ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dementia

Condition category

Condition code

Neurological

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]

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]

Mean functional independence score (measured using Disability Assessment for Dementia -DAD)

Timepoint [1]

Baseline, 20 weeks post commencement of intervention (primary outcome) and 52 weeks (secondary) post commencement of intervention

Secondary outcome [1]

Mean quality of life score (measured by Quality of life in Alzheimer's disease, QOL-AD)

Timepoint [1]