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Completed

NCT Number: NCT01772446

Effectiveness of SMS in Diabetes Control

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.

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Key information

Age range

35 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Comarca Araba

Vitoria-Gasteiz, Álava, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

SMS messaging

Behavioral

SMS MESSAGING TO MOBILE PHONE TO REMEMBER THE NEXT CONTROL OF GLYCATED DIABETES

Primary outcomes

  1. Compare the percentage of patients in the intervention group versus the control group who get a HbA1c below 7%

    Time frame: 12 months

Secondary outcomes

  1. Compare the mean change in HbA1c values between SMS group patients and control patients

    Time frame: 6 and 12 months

  2. Compare the percentage of patients in the intervention group compared with the control group that meet the following preventive recommendations

    Time frame: 12 months

  3. In patients with predictive risk index <1.5, to compare the incidence of diabetic complications in each group

    Time frame: 12 months

  4. 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

  5. To identify factors associated with better compliance of preventive activities in both groups

    Time frame: 12 months

  6. 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

Sponsors and collaborators

Lead sponsor

Basque Health Service

Other Gov

Registry information

Official study title

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

Acronym: SMSaludD

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 21, 2013
Registry last updated
Jul 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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