mHealth Intervention to Support Diabetes Medication Adherence (Pilot Study) (DIABE-TEXT)

Fundació d'investigació Sanitària de les Illes Balears

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: DIABE-TEXT

Study type: Interventional

Funder types: Other

Identifiers

NCT04738591

IB 43/20/20 PI (Other Identifier)

RTI2018-096935-A-I00_pilot

Details and patient eligibility

About

This study aims at evaluating the feasibility 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.

Full 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 three 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 three months, the research assistant will contact the primary care center and the patient to arrange blood test analyses.

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients registered in the Public Health Service of the Balearic Islands
• With type 2 diabetes
• At least one prescription of an oral glucose-lowering drug
• With results of HbA1C>8% from 3 months prior to recruitment.

Exclusion criteria

• Younger than 18 years old
• With insulin treatment.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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207 participants in 2 patient groups

DIABE-TEXT

Experimental group

Description:

Participants allocated to the intervention group will receive text messages in their mobile phones with content about diabetes management, general information about diabetes, medicines, diet and physical activity recommendations and motivational prompts to engage participants in a healthy lifestyle and a good adherence to medication plan. They will also receive reminders for healthcare visits, drug dispensation from the pharmacy and updated results from blood test records.

Treatment:

Device: DIABE-TEXT

Usual care

No Intervention group

Description:

Participants allocated to the control group will not receive any intervention apart from usual care.