Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001045808
Ethics application status
Approved
Date submitted
30/05/2021
Date registered
9/08/2021
Date last updated
29/07/2022
Date data sharing statement initially provided
9/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
DIGIFALE: A digital health literacy programme for Pacific communities
Scientific title
DIGIFALE: A non-randomised intervention to determine the acceptability of a culturally contextualised mobile literacy programme for digital health literacy among Pacific communities in Aotearoa / New Zealand
Secondary ID [1] 304352 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Digital health literacy 322125 0
Condition category
Condition code
Public Health 319830 319830 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a non-randomised digital health literacy programme. Participants will participate in FIVE group sessions delivered over five weeks, with each group session lasting approximately 1.5-2 hours. Digital literacy questions will be asked at baseline and at five weeks, which includes demographics. Participants will receive a mobile phone and progress through culturally contextualised modules that build on necessary skills moving individuals from basic mobile literacy to digital health literacy. Participants will learn in a culturally aligned environment that is familiar to them.

The programme will utilise a ‘train the trainer’ approach using DIGIFALE navigators to deliver the sessions. The lead researcher will facilitate a workshop with DIGIFALE navigators, provide an overview of the programme, and cover core subject areas related to the programme sessions and adult learning principles. Each cohort of DIGIFALE participants (Niue, Samoa, Tonga, Cook Island) will have DIGIFALE navigators from their ethnic specific background to enable sessions to be delivered in their first Pacific language. The study researcher and a community engagement coordinator will work alongside the DIGIFALE navigators as they lead and deliver the sessions within their cohort.

The mode of delivery is group sessions of no more than 15 people, delivered face-to-face in an environment that is familiar to participants such as a church setting or community hall. The trained DIGIFALE navigators (n=10) will work closely with participants during each session.

The DigiFale modules which provide the digital skills, are designed so that each session builds on the previous one. Each training session will start with what is relevant for individuals, consisting of four main types of activities: 1) Explanation: Short explanations to introduce benefits of a service; 2) Activity: Practical exercises on phones; 3) Discussion: To encourage elderly participants to consider the relevance in their lives; and 4) Recap: To reinforce lessons of each module. An outline of the sessions is provided below:
- Session One - Introduction to DIGIFALE & navigating your phone: This session is designed to introduce participants to DIGIFALE and for participants to become familiar with their phone and phone icons. Participants will learn about gestures and how to make phone calls, send text messages, find phone characters, take photos and videos.
- Session Two – Navigating online: This session introduces participants to Gmail; Google; YouTube; and importantly, digital wellbeing and online safety.
- Session Three – Connecting online: This session introduces participants to sending and receiving emails; zoom; online Government services (my Inland Revenue) and QR scanning (includes COVID-19 app).
- Session Four – Connecting with health services online: This session introduces participants to patient portals, using Google to search for online health websites (e.g Ministry of Health), digital wellbeing and online safety.
- Session Five – Reconnecting & digital wellbeing: This session provides participants an opportunity to reflect on their learning to date and to build on knowledge they have acquired during the previous sessions.

To monitor adherence to the intervention, session attendance will be recorded by DIGIFALE navigators at every session.
Intervention code [1] 320708 0
Behaviour
Intervention code [2] 320712 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327703 0
Change in digital literacy skills.

Changes in digital literacy skills will be assessed using a study-specific pre/post questionnaire assessing five domains which include:
1. Basic skills
2. Skills to carry out online activities and services
3. Social connection skills
4. Skills to be safe online
5. Skills to access digital health services
Timepoint [1] 327703 0
Baseline and five weeks post-intervention commencement.
Secondary outcome [1] 396262 0
Participant satisfaction

This will be assessed with a study-specific questionnaire. Participants can complete this on paper or electronically. The questionnaires will be de-identified.
Timepoint [1] 396262 0
Participants will be asked to complete a questionnaire at completion of the intervention, which maybe between 5 - 10 weeks post-intervention commencement.
Secondary outcome [2] 396263 0
Attendance
Timepoint [2] 396263 0
Attendance will be recorded at all five DIGIFALE sessions (session 1, 2, 3, 4, 5).
Attendance will be assessed based on the number of sessions the participant attended (% of 5).
Secondary outcome [3] 398337 0
Intergenerational communication and social connection.

A sample of participants will be invited at the end of the programme where they will be asked about their experiences around intergenerational communication and social connection.. The family group tutala (discussion using semi-structured questionairre) with participants and family members will last approximately 1-1.5 hours and will be recorded using a digital audio recorder and field notes. Participation in the group tutala is entirely voluntary. If individuals choose not to take part, they will be free to withdraw at any time without giving a reason.
Timepoint [3] 398337 0
At the completion of the intervention which maybe between 6 - 10 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
• Self-identified as Pacific
• Aged 18 years or older
• Considered digitally excluded (No mobile phone; used a mobile phone but stopped using this because it was too difficult; not confident using a mobile phone)
• Ability to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not available for the duration of the programme

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We aim to recruit 60 Pacific adults onto the programme from four Pacific ethnic communities - Niue, Cook Island, Samoa and Tonga. There will be four groups each with fifteen Pacific adults to enable ideal conditions when learning digital literacy skills.

Baseline characteristics will be summarised using descriptive analysis.
Analysis of pre and post-survey measures will be analysed for changes in skills.
Thematic analysis will be used to explore patient satisfaction and feedback.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/08/2021
Actual
1/02/2022
Date of last participant enrolment
Anticipated
31/07/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
60
Accrual to date
60
Final
Recruitment outside Australia
Country [1] 23738 0
New Zealand
State/province [1] 23738 0
Auckland

Funding & Sponsors
Funding source category [1] 308723 0
Government body
Name [1] 308723 0
New Zealand Ministry of Health
Country [1] 308723 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Moana Connect
Address
Level 1, 141 Bader Drive
Mangere
Auckland
2022
Country
New Zealand
Secondary sponsor category [1] 309621 0
University
Name [1] 309621 0
University of Auckland
Address [1] 309621 0
Department of Epidemiology and Biostatistics
University of Auckland
Private Bag 92019
Auckland
1142
Country [1] 309621 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308646 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 308646 0
Ethics committee country [1] 308646 0
New Zealand
Date submitted for ethics approval [1] 308646 0
21/04/2021
Approval date [1] 308646 0
10/05/2021
Ethics approval number [1] 308646 0
21/STH/110

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

Contacts
Principal investigator
Name 111418 0
Mrs Amio Matenga Ikihele
Address 111418 0
Moana Connect
Level 1, 141 Bader Drive, Mangere
2022 Auckland
Country 111418 0
New Zealand
Phone 111418 0
+64 211752087
Fax 111418 0
Email 111418 0
[email protected]
Contact person for public queries
Name 111419 0
Amio Matenga Ikihele
Address 111419 0
Moana Connect
Level 1, 141 Bader Drive, Mangere
2022 Auckland
Country 111419 0
New Zealand
Phone 111419 0
+64 211752087
Fax 111419 0
Email 111419 0
[email protected]
Contact person for scientific queries
Name 111420 0
Amio Matenga Ikihele
Address 111420 0
Moana Connect
Level 1, 141 Bader Drive, Mangere
2022 Auckland
Country 111420 0
New Zealand
Phone 111420 0
+64 211752087
Fax 111420 0
Email 111420 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not asked participants consent to share data on an individual basis.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11830Study protocol    382090-(Uploaded-16-07-2021-09-58-28)-Study-related document.pdf



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.