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. 2022 Jan 10;2022(1):CD002990. doi: 10.1002/14651858.CD002990.pub4

Rice 2010.

Study characteristics
Methods Design: RCT Follow‐up: 12 months Control group: usual care
Participants Recruitment: hospital (Veterans Affairs medical centres)
Assessed for eligibility: 1739
Randomly assigned: SM: 372; UC: 371
Completed: SM: 336; UC: 323
Mean age: SM: 69.1 (SD 9.4) years; UC: 70.7 (SD 9.7) years
Gender (% male): SM: 97.6%; UC: 98.4%
COPD diagnosis: clinical diagnosis of COPD with post‐bronchodilator spirometry showing a FEV₁ < 70% predicted and a FEV₁/FVC < 0.70
Inclusion of participants in the acute phase: not reported
Major inclusion criteria: a diagnosis of COPD at high risk of hospitalisation as predicted by one or more of the following during the previous year: hospital admission or ED visit for COPD, chronic home oxygen use or course of systemic corticosteroids for COPD
Major exclusion criteria: inability to have access to a home telephone line or sign a consent form, any condition that would preclude effective participation in the study or likely to reduce life expectancy to less than a year
Interventions Mode: group sessions at an outpatient clinic, one‐page handout summary and number for help line, telephone calls
Duration: one face‐to‐face group session (60 to 90 min) by a respiratory therapist case manager, 12 monthly phone calls (10 to 15 minutes each)
Professional: respiratory therapist case manager
Assignment of case managers: "case managers were respiratory therapists who had completed a one‐day training session.” Appendix 1, p. 2. The case manager was 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, COPD medication intake
Self‐management topics: exercise, oximetry, recommendation concerning influenza and pneumococcal vaccinations, instruction in hand hygiene
Behavioural change techniques: 4 clusters: goals and planning, feedback and monitoring, social support, shaping knowledge
Outcomes 1. Hospital admissions and ED visits for COPD
2. All‐cause hospitalisations and all‐cause ED visits
3. Hospital and intensive care unit lengths of stay
4. Respiratory medication use
5. Change in respiratory quality of life (SGRQ)
6. All‐cause mortality
Notes Source of funding: this study was supported by an unrestricted grant from the Veterans Integrated Service Network 23 Primary Care and Research Services and by the Center for Chronic Disease Outcomes Research, a Veterans Affairs Health Services Research and Development Center of Excellence
Conflict of interest: several study authors (i.e. K.L.R., M.C., D.E.N.) reported that they or family members received financial benefits from a commercial entity. The other study authors (i.e. H.E.B., J.G., T.M.S., D.B.N., S.K., M.T., L.J.G., C.B., do not have financial relationships with a commercial entity that has an interest in the subject of this manuscript