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Implementing a comprehensive adherence protocol for children and adolescents living with Cystic Fibrosis – An implementation study.

Implementing a comprehensive adherence protocol for children and adolescents living with Cystic Fibrosis – feasibility, appropriateness and acceptability.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001730190
Enrollment
88
Registered
2019-12-09
Start date
2018-12-03
Completion date
2019-12-20
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Study Aim The primary aim of this project is to evaluate the feasibility, acceptability and appropriateness of implementing a comprehensive adherence protocol into the Queensland Children's Hospital Cystic Fibrosis clinic. Study Design This is a mixed method, implementation study design. The four-phase Replicating Effective Programs (REP) framework developed to translate effective health services interventions into community-based settings, will inform implementation. Focus groups and interviews will form the needs assessment (pre-conditions), Descriptive data will be collected throughout implementation and interviews will be conducted post implementation to evaluate the change process. Pre-Conditions Phase: The researchers will review literature, existing adherence promotion interventions, clinic processes and resources. From this, the team will determine the core components of the iCARE intervention and create an implementation strategy that will support translation into the existing LCCH clinic structure and resourcing. Pre- Implementation Phase: The iCARE protocol, business case and draft implementation plan will be presented to the Cystic Fibrosis care team. Focus groups and consumer interviews will be used to gather qualitative data on adherence assessment and intervention and inform the implementation plan. Implementation Phase: All children and family’s accessing the clinic will receive the adherence promotion protocol as part of their routine clinic attendance. The research team will continue to collaborate with consumers and staff to troubleshoot, provide feedback and booster training as indicated. The implementation plan will continue to be modified and refined according to staff and consumer input. The researchers will record all facilitator input via technical assistance and training logs. Retrospective chart audit and a protocol checklist will be utilised to monitor fidelity and uptake of each aspect of the protocol into routine care. Maintenance and Evolution: Following three months of clinic implementation, the implementation process will be evaluated by the research team. Participants (staff and consumers) will be recruited to complete qualitative evaluation of the protocol and its components. Following the completion of the project, it is anticipated that the protocol will continue to be used in the clinic as standard care, if deemed acceptable to staff and consumers and sustainable within the existing resourcing of the clinic.

Interventions

The intervention in this study is the implementation of comprehensive adherence protocol to clinical care provision. The comprehensive adherence protocol will be adapted from the CF MyWay adherence protocol. This protocol involves the delivery of 5 items: 1. Written treatment plans to all patients provided 3 monthly 2. Problem solving intervention with both the child and parent involved provided 3 monthly 3. Assessment of knowledge using the Knowledge of Disease Management assessments(KoDM) for

The intervention in this study is the implementation of comprehensive adherence protocol to clinical care provision. The comprehensive adherence protocol will be adapted from the CF MyWay adherence protocol. This protocol involves the delivery of 5 items: 1. Written treatment plans to all patients provided 3 monthly 2. Problem solving intervention with both the child and parent involved provided 3 monthly 3. Assessment of knowledge using the Knowledge of Disease Management assessments(KoDM) for child and parent completed annually 4. Assessment of adherence level via Treatment Adherence Questionnaire (TAQ-CF) three monthly 5. Completion of Observed Skills Manual by treating therapist annually All of the above interventions will be administered by a member of the treating team, face to face, during usual clinic encounters at the Queensland Children's Hospital Clinic.

Sponsors

Children's Health Queensland - Hospital and Health Service
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Primary purpose
Educational / counselling / training

Eligibility

Sex/Gender
All
Age
8 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants will be children aged between 8 and 18 (i) and/or caregivers of a children aged 0-18 (ii) with a confirmed diagnosis of CF (iii) that are receiving care from the QCH CF clinic (iv). Participants will also include clinicians including respiratory physicians, cystic fibrosis nurses, physiotherapists, social workers, occupational therapists and dieticians whom work within the QCH CF clinic at time of recruitment (v).

Exclusion criteria

Participants will be excluded from the study if they receive care via outreach services or do not receive care at QCH during the implementation phase of the study. Staff will be excluded if they are not working within the QCH CF clinic at the time of recruitment.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 13, 2026