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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: DIABE-TEXT

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.

• Study Type: Interventional
• Enrollment (Actual): 741
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Balearic Islands
    • Palma De Mallorca, Balearic Islands, Spain, 07002
      • Ignacio Ricci-Cabello

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DIABE-TEXT; 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.	Device: DIABE-TEXT; Participants will receive 170 text messages in their mobile phones during twelve months.
No Intervention: Usual care; Participants allocated to the control group will not receive any intervention apart from usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycated Hemoglobin (HbA1c) (%)	Extracted from electronic health records	Baseline
Glycated Hemoglobin (HbA1c) (%)	Extracted from electronic health records	12 months
Mean adherence to antidiabetic drugs (%)	Medication possession ratio for antidiabetic drugs	Baseline
Mean adherence to antidiabetic drugs (%)	Medication possession ratio for antidiabetic drugs	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to oral antidiabetic medication (7 items ad hoc questionnaire)	7 points = adherent; <7 points = non-adherent	Baseline
Adherence to oral antidiabetic medication (7 items ad hoc questionnaire)	7 points = adherent; <7 points = non-adherent	12 months
Health-related quality of life (EQ-5D-5L)	EQ-5D-5L index score	Baseline
Health-related quality of life (EQ-5D-5L)	EQ-5D-5L index score	12 months
Self-efficacy to manage Diabetes (DSES-S)	The score for each item is the number circled. If two consecutive numbers are circled, code the lower number (less self-efficacy). If the numbers are not consecutive, do not score the item. The score for the scale is the mean of the eight items. If more than two items are missing, do not score the scale. Higher number indicates higher self-efficacy.	Baseline
Self-efficacy to manage Diabetes (DSES-S)	The score for each item is the number circled. If two consecutive numbers are circled, code the lower number (less self-efficacy). If the numbers are not consecutive, do not score the item. The score for the scale is the mean of the eight items. If more than two items are missing, do not score the scale. Higher number indicates higher self-efficacy.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
14-point Mediterranean diet adherence screener (MEDAS-14)	The score range from 0 to 14. A higher score means a higher adherence to Mediterranean diet. We classified participants as low adherents (≤5), moderate adherents (6-9) or high adherents (≥10).	Baseline
14-point Mediterranean diet adherence screener (MEDAS-14)	The score range from 0 to 14. A higher score means a higher adherence to Mediterranean diet. We classified participants as low adherents (≤5), moderate adherents (6-9) or high adherents (≥10).	12 months
International Physical Activity Questionnaire (IPAQ)	6-items adapted from the short version of the IPAQ by the Public Health System of the Balearic Islands: https:// apps.caib.es/plasalutfront/formularios/ipaq/ipaq.xhtml Result options are: low, moderate or high level of physical activity	Baseline
International Physical Activity Questionnaire (IPAQ)	6-items adapted from the short version of the IPAQ by the Public Health System of the Balearic Islands: https:// apps.caib.es/plasalutfront/formularios/ipaq/ipaq.xhtml Result options are: low, moderate or high level of physical activity	12 months

Collaborators and Investigators

• Sponsor: Fundació d'investigació Sanitària de les Illes Balears

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2021
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: diabetes; adherence; medication; healthy lifestyle; mHealth; SMS; glycaemic control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: RTI2018-096935-A-100_rct; IB 4320/20 PI (Other Identifier: Research Ethics Committee of the Balearic Islands)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No