NCT05006872

mHealth Intervention to Support Diabetes Medication Adherence

Supporting People With Type 2 Diabetes in Effective Use of Their Medicine Through a System Comprising Mobile Health Technology Integrated With Clinical Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 742 (actual)
• Sponsor: Fundació d'investigació Sanitària de les Illes Balears · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	DIABE-TEXT	Participants will receive 170 text messages in their mobile phones during twelve months.

Timeline

• Start date: 2021-10-06
• Primary completion: 2023-03-31
• Completion: 2023-04-30
• First posted: 2021-08-16
• Last updated: 2025-02-28
• Results posted: 2025-02-28

Locations

1 site across 1 country: Spain