memory problems.
Scientific title
Testing the impact of a nurse-led care co-ordination on days living in the community and improving quality of life among people living with dementia and their carers.
Secondary ID [1] 310728 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 331669 0
Condition category
Condition code
Neurological 328396 328396 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
People with dementia and carers allocated to the intervention arm will be referred to a Dementia Nurse. Dementia Nurses for this project will be employed by our Partner Organisation – Hunter Primary Care. The Dementia Nurse’s role will be to provide direct support to the person with dementia, their carer and GP/general practice nurse through care-coordination. The intervention will comprise:

Assessing needs and priorities of the person with dementia and their carer (Dementia Nurse, person with dementia and carer. The nurse will conduct a home visit and complete a wellbeing assessment. This will assess the person’s need for additional help across a range of areas including mobility/ functional, health care needs, mental health and practical support. This is expected to take 1-2 hours and may be spread over 2 visits if required. The assessment will occur within 4 weeks of trial enrolment. The nurse will provide feedback on the assessment results to the person with dementia and their carer. A shared-decision making approach will be used to identify priorities for care planning.

Case conference consultation (Dementia Nurse, GP and practice nurse). The Dementia Nurse will organize a case conference with the patient’s GP and practice nurse. Results of the Dementia Nurse assessment and any recommendations arising from this will be discussed.

Facilitating timely communication across settings: The Dementia Nurse will recommend that the general practice nurse provide the patient and carer with a copy of the patient’s Health Summary. This is an automated summary that is produced by practice software that shows the patient’s key diagnoses and medications. They will be asked to advise the carer that in the event of an unplanned transition (e.g., ED presentation), they should provide the health summary to the treating doctor.

Care co-ordination and integration (Dementia nurse). In line with any agreements with the GP and general practice nurse, the Dementia Nurse will follow-up on referrals to community programs, Dementia Australia, community nursing, and assist the person to navigate the aged care system.

Brief interventions (Dementia nurse, person with dementia and carer, up to 4 sessions).
The Dementia Nurse will provide up to 4 targeted sessions with the person with dementia and their carer. The focus of these will be informed by priority issues identified in the assessment and care plan. These are expected to be 45 minutes in duration and to occur monthly following the needs assessment.

Review and second case conference (Dementia nurse, occurs 6 months post referral). The nurse will re-assess the person with dementia’s needs and discuss the adequacy of existing supports with them and their carer. This will occur 6 months post enrollment with the assessment taking 1-2 hours. The Dementia Nurse will contact the patient’s GP and offer to participate in a second case conference to feedback results of the reassessment as well as any other issues arising from the brief interventions delivered. This will occur within 4 weeks of the second needs assessment (i.e. 7 months post enrollment).



Addressing carer needs. The intervention will address carer needs as well. Carers will attend Dementia Nurse sessions with the person with dementia and will learn strategies to support their family member at home. Care co-ordination aspects of the intervention will relieve the role of the carers in navigating the health system. Carers will also be supported to discuss, together with the patient, safety issues and planning for future healthcare transitions. If the carer is identified as being depressed or needing their own aged care services then the carer will be supported to access these. Carers will be able to contact the Dementia nurse with questions in between scheduled appointments and will be given information about where to access help outside of business hours.

Delivery of the intervention will be completed by 7 months post enrollment for each participant.

Patient management records kept by the nurse will be audited to determine whether needs assessment, case conferences and brief intervention sessions have been completed for each client.
Intervention code [1] 327135 0
Lifestyle
Intervention code [2] 328047 0
Behaviour
Comparator / control treatment
Usual care arm
At diagnosis, geriatricians may refer to myagedcare and Dementia Australia. GPs manage ongoing care, however, there is no established common structured method for assessing needs, or facilitating access to multidisciplinary care or interventions aimed at improving quality of life.
Control group
Active

Outcomes
Primary outcome [1] 336235 0
Days spent in the community
Timepoint [1] 336235 0
12 month post enrollment.
Secondary outcome [1] 427477 0
Quality of life (QoL) (people with dementia). This will be administered via interview.
Timepoint [1] 427477 0
Baseline (enrollment), 6 months' post enrollment, 12 months post enrollment.
Secondary outcome [2] 432021 0
Quality of life (carers) will be assessed by self administered questionnaire.
Timepoint [2] 432021 0
Baseline (at enrollment), 6 months post enrollment and 12 months post enrollment.

Eligibility
Key inclusion criteria
Eligibility criteria for people with dementia
People who are aged 65 or older, have a medical diagnosis of any type and stage of dementia or who have suspected dementia with a score of 82 or below on the Addenbrooke's Cognitive Examination - III (ACE - III), attend a participating health or support service, are living in the community, and have an adult carer.

Eligibility criteria for carers
Participants with dementia will be asked to nominate an informal, adult carer. This will be defined as a person who is the main source of practical and / or emotional support for the person with dementia.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who have a clinician-judged life expectancy of less than 12 months or who are receiving intensive and ongoing support from the Community Dementia Service will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Using a randomised controlled design, people with dementia and their carers will be randomly assigned as a dyad to the intervention or usual care arm. Randomisation will occur after baseline data collection, thus allocation will be concealed at the time of recruitment into the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
People with dementia and carers will be randomised as a unit using a computer-generated randomisation sequence with block sizes of 4-6.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis
Analytic strategies will follow current CONSORT guidelines including conducting analysis according to original assigned groups as the primary analytic framework with clear explanation of inclusion rules in all supplementary analyses. Analysis will follow the intention to treat principles. People with dementia and carers’ data will be analysed separately. Differences between groups in participants’ quality of life at 12 months follow-up will be assessed using linear mixed effects regression. The model for people with dementia will focus on days in community as the outcome variable; the secondary analysis focusing on time to first hospitalisation will be done using a competing risk model, where competing risk will be mortality, i.e., those who die cannot then have an admission to hospital. Models for the analysis of QoL will use linear mixed models to handle repeated measures of QoL at baseline, 6, and 12 months; these mixed models allow for some missing data by using the others in the sample to extrapolate the trajectory. Differences in dichotomous secondary outcomes will be assessed using logistic mixed effects models, and differences in count outcomes (frequency of review) will be assessed using Poisson (or negative binomial) mixed models.

Qualitative analysis
An inductive Thematic Analysis will be used to analyse the transcribed interview data, using Nvivio 12 to assist in the qualitative aspects of the analysis. This type of analysis is appropriate as it is deemed important for theme generation to be a largely inductive process which will allow for an exploratory identification of all aspects of the participant experience relating to perceived acceptability, intervention usefulness, and recommendation for scale-up.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/03/2024
Actual
Date of last participant enrolment
Anticipated
27/03/2026
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
460
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26075 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 41930 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 314951 0
Government body
Name [1] 314951 0
Australian Department of Health and Aged Care, Medical Research Future Fund
Country [1] 314951 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan. NSW 2308
Country
Australia
Secondary sponsor category [1] 316957 0
None
Name [1] 316957 0
Address [1] 316957 0
Country [1] 316957 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313931 0
Hunter New England Local Health District Human Research Ethics Committee
Ethics committee address [1] 313931 0
Ethics committee country [1] 313931 0
Australia
Date submitted for ethics approval [1] 313931 0
27/09/2023
Approval date [1] 313931 0
24/10/2023
Ethics approval number [1] 313931 0
2023/ETH01221

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

Contacts
Principal investigator
Name 129834 0
Prof Mariko Carey
Address 129834 0
School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, NSW 2308
Country 129834 0
Australia
Phone 129834 0
+61 02 40420702
Fax 129834 0
Email 129834 0
Mariko.Carey@newcastle.edu.au
Contact person for public queries
Name 129835 0
Mariko Carey
Address 129835 0
School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, NSW 2308
Country 129835 0
Australia
Phone 129835 0
+61 02 40420702
Fax 129835 0
Email 129835 0
Mariko.Carey@newcastle.edu.au
Contact person for scientific queries
Name 129836 0
Mariko Carey
Address 129836 0
School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, NSW 2308
Country 129836 0
Australia
Phone 129836 0
+61 02 40420702
Fax 129836 0
Email 129836 0
Mariko.Carey@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Our ethics approval does not permit sharing of individual level data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20577Study protocol    This will be submitted for publication to an open ... [More Details]



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.