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

• ClinicalTrials.gov Identifier: NCT05006872
• Recruitment Status: Active, not recruiting
• First Posted: August 16, 2021
• Last Update Posted: July 5, 2022
• Sponsor: Fundació d'investigació Sanitària de les Illes Balears
• Information provided by (Responsible Party): Fundació d'investigació Sanitària de les Illes Balears

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Device: DIABE-TEXT	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 741 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Masking Description: Healthcare providers (doctors and nurses from the participants' health centres, do not know if their patients are participating in the study nor the group (intervention vs control) they are. Just if a patient ask them for more information related to the study or text messages, they will know about it. Also, the interviewers that evaluate and register participants data are masked until randomization. After 12 months of follow-up, the interviewers will be masked before post-intervention evaluation. The primary outcome HbA1c is an objective measure and assessors of this outcome will be blinded to treatment allocation.
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: October 6, 2021
• Estimated Primary Completion Date: March 31, 2023
• Estimated Study Completion Date: April 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Glycated Hemoglobin (HbA1c) (%) [ Time Frame: Baseline ]
   Extracted from electronic health records
2. Glycated Hemoglobin (HbA1c) (%) [ Time Frame: 12 months ]
   Extracted from electronic health records
3. Mean adherence to antidiabetic drugs (%) [ Time Frame: Baseline ]
   Medication possession ratio for antidiabetic drugs
4. Mean adherence to antidiabetic drugs (%) [ Time Frame: 12 months ]
   Medication possession ratio for antidiabetic drugs

Secondary Outcome Measures :

1. Adherence to oral antidiabetic medication (7 items ad hoc questionnaire) [ Time Frame: Baseline ]
   7 points = adherent; <7 points = non-adherent
2. Adherence to oral antidiabetic medication (7 items ad hoc questionnaire) [ Time Frame: 12 months ]
   7 points = adherent; <7 points = non-adherent
3. Health-related quality of life (EQ-5D-5L) [ Time Frame: Baseline ]
   EQ-5D-5L index score
4. Health-related quality of life (EQ-5D-5L) [ Time Frame: 12 months ]
   EQ-5D-5L index score
5. Self-efficacy to manage Diabetes (DSES-S) [ Time Frame: Baseline ]
   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.
6. Self-efficacy to manage Diabetes (DSES-S) [ Time Frame: 12 months ]
   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.

Other Outcome Measures:

1. 14-point Mediterranean diet adherence screener (MEDAS-14) [ Time Frame: Baseline ]
   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).
2. 14-point Mediterranean diet adherence screener (MEDAS-14) [ Time Frame: 12 months ]
   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).
3. International Physical Activity Questionnaire (IPAQ) [ Time Frame: Baseline ]
   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
4. International Physical Activity Questionnaire (IPAQ) [ Time Frame: 12 months ]
   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

Eligibility Criteria

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

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

Contacts and Locations

Locations

Spain

Ignacio Ricci-Cabello

Palma De Mallorca, Balearic Islands, Spain, 07002

Sponsors and Collaborators

Fundació d'investigació Sanitària de les Illes Balears

More Information

• Responsible Party: Fundació d'investigació Sanitària de les Illes Balears
• ClinicalTrials.gov Identifier: NCT05006872
• Other Study ID Numbers: RTI2018-096935-A-100_rct; IB 4320/20 PI ( Other Identifier: Research Ethics Committee of the Balearic Islands )
• First Posted: August 16, 2021
• Last Update Posted: July 5, 2022
• Last Verified: February 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundació d'investigació Sanitària de les Illes Balears:

diabetes; medication; adherence; glycaemic control; healthy lifestyle; mHealth; SMS

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases