Sanchez‐Nieto 2016.
Study characteristics | |
Methods | Design: RCT Follow‐up: 12 months Control group: usual care |
Participants |
Recruitment: hospital (outpatient) Assessed for eligibility: 250 Randomly assigned: SM: 51; UC: 45 Completed: SM: 47; UC: 38 Mean age: SM: 68.2 (SD 7.2) years; UC: 67.1 (SD 6.8) years Gender (% male): SM: 92.2; UC: 88.9 COPD diagnosis: post‐bronchodilator FEV1/FVC < 70% Inclusion of participants in acute phase: no Major inclusion criteria: clinical stability (at least in the 3 months prior to randomisation, with no change in medication or usual symptoms); active smoker or prior history of smoking of at least 10 pack‐years; post‐bronchodilator FEV1/FVC < 70%; normal cognitive status (assessed by the intersecting pentagons test) to read and understand written texts, and receive training in inhalation techniques or self‐care education sessions; physical status that allows for regular walking or exercise; no diagnoses of asthma, advanced heart failure, unstable ischaemic heart disease, terminal disease, dementia or uncontrolled psychiatric disorders; ability to read texts; no participation in any pulmonary rehabilitation program in the previous year Major exclusion criteria: not reported |
Interventions |
Mode: group and individual sessions at the hospital; written material with treatment instructions Duration: 1 face‐to‐face group session (40 min), and 3 face‐to‐face individual sessions (20 min each) Professional: respiratory specialist, nurse, physiotherapist Assignment of case managers: yes (telephone assistance to intervention participants), accessible to participants during the complete follow‐up period Self‐management components: self‐recognition of COPD exacerbations, use of a COPD exacerbation action plan, home‐based physical exercise, COPD medication intake Self‐management topics: main characteristics of the disease Behavioural change techniques: 3 clusters: goals and planning, feedback and monitoring, shaping knowledge |
Outcomes | 1. Combined number of hospital admissions, and A&E department visits for COPD exacerbations 2. Hospitalisatons for COPD exacerbations 3. A&E visits for COPD exacerbations 4. Lengths of stay 5. Antibiotic or glucocorticoid treatment 6. All‐cause mortality |
Notes | Source of funding: Gas Medi SA, Boehringer Ingelheim, Chiesi, Menarini Conflict of interest: none declared |