ANZCTR - Registration

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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]

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

mild cognitive impairment

Condition category

Condition code

Neurological

Dementias

Public Health

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]

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]

Changes in weight- this will be measured using a digital scale

Timepoint [1]

The time point will be 6 months post enrolment in the study.

Primary outcome [2]

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]

6 months post enrolment

Primary outcome [3]

changes in dietary habits as measured by the MEDAS ( Mediterranean diet adherence scale)

Timepoint [3]

6 months post enrolment

Secondary outcome [1]

changes in exercise frequency as measured on the NZPAQ ( New Zealand physical activity questionnaire)

Timepoint [1]

6 months post enrolment

Secondary outcome [2]

Measure of quality of life using the SF36 ( short form 36)

Timepoint [2]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Bay of Plenty

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Tauranga Hospital

Address [1]

Mental Health Services for Older People
Tauranga Hospital
Cameron Rd
Tauranga
Private bag 12024
3143

Country [1]

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]

Individual

Name [1]

Dr Gary Cheung

Address [1]

Department of Psychological medicine
University of Auckland
Private Bag 92109
Auckland Mail centre
Auckland
1142

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
 Health and Disability Ethics Committees
 PO Box 5013
 Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

31/05/2018

Approval date [1]

08/06/2018

Ethics approval number [1]

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]

/AnzctrAttachments/374676-protocol version 3.docx (Protocol)

Attachments [2]

/AnzctrAttachments/374676-2. PIS FW Intervention Prevention of Dementia.pdf (Participant information/consent)

Attachments [3]

/AnzctrAttachments/374676-3. PCF FW Intervention Prevention of Dementia.pdf (Participant information/consent)

Attachments [4]

/AnzctrAttachments/374676-5. Study Questionnaires.pdf (Supplementary information)

Attachments [5]

/AnzctrAttachments/374676-4. GP Family Whanau Intervention and Prevention of Dementia Study.pdf (Supplementary information)

Attachments [6]

/AnzctrAttachments/374676-6. Brochure Family Whanau Intervention and Prevention of Dementia Study.pdf (Publication)

Contacts

Principal investigator

Name

Dr Bronwyn Copeland

Address

Mental Health Services for Older People
Tauranga Hospital
Cameron Rd
Tauranga
Private bag 12024
3143

Country

New Zealand

Phone

+64 75798335

Fax

+64 7 5713900

Bronwyn.Copeland@bopdhb.govt.nz

Contact person for public queries

Name

Cheryl Collier

Address

Mental Health Services for Older People
Tauranga Hospital
Cameron Rd
Tauranga
Private bag 12024
3143

Country

New Zealand

Phone

+64 75798335

Fax

+64 7 5713900

Cheryl..Collier@bopdhb.govt.nz

Contact person for scientific queries

Name

Bronwyn Copeland

Address

Mental Health Services for Older People
Tauranga Hospital
Cameron Rd
Tauranga
Private bag 12024
3143

Country

New Zealand

Phone

+64 75798335

Fax

+64 7 5713900

Bronwyn.Copeland@bopdhb.govt.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

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