Effectiveness of SMS in Diabetes Control

NCT ID: NCT01772446

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-10-31

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

CONTROL GROUP

ROUTINE CLINICAL PRACTICE

Group Type: NO_INTERVENTION

No interventions assigned to this group

SMS MESSAGING

SMS MESSAGES TO MOBILE PHONE TO REMEMBER THE NEXT CONTROL OF GLYCATED HEMOGLOBIN

Group Type: EXPERIMENTAL

SMS MESSAGING

Intervention Type: BEHAVIORAL

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

Interventions

SMS MESSAGING

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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%

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Basque Health Service

OTHER_GOV

Sponsor Role: lead

Responsible Party

Raquel Cobos Campos

Epidemiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Comarca Araba

Vitoria-Gasteiz, Álava, Spain

Countries

Spain

Other Identifiers

PAPPS-01

Identifier Type: -

Identifier Source: org_study_id