Specialty: General Practice, Primary sub-specialty: General Practice
Conditions
Interventions
Mixed-methods explanatory sequential design with two main components: Randomised Controlled Trial (RCT) and Qualitative Parallel Process Evaluation (QPPE).
Recruitment:
This study will recruit approx
those in the control arm receive OptiMed alone. Consented participants in the intervention arm will be provided with the PrimaryBreathe treatment from a trained health-professional participant.
All pa
Sponsors
University of Cambridge
Cambridgeshire and Peterborough Integrated Care Board
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: General practice site eligibility 1. Located in England’s Regional Research Delivery Network (RRDN) regions 2. Practice uses either SystmOne or EMIS (also known as Optum) 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). Trial participants Health professional eligibility 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. Registered health professional OR a Health and Wellbeing Coach. Patient eligibility 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 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. Qualitative parallel process evaluation participants General practice staff eligibility 1. Health professional participant in the trial OR involved in the administrative delivery of the trial at a participating site through their professional role, AND 2. Able to provide informed consent, AND 3. Aged 18 years or over. Patient eligibility 1. Patient participant in the trial intervention arm Carer eligibility 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 trial intervention arm. Patient non-participant eligibility 1. Invited to participate as patient participant in the trial, AND 2. Notified trial team they did not want to participate, AND 3. Able to provide informed consent, AND 4. Aged 18 years or over. CBIS staff eligibility 1. CBIS staff involved in the delivery of the intervention training, AND 2. Able to provide informed consent, AND 3. Aged 18 years or over.
Exclusion criteria
Exclusion criteria: General practice site eligibility 1. Participated in the PrimaryBreathe intervention co-design study or the PrimaryBreathe feasibility study Trial participants 1. Health professional eligibility 2. Working exclusively as a Health Care Assistant with no other registered profession(s) Patient eligibility 1. Likely to be in the last three months of life, OR 2. Known acute on chronic deterioration in breathlessness over preceding days or a small number of weeks, OR 3. Known ICU admission in the three months prior to recruitment, OR 4. Known major surgery during the preceding four weeks or scheduled within the next three months after recruitment, OR 5. A symptom-directed intervention is inappropriate for the individual, for example, they do not have the cognitive capacity to benefit and/or engage with study interventions, OR 6. Considered unable to complete study measures, OR 7. Patient is housebound Qualitative parallel process evaluation participants General practice staff eligibility 1. Not meeting the key exclusion criteria Patient eligibility 1. Not meeting the key exclusion criteria Carer eligibility 1. Patient participant does not agree to carer inclusion Patient non-participant eligibility 1. Not meeting the key exclusion criteria CBIS staff eligibility 1. Not meeting the key exclusion criteria
Countries
England, United Kingdom
Contacts
Public ContactCheryl Chapman
Outcome results
None listed