Phase 1 Protocol

Co-design Practical Strategies for the CT-iSupport Trial

Overview

This protocol provides a step-by-step guide for the research team and partner organisations involved in Phase 1 of the “Cross-sector collaboration to scale up a Culturally Tailored iSupport model to address unmet needs of dementia carers: the CT-iSupport trial” project

Overall Aim and Research questions for Phase 1

The primary aim of Phase 1 is to co-design Practical Strategies with stakeholders to scale up the Culturally-tailored iSupport model of care (CT-iSupport) within a cross-sector collaborative context. This foundational work is crucial for the effective implementation and scalability of the CT-iSupport intervention.

The key research questions guiding this phase are:

• What are stakeholders’ perspectives on Practical Strategies, including resources and tools, to maximise the acceptability, fidelity, and feasibility of CT-iSupport?

• What are stakeholders’ perspectives on a training program for CT-iSupport providers?

Study Design:

Phase 1 will utilise a qualitative descriptive approach. This approach facilitates dialogue with stakeholders in a naturalistic setting. The entire process will be guided by co-design principles.

Leadership:

The study will be jointly led by Chief Investigators (CIs) Prof. Lily Dongxia Xiao, Prof. Gillian Harvey, and Prof. Stacey George. Their expertise in dementia, primary care, and implementation research is critical for this phase.

Participant Recruitment and Eligibility:

Phase 1 will recruit two distinct groups of participants: Culturally and Linguistically Diverse (CALD) carers and relevant staff members from partner organisations.

CALD Carers:

Inclusion Criteria:

▪ Aged 18 years or over.

▪ Born in a country where the official language is not English, and primarily speak one of the following languages at home: Italian, Greek, Mandarin, Cantonese, Vietnamese, Bahasa, or Spanish.

▪ Provide care for an adult CALD person with dementia (CALD-PWD) at least twice a week.

Exclusion Criteria: Carers with health conditions that could significantly impact their ability to participate, or those already involved in other studies

Recruitment Process:

1. Identification: Administrative staff from the nine aged care partner organisations will identify potential CALD carer participants from their databases based on the established inclusion and exclusion criteria.

2. Initial Contact: Invitations to participate, providing detailed information about the study, will be sent to these potential carers.

3. Follow-up and Consent: A bilingual researcher will follow up with interested carers to assess their eligibility, discuss the study in detail, and obtain their informed consent (likely signed). This recruitment process has prior ethics approval.

//Estimated Sample Size:

Approximately 70 carers (6-8 participants per focus group, with one group for each of the seven language communities)

Staff participants:

Inclusion Criteria: Individuals holding leading or managing roles, or those providing direct care services for CALD-PWD or their carers within aged care providers, Carer Gateway providers, or Primary Health Networks (PHNs).

Exclusion Criteria: Staff who do not provide direct care to CALD-PLWD or have less than three years of dementia care experience.

Recruitment Process:

Recruitment Process:

1. Initial Contact: Flyers and email invitations will be distributed to potential staff members.

2. Expression of Interest: Interested and eligible staff will contact a researcher to indicate their voluntary interest in the study.

 

//Estimated Sample Size:

Approximately 30 staff members (6-8 participants per focus group, with one group each for aged care staff, Carer Gateway providers, and PHNs providers)

 

Ethical Considerations:

• Translation of Documents: All participant recruitment documents, including the Participant Information and Consent Form (PICF), will be translated into Chinese (Cantonese and Mandarin), Indonesian, Italian, Greek, Spanish, and Vietnamese. This will be done by partner organisations and advisory group members to enhance accessibility for CALD carers.

• Informed Consent: Potential participants will receive comprehensive information about Phase 1 in their preferred language. Discussions will be facilitated by bilingual researchers who share their cultural and linguistic background to ensure genuine understanding. Formal written consent will be obtained from all participants prior to their involvement.

• Voluntary Participation and Withdrawal: Participation is strictly voluntary. Participants will be explicitly informed of their right to withdraw at any time, for any reason, without penalty or negative consequences to their access to care services or relationships with the research team or partner organisations. This includes the option to decline participation, leave a focus group at any point, or request their data be removed from the study after participation.

 

• Managing Conflicts of Interest: Industry partners’ representatives in management roles have a potential conflict of interest. To mitigate this, they will not participate in direct participant recruitment or data collection. They will only access de-identified data for analysis and reporting.

• Confidentiality and Data Protection: Each participant will be assigned a unique code. Only the Chief Investigator and site-specific researchers involved in data collection will link real names to codes.

• Minimising Psychological Harm: Discussions about caring experiences can be emotionally distressing. Researchers will be trained to monitor for distress, offer breaks, and provide information on free counselling services (e.g., Dementia Australia Helpline, Beyond Blue).

 

Data Collection Methods

Document Review: Participants will undertake a pre-focus group review of draft strategies, drawing on existing work and literature. This review is expected to last no more than two hours.

Focus Groups:

  • Structure: One focus group will be conducted for each of the seven CALD language groups, and three separate focus groups for staff representatives (aged care, Carer Gateway, and PHNs).
  • Facilitation: Each group will be facilitated by two researchers (one lead, one observer). CALD carer groups will be facilitated by researchers sharing the same culture and language.
  • Duration: Each focus group will last between 1.5 and 2 hours.
  • Discussion Guide: A semi-structured discussion guide will be used, focusing on the acceptability, fidelity, and feasibility of CT-iSupport.
  • Recording: Discussions will be audio-recorded and transcribed verbatim.

 

Data Analysis and Storage

Qualitative Analysis: Transcribed data will be analysed using reflexive thematic analysis. NVivo software will assist with coding processes and theme identification.

Data Storage:

  • Electronic Data: De-identified transcripts and online survey data will be stored in password-protected folders on the Flinders University Research Drive. Access is restricted to designated researchers (CI Xiao and Dr. Kham Tran).
  • Hard Copy Data: Signed consent forms will be stored in a secure locked filing cabinet in the CI’s office during the analysis period. Upon project completion, hard copies will be moved to a secure, approved university facility, with access limited to CI Xiao.
  • Retention and Destruction: All data will be securely stored at Flinders University for five years after the publication of results, after which it will be securely destroyed according to university protocols.

Participant Remuneration and Feedback

• Reimbursement: Participants in focus groups will receive a $// gift card as a modest acknowledgement for their time and effort.

• Feedback to Participants: Summaries of contributions and co-created strategies will be documented, synthesised, and shared with all participants. This ensures participants can see the impact of their input on the CT-iSupport model.

• Feedback to Organisations: Regular updates will be provided to partner organisations through monthly Steering Committee meetings and other forums.

 

 

Key Deliverables and Outcomes for Phase 1

• Development of evidence-based training strategies for CT-iSupport providers (to be evaluated in Phase 2).

• Development of Practical Strategies with associated resources to maximise the acceptability, fidelity, and feasibility of the CT-iSupport (to be tested in Phase 3). 

 

Phase 1 timeline

March 2025 – August 2025: Secure Human Research Ethics Committee (HREC) and Site Research Governance Office (RGO) approvals for Phase 1

September 2025 – February 2026:

◦ Recruit participants and complete all focus groups with stakeholders.

◦ Complete reporting on the co-designed strategies for scaling up CT-iSupport.

◦ Organise necessary resources and toolkits to support the subsequent CT-iSupport trials.

◦ Submit the annual project report.

 

Interested In Participating?

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//Appendices

List of appendices to be added here (with attached file)

  • Appendix 1: PCIF for carers
  • Appendix 1.2. PCIF for staff
  • Appendix 2.1. Flyer for carers
  • Appendix 2.2. Flyer for staff
  • …