Clinical trial NCT03453970: Effectiveness of a Diabetes Education Program Based on Tailored Interventions (Edep-Ti Study)
Official title: Effectiveness of a Diabetes Education Program Based on Tailored Interventions in the Andalusian Public Health and Social System (Edep-Ti Study).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: patient education
self-care
Controlled Trial
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: GOALS:

PRIMARY:

1. Analyze the overall impact of the proposed diabetes education program on metabolic control (HbA1c) and modifiable cardiovascular risk factors (lipid profile and blood pressure).

   SECONDARY:
2. Evaluate the effectiveness of the program on smoking habits and body mass index (weight, height).
3. Analyze the impact of the program on the quality of life related to health.
4. Check the effect on lifestyles: compliance levels of physical exercise and adherence to diet mediterranean.

DESIGN: Cluster randomized controlled trial

Detailed description: The reference population will be patients with a diagnosis of diabetes mellitus in treatment with oral antidiabetics, excluding the insulinized patients. They will then be randomly assigned by cluster, to the intervention group (individual education) or control (usual care) in the context of each health center participating in the project. After randomization centers, all professionals who decide to cooperate receive a training process on methodology for measuring results (clinical and questionnaire variables), while assigned to the experimental intervention, will also receive training on how to carry out the program of diabetologic education proposed. The follow-up period for both groups is 18 months obtained as clinical determinations: glycosylated hemoglobin (metabolic control), blood pressure, lipid profile, smoking and BMI; and as results reported by the patient through questionnaires: quality of life related to health, level of physical activity performed or adherence to the Mediterranean diet.

Eligibility criteria: Inclusion Criteria:

* Patients with Type II Diabetes Mellitus diagnosed \<10 years and classified in a computerized clinical history with poor metabolic control and in treatment with oral antidiabetics.
* HbA1c\> 7% in the last control available (\<1 year); or poor control of one of the following cardiovascular risk factors (in the last year): SBP\> 140 mmHg or DBP\> 90 mmHg, or presence of tobacco habit or dyslipidemia (LDL-c \> = 100 mg / dL) or BMI\> 30; or in treatment with: ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, calcium channel blockers or diuretics and lipid-lowering drugs.

Exclusion Criteria:

* Diabetes Mellitus type 1
* Insulinized patients.
* Patients who have received some type of structured educational intervention in the last year according to the data obtained in their clinical history.
* Patients with some type of sensory or mental disability.
* Gestational diabetes.
* Patients with age equal to or greater than 75 years of age or minors.
* Patients with inability to travel to their Health Center.

Primary outcomes:
measure: Change from basal glycosylated hemoglobin (HbA1c) at 6 months, change from basal HbA1c at 12 months and change from basal HbA1c at 18 months
timeFrame: 0,6,12 and18 months
measure: Lipidic profile: change from basal total cholesterol (TC) at 6 months, change from total basal cholesterol at 12 months and change from total basal cholesterol at 18 months.
timeFrame: 0,6,12 and18 months
measure: Lipidic profile: change from baseline LDL cholesterol (LDLc) at 6 months, change from baseline LDLc at 12 months and change from baseline LDL cholesterol at 18 months.
timeFrame: 0,6,12 and18 months
measure: Lipidic profile:change from basal triglyceride (TG) levels at 6 months, change from basal TG levels at 12 months and change from baseline TG levels at 18 months.
timeFrame: 0,6,12 and18 months
measure: Change from baseline systolic blood pressure (SBP) at 6 months, change from baseline systolic blood pressure at 12 months and change from baseline systolic blood pressure at 18 months.
timeFrame: 0,6,12 and18 months
measure: Change from baseline diastolic blood pressure (DBP) at 6 months, change from baseline diastolic blood pressure at 12 months and change from baseline diastolic blood pressure at 18 months.
timeFrame: 0,6,12 and18 months
Secondary outcomes:
measure: Development in smoking habits
timeFrame: 0,6,12 and18 months
measure: Smoking rate
timeFrame: 0,6,12 and18 months
measure: Change from baseline weight at 6 months, change from baseline weight at 12 months and change from baseline weight at 18 months.
timeFrame: 0,6,12 and18 months
measure: Change in the quality of life related to health (HRQoL) from the baseline determination at 6 months, change in the HRQoL from the baseline determination at 12 months and change in the HRQoL from the baseline determination at 18 months.
timeFrame: 0,6,12 and18 months
measure: Change from the basal level of physical activity to 6 months, change from the basal level of physical activity to 12 months and change from the basal level of physical activity to 18 months.
timeFrame: 0,6,12 and18 months
measure: Change from the baseline level of adherence to the diet at 6 months, change from the baseline level of adherence to the diet at 12 months and change from the baseline level of adherence to the diet at 18 months.
timeFrame: 0,6,12 and18 months
Other outcomes:
measure: Change from the initial assessment of barriers to self-care at 6 months, change from the initial assessment of barriers to self-care at 12 months and change from the initial assessment of barriers to self-care at 18 months
timeFrame: 0,6,12 and18 months
measure: Participation in the program
timeFrame: 18 months
Locations:
city: Málaga
country: Spain
facility: Public Health Service of Andalucía
Study officials:
affiliation: Public Health Service of Andalucía
name: Jorge Caro Bautista
role: PRINCIPAL_INVESTIGATOR
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