Chronic obstructive pulmonary disease Respiratory Chronic obstructive pulmonary disease
Conditions
Interventions
This is a mixed-methods feasibility trial including a parallel-group, assessor-blinded prospective randomised controlled trial, with embedded qualitative interviews and focus groups. The principal obj
Sponsors
Royal Brompton & Harefield NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Randomised controlled trial inclusion criteria: 1.1 > 40 years of age 1.2 Diagnosis of chronic obstructive pulmonary disease (COPD) 1.3 Hospitalisation (inpatient on a medical assessment unit or hospital ward) with a primary diagnosis of an acute exacerbation of COPD 1.4 Accepted for Hospital at Home care by Hillingdon Integrated Respiratory Service according to local Standard Operating Procedures (no impaired consciousness – Glasgow Coma Scale = -2 points 2.4.2 Change in CAT score of 18 years of age 3.2 Able to understand and speak English 3.3 Able to give valid informed consent 4. Staff focus groups purposive sampling criteria: 4.1 Provider of usual care 4.2 Provider of outpatient-based PR 4.3 Provider of study intervention procedures 4.4 Provider of study assessments
Exclusion criteria
Exclusion criteria: Randomised controlled trial exclusion criteria: 1. Receiving specialist palliative care with expectation of death within three months as judged by the specialist palliative care service; 2. No fixed abode or contact number; 3. Evidence of an environment that would make delivery of study intervention and/or usual care unsafe; 4. Evidence of acute coronary syndrome, unstable ischaemic heart disease or any condition that would make exercise unsafe.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Due to this being a feasibility trial, there are no primary or secondary outcome measures (see below) | — |
Secondary
| Measure | Time frame |
|---|---|
| In order to address the principal research objective, there will be measures recorded pertaining to: 1. Feasibility outcomes: 1.1 Number of patients screened for eligibility, proportion of eligible patients randomised, proportion of participants remaining in the trial at four weeks, three months and 12 months 1.2 Proportion of patients for which assessor blinding is maintained 1.3 Number of HaH visits and type of HaH care provided; proportion implemented by different healthcare professionals; contamination in usual care group 1.4 Home-based exercise training uptake and adherence 1.5 Proportion referred to outpatient-based PR at discharge and on discharge from HaH service 1.6 Uptake and completion of outpatient-based PR 2. Clinical outcomes: Completion rates, missing data, variances, difference and 95% confidence intervals between groups for outcomes listed below: 2.1 London Chest Activities of Daily Living questionnaire 2.2 Physical activity levels 2.3 Short Physical Performance Battery 2.4 Muscle strength (lower limb and hand grip) 2.5 COPD Assessment Test questionnaire 2.6 Euro-Qol 5-Dimensions 5-Levels questionnaire 2.7 Hospital Anxiety and Depression Scale 2.8 Modified Centre for Epidemiological Studies - Depression Score 2.9 Six-minute self-paced step test 2.10 Bio-electrical impedance analysis 3. Safety outcomes: 3.1 Adverse events 3.2 Health resource usage 3.3 Mortality 4. Qualitative outcomes: 4.1 Experiences and preferences of people living with COPD, their family members or carers and healthcare professionals throughout the HaH | — |
Countries
United Kingdom
Outcome results
None listed