mHealth Intervention to Support Diabetes Medication Adherence

Diabetes Mellitus, Type 2 Clinical Trial

— DIABE-TEXT  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05006872
• Other study ID #: RTI2018-096935-A-100_rct
• Secondary ID: IB 4320/20 PI
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 6, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: February 2022
• Source: Fundació d'investigació Sanitària de les Illes Balears
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 741
• Est. completion date: April 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• DIABE-TEXT
Participants will receive 170 text messages in their mobile phones during twelve months.

Locations

Country	Name	City	State
Spain	Ignacio Ricci-Cabello	Palma De Mallorca	Balearic Islands

Sponsors (1)

Lead Sponsor	Collaborator
Fundació d'investigació Sanitària de les Illes Balears

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	Glycated Hemoglobin (HbA1c) (%)	Extracted from electronic health records	Baseline
Primary	Glycated Hemoglobin (HbA1c) (%)	Extracted from electronic health records	12 months
Primary	Mean adherence to antidiabetic drugs (%)	Medication possession ratio for antidiabetic drugs	Baseline
Primary	Mean adherence to antidiabetic drugs (%)	Medication possession ratio for antidiabetic drugs	12 months
Secondary	Adherence to oral antidiabetic medication (7 items ad hoc questionnaire)	7 points = adherent; <7 points = non-adherent	Baseline
Secondary	Adherence to oral antidiabetic medication (7 items ad hoc questionnaire)	7 points = adherent; <7 points = non-adherent	12 months
Secondary	Health-related quality of life (EQ-5D-5L)	EQ-5D-5L index score	Baseline
Secondary	Health-related quality of life (EQ-5D-5L)	EQ-5D-5L index score	12 months
Secondary	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
Secondary	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