Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001323617
Ethics application status
Not yet submitted
Date submitted
2/12/2014
Date registered
17/12/2014
Date last updated
27/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A psychoeducation intervention for family caregivers of people with dementia using a mobile application: a feasibility study
Scientific title
For caregivers of people living with dementia, does psychoeducation via mobile application, compared to no intervention, improve quality of life, improve coping, and reduce burden?
Secondary ID [1] 285777 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 293660 0
Condition category
Condition code
Neurological 293958 293958 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive an 8-week psycho-educational intervention delivered through mobile application. The aim of the intervention is to help caregivers learn behaviour management skills in order to manage behavioural and psychological symptoms of dementia (BPSD) in people living with dementia (PLWD), and provide them with knowledge about dementia and psychological support. While the content of mobile application is developed partly based on a previous program conducted by the chief investigator, the app will be developed using novel ways of interaction between the caregiver and program. This application consists of three components:
(1) information about dementia such as causes, sign and symptoms, available community resources, fall prevention and long-term caregiving issues;
(2) the application with 10 scenarios 3-dimension simulation and animated videos about management of the common behaviour problems anxiety and agitation, aggression, confusion, repetition, suspicion, wandering, sleep problems, searching or hiding things, hallucination and delusion, and refusal; and
(3) interactive learning sessions.

Topics covered in the interactive learning sessions include:
(1) Introduction to Dementia and BPSD,
(2) Behaviour Management Strategies,
(3) Problem-solving Skills,
(4) Communication Skills,
(5) Pleasant Events Scheduling,
(6) Managing Caregiver Stress,
(7) Emotional Coping Strategies, and
(8) Positive Aspects of Caregiving.

The application will be available 24 hours every day for the duration of the intervention. Participants will be able to access the application as much as they wish to during the intervention.

One week before the intervention starts, a face to face demonstration on how to download and use the mobile application will be provided to all participants. They are advised to complete one session every week and to complete the eight sessions within eight weeks. All participants will receive weekly telephone call to remind them to complete each session, address issues encountered when using the mobile application.
Intervention code [1] 290736 0
Behaviour
Intervention code [2] 290737 0
Lifestyle
Comparator / control treatment
Control group participants will receive the standard treatment which consists of routine care and support provided by the clinic such as information about dementia and referral to community resources upon their request and when the needs arise.
Control group
Active

Outcomes
Primary outcome [1] 293729 0
Subjective and objective burden as measured by Zarit Burden Inventory.
Timepoint [1] 293729 0
Baseline, immediately after, and 3 months after the intervention
Primary outcome [2] 293730 0
Coping strategies as measured by Family Crisis Oriented Personal Evaluation Scales.
Timepoint [2] 293730 0
Baseline, immediately after, and 3 months after the intervention
Primary outcome [3] 293731 0
Depression as measured by Centre for Epidemiologic Studies Depression Scale.
Timepoint [3] 293731 0
Baseline, immediately after, and 3 months after the intervention
Secondary outcome [1] 311689 0
Gains in dementia caregiving as measured by Gain in Alzheimer Care Instrument.
Timepoint [1] 311689 0
Baseline, immediately after, and 3 months after the intervention
Secondary outcome [2] 311690 0
Composite secondary outcome - PLWD’s severity and frequency of neuropsychiatric symptoms and caregiver’s distress as measured by Neuropsychiatric Inventory Questionnaire.
Timepoint [2] 311690 0
baseline, immediately after, and 3 months after the intervention.
Secondary outcome [3] 311691 0
Composite secondary outcome - Frequency of behavior problems in the persons with dementia and the family caregiver’s reactions to these behavior problems as measured by Revised Memory and Behaviour Problem Checklist
Timepoint [3] 311691 0
Baseline, immediately after, and 3 months after the intervention.

Eligibility
Key inclusion criteria
Participants will be the primary family caregivers of the person with dementia with mild to moderate stage of dementia as determined by the geriatrician/neurologist/psychiatrist. Family caregivers can be the PLWD’s spouse, child, daughter/son in-law, or sibling. The inclusion criteria for family caregiver include
(1) age 18 and above;
(2) care for a person with dementia, who has three or more behavior problems at home as assessed by Neuropsychiatric Inventory questionnaire (NPI-Q);
(3) have access to a smart phone (such as iPhone or Android phone) or tablet computer (such as iPad or Samsung Galaxy Note) and know how to use download applications from application distribution platforms (i.e. Apple AppStore or Google Play Store);
(4) able to understand English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The family caregiver will be excluded if they are suffering from any mental illness or major physical illnesses such as cancer.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A convenience sample will be recruited from centers such as Carers NSW and Alzheimer’s Australia NSW/ QLD, Memory Clinics and outpatient clinics in the Hunter Region and randomized into intervention and control group. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participants will be randomized by computerized random-number generator software. Participants whose numbers are selected will be assigned to intervention group. Using this method, participants would have equal chances of being selected into intervention and control group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
none
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
PASW 18.0 version of the statistical analysis software will be used for data analysis. Descriptive statistics will be used to describe the demographic data of the participants. Homogeneity between groups at baseline will be examined by comparing the demographic and baseline data using Chi-square test or Fisher’s exact test and independent t-test. Assume that the distribution of outcome observations are normal, Repeated measure ANOVA test will be performed to examine the mean changes in the instrument scores among the repeated measures at three time points of baseline, post-1 immediate after program and post-2 at 3-month follow up. Both intention-to-treat analysis and per-protocol analysis will be performed. The results will be compared to examine the effect of lost-to-follow-up on the results of the study. Qualitative data will be transcribed and analysed by content analysis. Meaningful entities in the data will be identified and coded, and subsequently formed categories and themes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2016
Actual
Date of last participant enrolment
Anticipated
31/01/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 9010 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 290340 0
University
Name [1] 290340 0
University of Newcastle
Country [1] 290340 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr
Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 289062 0
Hospital
Name [1] 289062 0
Calvary Mater
Address [1] 289062 0
Locked Mail Bag 7
Hunter Region Mail Centre
NSW 2310
Country [1] 289062 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292045 0
Hunter New England Health Human Research Ethic Committee
Ethics committee address [1] 292045 0
Research Ethics and Governance Unit
Hunter New England Local Health District
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 292045 0
Australia
Date submitted for ethics approval [1] 292045 0
01/02/2016
Approval date [1] 292045 0
Ethics approval number [1] 292045 0

Summary
Brief summary
Aims
This study aims to: 1) develop and examine the feasibility and effect of a psycho-education intervention delivered via mobile application for family caregivers of people with dementia on caregiver burden, coping strategies, depression, gain in caregiving, distress caused by BPSD, and frequency and severity of BPSD over a 3-month follow-up; and 2) examine family caregivers’ appraisal and perceived benefits of the intervention.
Hypotheses
Primary outcomes
When compared with the routine care control group across two time points (immediately and 3-month post intervention), the intervention group will have significantly: lower level of caregiver burden, and higher level of coping strategies.
Secondary outcomes
When compared with the routine care control group across two time points (immediately and 3-month post intervention), the intervention group will have significantly: lower level of depression, higher level of gain in caregiving, lower level of distress caused by BPSD, and reduction in the frequency and severity of BPSD
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53226 0
Prof Sally Chan
Address 53226 0
The University of Newcastle
Richardson Wing, University Drive
Callaghan
NSW 2308
Country 53226 0
Australia
Phone 53226 0
61 2 49216770
Fax 53226 0
61 2 49316301
Email 53226 0
[email protected]
Contact person for public queries
Name 53227 0
Prof Sally Chan
Address 53227 0
University of Newcastle
Richardson Wing, University Drive
Callaghan
NSW 2308
Country 53227 0
Australia
Phone 53227 0
61 2 49216770
Fax 53227 0
61 2 49316301
Email 53227 0
[email protected]
Contact person for scientific queries
Name 53228 0
Prof Sally Chan
Address 53228 0
University of Newcastle
Richardson Wing, University Drive
Callaghan
NSW 2308
Country 53228 0
Australia
Phone 53228 0
61 2 49216770
Fax 53228 0
61 2 49316301
Email 53228 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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