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

Bucknall 2012.

Study characteristics
Methods Design: RCT Follow‐up: 12 months Control group: usual care
Participants Recruitment: hospital (inpatient)
Assessed for eligibility: 1405
Randomly assigned: SM: 232; UC: 232
Completed: SM: 211; UC: 200
Mean age: SM: 70.0 (SD 9.3) years; UC: 68.3 (SD 9.2) years
Gender (% male): SM: 38; UC: 35
COPD diagnosis: chronic irreversible airflow limitation with FEV₁ < 70% predicted and a FEV₁ /FVC ratio of < 70%
Inclusion of participants in the acute phase: not reported
Major inclusion criteria: admitted to hospital with an acute exacerbation of COPD
Major exclusion criteria: a history of asthma or left ventricular failure, evidence of active malignant disease or any evidence of confusion/poor memory, assessed with the abbreviated mental test (scores of 9/10 or 10/10 required)
Interventions Mode: individual sessions at the participant's home, adapted "Living well with COPD" booklets, telephone calls
Duration: four face‐to‐face individual sessions of 40 minutes each, scheduled fortnightly, over a two‐month period. There were also 828 phone calls to the intervention group participants (mean 4.6 phone calls per intervention participant). There were at least 6 subsequent home visits (but more frequently on request) thereafter for a total of 12 months
Professional: study nurse
Assignment of case managers: "Study nurses’ training was based on self regulation theory" (Bucknall 2012, p. 2). "Nurses were trained to deliver a structured self‐management programme in four fortnightly home visits (…). Nurses without previous respiratory training completed three half day training sessions" (p. 3). Case managers were accessible to participants during the complete follow‐up period.
Self‐management components: smoking cessation, self‐recognition of COPD exacerbations, use of a COPD exacerbation action plan, diet (optional), COPD medication intake (i.e. adherence, inhalation technique), coping with breathlessness
Self‐management topics: exercise
Behavioural change techniques: 8 clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, natural consequences, comparison of behaviour, repetition and substitution, self‐belief
Outcomes 1. Time to first acute hospital admission with a COPD exacerbation
2. Death due to COPD within 12 months of randomisation
3. Morbidity (change from baseline at 6 and 12 months in SGRQ)
4. Likelihood of anxiety or depression (HADS)
5. Sense of self‐efficacy (CSES)
6. Quality of life (EuroQol 5D)
Notes Self‐management materials based on the "Living Well with COPD" programme and previously adapted for the UK population and healthcare setting by an iterative process, were used (p. 2). Extra information from author: "We used adapted “Living with COPD” booklets and daily diary cards (Stockley et al. – originally developed for use in Bronchiecistasis, piloted these and adapted them for this study, to include a line for recording steroid and antibiotic usage."
Source of funding: in addition to funding from the Chief Scientist Office, Scottish Health Department (CZH/4/246), this study was supported by educational grants from Boehringer Ingelheim, GlaxoSmithKline, and Astra Zeneca.
Conflict of interest: in addition to the Chief Scientist Office grant (CZH/4/246), CEB’s institution received financial support for the employment of a research fellow from Boehringer Ingelheim, GlaxoSmithKline, and Astra Zeneca, and JC holds other grants; no financial relationships with any organisations 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.