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Effectiveness of SMS in Diabetes Control (SMSaludD)

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ClinicalTrials.gov Identifier: NCT01772446
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
Raquel Cobos Campos, 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.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: SMS MESSAGING Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   35 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772446


Locations
Spain
Comarca Araba
Vitoria-Gasteiz, Álava, Spain
Sponsors and Collaborators
Basque Health Service

Responsible Party: Raquel Cobos Campos, Epidemiologist, Basque Health Service
ClinicalTrials.gov Identifier: NCT01772446     History of Changes
Other Study ID Numbers: PAPPS-01
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016

Keywords provided by Raquel Cobos Campos, Basque Health Service:
diabetes
management
glycated hemoglobin
preventive activities