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Trial registered on ANZCTR


Registration number
ACTRN12618000600246
Ethics application status
Approved
Date submitted
9/04/2018
Date registered
18/04/2018
Date last updated
17/11/2022
Date data sharing statement initially provided
6/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising functional independence of older persons with dementia: Evaluation of the Interdisciplinary Home-bAsed Reablement Program (I-HARP)
Scientific title
A multicentre pragmatic parallel-arm stratified randomised trial of the Interdisciplinary Home-bAsed Reablement Program (I-HARP) for improving functional independence of community dwelling older people with dementia
Secondary ID [1] 294525 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 307296 0
Condition category
Condition code
Neurological 306413 306413 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
I-HARP is an adaptation and expansion of a US reablement program, which addresses common challenges that frail older people commonly experience, including environmental risks for disability, functional decline and multimorbidities. I-HARP is underpinned by person-environment fit theory, disablement processes, and lifespan theory of control and resilience. Practice approaches use individualised, client-directed goal setting and care planning guided by the principles of motivational interviewing and interdisciplinary team work. Further, tailored to the unique needs of people with dementia, I-HARP incorporates the principles of cognitive rehabilitation, comprehensive cognitive and functional assessment, person-centred dementia care, shared decision making, partnership with the carer, and carer support.

The I-HARP consists of the following components and will be delivered over a 4 month period:
1) Up to 12 home visits of 1.5 hours (5-6 x Occupational Therapy (OT), 3-4 x Registered Nurse (RN), plus 2-4 additional options of allied-health support), tailored to the individual client’s needs.

RN Visit 1: Introduction, comprehensive RN clinical assessment with a particular focus on medication regimen, pain, incontinence, depression, sleep and other chronic disease management
RN Visit 2: brainstorming strategies, setting goals using the Bangor Goal Setting Interview (BGSI), action plans incorporating cognitive rehabilitation strategies, exercise regimen, medication management
RN Visit 3: reviewing the goals and strategies, communicating with healthcare providers where necessary, supporting the implementation of action plans, monitoring goals and strategies
RN Visit 4: Review of goals and action plans, and working out planning for the future to promote continued independence

OT Visits 1 and 2: Introduction, comprehensive OT assessment with a particular focus on cognitive and functional abilities, home safety and risk assessment, home modification/assistive devices work order.
OT Visits 3 to 5: brainstorming strategies, goal setting using the BGSI, action plans incorporating cognitive rehabilitation strategies, implementation of strategies, monitoring goals, adapting strategies to maximise independence, strength and balance exercises (may be shared with RN).
OT Visit 5 or 6: Review goals and action plans, identify successful strategies that improved performance and develop action plan to promote ongoing independence, review strength and balance exercises.

2) Minor home modification/home repairs and/or provision of assistive devices (up to value $1000), to improve home safety.

3) Three individual carer support sessions of 1.5 hours at the beginning, middle and end of home visits by a Case Coordinator (CC). The support session begins with a brief education of dementia and its impact, principles of reablement and person-centred care, and the goal of I-HARP, as well as discussing the carer’s role, needs and concerns (e.g. using activities in daily care, self-care, communication, enabling the person, and any issues arising from I-HARP). The 2nd and 3rd sessions cover the progress of I-HARP and any issues, challenges and concerns relevant to the implementation of I-HARP and carer needs. The 3rd session concludes with planning for future to ensure continuity of I-HARP.

The program will be tailored to suit each participant's needs, which will be determined following comprehensive assessments by the I-HARP interventionists (OT, RN and CC). Following the initial assessments, an interdisciplinary action plan with set goals and strategies will be formulated. To ensure interdisciplinary team work a case conference and ongoing communications will be maintained among the interventionists at each site.

The total number of home visits is set (a minimum of 10 and a maximum of 12). A minimum of 3 and a maximum of 4 visits by RN and a minimum of 5 and a maximum of 6 visits by OT. Following 1 carer support, 1 RN and 2 OT visits, an interdisciplinary case conference will be held among the I-HARP interventionists, during which a comprehensive care plan for each person with dementia will be discussed. The need for other allied health services (who will refer to, which allied health service and when) will be discussed during this case conference. The total number of home visits by each I-HARP clinician will be determined during this session, based on the tailored care plan for that particular person. However, the number of visits may change later stage if needed after the team discussion.

Participants (person with dementia and his/her carer) will be recruited across 3 public hospitals and 2 aged care services. The interventionists are the staff of the participating organisations, who have been trained to deliver respective components of I-HARP.

The treatment fidelity plan includes the following:
The site personnel (I-HARP interventionists) delegated to deliver the intervention will be selected carefully to ensure that they have the necessary qualifications, skills and experience to deliver the intervention to the expected standard. I-HARP clinicians will require a minimum 2 years of experience in the field and person centred care practice. At the commencement of the study (prior to participant recruitment), group training sessions will be held for I-HARP clinicians (RNs and OTs) and case coordinators from all sites. Participants of the training sessions will be provided with training manuals and will be trained in assessment tools and intervention techniques. The aim of the training sessions is to ensure that the intervention is delivered at a consistent standard by each clinician and case coordinator at each site.

The training manual is specifically designed for I-HARP taking into account the specific needs of people with dementia and their carers. It is based on the I-HARP pilot study training material which was an adaptation of the US CAPABLE program to address. The US CAPABLE is designed for older people without cognitive impairment or dementia and there is no carer support component. Refer to the reference:
Szanton SL, Wolff JW, Leff B, et al. CAPABLE trial: A randomized controlled trial of nurse, occupational therapist and handyman to reduce disability among older adults: Rationale and design. Contemporary Clinical Trials 2014; 38(1): 102-12.

I-HARP clinicians and case coordinators will be provided with scripts and checklists to maintain the consistency of delivery of intervention across individuals and sites. They will be asked to adhere to the guidelines and instructions provided. Collection of field notes and case notes will be monitored fortnightly by the project manager and the trial coordinator under the supervision of the chief investigator. The I-HARP checklist, detailed session notes of what has been planned and achieved for each home visit, and 20% of the audio recorded case conferences and home visit sessions will be randomly selected and reviewed by two of the chief investigators (CIA and CIG) and I-HARP trainers for quality check. The delivery of the interventions, and participant compliance with the intervention will be monitored. If the study assessments are carried out by more than one assessor, the inter-rater variability will be tested using a separate cohort of volunteers.

With amended ethics approval in response to the pandemic in 2020, in-person home visits for existing I-HARP intervention recipients were replaced by telephone/video conference as a temporary measure (27 March and 31 May). Those study participants were fully briefed of the options and their consent was obtained prior to the session.

After careful re-assessment of the health risks associated with the pandemic in May 2020, the research team sought and obtained amended approval from the Ethics Committee to resume face-to-face home visits with safety precautionary measures in place (7 May 2020), which were strictly adhered to by the I-HARP clinicians. Since then, all new and active study participants were informed of this modification and their verbal and written consent were obtained prior to the session regardless their decision to receive telehealth (telephone/video conferencing) or face-to-face in-person home visit. Any changes in the delivery mode continue to be monitored and recorded, which will be taken into account in data analysis.

The team resumed all face-to-face home visit assessment for new enrollments in the first week of June 2020 (fortnightly reporting to the ethics office were in place till the end of October 2020, and from November 2020, monthly reporting were in place) and continued face-to-face home visits with the approved pandemic safety measures in place. All participants had the option to have their intervention delivered via face-to-face home visits or via telehealth until June 2021.

Due to a highly infectious new variant emerging, a major public health order was again introduced in the last week of June 2021 (continued till mid October 2021). Following advice from the Ethic Office, the research team again ceased all face-to-face in person home visits (telehealth only allowed, which affected two dyads in the intervention group).

Any changes in the delivery mode have been recorded, which will be taken into account in data analysis.

In addition, an additional hospital, which is part of the service linked to the existing hospital site, has been invited to join the trial to address delays in recruitment. Therefore, the total number of hospitals participating in the trial is 4.
Intervention code [1] 300825 0
Rehabilitation
Comparator / control treatment
The control group will be allowed to receive usual care under their hospital or community based aged care services, which may involve ad hoc nursing and allied health services, and home modifications, without the components of structured cognitive rehabilitation. The ‘usual care’ refers to the standard healthcare and aged care services the person with dementia will receive in their everyday life, based on his/her needs, irrespective of their involvement in I-HARP. Being in the study does not restrict them from receiving their standard care.
Control group
Active

Outcomes
Primary outcome [1] 305425 0
Mean functional independence score (measured using Disability Assessment for Dementia -DAD)
Timepoint [1] 305425 0
Baseline, 20 weeks post commencement of intervention (primary outcome) and 52 weeks (secondary) post commencement of intervention
Secondary outcome [1] 345173 0
Mean quality of life score (measured by Quality of life in Alzheimer's disease, QOL-AD)
Timepoint [1] 345173 0
Baseline, 20 weeks post commencement of intervention and 52 weeks post commencement of intervention
Secondary outcome [2] 345174 0
Mean mobility score (measured by Short Physical Performance Battery, SPPB)
Timepoint [2] 345174 0
Baseline, 20 weeks post commencement of intervention and 52 weeks post commencement of intervention
Secondary outcome [3] 345175 0
Mean depressive symptoms score (measured by Collateral Source version Geriatric Depression Scale-15 item, CS-GDS-15)
Timepoint [3] 345175 0
Baseline, 20 weeks post commencement of intervention and 52 weeks post commencement of intervention
Secondary outcome [4] 345177 0
Mean health related quality of life score (measured by 5-Level version of the EuroQol five dimensions, EQ-5D-5L).

This outcome will be measured in both the carer and the client with dementia
Timepoint [4] 345177 0
Baseline, 20 weeks post commencement of intervention and 52 weeks post commencement of intervention
Secondary outcome [5] 345178 0
Mean carer burden score (measured by Zarit Burden Inventory, ZBI)
Timepoint [5] 345178 0
Baseline, 20 weeks post commencement of intervention and 52 weeks post commencement of intervention
Secondary outcome [6] 345179 0
Mean home environment safety score (measured by The Home Safety Self-Assessment Tool, HSSAT)
Timepoint [6] 345179 0
Baseline, 20 weeks post commencement of intervention and 52 weeks post commencement of intervention
Secondary outcome [7] 345180 0
Costs of the delivery of the intervention (I-HARP) and all contributing costs (i.e. training of interventionists, care coordination, travel, supervision, minor home modifications/assistive devices), monitored and recorded by I-HARP project team.
Timepoint [7] 345180 0
Baseline, 20 weeks post commencement of intervention and 52 weeks post commencement of intervention
Secondary outcome [8] 345720 0
Costs to the participants including healthcare/aged care/community services used by the participants, medication costs and any other costs associated with falls and minor/injuries to the client with dementia, and carer workforce participation. The information will be recorded by the carer on an ongoing basis using the ‘carer diary’ provided to the carer. This information will be collected monthly via a phone call to the carer.
Timepoint [8] 345720 0
Baseline, 20 weeks post commencement of intervention and 52 weeks post commencement of intervention
Secondary outcome [9] 345721 0
Incidents of unplanned hospital admission
Timepoint [9] 345721 0
Baseline, 20 weeks post commencement of intervention and 52 weeks post commencement of intervention
Secondary outcome [10] 345722 0
Events of primary care (GP) visit
Timepoint [10] 345722 0
Baseline, 20 weeks post commencement of intervention and 52 weeks post commencement of intervention
Secondary outcome [11] 345723 0
Events of residential aged care home admission
Timepoint [11] 345723 0
Baseline, 20 weeks post commencement of intervention and 52 weeks post commencement of intervention
Secondary outcome [12] 345724 0
Incidents of falls and other minor injuries
Timepoint [12] 345724 0
Baseline, 20 weeks post commencement of intervention and 52 weeks post commencement of intervention
Secondary outcome [13] 345725 0
Events of aged care service use
Timepoint [13] 345725 0
Baseline, 20 weeks post commencement of intervention and 52 weeks post commencement of intervention
Secondary outcome [14] 345726 0
Mean hours of carer paid workforce participation
Timepoint [14] 345726 0
Baseline, 20 weeks post commencement of intervention and 52 weeks post commencement of intervention
Secondary outcome [15] 345744 0
Other system costs that occur to the healthcare system (secondary outcomes #9-13 multiplied by unit costs derived in the literature)
Timepoint [15] 345744 0
Baseline, 20 weeks post commencement of intervention and 52 weeks post commencement of intervention

Eligibility
Key inclusion criteria
Participants should meet the following criteria to be eligible to be included in the study:
• Should be 60 years or over
• Have mild to moderate dementia as rated by the Global Deterioration Rating Scale for Assessment of Primary Degenerative Dementia (GDRS), Stage 4-5 (mild-moderate)
• Have conversational English language ability
• Have a cognitively able carer who has at least four days or seven hours per week contact
• Provides consent for participation in study(both participant with dementia and carer must consent)
• Agrees to be randomised

There is no other specific criteria for carer (see Point 4).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Potential participants who meet any of the following criteria should be excluded from the study:
• Have a terminal illness with <1 year expected survival or having active cancer therapy
• Plan to move in <1 year
• On a cholinesterase inhibitor, and have not been on a stable dose for at least 3 months
• Have severe dementia (GDRS >5)
• Have a home environment that is deemed unsafe for the I-HARP clinicians and assessors to carry out home visits (following pre-home visit safety screening)
• Have enrolled into another similar intervention trial to I-HARP.

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)
Opaque sequentially numbered envelopes will be used to maintain allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed separately for each recruitment site (each hospital geriatric service and aged care service), and will be stratified by severity of dementia (mild according to GDRS 4 vs moderate according to GDRS 5). Randomisation sequence will be generated by computer-generated random permuted blocks of varying size.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Each indicator of the implementation outcomes will be analysed using descriptive and inferential statistics as well as qualitative content analysis. Intention-to-treat analysis of the primary outcomes (using the DAD) will include an unadjusted comparison between intervention and control groups at Time 2 (short-term effect) and Time 3 (longer-term effect) using two sample t-tests of the change from baseline. Secondary analyses will use linear regression to adjust for the baseline value of that outcome, recruitment centre and other covariates (age, severity of cognitive impairment, and pension status).

The economic evaluation of I-HARP will involve costing the intervention itself (e.g. clinicians’ training time, delivery, travel, supervision, care coordination time, minor home modification/assistive devices, intervention materials) and any change in carer workforce participation and health-related client costs over the 52-week period (medications, allied health services, community/aged care, visits to specialists, GPs, hospitals). By combining these cost data with outcome data, relating to mortality and health-related quality of life (using the EQ-5D), a cost-utility analysis will be undertaken, reporting a cost per quality-adjusted life year (QALY) of the I-HARP intervention relative to controls. The economic evaluation will present both a ‘within-trial result’ (i.e. considering only those costs and outcomes accruing over 52 weeks) as well as to be extrapolated over a longer time period, such as ten years. As we will have 52 weeks of participant-level data, we will apply bootstrapping methods to estimate the uncertainty around cost-effectiveness figures.

The sample size refers to the number of dyads.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/04/2018
Actual
8/05/2018
Date of last participant enrolment
Anticipated
31/12/2020
Actual
12/03/2021
Date of last data collection
Anticipated
31/05/2022
Actual
31/05/2022
Sample size
Target
176
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10582 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 10583 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 10584 0
Anglican Community Services - Baulkham Hills
Recruitment hospital [4] 10585 0
BaptistCare NSW & ACT - Baulkham Hills
Recruitment hospital [5] 10586 0
Canterbury Hospital - Campsie
Recruitment hospital [6] 16392 0
Ryde Hospital - Eastwood
Recruitment postcode(s) [1] 22300 0
2139 - Concord
Recruitment postcode(s) [2] 22301 0
2065 - St Leonards
Recruitment postcode(s) [3] 22302 0
2153 - Baulkham Hills
Recruitment postcode(s) [4] 22303 0
2194 - Campsie
Recruitment postcode(s) [5] 29936 0
2122 - Eastwood

Funding & Sponsors
Funding source category [1] 299150 0
Government body
Name [1] 299150 0
National Health and Medical Research Council
Country [1] 299150 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 298408 0
None
Name [1] 298408 0
Address [1] 298408 0
Country [1] 298408 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300077 0
Sydney Local Health District Human Research Ethics Committee – Concord Repatriation General Hospital
Ethics committee address [1] 300077 0
Ethics committee country [1] 300077 0
Australia
Date submitted for ethics approval [1] 300077 0
22/01/2018
Approval date [1] 300077 0
08/03/2018
Ethics approval number [1] 300077 0
HREC/18/CRGH/11

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

Contacts
Principal investigator
Name 82494 0
Prof Yun-Hee Jeon
Address 82494 0
Sydney Nursing School
Rm 234, RC Mills Building (A26) Fisher Road The University of Sydney NSW 2006
Country 82494 0
Australia
Phone 82494 0
+61 2 9351 0674
Fax 82494 0
+61 2 9351 0679
Email 82494 0
yun-hee.jeon@sydney.edu.au
Contact person for public queries
Name 82495 0
Yun-Hee Jeon
Address 82495 0
Sydney Nursing School
Rm 234, RC Mills Building (A26) Fisher Road The University of Sydney NSW 2006
Country 82495 0
Australia
Phone 82495 0
+61 2 9351 0674
Fax 82495 0
+61 2 9351 0679
Email 82495 0
yun-hee.jeon@sydney.edu.au
Contact person for scientific queries
Name 82496 0
Yun-Hee Jeon
Address 82496 0
Sydney Nursing School
Rm 234, RC Mills Building (A26) Fisher Road The University of Sydney NSW |2006
Country 82496 0
Australia
Phone 82496 0
+61 2 9351 0674
Fax 82496 0
+61 2 9351 0679
Email 82496 0
yun-hee.jeon@sydney.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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7521Study protocolJeon, Y-H., Simpson, J., Low, L-F, Woods, R., Norman, R., Mowszowski, L., Clemson, L., Naismith, S., Brodaty, H., Hilmer, S., Amberber, AM., Gitlin, L., Szanton, S. (2019). A pragmatic randomised controlled trial (RCT) and realist evaluation of the Interdisciplinary Home-bAsed Reablement Program (I-HARP) for improving functional independence of community dwelling older people with dementia: An effectiveness-implementation hybrid design. BMC Geriatrics. DOI: 10.1186/s12877-019-1216-x   



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA pragmatic randomised controlled trial (RCT) and realist evaluation of the interdisciplinary home-bAsed Reablement program (I-HARP) for improving functional independence of community dwelling older people with dementia: an effectiveness-implementation hybrid design.2019https://dx.doi.org/10.1186/s12877-019-1216-x
N.B. These documents automatically identified may not have been verified by the study sponsor.