Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000547246
Ethics application status
Approved
Date submitted
26/03/2018
Date registered
12/04/2018
Date last updated
13/07/2021
Date data sharing statement initially provided
20/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Whanau/Family Intervention for REducing risk factors Dementia (WIRED)
Scientific title
Pilot study: Randomized control trial investigating whether the impact of an information booklet on risk factors for dementia would be effective in changing behaviours of the whanau/ family of a patient who has received a diagnosis of dementia or Mild cognitive impairment.
Secondary ID [1] 294270 0
none
Universal Trial Number (UTN)
u 1111-1207-8011
Trial acronym
WIRED: Whanau/Family Intervention for REducing risk factors Dementia
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Dementia 306955 0
mild cognitive impairment 306969 0
Condition category
Condition code
Neurological 306063 306063 0 0
Dementias
Public Health 306064 306064 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is giving the participant an educational pamphlet developed by the memory service based at Tauranga hospital about the reversible risk factors for dementia. The participants will be able to take this pamphlet home with them. This will be in addition to treatment as usual.. This consists of sitting in on their parents consultation with the geriatric psychiatrist ( Dr Bronwyn Copeland) and discussion about memory issues. Implicit in this, is the discussion regarding lifestyle factors and the impact that this can make on memory. This discussion is more focused at the individual with the memory impairment rather than the family member. For those family members that are not able to be present at the consultation. A video documenting these lifestyle factors can be viewed if they would like to participate in the consultation.
The intervention is the pamphlet will be given to the participant once consent to participate in the study has been granted and will be given by one of the investigators. It will be given to them face to face and at the clinic. This intervention will only be given to them once.
Intervention code [1] 300572 0
Lifestyle
Comparator / control treatment
The control group will receive treatment as usual. This consists of sitting in on their parents consultation and discussion about memory issues. Implicit in this is the discussion regarding lifestyle factors and the impact that this can make on memory. This discussion is more focused at the individual with the memory impairment rather than the family member. For those family members that are not able to be present at the consultation. A video documenting these lifestyle factors can be viewed if they would like to participate in the consultation.
Control group
Active

Outcomes
Primary outcome [1] 305095 0
Changes in weight- this will be measured using a digital scale
Timepoint [1] 305095 0
The time point will be 6 months post enrolment in the study.
Primary outcome [2] 305096 0
changes in smoking status. This will be measured from asking the questions on our questionnaire that has been submitted asking whether the individual is smoking and how many they have smoked on average in the last 28 days.
Timepoint [2] 305096 0
6 months post enrolment
Primary outcome [3] 305097 0
changes in dietary habits as measured by the MEDAS ( Mediterranean diet adherence scale)
Timepoint [3] 305097 0
6 months post enrolment
Secondary outcome [1] 344156 0
changes in exercise frequency as measured on the NZPAQ ( New Zealand physical activity questionnaire)
Timepoint [1] 344156 0
6 months post enrolment
Secondary outcome [2] 344157 0
Measure of quality of life using the SF36 ( short form 36)
Timepoint [2] 344157 0
6 months post enrolment

Eligibility
Key inclusion criteria
Children of a patient who has been diagnosed with mild cognitive impairment or dementia at the memory service at Tauranga hospital. Over the age of 18 and able to give consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
no exclusion criteria

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)
The allocation of a participant into either the control or the intervention group will be done by contacting Dr Gary Cheung who is based in Auckland University who will hold the allocation schedule. The investigator who identifies a potential participant will be unaware as to which group the participant will be allocated to, as it will be done by the allocation schedule held off site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by a statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
the intervention group is part of the study for 6 months after they have received the pamphlet in addition to treatment as usual.
the control group will be exposed to treatment as usual and this will act as a comparison group for the intervention. After 6 months, they will be offered the intervention ( I.e the pamphlet) and will therefore act as their own controls)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The total sample size is reduced to 10 due to major difficulty with recruitment. Inferring statistics are not possible. We will therefore present descriptive statistics only.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
18/06/2018
Actual
29/08/2018
Date of last participant enrolment
Anticipated
30/09/2021
Actual
30/09/2020
Date of last data collection
Anticipated
30/06/2022
Actual
30/10/2020
Sample size
Target
10
Accrual to date
Final
5
Recruitment outside Australia
Country [1] 9676 0
New Zealand
State/province [1] 9676 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 298907 0
Hospital
Name [1] 298907 0
Tauranga Hospital
Country [1] 298907 0
New Zealand
Primary sponsor type
Individual
Name
Dr Bronwyn Copeland
Address
Mental Health Services for Older People
Tauranga Hospital
Cameron Rd
Tauranga
Private bag 12024
3143
Country
New Zealand
Secondary sponsor category [1] 298121 0
Individual
Name [1] 298121 0
Dr Gary Cheung
Address [1] 298121 0
Department of Psychological medicine
University of Auckland
Private Bag 92109
Auckland Mail centre
Auckland
1142
Country [1] 298121 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299848 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 299848 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 299848 0
New Zealand
Date submitted for ethics approval [1] 299848 0
31/05/2018
Approval date [1] 299848 0
08/06/2018
Ethics approval number [1] 299848 0
18/CEN/77

Summary
Brief summary
As a memory service, we have recently compiled a brochure specifically for the children/ whanau of the people who have been diagnosed with memory impairment. The purpose of the brochure is to provide the whanau with information on the preventable risk factors for dementia so that they can alter them now when it counts and could decrease the risk of developing dementia. Many public health measures addressing these in the general public seem to fall on deaf ears, but my hope is that if our participants parent has just received a diagnosis of dementia, the response might be, “ I hope it won’t happen to me”. We therefore felt that this would be a perfect audience to target and potentially could have far reaching ramifications for the wider whanau.

This study will be working with the family members of people that have just been diagnosed with dementia or mild cognitive impairment in our memory service and investigating whether our intervention ( pamphlet) would be helpful in them reducing their risk factors for dementia. This is not a long-term longitudinal follow up study, it is more to investigate whether the information that we provide will alter their behaviours – ie smoking, exercise and diet in a 6-month period. If this proves to be beneficial, then we could consider a future longitudinal study.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2497 2497 0 0
/AnzctrAttachments/374676-protocol version 3.docx (Protocol)
Attachments [2] 2534 2534 0 0
/AnzctrAttachments/374676-2. PIS FW Intervention Prevention of Dementia.pdf (Participant information/consent)
Attachments [3] 2535 2535 0 0
/AnzctrAttachments/374676-3. PCF FW Intervention Prevention of Dementia.pdf (Participant information/consent)
Attachments [4] 2537 2537 0 0
/AnzctrAttachments/374676-5. Study Questionnaires.pdf (Supplementary information)
Attachments [5] 2541 2541 0 0
/AnzctrAttachments/374676-4. GP Family Whanau Intervention and Prevention of Dementia Study.pdf (Supplementary information)
Attachments [6] 2542 2542 0 0
/AnzctrAttachments/374676-6. Brochure Family Whanau Intervention and Prevention of Dementia Study.pdf (Publication)

Contacts
Principal investigator
Name 81762 0
Dr Bronwyn Copeland
Address 81762 0
Mental Health Services for Older People
Tauranga Hospital
Cameron Rd
Tauranga
Private bag 12024
3143
Country 81762 0
New Zealand
Phone 81762 0
+64 75798335
Fax 81762 0
+64 7 5713900
Email 81762 0
Bronwyn.Copeland@bopdhb.govt.nz
Contact person for public queries
Name 81763 0
Ms Cheryl Collier
Address 81763 0
Mental Health Services for Older People
Tauranga Hospital
Cameron Rd
Tauranga
Private bag 12024
3143
Country 81763 0
New Zealand
Phone 81763 0
+64 75798335
Fax 81763 0
+64 7 5713900
Email 81763 0
Cheryl..Collier@bopdhb.govt.nz
Contact person for scientific queries
Name 81764 0
Dr Bronwyn Copeland
Address 81764 0
Mental Health Services for Older People
Tauranga Hospital
Cameron Rd
Tauranga
Private bag 12024
3143
Country 81764 0
New Zealand
Phone 81764 0
+64 75798335
Fax 81764 0
+64 7 5713900
Email 81764 0
Bronwyn.Copeland@bopdhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This was not included in the original design.


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.