Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000885695
Ethics application status
Approved
Date submitted
14/06/2023
Date registered
17/08/2023
Date last updated
8/04/2024
Date data sharing statement initially provided
17/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising functional and social independence and safety of older people living with dementia in care homes: Implementation Research of Interdisciplinary Care Home-bAsed Reablement Program (I-CHARP)
Scientific title
Optimising functional and social independence and safety of older people living with dementia in care homes: Implementation Research of Interdisciplinary Care Home-bAsed Reablement Program (I-CHARP)
Secondary ID [1] 309904 0
Nil known
Universal Trial Number (UTN)
U1111-1293-8094
Trial acronym
I-CHARP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 330368 0
Mild cognitive impairment 330370 0
Condition category
Condition code
Neurological 327212 327212 0 0
Dementias
Neurological 327213 327213 0 0
Alzheimer's disease
Physical Medicine / Rehabilitation 327671 327671 0 0
Occupational therapy
Physical Medicine / Rehabilitation 327795 327795 0 0
Physiotherapy
Physical Medicine / Rehabilitation 327796 327796 0 0
Speech therapy
Physical Medicine / Rehabilitation 327797 327797 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The results of the recent pragmatic randomized control trial (RCT) of the Interdisciplinary Home-bAsed Reablement Program (I-HARP) have shown that a structured, evidence based and person-centred rehabilitation program delivered in the community improved daily functioning of people with mild dementia, enabling them to live longer at home. This NHMRC partnership project, Optimising functional independence of older persons with dementia: Implementation and evaluation of the Interdisciplinary Care Home-bAsed Reablement Program (I-CHARP), builds on I-HARP in order to transfer the program logic of I-HARP to residential aged care settings.

I-CHARP sessions delivered over 4-6 months by the I-CHARP clinicians (registered nurses, RNs, and occupational therapists, OTs) will include:
1) An initial comprehensive assessment (in the 1st session) performed by a) an OT for cognitive and functional abilities, strength, balance and home safety risks, and b) an RN for the medication regimen, pain, incontinence, depression and other chronic disease management issues. A case conference (30 min to 1 hour between the I-CHARP RN and OT) will take place soon after the 1st session (within a week) to discuss potential goals and strategies that the resident may consider.
2) Subsequent interdisciplinary, tailored care planning to enhance self-care ability using person-centred goal setting. I-CHARP clinicians will work closely with the person with dementia and the care staff to help them identify the goals and action strategies that the client aims to achieve in the following 3 months.
3) Implementation of the plan through a series of one-on-one sessions, including cognitive rehabilitation, combining compensatory (e.g. calendars, diaries, reminders) and restorative strategies (e.g. mnemonics, semantic association, spaced retrieval), energy conservation and task simplification strategies, balance and strength exercises, pain relief, anxiety and depression management, problem solving, medication simplification/adherence training, and minor home alterations and assistive devices.
4) I-CHARP clinicians (i.e. RNs and OTs) are employed by the partner aged care providers and will be trained and supervised by the I-CHARP trainers and CIs and AIs with rehabilitation expertise. Training involves the principles of I-CHARP, key rehabilitation interventions and strategies (e.g., comprehensive assessments, cognitive rehabilitation, motivational interviewing, goal settings, person centred care, exercise, clinical management, etc.), as well as roles and responsibilities as I-CHARP clinicians. The one off interactive three day training will be delivered in person or via online over three days (RNs and OTs trained together for 2 days and one additional day for RNs). Ongoing clinical supervision will be provided by rehabilitation experts (up to 10 sessions of ~30 min per session over the intervention period). Training will take place immediately before the intervention (within 4 weeks of the training the intervention will commence)
5) When the OT in-person session is not possible (due to lack of availability of local OT) the intervention is carried out via video telehealth conference. The method of the intervention delivery and any adjustments made will be recorded and monitored for fidelity.
6) The delivery of the I-CHARP intervention is supported through the deployment of an implementation strategy – REACH Network (a web portal that supports information and a community of practice for I-CHARP clinicians and management of intervention sites).

The I-CHARP RN will act as a case coordinator while working closely with the I-CHARP OT; The I-CHARP RN will be responsible for engaging and supporting other care staff and regular visitors closely involved in care (working as partner/collaborator in care). For example, residents reaching I-CHARP will participate in setting goals and strategies and for them to act on those strategies they are likely to require ongoing prompting and support (e.g., strength and balance exercises, using a technology device to enhance social and/or cognitive activities, etc.)

The delivery model has been co-designed with the partner organisations to ensure staff employed by the partner organisations are primary sources of the delivery, while making an allowance for the fact allied health services often require engagement of external services. Each partner organisation formed a co-design group and they were presented with the I-HARP model and invited to provide feedback. Senior management of the partner organisations are members of a consortium to allow for cross organisation discussion and consensus. Monthly co-design groups and additional consortium groups took place to discuss their existing models of care and ways to incorporate/integrate I-CHARP, with a particular focus on staffing and other resource implications. The co-design process took place over 6 months, 4 months prior to the delivery of the intervention.

I-CHARP uses the same principles and procedures as I-HARP and integrated into residential aged care services as a model of care. The different aspects of I-CHARP from I-HARP include:
1) OT sessions can be delivered via telehealth and all OT sessions are supported by RN;
2) minor home modification and/or assistive devices to the value of up to $400;
3) the frequency and length of the sessions (4-5 OT full sessions, 8-9 RN full sessions, plus ~8 RN short sessions of 15 min which can be delegated to personal care workers, PCW). Flexibility of the intervals and the length of the sessions is emphasised;
4) I-CHARP has no specific carer support sessions and instead engages the whole of the participating care home staff, managers and regular visitors; and
5) Same as I-HARP, up to 4 sessions with other allied health professionals will be supported per resident as part of I-CHARP.
Intervention code [1] 326328 0
Rehabilitation
Intervention code [2] 326329 0
Behaviour
Intervention code [3] 326330 0
Lifestyle
Comparator / control treatment
In I-CHARP the comparison group will continue care as usual, which may involve ad hoc nursing and allied health services, and environment modifications, without the components of structured cognitive rehabilitation.
Control group
Active

Outcomes
Primary outcome [1] 335086 0
Change in functional independence assessed using the·Disability Assessment for Dementia (DAD)
Timepoint [1] 335086 0
4 months post baseline (plus up to 2 months of a stop the clock period for accounting for any inevitable interruption of care delivery). Again at 12mths and 18mths post baseline as secondary outcome.
Secondary outcome [1] 422966 0
Change in quality of life assessed by Quality of Life in Alzheimer's Disease (QoL-AD), the 5-Level version of the EuroQol five dimensions (EQ-5D-5L) for health related QoL and EQ Health and Wellbeing instrument for health and wellbeing related quality of life (EQ-HWB-S).
Timepoint [1] 422966 0
4 months post baseline (plus up to 2 months of a stop the clock period for accounting for any inevitable interruption of care delivery), again at 12mths and 18mths post baseline.
Secondary outcome [2] 424766 0
Change in mobility assessed through the Short Physical Performance Battery (SPPB) for objective physical function (4-m walking speed, repeated chair stands, and standing balance in progressively more-challenging positions).
Timepoint [2] 424766 0
4 months post baseline (plus up to 2 months of a stop the clock period for accounting for any inevitable interruption of care delivery), again at 12mths and 18mths post baseline.
Secondary outcome [3] 424767 0
Change in environment safety assessed through The Home Falls and Accidents Screening Tool (Home FAST) for the adaptable overall physical environment safety.
Timepoint [3] 424767 0
4 months post baseline (plus up to 2 months of a stop the clock period for accounting for any inevitable interruption of care delivery), again at 12mths and 18mths post baseline.
Secondary outcome [4] 424768 0
Change in care quality based on routinely collected data through The National Aged Care Mandatory Quality Indicator Program.
Timepoint [4] 424768 0
4 months post baseline (plus up to 2 months of a stop the clock period for accounting for any inevitable interruption of care delivery), again at 12mths and 18mths post baseline.
Secondary outcome [5] 424769 0
Change in staff competency in person centred care using Approaches to Dementia Questionnaire
Timepoint [5] 424769 0
4 months post baseline (plus up to 2 months of a stop the clock period for accounting for any inevitable interruption of care delivery), again at 12mths and 18mths post baseline.
Secondary outcome [6] 424770 0
Change in overall healthcare costs based on individual resident participant’s information about any ED and hospital transfers (number of transfers, reasons for being sent and length of hospitalisation), GP consultations (number of visits) and specialist consultations (number and type of visits) from residents' medical records.
Timepoint [6] 424770 0
4 months post baseline (plus up to 2 months of a stop the clock period for accounting for any inevitable interruption of care delivery), again at 12mths and 18mths post baseline.
Secondary outcome [7] 425374 0
The cost of the intervention delivery (staffing, hours, environmental modifications), as well as the cost of training and supervision (from administration records kept by the project team)
Timepoint [7] 425374 0
Throughout the study period of 18 months (total cost)
Secondary outcome [8] 425375 0
Changed staff Self-Efficacy in Reablement Approaches to Care of People living with Dementia
Timepoint [8] 425375 0
4 months post baseline (plus up to 2 months of a stop the clock period for accounting for any inevitable interruption of care delivery), again at 12mths and 18mths post baseline.
Secondary outcome [9] 425376 0
Changed staff perception on their workplace environment using Wellness and Reablement Organisational Self Assessment Tool.
Timepoint [9] 425376 0
4 months post baseline (plus up to 2 months of a stop the clock period for accounting for any inevitable interruption of care delivery), again at 12mths and 18mths post baseline.
Secondary outcome [10] 425378 0
Perceptions and experiences concerning I-CHARP implementation based on focus groups/interviews with I-CHARP clinicians, managers, staff, and regular visitors)
Timepoint [10] 425378 0
6 months post baseline for the intervention group only
Secondary outcome [11] 425379 0
Resident participation/activities in I-CHARP based on the I-CHARP clinicians’ case/clinical notes and field notes
Timepoint [11] 425379 0
During the intervention period (4-6 months) for the intervention group only

Eligibility
Key inclusion criteria
Residents:
1) be current residents from Australian government approved and accredited residential aged/dementia care homes operated by the two participating aged care providers;
2) be aged 60 years or older;
3) have mild cognitive impairment (MCI), or mild to moderate dementia rated on the Global Deterioration Rating Scale for Assessment of Primary Degenerative Dementia (GDRS) 3-5; and
4) consent to study participation.

All care staff and managers will be eligible and invited to participate in the surveys (all participating sites). All care staff and managers, I-CHARP clinicians and regular visitors of the I-CHARP resident participants will be eligible and invited to qualitative interviews (intervention sites only).
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Resident:
1) is not permanent residents of the care home;
2) is in active palliative care;
3) has a burden of disease and or treatment (for example, cancer) where participating in I-CHARP would be overwhelming to them; or
4) has severe dementia (GDRS >5)

Regular visitor:
1) Visits less than once every 2 weeks
2) Unable to participate in focus groups due to cognitive, memory or time constraints.

Staff Survey - NA
Staff/Manager/ICHARP Clinician Focus groups- NA

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)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The I-CHARP study uses a hybrid design involving testing of the implementation strategy (REACH network) while observing/gathering information on the clinical intervention (I-CHARP) and related outcomes. The evaluation takes place in three cycles over four years using a cluster quasi-experimental design and qualitative methods. As an implementation trial, allocation of sites (clusters) is determined by each participating organisation's choice (not by researchers).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Differences between the intervention and comparison groups will be tested using Chi Square tests for categorical variables, and t tests and ANOVA for continuous variables. Non-parametric methods will be used as appropriate. Hierarchical Mixed Models (HMM) (IBM SPSS Statistics) will be used to test for between- and within-group differences over time in the primary outcomes in the intervention strategy, and between group differences in the implementation strategy. In secondary analyses, the baseline outcome will be used as a covariate for the remaining timepoints, as well as other covariates as appropriate (e.g., age & dementia severity). Potential confounders between the intervention and control group due to non-random sampling (e.g., rurality/remoteness, care home size, staffing levels, major outbreaks, other interventions introduced during the trial) will be entered into the mixed modelling where relevant. Analysis of the implementation strategy will also use HMMs. A within-trial cost-effectiveness analysis of the I-CHARP intervention will also be undertaken from the health/social care system perspective. Primary Analysis will be by intention-to-treat and at the individual level. We will account for all costs to implement the intervention throughout the trial process. For each resident, we will collect information related to their health service use, including episodes of hospital admission, GP or specialist visits and related services if relevant (site audit data). Costs will be valued based on government charges using publicly available data and reported in Australian dollars. Utility will be calculated from the QOL-AD and EQ5D-5L using the Australian algorithms and multiplied using the area under the curve method by the time in the trial to derive the QALYs. The cost-utility will be modelled using techniques appropriate for clustered data (accounting for the quasi-experimental nature with appropriate adjustment) and the non-normal nature of both the cost and outcome variables (e.g., generalised linear model with robust standard errors). Following the base case analysis, univariate and probabilistic sensitivity analyses will be conducted around key parameters likely to influence the cost and effectiveness estimates (incl. variability in the sampling, trial sites and resident population).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/08/2023
Actual
25/08/2023
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
30/09/2027
Actual
Sample size
Target
900
Accrual to date
117
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC

Funding & Sponsors
Funding source category [1] 314088 0
Government body
Name [1] 314088 0
National Health and Medical Research Council (NHMRC)
Country [1] 314088 0
Australia
Funding source category [2] 314496 0
Commercial sector/Industry
Name [2] 314496 0
Calvary Health Care
Country [2] 314496 0
Australia
Funding source category [3] 314497 0
Commercial sector/Industry
Name [3] 314497 0
Whiddon
Country [3] 314497 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 316003 0
None
Name [1] 316003 0
NA
Address [1] 316003 0
NA
Country [1] 316003 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313225 0
Concord Repatriation Hospital Human Research Ethics Committee
Ethics committee address [1] 313225 0
Ethics committee country [1] 313225 0
Australia
Date submitted for ethics approval [1] 313225 0
05/06/2023
Approval date [1] 313225 0
25/07/2023
Ethics approval number [1] 313225 0
2023/ETH01261

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

Contacts
Principal investigator
Name 127410 0
Prof Yun-Hee Jeon
Address 127410 0
RC Mills Building (A26) | Fisher Road | The University of Sydney | NSW |2006
Country 127410 0
Australia
Phone 127410 0
+61 2 93510674
Fax 127410 0
Email 127410 0
[email protected]
Contact person for public queries
Name 127411 0
Yun-Hee Jeon
Address 127411 0
RC Mills Building (A26) | Fisher Road | The University of Sydney | NSW |2006
Country 127411 0
Australia
Phone 127411 0
+61 2 93510674
Fax 127411 0
Email 127411 0
[email protected]
Contact person for scientific queries
Name 127412 0
Yun-Hee Jeon
Address 127412 0
RC Mills Building (A26) | Fisher Road | The University of Sydney | NSW |2006
Country 127412 0
Australia
Phone 127412 0
+61 2 93510674
Fax 127412 0
Email 127412 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.