title: A randomised, controlled trial of the effects of a mobile telehealth intervention on clinical and patient-reported outcomes in people with poorly controlled diabetes.
abstract: Objective The objective of this research is to determine the effects of mobile telehealth (MTH) on glycosylated haemoglobin (HbA1c) and other clinical and patient-reported outcomes in insulin-requiring people with diabetes. Methods A nine-month randomised, controlled trial compared standard care to standard care supplemented with MTH (self-monitoring, mobile-phone data transmissions, graphical and nurse-initiated feedback, and educational calls). Clinical (HbA1c, blood pressure, daily insulin dose, diabetes outpatient appointments (DOAs)) and questionnaire data (health-related quality of life, depression, anxiety) were collected. Mean group changes over time were compared using hierarchical linear models and Mann-Whitney tests. Results Eighty-one participants with a baseline HbA1c of 8.98% ± 1.82 were randomised to the intervention ( n = 45) and standard care ( n = 36). The Group by Time effect revealed MTH did not significantly influence HbA1c ( p = 0.228), but p values were borderline significant for blood pressure ( p = 0.054) and mental-health related quality of life ( p = 0.057). Examination of effect sizes and 95% confidence intervals for mean group differences at nine months supported the existence of a protective effect of MTH on mental health-related quality of life as well as depression. None of the other measured outcomes were found to be affected by the MTH intervention. Conclusions Findings from this study must be interpreted with caution given the small sample size, but they do not support the widespread adoption of MTH to achieve clinically significant changes in HbA1c. MTH may, however, have positive effects on blood pressure and protective effects on some aspects of mental health.
authors.affiliation: 1 Institute of Cardiovascular Science, University College London, United Kingdom (currently at the Ottawa Hospital Research Institute, Canada).
authors.forename: Justine S
authors.initials: JS
authors.lastname: Baron
authors.affiliation: 2 Centre for Health Services Research, School of Health Sciences, City University London, United Kingdom.
authors.forename: Shashivadan
authors.initials: S
authors.lastname: Hirani
authors.affiliation: 2 Centre for Health Services Research, School of Health Sciences, City University London, United Kingdom.
authors.forename: Stanton P
authors.initials: SP
authors.lastname: Newman
mesh_terms: D015190:Blood Glucose Self-Monitoring / Q000379:methods; D040421:Cell Phone; D003920:Diabetes Mellitus / Q000097:blood / Q000523:psychology / Q000628:therapy*; D000066498:Emotional Adjustment; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D017216:Telemedicine / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human
keywords: Telehealth; controlled trial; glycosylated haemoglobin; mobile health; patient-reported outcomes; randomised