Effectiveness of SMS in Diabetes Control

Diabetes Clinical Trial

— SMSaludD  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772446
• Other study ID #: PAPPS-01
• Status: Completed
• Phase: N/A
• First received: January 10, 2013
• Last updated: July 19, 2016
• Start date: June 2013
• Est. completion date: October 2015

Study information

• Verified date: July 2016
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 74 Years

Eligibility

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%

Related Conditions & MeSH terms

• Diabetes

Intervention

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

Locations

Country	Name	City	State
Spain	Comarca Araba	Vitoria-Gasteiz	Álava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the percentage of patients in the intervention group versus the control group who get a HbA1c below 7%		12 months
Secondary	Compare the mean change in HbA1c values between SMS group patients and control patients		6 and 12 months
Secondary	Compare the percentage of patients in the intervention group compared with the control group that meet the following preventive recommendations		12 months
Secondary	In patients with predictive risk index <1.5, to compare the incidence of diabetic complications in each group		12 months
Secondary	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)		6 and 12 months
Secondary	To identify factors associated with better compliance of preventive activities in both groups		12 months
Secondary	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.		at 12 month