Effectiveness of SMS in Diabetes Control (SMSaludD)

July 19, 2016 updated by: Raquel Cobos Campos, Basque Health Service

Effectiveness of Sending Sms Text Messages to Mobile Phone Patients to Remind Upcoming Appointments and Improve the Control of Diabetic Patients in Primary Care

Introduction: The Spanish Society of Family and Community Medicine, started the Program of Preventive Activities and Health Promotion, which generates periodic recommendations of preventive methods based on scientific evidence. In the last update it has become evident the need of modifications to adapt the program to modern times and focuses on improving accessibility and offering more flexible responses to users of the program. In this sense, the mobile phone technology could be useful, specifically the messaging service to remind patients their appointments and increase attendance rates. Main objective Compare the percentage of patients in the intervention group compared with the control group who achieved a figure of HbA1c <7% in 2013.Design: single blind Randomized Clinical Trial. Study population: Patients with diabetes with or without hypertension or lipid metabolism disorder, over 18 years, belonging to the Public Health System of Basque Country (primary care) meeting the inclusion / exclusion criteria. Sample size: 238 patients (119 per arm) to detect a difference of 16% in the percentage of patients with HbA1c lower than 7% between groups: Short Messages Standard (SMS) group: Mobile messages reminding the next review of Papps. Control group: Routine clinical practice. Statistical analysis: The relationship between the intervention received and the main variable (compliance with preventive activities at 12 months) were analyzed using a logistic regression model.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Álava
      • Vitoria-Gasteiz, Álava, Spain
        • Comarca Araba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetic patients with or without hypertension or lipid metabolism disorder,
  • Aged between 35 and 74 years old with or without hypertension or lipid metabolism disorder,
  • Mobile phone holder,
  • Able to read messages via mobile phone.

Exclusion criteria:

  • Pregnant women,
  • Patients whose next date for HbA1c control is less than 2 months
  • Patients with HbA1c <7%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: CONTROL GROUP
ROUTINE CLINICAL PRACTICE
Experimental: SMS MESSAGING
SMS MESSAGES TO MOBILE PHONE TO REMEMBER THE NEXT CONTROL OF GLYCATED HEMOGLOBIN
Behavioral: SMS MESSAGING
SMS MESSAGING TO MOBILE PHONE TO REMEMBER THE NEXT CONTROL OF GLYCATED DIABETES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare the percentage of patients in the intervention group versus the control group who get a HbA1c below 7%
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare the mean change in HbA1c values between SMS group patients and control patients
Time Frame: 6 and 12 months
6 and 12 months
Compare the percentage of patients in the intervention group compared with the control group that meet the following preventive recommendations
Time Frame: 12 months
12 months
In patients with predictive risk index <1.5, to compare the incidence of diabetic complications in each group
Time Frame: 12 months
12 months
Evaluate the percentage of patients who are controlled. We consider controlled patient when HbA1C <7%, BP <140/80 and cardiovascular risk <20% measured by the scale of Heart Register of Gerona (REGICOR)
Time Frame: 6 and 12 months
6 and 12 months
To identify factors associated with better compliance of preventive activities in both groups
Time Frame: 12 months
12 months
Evaluate whether the intervention is more effective (reducing HbA1c below 7%) in patients with predictive risk index <1.5, or in patients with predictive risk index> 1.5.
Time Frame: at 12 month
at 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basque Health Service

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

January 10, 2013

First Submitted That Met QC Criteria

January 17, 2013

First Posted (Estimate)

January 21, 2013

Study Record Updates

Last Update Posted (Estimate)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAPPS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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