Chronic obstructive pulmonary disease, and other morbidities Respiratory
Conditions
Interventions
Method of randomisation: Interactive Voice Response system operated by the Robertson Centre for Biostatistics, Glasgow University.
Intervention arm: Pharmacist home visits every month for 6 months t
Sponsors
NHS Greater Glasgow and Clyde
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (>18 years) 2. With COPD and FEV1< 80% predicted 3. FEV1/FVC ratio<0.7; mMRC =215 4. Living at home 5. On a hospital respiratory outpatient clinic list
Exclusion criteria
Exclusion criteria: Lung or suspected other malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 07/08/2024: The primary outcome for this pilot study, was whether to progress to a definitive RCT based on achievement of four progression criteria: 1. Recruitment of at least 70% invited participants within four months; 2. At least 70% of intervention arm participants receiving TICC PCP as planned (at least monthly for 6 months then every two months) from the date of allocation to intervention arm; 3. At least 80% of participants (excluding those who died or developed incapacity before the end of the study) remaining in the study until 21-month data collection; 4. At least 90% of in-person data collected at each study time point (baseline and every three months for up to 21 months). Researchers did not take blood samples during assessments and so the availability of blood results, depended on whether the participant had bloods collected recently as part of their routine care. Therefore, blood results were excluded from the calculation of missing data. A modified version of the Patient Experience with Treatment and Self-management (PETS: a patient-reported measure of treatment burden) was used, which had not been validated, therefore PETS responses were not included in data collection calculations. The percentage of missing data was calculated as the: number of missing data points divided by the total number of possible data points. _____ Previous primary outcome measure: Whether the researchers should proceed to a definitive trial, based on: 1. Eligibility 2. Recruitment 3. Retention 4. Implementation of study procedures (extent of collection of information every three months and time taken; randomisation, intervention delivery (completeness and fidelity between sites)) 5. Range of outcomes and optimal duration of follow up 6. Sample size 7. Completeness of efficacy outcome measures and estimates of variability collected from patients, clinical records, and through ISD Scotland record linkage =70% of invited patients agre | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 07/08/2024: The following secondary outcomes and resource use will be measured by independent researchers extracting data from primary and secondary care health records at 3, 6, 9, 12, 15, 18, and 21 months whilst the participant remains in the study: 1. the number of, and the number of people with: Primary care contacts (GP, nurse, healthcare assistant, pharmacist or other), in person or by phone; 2. the number of prescribed medicines for respiratory conditions; 3. the number of prescribed medicines for: bone health; gastrointestinal problems; pain; skin conditions; cardiovascular disorders; depression; anxiety; anaemia; and vitamin or other dietary insufficiency; 4. the total number of prescribed medicines; 5. the total number of, the number of people with, and time to first: ED attendances (without admission) for respiratory reasons; 6. the total number of, the number of people with, and time to first: ED attendances (without admission) for non-respiratory reasons; 7. the total number of, the number of people with, and time to first: hospitalisation for respiratory reasons; 8. the total number of, the number of people with, and time to first: hospitalisation for non-respiratory reasons; 9. the duration of hospitalisation for respiratory reasons; 10. the duration of hospitalisations for non-respiratory reasons; 11. the number of out-patient attendances and out-patient non-attendance for respiratory and other reasons; 12. the total number of, time to, and causes of death. The following secondary outcomes will be collected from participants during home visits by independent researchers at the same time points noted above whilst the participant remains in the study: 1. the number of COPD exacerbations (confirmed by patient report on use of rescue pack (steroids and/or antibiotics); 2. HRQoL using the EQ-5D-5L instrument score and individual domain scores; 3. modified Medical Research Council Dyspnoea scale (mMRC) score; 4. | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactRichard Lowrie
Outcome results
None listed