Fan 2012.

Study characteristics
Methods	Design: RCT Follow‐up: 12 months Control group: guideline‐based usual care
Participants	Recruitment: outpatient clinic Assessed for eligibility: 467 Randomly assigned: SM: 209; UC: 217 Completed: SM: 193; UC: 203 Mean age: SM: 66.2 (SD 8.4) years; UC: 65.8 (SD 8.2) years Gender (% male): SM: 97.6; UC: 96.3 COPD diagnosis: GOLD, a post‐bronchodilator ratio of FEV₁/FVC < 0.70 with an FEV₁ < 80% predicted. At baseline and 1‐year study visits, post‐bronchodilator spirometry performed according to ATS criteria. Inclusion of participants in the acute phase: no Major inclusion criteria: hospitalised for COPD in the 12 months before enrolment, post‐bronchodilator ratio of FEV₁ to FVC < 0.70 with an FEV₁ < 80% predicted, older than 40 years, current or past history of cigarette smoking (> 10 pack‐years), at least 1 visit in the past year to either a primary care or pulmonary clinic at a Veterans Affairs medical centre, no COPD exacerbation in the past 4 weeks, ability to speak English, and access to a telephone Major exclusion criteria: primary diagnosis of asthma or any medical conditions that would impair ability to participate in the study or to provide informed consent
Interventions	Mode: individual and group sessions at hospital outpatient clinics, telephone calls, educational booklet Duration: four face‐to‐face individual sessions of 90 minutes each, scheduled weekly. The individual lessons were reinforced during a group session and by six phone calls, one per month for three months and every three months thereafter. Professional: case manager (various health‐related professionals). Assignment of case managers: before starting the study, all case managers received a three‐day training course with workshops covering detailed aspects of the self‐management programme, and all were supervised by the site investigator. Case managers were accessible to participants during the complete follow‐up period. Self‐management components: self‐recognition of COPD exacerbations, use of a COPD exacerbation action plan, COPD medication intake (i.e. adherence, inhalation technique) Self‐management topics: not reported Behavioural change techniques: 9 clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, natural consequences, associations, repetition and substitution, regulation, antecedents
Outcomes	1. Time from randomisation to first COPD hospitalisation 2. All‐cause mortality 3. Number of COPD exacerbations, based on symptoms 4. Health‐related quality of life 5. Patient satisfaction 6. Medication adherence 7. COPD‐related knowledge, skill acquisition and self‐efficacy
Notes	This multi site RCT of an educational and acute care management programme was stopped early when a safety monitoring board noted excess mortality in the intervention group. The mean follow‐up time was 250 days. Source of funding: Veterans Affairs Cooperative Study Program Conflict of interest: none declared