Description of the Danish TeleCare North cluster-randomised trial
| Eligible criteria for clusters | All municipalities in North Denmark Region except one (a small island off the coast), 10 municipalities in all. Each municipality consisted of between 2 and 5 municipality districts and these districts were randomisation units, 26 municipality districts in total (13 in each arm). |
| Eligible criteria for patients | COPD as primary disease, diagnosis by spirometry, in treatment according to guidelines recommended by ‘The Global Initiative for Chronic Obstructive Lung Disease’,1 at least two exacerbations within the past 12 months, motivated for treatment, fixed residence in North Denmark Region, The Modified Medical Research Council scale (mMRC)≥2 or mMRC≥3 and COPD Assessment Test≥10. Exclusion criteria were: no phone line or Global System for Mobile communications coverage, unable to understand Danish sufficiently to complete the study questionnaires or diagnosed with a cognitive impairment |
| Intervention group: cluster-level intervention | Municipality district healthcare personnel (primarily nurses and health assistants) were trained in two separate sessions. One session focused on the technical aspects of the tablet and physical measurements. Another session focuses on general disease awareness and communication with patients. The training was performed by members of the trial administration office. General practitioners were responsible for establishing threshold values for physical measurements. Nurses in the patient’s residing municipality were responsible for monitoring the data obtained and should incorporate monitoring time duties with their existing job responsibilities. Exemptions were patients with COPD receiving oxygen therapy and patients with COPD with open hospital admissions who were monitored at their hospital as usual. Patients were monitored asynchronously by a nurse on a daily basis. Measurements were classified with either a green, yellow or red code (green code: no threshold values were exceeded; yellow code: one or more values exceeded the threshold values; red code: one or more values exceeded the threshold values and had not previously been recorded). The nurse had the option to contact the patient by telephone and/or the patient’s general practitioner and/or dispatch an ambulance. Installation, swopping of defects, deinstallation and technical support and maintenance of the equipment was handled by information technology specialists |
| Intervention group: patient-level intervention | Telephone contact to each patient from municipality healthcare personnel no later than 10 days after randomisation, and a 45 min appointment scheduled for patients who wanted to receive the tablet at home. For those who wished to receive the tablet at a municipality health centre, a 75 min appointment was scheduled with 3–4 patients in each group. At both appointments, a nurse from the patients’ municipalities demonstrated the use of the tablet and instructed patients in how to conduct physical measurement. Patients were asked to measure their vital signs daily during the first 2 weeks (both weekdays and weekends) and 1–2 times weekly after the first 2 weeks. A 45 min follow-up visit was scheduled 3–4 weeks after the first appointment to check if the patient used the device appropriately and if the threshold values of the physical measurements needed to be adjusted |
| Intervention group: device | All patients received the same device and peripherals. It consisted of a standard tablet (Samsung Galaxy) containing information on handling COPD in general and software (two apps) that automatically instructs the patient in handling COPD during exacerbations. The tablet can collect and wirelessly transmit data on blood pressure, pulse, blood oxygen saturation and weight via an attached Fingertip Pulse Oximeter, a digital blood pressure monitor, and a scale |
| Control group: usual care | Usual practise for caring for patients with COPD is the responsibility of the patient’s general practitioner (treatment and monitoring) and the municipalities (practical help and home nursing care). Patients with COPD can make appointments with their general practitioner or call the emergency contact number without copayment in order to get treatment or advice in managing COPD, but this advice is not personalised. Community care administered by municipality district personnel comes at regular intervals based on a clinically based estimate of the patients’ needs, but these personnel are not necessarily certified nurses and often not fully educated in COPD and not on call |
COPD, chronic obstructive pulmonary disease.