Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000117314
Ethics application status
Approved
Date submitted
12/01/2017
Date registered
23/01/2017
Date last updated
17/12/2019
Date data sharing statement initially provided
18/12/2018
Date results information initially provided
17/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does telehealth delivery of the 'Care of People with dementia in their Environments' (COPE) program provide a non-inferior alternative to face-to-face treatment for community dwelling people with cognitive impairment?
Scientific title
Does telehealth delivery of the COPE program provide a non-inferior alternative to face-to-face treatment for community dwelling people with cognitive impairment?
Secondary ID [1] 290882 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Dementia 301595 0
Functional decline 301596 0
Condition category
Condition code
Neurological 301303 301303 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Face-to-face delivery of a nonpharmacological program provided by an occupational therapist.
The intervention for both study groups will be based on the Care of Persons with Dementia in their Environments (COPE) intervention as described by Professor Laura Gitlin and colleagues. The COPE intervention incorporates environmental modification to decrease stressors, match the environment to the capabilities of the person with dementia and engage the person with dementia in daily activities. The therapist works with the person with dementia and their carer to identify key challenges and then problems solves using a collaborative approach and the use of skills building and role play.
MATERIALS: The intervention will be delivered using the COPE Intervention Manual and the COPE Occupational Therapy Intervention Documentation Binder developed by Professor Gitlin and colleagues. The COPE Intervention Manual is complemented by prescriptions that provide specific strategies and advice for specific behavioural and psychological symptoms of dementia. The manual has been refined based on the learnings of the initial trial. Carers will also be provided with a loan copy of the book “A Caregiver’s Guide to Dementia” by Professor Gitlin and Dr Piersol.
INTERVENTIONIST: The interventionist is a registered occupational therapist. The therapist will receive training in administering the COPE intervention and will be supported by the coordinating principal investigator who will discuss all cases with the therapist.
MODE OF DELIVERY: In this study arm one will receive the intervention using the traditional face-to-face method of delivery. Up to ten visits over four months will take place in the person's home. The exact number of sessions and the frequency of sessions will be determined by the therapist based on the participant's treatment goals, progress and needs. Each session will last approximately 60 minutes.
Fidelity will be examined by reviewing treatment notes of the treating therapist.
Intervention code [1] 296829 0
Rehabilitation
Intervention code [2] 296842 0
Treatment: Other
Intervention code [3] 296923 0
Behaviour
Comparator / control treatment
Arm 2: Telehealth delivery of a nonpharmacological program provided by an occupational therapist.
The second study arm will receive the COPE program using telehealth via two in-home visits (visits 1 and 2) with the remainder delivered via videoconferencing.
The telehealth equipment used for each participant in the telehealth group will be based on their individual experience, equipment and capability. We intend to build on existing technology use and skills of carers and people with dementia. Therefore if they own a personal computer, laptop or tablet computer with existing free videoconferencing software (skype or facetime) we will use these devices to conduct the intervention from session three onwards. If they are confident using these devices and are willing to download the free software we will assist them to do this. If the person does not have a device suitable, we will loan them a tablet computer with the associated software (skype or facetime) for the duration of the intervention program. We will spend approximately one hour with all participants setting up the technology and practising use during the second consultation. If necessary we will seek technical support to do so. We will also provide each dyad with a short instruction guide with photos demonstrating how to use the technology and fix common problems. The program will be delivered over up to ten consultations over a four month period.
Control group
Active

Outcomes
Primary outcome [1] 300714 0
Caregiving Mastery Index completed by the caregiver
Timepoint [1] 300714 0
4 month follow up examination (post intervention)
9 months post randomisation
Secondary outcome [1] 330685 0
Caregiver Assessment of Function and Upset completed by the caregiver
Timepoint [1] 330685 0
4 month follow up examination (post intervention)
9 months post randomisation
Secondary outcome [2] 330686 0
Perceived Change Scale completed by the caregiver
Timepoint [2] 330686 0
4 month follow up examination (post intervention)
9 months post randomisation
Secondary outcome [3] 330687 0
Caregiver Behavioural Occurrence and Upset Scale completed by the caregiver
Timepoint [3] 330687 0
4 month follow up examination (post intervention)
9 months post randomisation

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if they have a diagnosis of dementia or probable dementia and a score of <24/30 on the Mini Mental State Examination. Participants must require assistance with activities of daily living and have a carer/supporter who is able to participate in the videoconferencing intervention. The carer must report that they are having difficulty assisting the person to manage activities of daily living and/or behavioural and psychological symptoms of dementia. Caregivers must be willing to try a different approach to the usual model of care which is delivered face-to-face. There are no other specific inclusion/exclusion criteria for caregivers. People allocated to the telehealth group will be provided with training and support in using the telehealth technology whether that is using the videoconferencing software on their computer or tablet. Where the person is provided with a tablet to use within the study they will be trained in its use.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Failure to meet the above criteria

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)
The sequence will be placed into sequentially numbered, opaque, sealed envelopes which will be held by a member of the research department not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated using an online computer randomisation software program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/03/2017
Actual
1/05/2017
Date of last participant enrolment
Anticipated
31/01/2019
Actual
4/04/2019
Date of last data collection
Anticipated
30/01/2020
Actual
Sample size
Target
60
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7265 0
Repatriation Hospital - Daw Park
Recruitment hospital [2] 7266 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 15031 0
5041 - Daw Park
Recruitment postcode(s) [2] 15032 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 295319 0
Government body
Name [1] 295319 0
NHMRC-ARC Dementia Research Development Fellowship grant
Country [1] 295319 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 294141 0
None
Name [1] 294141 0
Address [1] 294141 0
Country [1] 294141 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296652 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 296652 0
Flinders Medical Center, Flinders Drive, Bedford Park, SA 5041
Ethics committee country [1] 296652 0
Australia
Date submitted for ethics approval [1] 296652 0
24/08/2016
Approval date [1] 296652 0
17/11/2016
Ethics approval number [1] 296652 0
OFR # 346.16 - HREC/16/SAC/310

Summary
Brief summary
The "COPE" program is a structured program provided by occupational therapists for people with dementia and their carers. The program aims to improve independence and support the caregiver to manage stress and provide care. The program has been shown to be effective in a large randomised trial in the United States. However, neither the COPE program, nor similar evidence based occupational therapy programs for people with dementia have been translated into clinical practices. One of the main barriers is that these programs involve up to ten home visits; this is too resource intensive for many organisations and can not be delivered in the country.
This project is a randomised controlled trial. The aim of this project is to compare two methods of delivering the COPE program: 1) traditional facetoface delivery, and 2) telehealth delivery. The content of the program will be the same but the method of delivery will be different. 174 participants will be randomised into the two groups of the trial and outcomes will be assessed at the end of intervention and at 9 months (following randomisation).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71618 0
Dr Kate Laver
Address 71618 0
Flinders University, GPO Box 2100, Adelaide SA 5000
Country 71618 0
Australia
Phone 71618 0
+61 8 8276 9666
Fax 71618 0
Email 71618 0
kate.laver@flinders.edu.au
Contact person for public queries
Name 71619 0
Dr Kate Laver
Address 71619 0
Flinders University, GPO Box 2100, Adelaide SA 5000
Country 71619 0
Australia
Phone 71619 0
+61 8 8276 9666
Fax 71619 0
Email 71619 0
kate.laver@flinders.edu.au
Contact person for scientific queries
Name 71620 0
Dr Kate Laver
Address 71620 0
Flinders University, GPO Box 2100, Adelaide SA 5000
Country 71620 0
Australia
Phone 71620 0
+61 8 8276 9666
Fax 71620 0
Email 71620 0
kate.laver@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
SourceTitleYear of PublicationDOI
EmbaseDoes Telehealth Delivery of a Dyadic Dementia Care Program Provide a Noninferior Alternative to Face-To-Face Delivery of the Same Program? A Randomized, Controlled Trial.2020https://dx.doi.org/10.1016/j.jagp.2020.02.009
N.B. These documents automatically identified may not have been verified by the study sponsor.