Bischoff 2012.
Study characteristics | |
Methods | Design: RCT Follow‐up: 24 months Control group: usual care |
Participants |
Recruitment: general practice Assessed for eligibility: 748 Randomly assigned: SM: 55; UC: 55 Completed: SM: 49; UC: 44 Mean age: SM: 65.5 (SD 11.5) years; UC: 63.5 (SD 10.3) years Gender (% male): SM: 67; UC: 51 COPD diagnosis: GOLD criteria, confirmed with spirometry (FEV1/FVC ratio < 0.7) Inclusion of participants in the acute phase: not reported Major inclusion criteria: aged at least 35 years, post‐bronchodilator ratio of FEV1/FVC < 0.70 Major exclusion criteria: post‐bronchodilator FEV1 < 30% predicted, treatment by a respiratory physician, severe comorbid conditions with a reduced life expectancy, inability to communicate in the Dutch language, and objections to one or more of the modes of disease management used in the study |
Interventions |
Mode: individual sessions at the general practice, paper modules "Living well with COPD", telephone calls Duration: 2 to 4 individual face‐to‐face sessions of one hour each, scheduled over 4 to 6 consecutive weeks; 6 telephone calls to reinforce self‐management skills Professional: practice nurse of each participating practice Assignment of case managers: yes, accessible to participants during the complete follow‐up period Self‐management components: smoking cessation, self‐recognition of COPD exacerbations, COPD exacerbation action plan, exercise / physical activity component (optional), diet, medication, coping with breathlessness, managing anxiety and stress Self‐management topics: keeping a healthy and fulfilling lifestyle Behavioural change techniques: 2 clusters: goals and planning, feedback and monitoring |
Outcomes | 1. Change from baseline in health‐related quality of life (CRQ) 2. Change in CRQ domain scores 3. Exacerbation frequency and management, based on symptoms 4. Total and five domain scores for self‐efficacy (CSES) |
Notes | A third group of participants (n = 55) were assigned to routine monitoring through scheduled periodic monitoring visits as an adjunct to usual care. However, this group did not include an action plan. Source of funding: this study was funded by the Netherlands Organisation for Health Research and Development (ZonMw) and Partners in Care Solutions for COPD (PICASSO). Conflict of interest: no authors received any support from any company for the submitted work; no authors have any relationship with any company that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work. |