Mitchell 2014.
Study characteristics | |
Methods | Design: RCT Follow‐up: 6 months Control group: usual care |
Participants |
Recruitment: general practice Assessed for eligibility: 326 Randomly assigned: SM: 89; UC: 95 Completed: SM: 65; UC: 79 Mean age: SM: 69 (SD 8 years); UC: 69 (SD 10.1) years Gender (% male): SM: 60.7; UC: 49.5 COPD diagnosis: COPD confirmed by spirometry, with a FEV₁/FVC ratio < 0.7 Inclusion of participants in the acute phase: no Major inclusion criteria: have a diagnosis of COPD confirmed by spirometry, with a FEV₁/FVC ratio < 0.7, grade 2‐5 MRC dyspnoea scale, clinically stable for 4 weeks Major exclusion criteria: unable to undertake an exercise regime due to neurological, musculoskeletal or cognitive comorbidities, unable to read English to the reading age of an 8‐year‐old, completed pulmonary rehabilitation within the previous 12 months |
Interventions |
Mode: individual sessions at a GP's office or home‐based, telephone calls, workbook Duration: one face‐to‐face individual session for 30 to 45 minutes by a physiotherapist and two telephone calls at two and four weeks into the programme to reinforce skills and provide encouragement to progress Professional: physiotherapist, trainee health psychologist Assignment of case managers: yes, but after a second phone call, no access to the case manager Self‐management components: smoking cessation (optional), self‐recognition of COPD exacerbations, use of a COPD exacerbation action plan, home‐based exercise, management of psychological consequences (e.g. dealing with anger, depression, disease acceptance) Self‐management topics: diet, (maintenance) medication, coping with breathlessness Behavioural change techniques: 11 clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, natural consequences, comparison of behaviour, associations, repetition and substitution, regulation, antecedents, identity |
Outcomes | 1. Health status (CRQ dyspnoea domain) 2. Fatigue, emotion and mastery domains of the CRQ 3. Disease knowledge (Bristol COPD Knowledge Questionnaire) 4. Anxiety and depression (HADS) 5. Exercise capacity (ISWT, ESWT) 6. Self‐efficacy (Pulmonary Rehabilitation Adapted Index of Self‐Efficacy) 7. Healthcare utilisation (admissions, GP visits, ED visits, nurse home visits) 8. Medication use (courses of antibiotics) 8. Self‐reported smoking status |
Notes | Source of funding: National Institute for Health Research (NIHR) Conflict of interest: none declared |