Hernández 2015.
Study characteristics | |
Methods | Design: RCT Follow‐up: 12 (and 72 months passive follow‐up thereafter) Control group: usual care |
Participants |
Recruitment: hospital (outpatient) Assessed for eligibility: 860 Randomly assigned: SM: 71; UC: 84 Completed: SM: 54; UC: 55 Mean age: SM: 73 (SD 8) years; UC: 75 (SD 9) years Gender (% male): SM: 83; UC: 86 COPD diagnosis: a person not involved in the study identified the cases with COPD (ICD9‐CM 491, 492, 493 or 496) as the primary diagnosis for admission. However, lung function testing was also assessed before randomisation. COPD confirmed with spirometry (FEV1/FVC < 70%). Inclusion of participants in the acute phase: no Major inclusion criteria: clinically stable COPD participants with a history of at least two hospital admissions owing to severe respiratory exacerbations during two consecutive years. "We considered a broad spectrum of COPD diagnostic terms that include chronic obstructive inflammatory diseases; namely, emphysema, asthma, tuberculosis, chronic bronchitis and COPD, aged above 45 years and living at home within the healthcare area of the hospital (Barcelona‐Esquerra)" (p. 2). Major exclusion criteria: nursing home or not living in the area, participants in another randomised controlled trial, died prior to contact |
Interventions |
Mode: individual and group sessions at an outpatient clinic and at participants' homes Duration: at least one face‐to‐face individual session of 40 minutes at the participant's home within 72 hours after entry into the study by the primary care team (participants without mobility problems), four face‐to‐face individual sessions of 15 minutes education each at the participant's home by the primary care team (participants with mobility problems), one two‐hour individual or group educational programme of 40 minutes. Three group sessions for participants without mobility problems (two comprehensive assessments of 90 minutes each at the outpatient clinic and one 2‐hour educational programme) and for participants with mobility problems, the programme was done at home. In all visits, the nurses dedicated 15 minutes for education. Professional: specialised respiratory nurse, primary care team (physician, nurse and social worker) Assignment of case managers: the community care teams received training: a 2‐hour face‐to‐face educational training and 1‐day stay at the hospital ward, aiming at enhancing home‐based management of frail COPD participants. Case managers were accessible to participants during the complete follow‐up period. Self‐management components: smoking cessation (optional), self‐recognition of COPD exacerbations, use of a COPD exacerbation action plan, home‐based exercise or physical activity component, diet, COPD medication intake (i.e. adherence, inhalation technique), coping with breathlessness, comorbid condition (no further explanation regarding content) Self‐management topics: vaccination Behavioural change techniques: 7 clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, comparison of behaviour, associations, antecedents |
Outcomes | 1. Mental status 2. Activities of daily living (Lawton index) 3. Anxiety and depression (HADS) 4. Health‐related quality of life (SGRQ) 5. Sleepiness (Epworth sleepiness scale) 6. 6MWT 7. Nocturnal pulse oximetry and body mass distribution 8. Exacerbations |
Notes | Source of funding: this study was funded by NEXES (Supporting Healthier and Independent Living for Chronic Patients and Elderly). Conflict of interest: none declared |