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Adherence to treatment in adults with cystic fibrosis

Development and evaluation of an intervention to support Adherence to treatment in adults with cystic fibrosis: A feasibility study comprised of an external pilot randomised controlled trial and process evaluation (WP 3.1)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13076797
Enrollment
64
Registered
2016-06-07
Start date
2016-06-13
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders

Interventions

Study participants will be randomised to either the intervention arm (CFHealthHub) or control arm (usual care). Participants in both groups will contribute adherence data to CFHealthHub but only those

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosed with CF and within CF registry 2. Aged 16 years and above 3. Taking inhaled mucolytics or antibiotics via a chipped nebuliser (e.g. eTrack or I-Neb or able and willing to take via eTrack or I-Neb)

Exclusion criteria

Exclusion criteria: 1. Post-lung transplant 2. People on the active lung transplant list 3. Patients receiving palliative care, with palliative intent, for whom trial participation could be a burden 4. Participants who lack capacity to give informed consent 5) Participants using dry powder devices to take antibiotics or mucolytics

Design outcomes

Primary

MeasureTime frame
Number of pulmonary exacerbations of cystic fibrosis is measured using the modified Fuchs Criteria at baseline and 5 (+/- 1) months

Secondary

MeasureTime frame
1. Generic health status is measured using the EQ5D5L at baseline and 5 (+/- 1) months 2. Assessment of patient knowledge, skill, and confidence for self-management is measured using the Patient Activation Measure -13 at baseline and 5 (+/- 1) months 3. Life chaos is measured using the Confusion, Hubbub And Order Scale -6 at baseline and at 5 +/- 1 months 4. Habit-based behaviour patterns are measured using the Self-Reported Behavioural Automaticity Index at baseline and 5 (+/- 1) months 5. Disease specific health-related quality of life is measured using the Cystic Fibrosis Questionnaire-Revised at baseline and 5 (+/- 1) months 6. Depressive disorder severity is measured using the Patient Health Questionnaire depression scale -8 at baseline and 5 (+/- 1) months 7. Medication adherence is measured using the Medication Adherence Data -3 at baseline and 5 (+/- 1) months 8. Anxiety severity is measured using the General Anxiety Disorder -7 at baseline and 5 (+/- 1) months 9. Perceived necessities and concerns for nebuliser treatment are measured using the Capability Opportunity Motivation–Beliefs about Medicines Questionnaire at baseline and 5 (+/- 1) months 10. Resource use data is collected using the resource use form developed for the study at 5 (+/- 1) months 11. Acceptability of the intervention is determined through qualitative interviews with patients and members of the multidisciplinary CF team at 5 (+/- 1) months 12. Condition severity is measured using FEV1/FVC at routine clinic visits from baseline to study end

Countries

England, United Kingdom

Contacts

Public ContactChin Maguire
c.maguire@sheffield.ac.uk+44 114 222 0717

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026