Chronic breathlessness in adults over the age of 40 Respiratory
Conditions
Interventions
Randomisation will be clustered by GP practice with 5 practices in the Diagnostic pathway (intervention) arm and 5 practices in the Usual care arm.
The intervention is a structured clinical diagnosti
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults = 40 years old 2. Within two presentations to a GP with persistent exertional breathlessness for over 2 months 3. Able and willing to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Presence of a known diagnosis for symptoms 2. A known active malignancy or other unrelated illness that is likely to result in a prognosis of less than 1 year 3. If patient requires immediate hospital admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment rate assessed by the number of participants recruited over 12 months to inform number of GP practices needed for the ultimate cluster RCT accounting for population size | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures will be collected to help inform outcomes for the larger trial, to assess the impact of an earlier diagnosis. Measured at a research visit within 1 month of the participant consenting to have their details passed to the study team, and at a further research visit 12 months later. There will also be an interim 6-month phone call and postal questionnaires. 1. Diagnoses made and time to diagnosis assessed using patient medical records at 3 months and 1 year 2. Exercise capacity assessed using the Incremental Shuttle Walk Test (ISWT) 3. Strength and balance assessed using quadriceps maximal voluntary contraction (QMVC), handgrip using dynamometer, Short Physical Performance Battery (SPPB) and Timed Up and Go (TUG) 4. Health-related quality of life assessed using: 4.1. Quality-Adjusted Life Years (QALYs) assessed using the Euroqol Five Dimension and Five Level questionnaire (EQ5D-5L) 4.2. The Chronic Heart Questionnaire Self-Report (CHQ-SR) 4.3. Dyspnoea-12 questionnaire 4.4. Multi-Dimensional Dyspnoea Profile 4.5. Baseline Dyspnoea Index and Transition Dyspnoea Index (BDI/TDI) 4.6. Hospital Anxiety and Depression (HAD) 4.7. Patient Activation Measure (PAM) 4.8. A Likert scale 5. Participant activity levels measured using activity monitors (GT3x Actigraph and GENEActiv) 6. Frailty measured using: 6.1. Fried’s frailty definition 6.2. Rockwood Frailty Scale 6.3. Timed Up and Go test 6.4. Short Physical Performance Battery 6.5. Handgrip and quadriceps strength will be conducted as per the relevant SOPs 7. Identify sources of data and collect data to plan the economic evaluation 8. Healthcare utilisation at 12 months from patient healthcare records 9. Hospital admissions at 12 months and 5 years using NHS digital 10. Mortality at 12 months and 5 years using NHS digital Semi-structured interviews with general practitioners, other relevant healthcare professionals and patients will be conducted to assess: 11. The acceptability of the research visi | — |
Countries
England, United Kingdom
Outcome results
None listed