Clinical trial NCT05006872: mHealth Intervention to Support Diabetes Medication Adherence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
medication
adherence
glycaemic control
healthy lifestyle
mHealth
SMS
Lead sponsor: Fundació d'investigació Sanitària de les Illes Balears
Sponsor class: OTHER_GOV
First posted: 2021-08-16
Enrollment: 742
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims at evaluating the effectiveness of an intervention based on the use of a mobile-device based system delivering automated, tailored brief text messages to offer support for medicine use and lifestyle recommendations alongside usual care to people with type 2 diabetes.

Detailed description: A list of patients registered in primary care centers of the Balearic Islands and potentially meeting the eligibility criteria will be obtained from electronic health records (EHRs). A research assistant will contact the potential participants via phone to invite them to the study and confirm eligibility. All eligible participants will complete informed consent followed by baseline assessment over the phone before randomization. Participants will be randomly allocated using a computer-generated randomization sequence. All participants will continue with their usual diabetes care including all medical visits, tests, and diabetes support programs throughout the study. In addition, the intervention group will receive the text messaging intervention. Control participants will receive usual care only.

After twelve months of follow-up, all participants will complete post-intervention assessments via phone interview. Data on glycemic control (HbA1c) at baseline and post-intervention will be extracted from EHRs, as according to the protocol used for primary care providers in the Balearic Islands, patients with poor glycemic control (HbA1c \>8% ) must request an HbA1c determination every six months. Results of the most recent determination will be extracted from electronic medical records. For those patients with no recorded HbA1c within the previous four months, the research assistant will contact the primary care center to arrange blood test analyses.

Eligibility criteria: Inclusion Criteria:

* Patients registered in the Public Health Service of the Balearic Islands
* With type 2 diabetes
* At least one prescription of a glucose-lowering drug
* With results of HbA1c\>8% from 6 months prior to recruitment

Exclusion Criteria:

* Younger than 18 years old
* With insulin treatment
* Participating in another research study
* Not living in the Balearic Islands at some point during the study development

Primary outcomes:
measure: Glycated Hemoglobin (HbA1c) (%)
timeFrame: Baseline and post-intervention at 12 months
measure: Mean Adherence to Antidiabetic Drugs (%)
timeFrame: Baseline and post-intervention at 12 months
Secondary outcomes:
measure: Number of Participants Classified as Adherent Based on Self-reported Adherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire)
timeFrame: Baseline and post-intervention at 12 months
measure: Health-related Quality of Life (EQ-5D-5L)
timeFrame: Baseline and post-intervention at 12 months
measure: Self-efficacy to Manage Diabetes (DSES-S)
timeFrame: Baseline and post-intervention at 12 months
Other outcomes:
measure: 14-point Mediterranean Diet Adherence Screener (MEDAS-14)
timeFrame: Baseline and post-intervention at 12 months
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline and post-intervention at 12 months
Locations:
city: Palma De Mallorca
country: Spain
facility: Ignacio Ricci-Cabello
state: Balearic Islands
Study officials:
References:
citation: Zamanillo-Campos R, Fiol-DeRoque MA, Serrano-Ripoll MJ, Mira-Martinez S, Llobera-Canaves J, Taltavull-Aparicio JM, Leiva-Rus A, Ripoll-Amengual J, Angullo-Martinez E, Socias-Buades IM, Masmiquel-Comas L, Konieczna J, Zaforteza-Dezcallar M, Boronat-Moreiro MA, Gervilla-Garcia E, Ricci-Cabello I. 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. Contemp Clin Trials. 2024 Jan;136:107399. doi: 10.1016/j.cct.2023.107399. Epub 2023 Nov 22.