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Trial registered on ANZCTR


Registration number
ACTRN12621001175864
Ethics application status
Approved
Date submitted
28/07/2021
Date registered
1/09/2021
Date last updated
1/09/2021
Date data sharing statement initially provided
1/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
ECLIPSE: A pilot study of an early intervention to empower and support care partners of individuals with Alzheimer’s disease.
Scientific title
ECLIPSE: A pilot study investigating the impact of a group educational intervention on quality of life in partners of individuals with Alzheimer’s disease
Secondary ID [1] 304908 0
None
Universal Trial Number (UTN)
Trial acronym
ECLIPSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's 323044 0
Condition category
Condition code
Neurological 320614 320614 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interested care partners of people with mild Alzheimer’s disease will participate in the study. Four small-group sessions will be facilitated. The sessions will be held weekly via videoconference with up to 12 participants in total. Session attendance checklists will be used to monitor adherence to the intervention.

ECLIPSE will follow the COPE framework of Creativity, Optimism, Planning and Expert Information to develop problem-solving skills and awareness of stressors. Session topics will be derived from collaboration with a Consumer Advisory Group. Broadly, the emphasis will be:
1. Psychoeducation
2. Symptoms and changes
3. Strategies to manage changes
4. Self-care for care partners

Each session will be of approximately one and a half hours duration, and cover a particular topic. The sessions will be a mixture of information provided by experts in the field, group-led discussion based on care partner’s personal experiences, and interactive learning and development of new skills to assist them in their care partner role.
Intervention code [1] 321302 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328426 0
Mean quality of life score, as measured by the Adult Carer Quality of Life Questionnaire (AC-QoL)
Timepoint [1] 328426 0
Baseline, Post-intervention, and 3 months post-intervention.
Primary outcome [2] 328427 0
Mean coping strategies score, as measured by the Brief-COPE
Timepoint [2] 328427 0
Baseline, Post-intervention, and 3 months post-intervention.
Secondary outcome [1] 398982 0
Mean caregiver burden core, as measured by the Caregiver Burden Scale and Caregiver Reaction Scale
Timepoint [1] 398982 0
Baseline, Post-intervention, and 3 months post-intervention.
Secondary outcome [2] 398984 0
Mean confidence of Alzheimer's knowledge score, as measured by the Alzheimer's disease knowledge scale
Timepoint [2] 398984 0
Baseline, post-intervention and 3 months post-intervention
Secondary outcome [3] 398985 0
Mean stress score as measured by Kingston Care partner stress scale
Timepoint [3] 398985 0
Baseline, post-intervention and 3 months post-intervention
Secondary outcome [4] 398986 0
Mean life satisfaction score, as measured by Life Satisfaction Questionnaire
Timepoint [4] 398986 0
Baseline, post-intervention and 3 months post-intervention
Secondary outcome [5] 398987 0
Mean anxiety symptomatology score, as measured by Depression, Anxiety and Stress Scale
Timepoint [5] 398987 0
Baseline, post-intervention and 3 months post-intervention
Secondary outcome [6] 399906 0
Mean depressive symptomatology score, as measured by the Depression, Anxiety and Stress Scale.
Timepoint [6] 399906 0
Baseline, post-intervention and 3 months post-intervention

Eligibility
Key inclusion criteria
(i) Are aged 18 years or older
(ii) Identify as being a care partner of an individual with mild Alzheimer’s disease.
(iii) Engage in at least four hours of contact care per week.
(iv) Have been a care partner for no longer than five years.
(v) Are competent to consent based on their ability to provide a spontaneous narrative description of the key elements of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have participated in a care partner support intervention within the past six months.

Study design
Purpose of the study
Prevention
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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 309283 0
Charities/Societies/Foundations
Name [1] 309283 0
Epworth Medical Foundation
Country [1] 309283 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd
Clayton
VIC 3800
Country
Australia
Secondary sponsor category [1] 310253 0
None
Name [1] 310253 0
Address [1] 310253 0
Country [1] 310253 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309119 0
Monash Health
Ethics committee address [1] 309119 0
Ethics committee country [1] 309119 0
Australia
Date submitted for ethics approval [1] 309119 0
Approval date [1] 309119 0
15/06/2021
Ethics approval number [1] 309119 0

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

Contacts
Principal investigator
Name 113042 0
Dr Melanie Emonson
Address 113042 0
Epworth Centre for Innovation in Mental Health
888 Toorak Road
Camberwell VIC 3124
Country 113042 0
Australia
Phone 113042 0
+61 398054346
Fax 113042 0
Email 113042 0
melanie.emonson@monash.edu
Contact person for public queries
Name 113043 0
Melanie Emonson
Address 113043 0
Epworth Centre for Innovation in Mental Health
888 Toorak Road
Camberwell VIC 3124
Country 113043 0
Australia
Phone 113043 0
+61 398054346
Fax 113043 0
Email 113043 0
melanie.emonson@monash.edu
Contact person for scientific queries
Name 113044 0
Melanie Emonson
Address 113044 0
Epworth Centre for Innovation in Mental Health
888 Toorak Road
Camberwell VIC 3124
Country 113044 0
Australia
Phone 113044 0
+61 398054346
Fax 113044 0
Email 113044 0
melanie.emonson@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
No additional documents have been identified.