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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL GROUP | No Intervention | ROUTINE CLINICAL PRACTICE | |
| SMS MESSAGING | Experimental | SMS MESSAGES TO MOBILE PHONE TO REMEMBER THE NEXT CONTROL OF GLYCATED HEMOGLOBIN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMS MESSAGING | Behavioral | SMS MESSAGING TO MOBILE PHONE TO REMEMBER THE NEXT CONTROL OF GLYCATED DIABETES |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the percentage of patients in the intervention group versus the control group who get a HbA1c below 7% | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the mean change in HbA1c values between SMS group patients and control patients | 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 |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comarca Araba | Vitoria-Gasteiz | Álava | Spain |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 30, 2016 | |
| Reset | Feb 20, 2017 | |
| Release | Mar 13, 2020 | |
| Reset | Mar 25, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 30, 2016 | Feb 20, 2017 | |||
| Mar 13, 2020 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| In patients with predictive risk index <1.5, to compare the incidence of diabetic complications in each group | 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 |
| To identify factors associated with better compliance of preventive activities in both groups | 12 months |
| 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 |
| Mar 25, 2020 |