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EFFECTIVENESS OF SMS IN DIABETES CONTROL (SMSaludD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Basque Health Service
Sponsor:
Information provided by (Responsible Party):
Raquel Cobos Campos, Basque Health Service
ClinicalTrials.gov Identifier:
NCT01772446
First received: January 10, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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: 232 patients (116 per arm) to detect a difference 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.


Condition Intervention
Diabetes
Behavioral: SMS MESSAGING

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • Compare the percentage of patients in the intervention group versus the control group who get a HbA1c below 7% [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the mean change in HbA1c values ​​between SMS group patients and control patients [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Compare the percentage of patients in the intervention group compared with the control group that meet the following preventive recommendations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • In patients with predictive risk index <1.5, to compare the incidence of diabetic complications in each group [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • To identify factors associated with better compliance of preventive activities in both groups [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 232
Study Start Date: June 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772446

Locations
Spain
Comarca Araba Recruiting
Vitoria-Gasteiz, Álava, Spain
Contact: Raquel Cobos, Msc    945007413    raquel.coboscampos@osakidetza.net   
Sub-Investigator: Antxon Apiñaniz, MD         
Sponsors and Collaborators
Basque Health Service
  More Information

No publications provided

Responsible Party: Raquel Cobos Campos, Epidemiologist, Basque Health Service
ClinicalTrials.gov Identifier: NCT01772446     History of Changes
Other Study ID Numbers: PAPPS-01
Study First Received: January 10, 2013
Last Updated: January 7, 2014
Health Authority: Spain: Ethics Committee

Keywords provided by Basque Health Service:
diabetes
management
glycated hemoglobin
preventive activities

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014