A randomised controlled trial and parallel process evaluation to determine whether CFHealthHub, an intervention to help CF patients build better treatment habits, offers any benefit over usual care to adults with CF

Conditions

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

Bradley JM, Hutchings M, Arden MA, O'Cathain A, Maguire C, Wildman MJ, CFHealthHub Study Team.

2024-03-215 citations

An intervention to support adherence to inhaled medication in adults with cystic fibrosis: the ACtiF research programme including RCT

Martin J Wildman, Alicia O’Cathain, Daniel Hind, Chin Maguire, Madelynne A Arden et al. (28 authors)

Programme Grants for Applied Research2021-10-0111 citations

10.3310/pgfar09110

Feasibility study for supporting medication adherence for adults with cystic fibrosis: mixed-methods process evaluation

Daniel Hind, Sarah J Drabble, Madelynne A Arden, Laura Mandefield, Simon Waterhouse et al. (21 authors)

BMJ Open2020-10-0116 citations

10.1136/bmjopen-2020-039089

Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study

Daniel Hind, Sarah J Drabble, Madelynne A Arden, Laura Mandefield, Simon Waterhouse et al. (21 authors)

BMC Pulmonary Medicine2019-04-1139 citations

10.1186/s12890-019-0834-6

Interventions

The study is a mixed method study comprising a Quantitative component (parallel group, open labelled, external RCT) and a Qualitative component (audio recordings of consultations and interviews). Both

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Measure	Time frame
Number of exacerbations are measured based on the modified Fuch's criteria and determined by a combination of hospital and participant input at baseline to June 2019.	—

Secondary

Measure	Time frame
1. Patient knowledge, skills, and confidence for self-management is measured using Patient Activation Measure (PAM-13) at baseline and 12 months 2. Life chaos is measured using Assessment of routine at baseline and 12 months 3. Generic health status is measured using the EuroQuol (EQ5d-5L) at baseline, 12 months and around points of exacerbations 4. Habit based behavioural patterns are measured using Self-Report Behavioural Automaticity Index (SRBAI) at baseline and 12 months 5. Disease specific quality of life is measured using Cystic Fibrosis Questionnaire-Revised (CFQ-R) at baseline and 12 months 6. Depression severity is measured using the Patient Health Questionnaire depression scale (PHQ-8) at baseline and 12 months 7. Medication adherence is measured using MAD (Medication Adherence Data-3 items) at baseline and 12 months 8. Anxiety severity is measured using the General Anxiety Disorder 7-item anxiety scale (GAD-7) at baseline and 12 months 9. Beliefs about medication (specifically nebuliser use) is measured using The Capability Opportunity Motivation Behaviour Beliefs Questionnaire (COM-BMQ) at baseline and 12 months 10. Behaviour is measured using Behavioural question and questionnaire at baseline and 12 months 11. Clinical measures is measured using Medical adherence questions, BMI FEV1/FVC at baseline to end of study 12. Resource use is measured using questionnaire at 12 month visit	—

Measure

Time frame

1. Patient knowledge, skills, and confidence for self-management is measured using Patient Activation Measure (PAM-13) at baseline and 12 months 2. Life chaos is measured using Assessment of routine at baseline and 12 months 3. Generic health status is measured using the EuroQuol (EQ5d-5L) at baseline, 12 months and around points of exacerbations 4. Habit based behavioural patterns are measured using Self-Report Behavioural Automaticity Index (SRBAI) at baseline and 12 months 5. Disease specific quality of life is measured using Cystic Fibrosis Questionnaire-Revised (CFQ-R) at baseline and 12 months 6. Depression severity is measured using the Patient Health Questionnaire depression scale (PHQ-8) at baseline and 12 months 7. Medication adherence is measured using MAD (Medication Adherence Data-3 items) at baseline and 12 months 8. Anxiety severity is measured using the General Anxiety Disorder 7-item anxiety scale (GAD-7) at baseline and 12 months 9. Beliefs about medication (specifically nebuliser use) is measured using The Capability Opportunity Motivation Behaviour Beliefs Questionnaire (COM-BMQ) at baseline and 12 months 10. Behaviour is measured using Behavioural question and questionnaire at baseline and 12 months 11. Clinical measures is measured using Medical adherence questions, BMI FEV1/FVC at baseline to end of study 12. Resource use is measured using questionnaire at 12 month visit

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Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Contacts

Public ContactChin Maguire

c.maguire@sheffield.ac.uk+44 0114 222 0717

Outcome results

None listed