Lou 2015.
Methods | Design: RCT Follow‐up: 48 months Control group: usual care |
Participants |
Recruitment: healthcare units/centres in rural areas. Assessed for eligibility: 8,217. Randomly assigned: Self‐management (SM): 4,197; Usual care (UC): 4,020. Completed: SM: 3,418; UC: 2,803. Mean age: SM: 71.2 ± 7.4 years; UC: 71.5 ± 7.8 years. Gender (% male): SM: 47.8; UC: 47.9. COPD diagnosis: the subjects had to have a diagnosis of COPD according to the criteria proposed by the GOLD . Inclusion of participants in acute phase: no. Major inclusion criteria: at baseline, the subjects had to have a diagnosis of COPD according to the criteria proposed by GOLD . Major exclusion criteria: presence of fever, active tuberculosis, changes in radiographic images or medication in the 4 weeks immediately preceding recruitment, primary diagnosis of asthma or obvious bronchiectasis, cystic fibrosis, interstitial lung disease, previous lung‐volume‐reduction surgery, lung transplantation, pneumonectomy, uncontrolled or serious conditions that could potentially affect spirometry tests, and refusal to fill out psychological questionnaires. |
Interventions |
Mode: group and individual face‐to‐face sessions. Duration: 104 group sessions of 40‐60 minutes lecture each every 2 weeks, 104 individual follow‐up sessions at least once every two weeks. Every 2 months, the professionals examined the subjects collectively at the health‐care units. Professional: respiratory specialist, nurse psychologist, (respiratory) physiotherapist, peer led dietician, GPs, psychiatrists, rehabilitation specialists, other experts. Assignment of case manager: unclear. Self‐management components: education regarding COPD, smoking cessation, exercise or physical activity component, other: psychological counselling, review and adjustment of outpatient COPD medication. Unclear whether each included participant received at least two intervention components including an iterative process. Self‐management topics: unclear. Behavioural change techniques: at least goals and planning, feedback and monitoring, other unclear. |
Outcomes | 1. health status (BODE index) 2. changes in COPD knowledge, awareness and risk factors (survey) 3. changes in anxiety and depression symptoms (HADS) 4. changes in hospital admissions and ED visits 5. changes in medication regimens |
Notes | More information regarding COPD spirometry, intervention components and iterative process needed. |