DiabeText, a mobile health intervention to support medication taking and healthy lifestyle in adults with type 2 diabetes: Study protocol for a randomized controlled trial
AIM: To evaluate the effectiveness of DiabeText, a low-intensity, multifaceted, mobile health (mHealth) intervention to support medication taking and lifestyle change targeted to people with type 2 diabetes (T2D). DESIGN: Phase III, 12-months, two-arm (1:1 allocation ratio), randomized parallel-group trial. METHODS: We will recruit 740 adults with glycated hemoglobin (A1c) >8% (>64 mmol/mol) and with at least one prescription of a non-insulin antidiabetic drug. They will be allocated to a control (usual care) group or an intervention (DiabeText messaging intervention) group. The primary outcome measure will be A1c at 12 months follow-up. Secondary outcomes will include medication possession ratio and behavioral and psychological outcomes. DISCUSSION: Recent trials suggest that digital health interventions can effectively support diabetes self-management improving T2D control and reducing important T2D complications. In Spain this type of interventions is understudied. IMPACT: This trial will strengthen the evidence base of the impact of mHealth interventions to support diabetes self-management. If effective, DiabeText may offer a low-cost and highly scalable strategy to improve health at the population level in a sustainable way. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT05006872; Official Title: Supporting People with Type 2 Diabetes in Effective Use of their Medicine Through a System Comprising Mobile Health Technology Integrated with Clinical Care.
%0 Journal Article
%1 RN43
%A Zamanillo-Campos, R.
%A Fiol-DeRoque, M. A.
%A Serrano-Ripoll, M. J.
%A Mira-Martínez, S.
%A Llobera-Canaves, J.
%A Taltavull-Aparicio, J. M.
%A Leiva-Rus, A.
%A Ripoll-Amengual, J.
%A Angullo-Martínez, E.
%A Socias-Buades, I. M.
%A Masmiquel-Comas, L.
%A Konieczna, J.
%A Zaforteza-Dezcallar, M.
%A Boronat-Moreiro, M. A.
%A Gervilla-García, E.
%A Ricci-Cabello, I.
%D 2023
%J Contemp Clin Trials
%K grapp-caib
%P 107399
%R 10.1016/j.cct.2023.107399
%T DiabeText, a mobile health intervention to support medication taking and healthy lifestyle in adults with type 2 diabetes: Study protocol for a randomized controlled trial
%V 136
%X AIM: To evaluate the effectiveness of DiabeText, a low-intensity, multifaceted, mobile health (mHealth) intervention to support medication taking and lifestyle change targeted to people with type 2 diabetes (T2D). DESIGN: Phase III, 12-months, two-arm (1:1 allocation ratio), randomized parallel-group trial. METHODS: We will recruit 740 adults with glycated hemoglobin (A1c) >8% (>64 mmol/mol) and with at least one prescription of a non-insulin antidiabetic drug. They will be allocated to a control (usual care) group or an intervention (DiabeText messaging intervention) group. The primary outcome measure will be A1c at 12 months follow-up. Secondary outcomes will include medication possession ratio and behavioral and psychological outcomes. DISCUSSION: Recent trials suggest that digital health interventions can effectively support diabetes self-management improving T2D control and reducing important T2D complications. In Spain this type of interventions is understudied. IMPACT: This trial will strengthen the evidence base of the impact of mHealth interventions to support diabetes self-management. If effective, DiabeText may offer a low-cost and highly scalable strategy to improve health at the population level in a sustainable way. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT05006872; Official Title: Supporting People with Type 2 Diabetes in Effective Use of their Medicine Through a System Comprising Mobile Health Technology Integrated with Clinical Care.
@article{RN43,
abstract = {AIM: To evaluate the effectiveness of DiabeText, a low-intensity, multifaceted, mobile health (mHealth) intervention to support medication taking and lifestyle change targeted to people with type 2 diabetes (T2D). DESIGN: Phase III, 12-months, two-arm (1:1 allocation ratio), randomized parallel-group trial. METHODS: We will recruit 740 adults with glycated hemoglobin (A1c) >8% (>64 mmol/mol) and with at least one prescription of a non-insulin antidiabetic drug. They will be allocated to a control (usual care) group or an intervention (DiabeText messaging intervention) group. The primary outcome measure will be A1c at 12 months follow-up. Secondary outcomes will include medication possession ratio and behavioral and psychological outcomes. DISCUSSION: Recent trials suggest that digital health interventions can effectively support diabetes self-management improving T2D control and reducing important T2D complications. In Spain this type of interventions is understudied. IMPACT: This trial will strengthen the evidence base of the impact of mHealth interventions to support diabetes self-management. If effective, DiabeText may offer a low-cost and highly scalable strategy to improve health at the population level in a sustainable way. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT05006872; Official Title: Supporting People with Type 2 Diabetes in Effective Use of their Medicine Through a System Comprising Mobile Health Technology Integrated with Clinical Care.},
added-at = {2023-12-14T09:24:08.000+0100},
author = {Zamanillo-Campos, R. and Fiol-DeRoque, M. A. and Serrano-Ripoll, M. J. and Mira-Martínez, S. and Llobera-Canaves, J. and Taltavull-Aparicio, J. M. and Leiva-Rus, A. and Ripoll-Amengual, J. and Angullo-Martínez, E. and Socias-Buades, I. M. and Masmiquel-Comas, L. and Konieczna, J. and Zaforteza-Dezcallar, M. and Boronat-Moreiro, M. A. and Gervilla-García, E. and Ricci-Cabello, I.},
biburl = {https://www.bibsonomy.org/bibtex/21a9b6ff3ef57ca4efdf4a02d552534bd/nachoricci},
doi = {10.1016/j.cct.2023.107399},
interhash = {37c90fbc245769778bffe6a5eccd40db},
intrahash = {1a9b6ff3ef57ca4efdf4a02d552534bd},
issn = {1551-7144},
journal = {Contemp Clin Trials},
keywords = {grapp-caib},
pages = 107399,
timestamp = {2023-12-14T09:24:08.000+0100},
title = {DiabeText, a mobile health intervention to support medication taking and healthy lifestyle in adults with type 2 diabetes: Study protocol for a randomized controlled trial},
type = {Journal Article},
volume = 136,
year = 2023
}