Supporting breathless Respiratory
Conditions
Interventions
Mixed-methods explanatory sequential design with two main components: Feasibility-Trial (FT) and Feasibility-Qualitative (FQ).
Recruitment:
The study will recruit 6 practices and 10 eligible patients
health professionals delivering the intervention (a minimum of 6, at least 1 per site), patients (the largest group of 60), informal carers, general practice staff who are involved in the study admini
Sponsors
University of Cambridge
Cambridgeshire and Peterborough Integrated Care Board
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Feasibility-Trial (FT) General practice site inclusion criteria: 1. Located in the East of England or the Yorkshire and Humber Clinical Research Network (CRN; or Regional Research Delivery Network, RRDN), AND 2. Practice uses either SystmOne or EMIS electronic medical record software, AND 3. At least one eligible health professional working clinically in the practice is interested in delivering the intervention, AND 4. One General Practitioner (GP) at the practice is willing to oversee the study as site Principal Investigator (PI) Health professional inclusion criteria: 1. Working clinically within a participating general practice, AND 2. Interested in delivering the intervention, AND 3. Considered by the site PI to have sufficient skill and enthusiasm to be suitable to deliver the intervention after training, AND 4. Clinically qualified OR a Health and Wellbeing Coach AND 5. Able to provide informed consent Patient inclusion criteria: 1. Registered at a participating general practice, AND 2. Aged 18 years or over, AND 3. Able to give informed consent, AND 4. Experiencing chronic breathlessness on exertion or at rest for at least 8 weeks with one or more of the nine index long-term conditions (LTCs), diagnosed in primary or secondary care, being a major contributor to the patient’s experience of chronic breathlessness, AND 5. Modified MRC scale self-assessment score of 2-4 Feasibility-Qualitative (FQ) General practice staff inclusion criteria: 1. Health professional participant in Feasibility-Trial OR involved in the administrative delivery of Feasibility-Trial at a participating site through their professional role, AND 2. Able to provide informed consent, AND 3. Aged 18 years or over. Patient inclusion criteria: Patient participant in Feasibility-Trial intervention arm Informal carer inclusion criteria: 1. Aged 18 years or over, AND 2. Able to provide informed consent, AND 3. Identified as a family member or friend giving support (unpaid/family carer) by a patient participant in the Feasibility-Trial intervention arm.
Exclusion criteria
Exclusion criteria: Feasibility-Trial (FT) General practice site exclusion criteria: Participated in the Primarybreathe intervention co-design study. Health professional exclusion criteria: There are no exclusion criteria if all the inclusion criteria have been met. Patient exclusion criteria: 1. Clinically considered by the site PI to be likely to be in the last three months of life, OR 2. Acute on chronic deterioration in breathlessness over preceding days or a small number of weeks, OR 3. Major surgery during the preceding four weeks or planned to occur within ten weeks after randomisation, OR 4. Site PI considers symptom-directed intervention to be inappropriate for the individual. Feasibility-Qualitative (FQ) General practice staff exclusion criteria: There are no exclusion criteria if the inclusion criterion is met. Patient exclusion criteria: There are no exclusion criteria if the inclusion criterion is met. Informal carer exclusion criteria The patient participant does not consent to informal carer inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life of patients with chronic respiratory diseases measured using the Chronic Respiratory Questionnaire (CRQ) Mastery Scale at baseline and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life of patients with chronic respiratory diseases measured using Chronic Respiratory Questionnaire total score (CRQ-Total) at baseline, 4, 8, 12, 16, 20 and 24 weeks 2. Health and quality of life measured using the EuroQol EQ-5D-3L questionnaire at baseline, 4, 8, 12, 16, 20 and 24 weeks 3. Number of unplanned primary care attendances due to breathlessness measured using data collected in patient records at one timepoint 4. Number of emergency department attendances due to breathlessness measured using data collected in patient records at one timepoint 5. Healthcare resource use measured using the Healthcare Resource Utilisation Questionnaire (HRUQ) at baseline, 4, 8, 12, 16, 20 and 24 weeks 6. Shortness of breath measured using the Numerical rating scale for worst breathlessness in the last 24 hours (NRS-worst) at baseline, 4, 8, 12, 16, 20 and 24 weeks 7. Anxiety measured using the General Anxiety Disorder-7 (GAD-7) at baseline, 4, 8, 12, 16, 20 and 24 weeks 8. Patient Health Questionnaire-9 (PHQ-9) at baseline, 4, 8, 12, 16, 20 and 24 weeks 9. (For health professionals) Normalisation measure development questionnaire, adapted to include an assessment of self-confidence in the ability to deliver the intervention measured using the Normalization Process Theory Measure (NoMAD-adapted) questionnaire. The study team will issue the NOMAD-adapted questionnaire in electronic (self-administered) format to health professional participants for completion after they have completed their PrimaryBreathe core training and assessment and before delivering their first intervention consultation; and near the end of their planned intervention delivery period. | — |
Countries
England, United Kingdom
Contacts
Public ContactCheryl Chapman
Outcome results
None listed