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Trial registered on ANZCTR


Registration number
ACTRN12617000238370
Ethics application status
Approved
Date submitted
2/02/2017
Date registered
16/02/2017
Date last updated
25/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evidence-based programs to improve the wellbeing of people with dementia and their carers: Implementing the Care of Older People in their Environments (COPE) program in the Australian Health Context
Scientific title
Evidence-based programs to improve the wellbeing of people with dementia and their carers: Implementing COPE in the Australian Health Context
Secondary ID [1] 290971 0
None
Universal Trial Number (UTN)
U1111-1191-8481
Trial acronym
COPE
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Dementia 301713 0
Cognitive impairment 301714 0
Alzheimer's Disease 301715 0
Vascular dementia 301716 0
Lewy body disease 301717 0
Frontotemporal dementia 301718 0
Functional decline 301849 0
Condition category
Condition code
Neurological 301416 301416 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Face-to-face delivery of 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.
METHOD: Intervention will be delivered by community based registered Occupational Therapists with their existing clients. Face-to-face visits occur in participant's home or in acute rehabilitation settings (where necessary) with the person with dementia and caregiver together. Number of visits will vary from three to ten, upon discretion of the therapist based on extend of difficulties and success of intervention. Length of visits will be one to two hours, as required.
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. Adherence to the program protocol will be monitored with intervention logs including length of visit, resources used, strategies discussed and assessments conducted. A Fidelity Assessment tool has also been developed for this study and will be completed by therapists within six months of first implementing COPE. Coaching meetings, with up to 6 therapists at a time together with a master trainer, will be conducted every 3 months to discuss difficult cases.
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.
Intervention code [1] 297032 0
Rehabilitation
Intervention code [2] 297043 0
Lifestyle
Intervention code [3] 297044 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300922 0
Activity Engagement Questionnaire completed by the caregiver about person with dementia
Timepoint [1] 300922 0
Baseline (first COPE session)
Final COPE session (number of sessions may vary)
Primary outcome [2] 300923 0
Perceived Change Index completed by caregiver
Timepoint [2] 300923 0
Baseline (first COPE session)
Final COPE session (number of sessions may vary)
Primary outcome [3] 300924 0
Determinants of Implementation Behaviour tool completed by COPE therapists
Timepoint [3] 300924 0
6 months post COPE training
Secondary outcome [1] 331218 0
Adherence Fidelity Tool developed by project team and designed for this study
Timepoint [1] 331218 0
6 months post COPE training
Secondary outcome [2] 331219 0
Resource Utilisation in Dementia-Lite questionnaire completed by participants with dementia and caregivers
Timepoint [2] 331219 0
Baseline (first COPE session)
Final COPE session (number of sessions may vary)
Secondary outcome [3] 331220 0
Adverse events reported by both participants and COPE therapists in qualitative interviews. Possible adverse events include physical harm when implementing suggested strategies (e.g. falls) or when strategies are not successful (e.g. violence).
Timepoint [3] 331220 0
6 months post COPE training
Secondary outcome [4] 331235 0
Participant dyad and COPE therapist expectations and experiences reported in qualitative interviews
Timepoint [4] 331235 0
Pre-baseline (before COPE training)
6 months post COPE training

Eligibility
Key inclusion criteria
Eligible participants with dementia will have a diagnosis of probable dementia, or a Mini-Mental State Examination (MMSE) score less than 24 (or equivalent score on a comparable tool such as the MOCA); and live in the community with or nearby a family caregiver.
Eligible caregivers provide regular oversight or care to a person with dementia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Caregivers who are under 18 years of age will be excluded from the dyad questionnaire and interview components of the study.
Failure to meet the above criteria

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Process evaluation design
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Case Audit data will be entered into SPSS. Socio-demographic data will be summarised descriptively (e.g. mean, range, percentage). We will also summarise service characteristics descriptively. In regards to the intervention approaches used, we will describe how commonly these approaches are used (e.g. percentage of cases where a particular approach was used) and also describe the average number of approaches (and range) used across clients (eg. 'therapists used an average of intervention approaches with clients').

The DIBQ responses will be coded in SPSS. As the sample will be too small for statistical analysis, the information gathered will be used as indicative and descriptive information to inform the development and outcomes of the intervention.

Responses to participant dyad survey data (pre and post measures) will be coded in SPSS, analysed descriptively and compared within and across groups. Data from the resource utilisation in dementia questionnaire (RUD Lite) will be used to cost both formal and informal services.

All interviews will be audio-recorded, transcribed verbatim and entered into QSR NVivo. Thematic analysis (developing codes) will identify patterns within the study group. A combination of inductive and deductive coding will be used. F or participant dyads coding will commence with experience of COPE program and perceptions of change, but will be open to unexpected findings that may contribute to these. For health professionals the four NPT constructs will inform analysis of data gathered in order to build a comprehensive assessment of the barriers and facilitators; and thus informing implementation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/11/2016
Date of last participant enrolment
Anticipated
29/04/2018
Actual
Date of last data collection
Anticipated
30/09/2018
Actual
Sample size
Target
103
Accrual to date
44
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 7420 0
Repatriation Hospital - Daw Park
Recruitment hospital [2] 7421 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment postcode(s) [1] 15225 0
5041 - Daw Park
Recruitment postcode(s) [2] 15226 0
2077 - Hornsby

Funding & Sponsors
Funding source category [1] 295486 0
Government body
Name [1] 295486 0
NHMRC Cognitive Decline Partnership Centre
Country [1] 295486 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 294305 0
None
Name [1] 294305 0
None
Address [1] 294305 0
None
Country [1] 294305 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296822 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 296822 0
Ethics committee country [1] 296822 0
Australia
Date submitted for ethics approval [1] 296822 0
23/03/2016
Approval date [1] 296822 0
18/11/2016
Ethics approval number [1] 296822 0
2016/292
Ethics committee name [2] 296823 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [2] 296823 0
Ethics committee country [2] 296823 0
Australia
Date submitted for ethics approval [2] 296823 0
23/08/2016
Approval date [2] 296823 0
25/10/2016
Ethics approval number [2] 296823 0
HREC/16/HAWKE/283

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1422 1422 0 0
/AnzctrAttachments/372204-COPE Protocol_v3_FINAL.pdf (Protocol)
Attachments [2] 1425 1425 0 0
/AnzctrAttachments/372204-Sydney Uni Approval Letter - 18 Nov 2016.pdf (Ethics approval)
Attachments [3] 1426 1426 0 0
/AnzctrAttachments/372204-NSLHD Approval Letter - HREC FINAL approval - HREC Exec meeting 21 September 2016 - RESP16188.pdf (Ethics approval)

Contacts
Principal investigator
Name 71874 0
Prof Lindy Clemson
Address 71874 0
The University of Sydney
Cumberland Campus,
Ageing, Work & Health Research Unit,
Faculty of Health Sciences
PO Box 170,
Lidcombe,
NSW, 1825
Country 71874 0
Australia
Phone 71874 0
+61 2 9351 9372
Fax 71874 0
Email 71874 0
lindy.clemson@sydney.edu.au
Contact person for public queries
Name 71875 0
Sally Day
Address 71875 0
The University of Sydney
Cumberland Campus,
Ageing, Work & Health Research Unit,
Faculty of Health Sciences
PO Box 170,
Lidcombe,
NSW, 1825
Country 71875 0
Australia
Phone 71875 0
+61 2 9351 9172
Fax 71875 0
Email 71875 0
sally.day@sydney.edu.au
Contact person for scientific queries
Name 71876 0
Kate Laver
Address 71876 0
Flinders University
Department of Rehabilitation and Aged Care
School of Health Sciences
GPO Box 2100
Adelaide 5001,
South Australia
Country 71876 0
Australia
Phone 71876 0
+61 8 7221 8335
Fax 71876 0
Email 71876 0
kate.laver@sa.gov.au

No information has been provided regarding IPD availability


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
EmbaseImplementation of an evidence-based intervention to improve the wellbeing of people with dementia and their carers: study protocol for 'Care of People with dementia in their Environments (COPE)' in the Australian context.2018https://dx.doi.org/10.1186/s12877-018-0790-7
N.B. These documents automatically identified may not have been verified by the study sponsor.