mHealth Intervention to Support Diabetes Medication Adherence (Pilot Study)

Not Applicable

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Device: DIABE-TEXT

Registration Number: NCT04738591

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 207

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DIABE-TEXT	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.

Primary Outcome Measures

Name	Time	Method
Glycated Hemoglobin (HbA1C)	Baseline and post-intervention at 3 months	HbA1c was extracted as percentage which is calculated following the standard formulae \[HbA1c(%)=(HbA1c(mmol/mol)+23.5)/10.93\] based on its concentration in blood samples. It identifies average plasma glucose concentration.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Classified as Adherent Based on Self-reporteAdherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire)	Baseline and post-intervention at 3 months	Number of participants classified as adherent based on Self-reported adherence to glucose medications was measured with a 7-items ad hoc questionnaire adapted from Chaves-Torres et al. for people with type 2 diabetes. Participants who obtained 7 points were considered adherent while the ones with \< 7 points were non-adherent.
Enrolment or Recruitment Rate	Baseline	(Patients enroled/ Total Eligible patients) x 100 percent
Retention Rate	3 months	(Patients who finish follow-up/Total recruited) x 100 percent