Jimenez‐Reguera 2020.
Study characteristics | ||
Methods | RCT; follow‐up: 10 months post rehabilitation ; control group: usual care following 8 weeks PR | |
Participants | Eligible: 44
Randomised: 44, I: 20, C: 24
Completed: 36; I: 17, C: 19
Mean age: I: 68 years, C: 68 years
Sex (% male): I: 41, C: 59
Inclusion criteria: COPD patient, between 55 and 85 years of age, with degree of severity II, III, or IV of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) scale, in a stable clinical situation (no exacerbations in the last 6 weeks) Major exclusion criteria: unstable cardiovascular disease or muscular or nervous system impairments that prevented performance of rehabilitation programme or evaluation tests; cognitive impairment that makes it difficult to understand the educational program and to manage the HappyAir system |
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Interventions | 10‐month PR maintenance programme following an integrated care plan using a mobile device with pulmonary care web‐based app (HappyAir app) HappyAir app comprised 2 components ‐ Educational programme providing patients advice about their disease ‐ Component for data collection for physical activity, medication intake, and disease HappyAir integrated plan was designed as a model of a therapeutic programme based on communication that introduced the figure of the therapeutic educator (physiotherapist or respiratory coach). Therapeutic educators had access to the platform for clinical evaluation assessment, recording weekly and monthly goals. Pulmonologist, physiotherapist had access to the platform to enter clinical data, communicate with therapeutic educator. Patients were made responsible for their self‐care and for management of their illness. Patient and educator shared responsibility Intervention duration: 8 weeks PR (both group); 10 months' maintenance programme Disciplines involved: physiotherapist or respiratory coach, pulmonologist |
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Outcomes | Adherence to maintenance program me (primary outcome); adherence to physical activity (Morisky‐Green Test) ; CAT; SGRQ; EQ‐5D; 6MWD | |
Notes | Power calculation based on primary outcome (adherence to maintenance program me ); likely to be underpowered for other outcomes Dominant component: self‐management |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "p atients were recruited by convenience sampling through face‐to‐face interviews at participating hospitals. The recruitment of subjects was performed from patients attending pneumology consultations at the rehabilitation service of the hospitals participating in the study " Quote: "w e used a computer‐generated simple randomisation procedure, using the online randomisation tool Research Randomizer " Comment: selecti on preceded an initial face‐to‐face interview. Initial sel e ction of study pop ulation may be biased by willingness to participate in the interview. Adequate randomisation procedures used, so unlikely that selection bias was introduced between groups |
Allocation concealment (selection bias) | Low risk | Quote: "b efore the beginning of the study, distribution was made in two groups through the Research Randomizer program, and a list of patients designated to each group was drawn up, considering a homogeneous distribution of groups for each hospital. This listing was sequentially numbered and coded " |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "d ue to the characteristics of the intervention, healthcare professionals and patients could not be blinded to the group assignment " |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: " t he follow‐up assessment of outcome measures of both groups was carried out by a blinded assessor " |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: s tudy dropout is balanced between groups (5/17 intervention; 5/19 control). Reasons for dropout are more or less comparable. Unclear if reasons are related to study allocation |
Selective reporting (reporting bias) | High risk | Comment: study protocol is not available. Lung function outcomes (FEV ₁, FVC, FEV ₁ /FVC ratio) and VAS results reported that were not specified in the trial registration |