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Trial registered on ANZCTR


Registration number
ACTRN12616001461482
Ethics application status
Approved
Date submitted
13/10/2016
Date registered
19/10/2016
Date last updated
21/05/2021
Date data sharing statement initially provided
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
‘Caring for the Carer’: implementing a comprehensive support service model for family caregivers looking after persons with age-related macular degeneration.
Scientific title
‘Caring for the Carer’: implementing a comprehensive support service model for family caregivers looking after persons with age-related macular degeneration.
Secondary ID [1] 290328 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related macular degeneration 300591 0
Emotional distress 300592 0
Condition category
Condition code
Mental Health 300444 300444 0 0
Other mental health disorders
Eye 300445 300445 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a comprehensive support service comprising: 1) mail-delivered cognitive behavioural therapy (M-CBT), designed to improve psychological adjustment and adaptive coping skills; 2) telephone-delivered group counselling sessions - allows carers to explore the impacts of caring and share their experiences; and 3) education on available community services/resources, financial benefits, and respite services.

The M-CBT will be delivered by mail plus weekly telephone contact by appropriately trained staff from our partner organisation - Macular Disease Foundation Australia (MDFA). The M-CBT will be conducted over 10 weeks with CBT modules mailed every 2 weeks. Each module will target a specific stressor and/or train a new adaptive coping method, and will be supported by targeted homework assignments for the caregiver to practice between sessions. Duration of these homework assignments is between 15-20 mins per week. These will draw upon standard CBT practice and on a number of additional sources including published trials, empirical studies, and treatment guides. The brief CBT program will consist of components shown to have beneficial impacts of psychological morbidity. These components will include: psycho-education on stress and arousal; slow breathing skills; adaptive coping skills like mindfulness relaxation, evidence based thinking, problem solving skills, and developing pleasant life event schedules.

The educational materials provided include age-appropriate case stories and examples of skill use. All material will be presented in both a didactic form (text based instructions/information) and a case-enhanced learning form (i.e., where educational stories are used to demonstrate the application of skills and problem resolution). The material sent out to participants will aim to increase their knowledge about support and respite services, and financial entitlements and benefits, how best to access them, which has been previously shown to increase carer sense of competence and reduce depression. MDFA staff will notify participants of new material, prompt them to view unread materials, encourage progress through the CBT modules and normalise the difficulties in learning new skills and managing symptoms. This will help maintain fidelity to the intervention.

The intervention also includes the Talk-Link counselling sessions; an existing service offered by our other partner organisation - Carers NSW. Participants will be asked to complete a form before the sessions to identify the issues they might want to discuss. These will then be developed into weekly topics to guide group discussions. Information/ newsletters are also provided by the facilitators. Using teleconferencing, a group of 6-8 caregivers and two trained facilitators will get together over the telephone, at the same time each week, to explore issues around caring for someone with AMD. Carers NSW have used this approach previously in older carers e.g. carers of people with dementia. These sessions will run for 6 consecutive weeks (starting in week 1 of the 10-week program), each weekly session lasts for 1 hr, and will be concurrent with the M-CBT program.

At the start of the program; guidelines; recommended timetable of the program, and the first intervention module will be mailed out to the intervention arm. In that first week, participants will receive a telephone call by MDFA staff encouraging them to participate and carry out the activities and skills in the module. Telephone calls will also be conducted each week of the program, and additional telephone calls may be made by MDFA staff if particular participants are experiencing difficulties in symptoms or have difficulties practising skills. Telephone calls will also assist monitoring of the participants activities and program achievements. The program will be written and designed to (1) remind participants about unread materials; (2) reinforce progress and skills practice; (3) normalise the challenges of learning new skills; and (4) emphasise that symptom reduction requires gentle, but consistent, practice of the skills over time. Costs for study participants will be reduced by providing reply paid envelopes, and the MDFA and Carers NSW already have toll free numbers that participants can contact them on. Calls will be logged for each participant.
Intervention code [1] 296138 0
Prevention
Intervention code [2] 296139 0
Behaviour
Comparator / control treatment
Wait-list controls will not receive any treatment during the study, however, this group will be offered the opportunity to receive the multi-component intervention after the study ends (that is, 6–18 months after inclusion).
Control group
Active

Outcomes
Primary outcome [1] 299878 0
Change in Caregiver Burden Scale (CBS) scores during the 12 month follow-up
Timepoint [1] 299878 0
12 month follow-up from baseline (i.e. pre-intervention).
Secondary outcome [1] 328376 0
Change in mental health status among carers, assessed by the Centre for Epidemiologic Studies Depression Scale.
Timepoint [1] 328376 0
12 month follow-up from baseline (i.e. pre-intervention).
Secondary outcome [2] 328377 0
Change in quality of life scores in carers, assessed by the EuroQoL - EQ-5D 5-level scale.
Timepoint [2] 328377 0
12 month follow-up from baseline (i.e. pre-intervention).
Secondary outcome [3] 328378 0
Cost effectiveness of intervention.

This analysis will be conducted from the perspective of the national health provider in Australia and will determine the cost per person to deliver the support service model and the cost-effectiveness compared with usual care. This will be a within-trial economic evaluation carried out within the time frame and context of the trial. Data on health-related quality of life will be collected during 12-months post-treatment using the EQ-5D-5L questionnaire. EQ-5D scores will be converted into utility values using a valuation algorithm for the Australian population.
Timepoint [3] 328378 0
12 month follow-up from baseline (i.e. pre-intervention).

Eligibility
Key inclusion criteria
(a) aged 18 years and over; (b) the primary caregiver to the individual with AMD and related to the care recipient (spouse/partner, child or sibling); and (c) willing to actively engage in at least 10 weekly therapy sessions over a three month period. A primary caregiver will defined as “any person who, without being a professional or belonging to a social support network, and in some way, is directly implicated in the patient’s eye care or is directly affected by the patient’s health problem”.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Caregivers will not be considered for the study if they lack sufficient fluency in spoken English to engage in therapy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Safety concerns
Other reasons/comments
Other reasons
Due to strict COVID-19 restrictions earlier in the year encouraging only essential work take place, a decision was made a stop recruitment early as study staff were unable to attend clinics to recruit patients/caregivers.
Date of first participant enrolment
Anticipated
21/11/2016
Actual
25/01/2017
Date of last participant enrolment
Anticipated
Actual
11/03/2020
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
120
Accrual to date
Final
94
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294707 0
Government body
Name [1] 294707 0
National Health and Medical Research Council
Country [1] 294707 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
Camperdown
NSW 2006
Country
Australia
Secondary sponsor category [1] 293555 0
Other Collaborative groups
Name [1] 293555 0
Westmead Institute for Medical Research
Address [1] 293555 0
176 Hawkesbury Road Westmead NSW 2145
Country [1] 293555 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296129 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 296129 0
Ethics committee country [1] 296129 0
Australia
Date submitted for ethics approval [1] 296129 0
Approval date [1] 296129 0
04/10/2016
Ethics approval number [1] 296129 0
2016/793

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

Contacts
Principal investigator
Name 69666 0
Prof Bamini Gopinath
Address 69666 0
The Australian Hearing Hub 16 University Avenue Macquarie University Macquarie Park NSW 2109
Country 69666 0
Australia
Phone 69666 0
+61 2 9850 8962
Fax 69666 0
Email 69666 0
bamini.gopinath@mq.edu.au
Contact person for public queries
Name 69667 0
Bamini Gopinath
Address 69667 0
The Australian Hearing Hub 16 University Avenue Macquarie University Macquarie Park NSW 2109
Country 69667 0
Australia
Phone 69667 0
+61 2 9850 8962
Fax 69667 0
Email 69667 0
bamini.gopinath@mq.edu.au
Contact person for scientific queries
Name 69668 0
Bamini Gopinath
Address 69668 0
The Australian Hearing Hub 16 University Avenue Macquarie University Macquarie Park NSW 2109
Country 69668 0
Australia
Phone 69668 0
+61 2 9850 8962
Fax 69668 0
Email 69668 0
bamini.gopinath@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified IPD that underlie results in a publication will be shared
When will data be available (start and end dates)?
Immediately after publication; no end date determined.
Available to whom?
Available to readers of the publishing journal.
Available for what types of analyses?
IPD only available to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator, Bamini Gopinath (bamini.gopinath@sydney.edu.au)


What supporting documents are/will be available?




Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCross-sectional study evaluating burden and depressive symptoms in family carers of persons with age-related macular degeneration in Australia.2021https://dx.doi.org/10.1136/bmjopen-2021-048658
N.B. These documents automatically identified may not have been verified by the study sponsor.