Koff 2009.
| Study characteristics | ||
| Methods | RCT; follow‐up 3 months; control group: usual care | |
| Participants | Eligible: 40 Randomised: 40, I: 20, C: 20 Completed: 38, I: 19, C: 19 Mean age: I: 67 years, C: 65 years Sex (% male): I: 45, C: 50 Inclusion criteria: clinical diagnosis of COPD, GOLD 3+4, with telephone land line Exclusion criteria: active treatment for lung cancer, illiteracy, non‐English‐speaking, inability to complete 6MWD |
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| Interventions | Integrated self‐man a gement education al program me wit h proactive remote disease monitoring ‐ Disease‐specific education, by respiratory therapist at enrolment and daily by Health Buddy System (telehealthcare). Education included disease description, medications and their use, nutrition, breathing techniques ‐ Teaching of self‐management skills (use of an oximeter and increased awareness of clinical changes/problems). Patients could contact the co‐ordinator in case of deterioration ‐ Patients were remotely monitored 5 days per week with the Health Buddy system for changes in symptoms, saturation, 6MWD, and lung function. Study co‐ordinator reviewed these results and patients were contacted if they were at high risk for exacerbation, when they started exacerbation management or had contact with respiratory physician/GP Intervention duration: 3 months Disciplines involved: physician, pulmonologist |
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| Outcomes | SGRQ, 6MWD, exacerbations, hospitalisations, ED visits, equipment satisfaction, number of calls | |
| Notes | Dominant component: self‐management | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "patients randomly selected their group assignment (by choosing a blinded envelope that contained a group indicator" |
| Allocation concealment (selection bias) | Low risk | Quote: "patients randomly selected their group assignment (by choosing a blinded envelope that contained a group indicator" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "because of the type of intervention, it was not possible to blind the subjects or investigators as to whether they were randomised to the treatment or control arms of the trial" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "primary end‐point was collected by the coordinator, and analysed by R.H. Jones" The co‐ordinator was also responsible for the intervention and therefore was not blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: dropout rates balanced in numbers across groups |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes reported |