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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Fundació d'investigació Sanitària de les Illes Balears
- Enrollment
- 207
- Locations
- 1
- Primary Endpoint
- Glycated Hemoglobin (HbA1C)
- Status
- Completed
- Last Updated
- last year
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.
Investigators
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.
Outcomes
Primary Outcomes
Glycated Hemoglobin (HbA1C)
Time Frame: 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 Outcomes
- 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)
- Enrolment or Recruitment Rate(Baseline)
- Retention Rate(3 months)