Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000282886
Ethics application status
Approved
Date submitted
19/01/2021
Date registered
15/03/2021
Date last updated
13/03/2023
Date data sharing statement initially provided
15/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
‘Taking charge’ after a diagnosis of mild cognitive impairment or dementia: does early intervention change quality of life?
Scientific title
‘Taking charge’ after a diagnosis of mild cognitive impairment or dementia: does early intervention change quality of life?
Secondary ID [1] 303205 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 320341 0
mild cognitive impairment 320343 0
Condition category
Condition code
Neurological 318256 318256 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Take Charge intervention:
Take Charge is considered a patient activation program in which the participant is encouraged to reflect on their values and their vision for the months ahead. The intervention will be provided by someone with training in a health field (such as nursing or allied health). Interventionists will be trained according to a training manual specifically adapted for this study.
The intervention will take place over two consultations. A Take Charge booklet will be used with participants to guide the intervention process. The role of the interventionist is to guide the participant through the activities in the workbook, to listen and to facilitate goal statements. The consultations may take place in person (in the person's own home or clinic) or via telehealth delivery (videoconferencing or telephone). The consultations will take place with the person and family or close friends for support as appropriate. The person and their family are encouraged to ‘take charge’ following a diagnosis of Mild Cognitive Impairment (MCI) or dementia, having considered their values, strengths and capabilities. They will decide for themselves where the key issues are, and be given basic skills and supports to write a self-directed rehabilitation plan for themselves (the person with MCI or dementia and their family). The first consultation is expected to last approximately 60 minutes.
A second consultation will take place six weeks later (also lasting approximately 60 minutes). The total duration of the study is six weeks in total and involve the two consultations (with no contact in between except to reschedule appointments if required). The second consultation will involve reviewing goals and setting new goals as appropriate.
The intervention is structured into discussion points which will be addressed by each participant. These points include hopes, fears, My ‘Best Day’, functional domains, family and friend networks and information needs. Discussion points and goals will vary depending on the individual needs of the participant. There is no set time to spend completing the workbooks and this will be managed at the discretion of the participant.
Fidelity will be monitored by review of the Take Charge workbooks ensuring that the discussion points have been addressed and goals have been identified.


Intervention code [1] 319508 0
Rehabilitation
Intervention code [2] 319509 0
Lifestyle
Intervention code [3] 319510 0
Behaviour
Comparator / control treatment
The control group will also receive two consultations, each lasting approximately 60 minutes. The person consulting with the control group will also have training in a health field and receive training in the approach. The person will provide verbal and written information about healthy lifestyle choices for brain and cardiovascular health (ie. diet, physical activity, regular health checks, maintaining social connections). The information has been specifically designed for this study. There will be no contact between consultations except for the need to reschedule appointments if required.
Control group
Active

Outcomes
Primary outcome [1] 326238 0
Health related quality of life related to physical functioning: Physical Component Summary of the SF36 tool (health related quality of life)
Timepoint [1] 326238 0
Baseline, 6 months after trial commencement
Secondary outcome [1] 390687 0
Health related quality of life related to physical functioning: Physical Component Summary of the SF36
Timepoint [1] 390687 0
Baseline, 3 months after trial commencement
Secondary outcome [2] 390688 0
Health related quality of life: Total score of the SF36
Timepoint [2] 390688 0
Baseline, 3 months after trial commencement, 6 months after trial commencement
Secondary outcome [3] 390689 0
Hope assessed using the Adult Hope Scale
Timepoint [3] 390689 0
Baseline, 3 months after trial commencement, 6 months after trial commencement
Secondary outcome [4] 390690 0
Instrumental activities of daily living assessed via the Frenchay Activities Index
Timepoint [4] 390690 0
Baseline, 3 months after trial commencement, 6 months after trial commencement
Secondary outcome [5] 390694 0
Health Service Utilisation (using the Resource Utilisation in Dementia Lite tool)
Timepoint [5] 390694 0
6 months after trial commencement
Secondary outcome [6] 391871 0
Satisfaction with the intervention to be measured using self-designed survey
Timepoint [6] 391871 0
3 months after trial commencement

Eligibility
Key inclusion criteria
Adult (>18 years old), diagnosed with mild cognitive impairment or mild dementia (MMSE 19-23/30) within the last six months, living in the community with or without a family member.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Live outside of the SALHN region, have other life limiting conditions where the person is not expected to live for a further 12 months or more.

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 randomisation sequence will be developed using an online random sequence generator. An online database (REDCAP) will be used to manage randomisation ensuring that the sequence is concealed from the study team until the point of randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use an online program to generate the randomisation schedule. Participants will be stratified by diagnosis (MCI or dementia) and then randomised.
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
Recruiting
Date of first participant enrolment
Anticipated
3/05/2021
Actual
25/06/2021
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
160
Accrual to date
145
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18455 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 32565 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 307608 0
Charities/Societies/Foundations
Name [1] 307608 0
Flinders Foundation
Country [1] 307608 0
Australia
Funding source category [2] 307610 0
Charities/Societies/Foundations
Name [2] 307610 0
Hospital Research Foundation
Country [2] 307610 0
Australia
Funding source category [3] 311131 0
Other Collaborative groups
Name [3] 311131 0
Dementia Centre for Research Collaboration
Country [3] 311131 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100,
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 308301 0
None
Name [1] 308301 0
Not applicable
Address [1] 308301 0
Not applicable
Country [1] 308301 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307661 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 307661 0
Ethics committee country [1] 307661 0
Australia
Date submitted for ethics approval [1] 307661 0
28/01/2021
Approval date [1] 307661 0
01/04/2021
Ethics approval number [1] 307661 0
2021/HRE00009

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

Contacts
Principal investigator
Name 108046 0
A/Prof Kate Laver
Address 108046 0
Flinders University, Flinders Drive, Bedford Park, SA 5042
Country 108046 0
Australia
Phone 108046 0
+61 8 7221 8335
Fax 108046 0
Email 108046 0
Kate.Laver@flinders.edu.au
Contact person for public queries
Name 108047 0
Kate Laver
Address 108047 0
Flinders University, Flinders Drive, Bedford Park, SA 5042
Country 108047 0
Australia
Phone 108047 0
+61 8 7221 8335
Fax 108047 0
Email 108047 0
Kate.Laver@flinders.edu.au
Contact person for scientific queries
Name 108048 0
Kate Laver
Address 108048 0
Flinders University, Flinders Drive, Bedford Park, SA 5042
Country 108048 0
Australia
Phone 108048 0
+61 8 7221 8335
Fax 108048 0
Email 108048 0
Kate.Laver@flinders.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
Ethics application does not request permission for data sharing


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.