%0 Journal Article %1 RN1 %A Zamanillo-Campos, R. %A Fiol deRoque, M. A. %A Serrano-Ripoll, M. J. %A Mira-Martínez, S. %A Ricci-Cabello, I. %D 2023 %J Int J Med Inform %K grapp-caib %P 105103 %R 10.1016/j.ijmedinf.2023.105103 %T Development and evaluation of DiabeText, a personalized mHealth intervention to support medication adherence and lifestyle change behaviour in patients with type 2 diabetes in Spain: A mixed-methods phase II pragmatic randomized controlled clinical trial %V 176 %X BACKGROUND: Despite the increasing interest in text-messaging interventions to support healthcare delivery, the available evidence about their effectiveness is still limited. OBJECTIVES: 1) to develop DiabeText, an intervention delivering automated, tailored brief text messages to support diabetes self-management; 2) to explore the potential impact of DiabeText on self-management behavior and glycaemic control, and; 3) to examine the feasibility of conducting a future phase III randomized clinical trial to evaluate the effectiveness of DiabeText. METHODS: 3-month, two-arm, randomized feasibility trial (ClinicalTrials.gov: NCT04738591) with patients with type 2 diabetes (HbA1c > 8%). Participants were allocated to the control (usual care) or DiabeText group (usual care + five text messages per week). Outcomes were: recruitment rate; follow-up rate, missing data; medication adherence; adherence to Mediterranean diet; physical activity; and HbA1c. In addition, after delivering the intervention, we conducted a qualitative study involving 14 semi-structured interviews with participants allocated to the DiabeText group, to understand their views about the intervention. RESULTS: From 444 screened people, we recruited 207 participants (recruitment rate = 47%), of which 179 completed the post-intervention interview (follow-up rate = 86%). We sent 7,355 SMS during the intervention period, of which 99% successfully reached the participants. At post-intervention, DiabeText was associated with non-statistically significant (p > 0.05) improvements in adherence to medication (OR = 2.0; 95%CI 1.0 to 4.2), Mediterranean diet (1.7; 0.9 to 3.2), and physical activity (1.7; 0.9 to 3.1). No between-group differences were observed in mean HbA1c (p = 0.670). The qualitative study indicated that participants perceived DiabeText as a helpful resource because it increased their awareness about the importance of adequate self-management and the sense of being cared for. CONCLUSIONS: DiabeText is the first system in Spain to integrate patient-generated and routinely collected clinical data to deliver tailored text messages to support diabetes self-management. More robust trials are needed to determine its effectiveness and cost-efficacy.

@article{RN1, abstract = {BACKGROUND: Despite the increasing interest in text-messaging interventions to support healthcare delivery, the available evidence about their effectiveness is still limited. OBJECTIVES: 1) to develop DiabeText, an intervention delivering automated, tailored brief text messages to support diabetes self-management; 2) to explore the potential impact of DiabeText on self-management behavior and glycaemic control, and; 3) to examine the feasibility of conducting a future phase III randomized clinical trial to evaluate the effectiveness of DiabeText. METHODS: 3-month, two-arm, randomized feasibility trial (ClinicalTrials.gov: NCT04738591) with patients with type 2 diabetes (HbA1c > 8%). Participants were allocated to the control (usual care) or DiabeText group (usual care + five text messages per week). Outcomes were: recruitment rate; follow-up rate, missing data; medication adherence; adherence to Mediterranean diet; physical activity; and HbA1c. In addition, after delivering the intervention, we conducted a qualitative study involving 14 semi-structured interviews with participants allocated to the DiabeText group, to understand their views about the intervention. RESULTS: From 444 screened people, we recruited 207 participants (recruitment rate = 47%), of which 179 completed the post-intervention interview (follow-up rate = 86%). We sent 7,355 SMS during the intervention period, of which 99% successfully reached the participants. At post-intervention, DiabeText was associated with non-statistically significant (p > 0.05) improvements in adherence to medication (OR = 2.0; 95%CI 1.0 to 4.2), Mediterranean diet (1.7; 0.9 to 3.2), and physical activity (1.7; 0.9 to 3.1). No between-group differences were observed in mean HbA1c (p = 0.670). The qualitative study indicated that participants perceived DiabeText as a helpful resource because it increased their awareness about the importance of adequate self-management and the sense of being cared for. CONCLUSIONS: DiabeText is the first system in Spain to integrate patient-generated and routinely collected clinical data to deliver tailored text messages to support diabetes self-management. More robust trials are needed to determine its effectiveness and cost-efficacy.}, added-at = {2023-06-05T06:46:41.000+0200}, author = {Zamanillo-Campos, R. and Fiol deRoque, M. A. and Serrano-Ripoll, M. J. and Mira-Martínez, S. and Ricci-Cabello, I.}, biburl = {https://www.bibsonomy.org/bibtex/2ab8cb6471f1cf90014fb41f9f07129a6/nachoricci}, doi = {10.1016/j.ijmedinf.2023.105103}, interhash = {d9ddb83edc37a12d2077a4d52f6acfc9}, intrahash = {ab8cb6471f1cf90014fb41f9f07129a6}, issn = {1386-5056}, journal = {Int J Med Inform}, keywords = {grapp-caib}, pages = 105103, timestamp = {2023-06-05T06:46:41.000+0200}, title = {Development and evaluation of DiabeText, a personalized mHealth intervention to support medication adherence and lifestyle change behaviour in patients with type 2 diabetes in Spain: A mixed-methods phase II pragmatic randomized controlled clinical trial}, type = {Journal Article}, volume = 176, year = 2023 }