Effectiveness of SMS in Diabetes Control

Not Applicable

Completed

• Conditions: Diabetes

• Registration Number: NCT01772446
• Lead Sponsor: Basque Health Service

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-17
• Study First Posted: 2013-01-21
• Study Start: 2013-06
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-19
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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%

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compare the percentage of patients in the intervention group versus the control group who get a HbA1c below 7%	12 months

Secondary Outcome Measures

Name	Time	Method
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
Compare the mean change in HbA1c values between SMS group patients and control patients	6 and 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)	6 and 12 months
Compare the percentage of patients in the intervention group compared with the control group that meet the following preventive recommendations	12 months
In patients with predictive risk index <1.5, to compare the incidence of diabetic complications in each group	12 months
To identify factors associated with better compliance of preventive activities in both groups	12 months

Trial Locations

Locations (1)

Comarca Araba; 🇪🇸 Vitoria-Gasteiz, Álava, Spain