Earle 2010.
Study characteristics | ||
Methods |
Mobile telemonitoring for achieving tighter targets of blood pressure control in patients with complicated diabetes: a pilot study RCT (NA clusters and NA providers), conducted in 1) The study was based at the Thomas Addison Unit, St. George’s Hospital, South London, UK, which serves an inner‐city population characterised by a diverse ethnic mix ‐ 22% of residents belong to a non‐white minority ethnic group ‐ with a social deprivation score that is higher than the national average (see www.capitalambition.gov.uk/documents). 2) Clinicians received patients' data in real‐time and using a web‐based application provided management advice to the patient and their physicians. In United Kingdom. 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (m‐Health group) (intervention arm) |
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Participants | Control arm N: 65 Intervention arm N: 72, NA, NA Diabetes type: 3 Mean age: 58.41 ± 9.55 % Male: NR Longest follow‐up: 6 months |
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Interventions |
Control arm: (usual care) 1) Patient education Intervention arm: (m‐Health group) 1) Case management 2) Electronic patient registry 3) Clinician education 4) Facilitated relay of clinical information 5) Patient education 6) Promotion of self‐management 7) Patient reminders |
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Outcomes | Glycated haemoglobin Systolic blood pressure Diastolic blood pressure |
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Funding source | The authors would like to acknowledge the financial and technical support from the IDEN Group, Motorola Inc., USA and the Motohealth team in the United Kingdom. This study was funded by Motorola Inc., USA. | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Patients were randomised to the m‐Health group (MH group) or usual care group (UC group) according to a computer‐generated random number sequence (Stat MateTM version 1.01i, GraphPad, San Diego, CA). |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Patient's baseline characteristics (selection bias) | Low risk | Table 1. All P values higher than 0.05. The groups were well matched according to their demographic characteristics (Table 1). |
Patient's baseline outcomes (selection bias) | Low risk | Table 1. All P values higher than 0.05. The groups were well matched according to their baseline blood pressure, diabetes control determined by the HbA1c, renal function and lipid profile (Table 1). |
Incomplete outcome data (attrition bias) | High risk | 26 out of 72 (36%) patients defaulted in the MH group compared with 16 out of 65 (25%) from the control group at 6 months. High and unbalanced numbers. In each group, 29 patients had a record of diabetic retinopathy. The higher than expected default rate in the intervention arm was largely the result of technological problems with the use of the hardware and the patient’s ability to transmit data. In particular, patients reported unreliability of the equipment and that the troubleshooting support systems were not intuitive. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective outcome (blood pressure). |
Selective reporting (reporting bias) | High risk | Retrospectively registered protocol. Results match protocol for blood pressure outcome, but they added an analysis based on racial heritage. HbA1c was previously published in reference 8. |
Risk of contamination (other bias) | Low risk | Patients allocated to the UC group did not receive any mHealth equipment. They were not required to report their blood pressure and did not receive any support from the research nurses. All of their management was provided by their local practitioners who were not involved in the study. |
Other bias | Low risk | No evidence of other risk of bias. |