Tabak 2014.
Study characteristics | ||
Methods | RCT; follow‐up: 9 months; control: usual care (control group also received an activity sensor to register activity levels) | |
Participants | Eligible: 101 Randomised: 29, I: 15, C: 14 Completed: 12, I: 10, C: 2 Mean age: I: 64 years, C: 63 years Sex (% male): 50, I: 50, C: 50 Inclusion criteria: COPE II criteria (e.g. no exacerbation in the month prior to enrolment and 3 or more exacerbations or 1 hospitalisation for respiratory problems in the 2 years preceding study entry), access to computer with Internet connection Major exclusion criteria: serious other disease with low survival rate; other disease influencing bronchial symptoms and/or lung function (e.g. cardiac insufficiency, sarcoidosis); uncontrolled diabetes mellitus during COPD exacerbation in the past or hospitalisation for diabetes mellitus in the 2 years preceding the study; need for regular oxygen therapy (> 16 hours per day or pO2 < 7.2 kPa); maintenance therapy with antibiotics; known alpha₁‐antitrypsin deficiency; impaired hand function causing inability to handle the application |
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Interventions | Components of telehealth programme ‐ Web‐based exercise programme (breathing exercise, relaxation, mobilisation, resistance and endurance training, muscle clearance) with individual exercise schemes created by physiotherapist, with feedback option for patients ‐ Individualised activity coach to monitor daily activity via an accelerometer‐based activity sensor and smartphone with encouraging motivational individualised daily messages ‐ Self‐management module on the web portal that enables patients to treat exacerbations themselves following a decision tree. Before use of self‐management module, attendance at 2 self‐management teaching sessions (90 minutes each) provided by nurse practitioner. Patients received recipes for their medication. Access to patient diary by chest physician and nurse practitioner ‐ Teleconsultation module allowing questions and comments between physiotherapist and patient Duration intervention: 9 months Disciplines involved: primary and secondary care professionals (physiotherapist, practice nurse, chest physician) |
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Outcomes | Adherence to intervention (primary outcome), satisfaction with received care (primary outcome), number of hospitalisations, duration of hospitalisations, number of ED visits, number of exacerbations, activity level (activity sensor), self‐perceived activity levels (Baecke Physical Activity Questionnaire), 6MWD, MFI (fatigue), CCQ, MRC Dyspnoea, EuroQol‐5D | |
Notes | Dominant component: telemonitoring | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “patients were randomised using a computer‐generated randomisation list where randomisation was applied in random blocks of two and four. Participants were allocated by a data manager in order of inclusion following the randomisation list” |
Allocation concealment (selection bias) | Low risk | Quote: "participants were allocated by a data manager in order of inclusion following the randomisation list, placed in a sealed envelope" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: due to the nature of the intervention, it is not likely that participants and treating healthcare providers were blinded to group allocation |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: not enough information provided to determine whether assessor was blinded to outcomes |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: large imbalance in dropout rates between intervention (n = 5) and control (n = 12) and reasons for missing data. Reasons for missing outcome data likely to be related to true outcome, being satisfied with received care |
Selective reporting (reporting bias) | High risk | Quote: “data in Table 5 (clinical outcomes) are descriptive only, and present T0–T2” Comment: clinical outcomes reported only up to 3 months, not for 6 and 9 months Quote: “exacerbation data were not available for the control group”; “the temporary unavailability of one physiotherapy practice, were also a reason not all measurements were assessed. This made us unable to report the number of exacerbations in the control group” Comment: exacerbations/relapses reported for telehealth and usual care Comment: due to scope of study (pilot RCT) and size of groups, no statistical tests were performed. Furthermore MRC Dyspnoea was reported only for T1 (1 month). Hence, study fails to report all study outcomes as specified in the protocol |