NCT03453970

Effectiveness of a Diabetes Education Program Based on Tailored Interventions (Edep-Ti Study)

Effectiveness of a Diabetes Education Program Based on Tailored Interventions in the Andalusian Public Health and Social System (Edep-Ti Study).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: University of Malaga · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
BEHAVIORAL	Therapeutic Education Program	The total duration of the program will be 12 weeks with a maximum of 6 sessions of 30 minutes each. In the first session, through the EBADE questionnaire, the needs will be identified by grouping them by the 4 constructs of the theory of planned behavior (behavioral beliefs, subjective norm, behaviors of perceived control and behavioral intention). The interventions and the number of sessions will be adapted depending on the areas identified with barriers. These interventions will be applied in both face-to-face and telephone modalities, using the Nursing Intervention Classification and their respective activities. The interventions will be carried out by nurses who have previously received training on the proposed program. Follow-ups will be carried out every 15 days.

Timeline

• Start date: 2018-12-01
• Primary completion: 2021-12-01
• Completion: 2021-12-31
• First posted: 2018-03-05
• Last updated: 2025-07-29

Locations

1 site across 1 country: Spain