mHealth Intervention to Support Diabetes Medication Adherence (Pilot Study)

Study Overview
=================
Brief Summary
-----------------
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.

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 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.

Official Title
-----------------
Feasibility Study Through a Phase II Randomized Clinical Trial of an Intervention Based on Short Message System (SMS) to Promote Adherence to Antidiabetic Medication and Healthy Lifestyles in Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Device: DIABE-TEXT


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DIABE-TEXT<br>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<br>* Participants will receive daily (from monday to friday) text messages in their mobile phones during three months.<br>|
| No Intervention: Usual care<br>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) |  | Baseline | 
| Glycated Hemoglobin (HbA1C) |  | 3 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 | 3 months | 
| Enrolment or recruitment rate | (Patients enroled/ Total Eligible patients) x 100 percent | Baseline | 
| Retention rate | (Patients who finish follow-up/Total recruited) x 100 percent | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Medication, Adherence, Glycaemic control, Healthy lifestyle, mHealth, SMS