Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001092785
Ethics application status
Approved
Date submitted
7/07/2022
Date registered
8/08/2022
Date last updated
24/03/2024
Date data sharing statement initially provided
8/08/2022
Date results information initially provided
23/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of an online psychosocial intervention for coping and well-being of carers of people living with dementia
Scientific title
Effectiveness of an online psychosocial intervention for coping and well-being of carers of people living with dementia
Secondary ID [1] 307422 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coping skills 326764 0
Depression 326765 0
Perceived burden 326766 0
Quality of life 326768 0
Condition category
Condition code
Neurological 323992 323992 0 0
Dementias
Mental Health 324033 324033 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive an information booklet about dementia as well as a weekly 30-minute individual supportive counselling session for eight weeks. The counselling sessions offer support and strategies to address the weekly concerns of the participant. Delivered weekly the eight sessions will focus on: Dementia understanding; coping strategies; building problem solving skills; stress management; self-care; providing emotional support through interactive activities; and future planning. The sessions will be delivered online (either by telephone or videoconferencing) depending on the personal preference of participants.
The counselling sessions will be interactive and carried out by the study research assistant who is a qualified mental health nurse and counsellor.
There are comprehensive guidelines for each session provided in a comprehensive protocol document. For example:
Session 4 Objective:
Increase carers’ knowledge about the consequences of stress and stress management
- Greet participant and introduce today’s session.
- Mention that previous studies reported that family carers are more likely to experience anxiety and stress and other mental health concerns.
- Ask the participant if he/she has been experiencing stress in their caring role and how he/she relieves stress.
- Invite the participant to talk about the strategies he/she has been using in managing stress related to the caregiving role, and whether the participant found those strategies helpful or not helpful.
- Discuss additional 3 stress management strategies appropriate for each carer (e.g., exercise, talking to family and friends, finding a hobby, relaxation, deep breathing).
- Teach and practice the above chosen 3 stress management techniques.
- Ask if the participant has any questions and address those questions.
- Explain what will happen in the next session.
- Conclude the session and thank the participant.
*Attendance Logs will be used during and after sessions to document attendance and report activities and outcomes.

The information booklet is readily available online and is the same booklet that the control group will receive. The booklet is encouraged to be used by Dementia Australia and accessible via https://www.dementia.org.au/sites/default/files/resources/The-Dementia-Guide-2019-v2.pdf

The booklet provides a description of the different types of dementia, what to expect as a carer, strategies to manage the care and wellbeing of people living with dementia and referral contact and crisis information. It is divided into 11 sections including Section 1 Information about dementia; Section 2 Understanding your diagnosis; Section 3 Health care team and treatment; Section 4 Planning for the future (such as financial management, government support); Section 5 Living well (such as coping with changes, reducing stress); Section 6 Support for people with dementia; Section 7 Dementia Australia service (such as information services and support services); Section 8 Residential care (such as choosing a residential care facility, understanding fees and costs); Section 9 Later stage of dementia (understating palliative care); Section 10 Checklists (of things to help them live well); and Section 11 Support and information for carers (such as getting emotional support and coping with changes in behaviours).
It may take approximately 6 hours to complete the whole booklet and is best utilised as a reference book to refer to specific information when required.
Although the information in the booklet will be incorporated in the sessions, the purpose of the booklet is to be read at the participants own discretion and to be used as a reference book for home use.
As the information in the booklet is to be used as reference material only, therefore no adherence will be monitored in relation to its contents.
Intervention code [1] 323859 0
Prevention
Intervention code [2] 323860 0
Behaviour
Comparator / control treatment
Participants allocated to the control group will receive an information booklet about dementia and one brief check-in telephone call (The phone call will last approximately 5-10 minutes). The same information booklet will be provided to carers in the control group as will be provided to the intervention group and is readily available online at the following link: https://www.dementia.org.au/sites/default/files/resources/The-Dementia-Guide-2019-v2.pdf

The brief telephone call (approximately 5-10 minutes), will be provided by the senior research assistant experienced in counselling, aged care and dementia care.
The senior research assistant will ask questions such as how they are going, if they found the information booklet useful, any concerns they are having, confirm referral crisis contacts and thank them for participating in the study.
Control group
Active

Outcomes
Primary outcome [1] 331792 0
Caregiver appraisals of coping (assessed by the Revised Caregiving Appraisal Scale-RCAS)
Timepoint [1] 331792 0
Baseline (pre-intervention), post intervention (within one week after the intervention), and at three months follow-up (primary endpoint) after intervention completion.
Secondary outcome [1] 411127 0
Caregiver depression assessed by the Center for Epidemiological Studies Depression Scale (CES-D)
Timepoint [1] 411127 0
Baseline (pre-intervention), post intervention (within one week after the intervention), and at three months follow-up after intervention completion.
Secondary outcome [2] 411142 0
Perceived caregiver burden assessed by the Zarit Burden Index
Timepoint [2] 411142 0
Baseline (pre-intervention), post intervention (within one week after the intervention), and at three months follow-up after intervention completion.
Secondary outcome [3] 411145 0
Quality of life assessed by the World Health Organization Quality of Life (WHOQOL)-BREF
Timepoint [3] 411145 0
Baseline (pre-intervention), post intervention (within one week after the intervention), and at three months follow-up after intervention completion.
Secondary outcome [4] 412628 0
Participant's experiences of the online sessions including the strengths and limitations of the intervention, and recommendations/ suggestions to improve the intervention program will be assessed using one-on-one, digitally recorded interviews conducted online via either telephone or videoconferencing that will be semi-structured using a study specific questionnaire.
Timepoint [4] 412628 0
Post intervention (within two weeks after intervention completion).

Eligibility
Key inclusion criteria
Carers of people living with dementia who meet the following inclusion criteria:
1) Aged 18 years or older
2) Living with or sharing cooking facilities with the care recipient; and
3) Providing unpaid care for a relative, friend or neighbour who has had dementia for at least 6 months in the community regardless of the number of hours per day they spend on care provision.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from the study if they 1) are unable to comprehend written English; or 2) have no access to the internet.

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)
Sealed opaque envelops.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using sealed opaque envelops (Someone external to the study to conduct the randomisation and place allocations into sealed opaque envelopes).
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
This is a pilot study, 100 participants who meet the inclusion criteria will be recruited. Data will be analysed using SPSS. Mixed model ANOVA will be used to determine differences between groups and over time. ANCOVA will be used as needed to assess the impact of the intervention on the primary and secondary outcomes adjusting for relevant covariates such as baseline demographic characteristics. Missing data will be handled on an intention to treat basis. At program completion, participants in the intervention group will be invited to participate in an online interview exploring their experiences about the online sessions including the strengths and limitations of the intervention, and recommendations/ suggestions to improve the intervention program. Interview data will be transcribed and analysed using thematic analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2022
Actual
15/08/2022
Date of last participant enrolment
Anticipated
31/01/2023
Actual
27/02/2023
Date of last data collection
Anticipated
30/07/2023
Actual
18/08/2023
Sample size
Target
100
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311697 0
University
Name [1] 311697 0
Griffith University
Country [1] 311697 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road, Nathan,
Queensland 4111 Australia
Country
Australia
Secondary sponsor category [1] 313154 0
None
Name [1] 313154 0
Address [1] 313154 0
Country [1] 313154 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311150 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 311150 0
Griffith University,
170 Kessels Road, Nathan,
Queensland 4111 Australia
Ethics committee country [1] 311150 0
Australia
Date submitted for ethics approval [1] 311150 0
17/03/2022
Approval date [1] 311150 0
14/04/2022
Ethics approval number [1] 311150 0
2022/187

Summary
Brief summary
Dementia is a condition that is in the top 5 leading causes of death for Australians. Informal carers report high levels of mental health concerns such as stress, anxiety, depression, social isolation, and poor quality of life (QoL). They are known to face significant strain associated with caregiving responsibilities. Maintaining the health and wellbeing of carers is essential to enable the continuation of care of family members as well as to prevent poor mental and physical health in carers. Despite the well-recognised need to support carers, limited programs have been delivered in Australia to promote their mental health and coping strategies. This aim of this study is to evaluate the effectiveness of an online psychosocial intervention on family carers’ coping skills, psychological wellbeing and QoL. The study hypotheses include:

Hypothesis 1: Participants in the intervention group will demonstrate significantly greater improvements in appraisals of coping at post-intervention than the control group.
Hypothesis 2: Participants in the intervention group will demonstrate a significantly greater reduction in depression at post-intervention than the control group.
Hypothesis 3: Participants in the intervention group will demonstrate significantly greater improvements in quality-of-life at post-intervention than the control group.
Hypothesis 4: Participants in the intervention group will demonstrate a significantly greater reduction in perceived burden at post-intervention than the control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120118 0
Dr Amornrat Saito
Address 120118 0
School of Nursing and Midwifery,
Logan campus, Griffith University
68 University Dr, Meadowbrook QLD 4131
Country 120118 0
Australia
Phone 120118 0
+61 7 33821287
Fax 120118 0
Email 120118 0
a.saito@griffith.edu.au
Contact person for public queries
Name 120119 0
Dr Amornrat Saito
Address 120119 0
School of Nursing and Midwifery,
Logan campus, Griffith University
68 University Dr, Meadowbrook QLD 4131
Country 120119 0
Australia
Phone 120119 0
+61 7 33821287
Fax 120119 0
Email 120119 0
a.saito@griffith.edu.au
Contact person for scientific queries
Name 120120 0
Dr Amornrat Saito
Address 120120 0
School of Nursing and Midwifery,
Logan campus, Griffith University
68 University Dr, Meadowbrook QLD 4131
Country 120120 0
Australia
Phone 120120 0
+61 7 33821287
Fax 120120 0
Email 120120 0
a.saito@griffith.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
No individual participant data will be shared. The findings from this study may be disseminated via journal articles and/ or conference presentations and will only include non-identifiable data, where data cannot be representative of a given individual. Results will be provided in an aggregate and in summary format and thus, it will be impossible to identify individual information. Publications and/or presentations for the research will not contain any individual identifying data.


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
No additional documents have been identified.