Randomized controlled study to evaluate the impact of flexible patient-controlled visits in people with type 1 diabetes: The DiabetesFlex Trial.

Autor: Laurberg T; Steno Diabetes Centre Aarhus, Aarhus University Hospital, Aarhus, Denmark., Schougaard LMV; AmbuFlex, Center for Patient-Reported Outcomes, Regional Hospital West Jutland, Herning, Denmark.; ResCenPI - Research Centre for Patient Involvement, Aarhus University and the Central Denmark Region, Denmark., Hjollund NHI; AmbuFlex, Center for Patient-Reported Outcomes, Regional Hospital West Jutland, Herning, Denmark.; Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark., Lomborg KE; ResCenPI - Research Centre for Patient Involvement, Aarhus University and the Central Denmark Region, Denmark.; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.; Steno Diabetes Centre Copenhagen, Herlev, Denmark., Hansen TK; Steno Diabetes Centre Aarhus, Aarhus University Hospital, Aarhus, Denmark.; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark., Jensen AL; Steno Diabetes Centre Aarhus, Aarhus University Hospital, Aarhus, Denmark.; ResCenPI - Research Centre for Patient Involvement, Aarhus University and the Central Denmark Region, Denmark.; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Jazyk: angličtina
Zdroj: Diabetic medicine : a journal of the British Diabetic Association [Diabet Med] 2022 May; Vol. 39 (5), pp. e14791. Date of Electronic Publication: 2022 Jan 18.
DOI: 10.1111/dme.14791
Abstrakt: Aim: The objective of this study was to assess the impact of health care-initiated visits versus patient-controlled flexible visits on clinical and patient-reported outcomes in people with type 1 diabetes.
Methods: The DiabetesFlex trial was a randomized controlled, pragmatic non-inferiority 15-month follow-up study comparing standard care (face-to-face visits every 4 months) with DiabetesFlex (patient-controlled flexible visits using patient-reported, outcome-based telehealth follow-up). Of 343 enrolled participants, 160 in each group completed the study. The primary outcome was mean change in HbA 1c from baseline to 15-month follow-up. Secondary outcomes were blood pressure, lipid levels, frequency of visits, the World Health Organization score-five well-being-index (WHO-5), the Problem Areas In Diabetes (PAID) scale and experience of participation in own care (participation score).
Results: The adjusted mean difference in HbA 1c between standard care and DiabetesFlex was similar and below the predefined non-inferiority margin of 0.4% (-0.03% [95%CI: 0.15, 0.11]/-0.27 mmol/mol [-1.71, 1.16]). No intergroup mean changes in lipid or blood pressure were observed. Conversely, DiabetesFlex participants presented an increased mean WHO-5 index of 4.5 (1.3, 7.3), participation score of 1.1 (0.5, 2.0), and decreased PAID score of -4.8 (-7.1, -2.6) compared with standard care. During follow-up, DiabetesFlex participants actively changed 23% of face-to-face visits to telephone consultations, cancelled more visits (17% vs. 9%), and stayed away without cancellation less often (2% vs. 8%).
Conclusion: Compared with standard care, flexible patient-controlled visits combined with patient-reported outcomes in participants with metabolic controlled type 1 diabetes and good psychological well-being further improved diabetes-related well-being and decreased face-to-face visits while maintaining safe diabetes management.
(© 2022 Diabetes UK.)
Databáze: MEDLINE
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