Haesum 2012.
| Study characteristics | ||
| Methods | RCT of a telerehabilitation programme; control: usual care (home exercises); follow‐up: 10 months | |
| Participants | Eligible: 114 Randomised: 111, I: 60, C: 51 Completed: 105, I: 57, C: 48 Mean age: I: 68 years, C: 68 years Sex (% male): 42.85 Inclusion criteria: over 18 years; can understand oral and written trial information; diagnosed COPD in stage III or IV (severe or very severe COPD); COPD as primary cause of reduction in function Major exclusion criteria: heart disease that could limit physical function; mental illness; terminal malignant disease; severe rheumatoid arthritis; pregnancy; living outside Aalborg Municipality |
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| Interventions | Telerehabilitation with a telehealth monitoring device Intervention components: telemonitoring, home exercise, advice from healthcare professionals on disease and training, team video meetings with healthcare professionals from primary and secondary care (to co‐ordinate and discuss COPD patients’ individual rehabilitation programme) Duration intervention: 4 months Involved disciplines: GP, district nurse, nurse and doctor at healthcare centre or hospital |
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| Outcomes | Admission rate per patient over a 10‐month period (primary outcome); cost of admission per patient (based on ambulatory contacts, GP contacts, emergency physician contacts, utilisation of other primary services, medicine consumption), SF‐36 | |
| Notes | Domi n ant component: telemonitoring ; SF‐36 not yet published | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "after confirming eligibility and obtaining written informed consent, the patients drew envelopes to see which group they would attend" |
| Allocation concealment (selection bias) | Unclear risk | Quote: "the envelopes were sealed and therefore the allocation was blinded for health‐care professionals, patients and researchers" Comment: it remains unclear whether envelopes were sequentially numbered and opaque |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: blinding of participants and personnel is not mentioned by study authors but is unlikely in light of the nature of the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: outcome assessors were blinded to group allocation (unpublished data) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: missing outcome data due to loss to follow‐up are balanced between groups (3 in intervention group, 3 in control group). Unlikely to have caused attrition bias |
| Selective reporting (reporting bias) | Unclear risk | Comment: according to study authors, QoL (SF‐36) will be reported in future publication |