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

University of Malaga

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Therapeutic Education Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03453970

AP-0005-2015 / PI14-01127

Details and patient eligibility

About

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

Full 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.

Enrollment: 410 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Type II Diabetes Mellitus diagnosed <10 years and classified in a computerized clinical history with poor metabolic control (HbA1c> 7% or BMI > 27.5) and in treatment with oral antidiabetics.

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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410 participants in 2 patient groups

Therapeutic Education Program

Experimental group

Description:

The program is based on adapted interventions and will consist of the following phases: Phase I: Identification of self-care needs in Diabetes Mellitus through the EBADE questionnaire. This instrument will identify the needs grouped by constructs of the theory of planned behavior (behavioral beliefs, subjective norm, behaviors of perceived control and behavioral intention). Phase II: Application of interventions adapted according to the behavioral mediator who encounters barriers. The interventions will be applied both in the face-to-face and telephone modality, using the Nursing Intervention Classification and their respective activities. Phase III: measurement of the clinical variables and reported by the patients described in the objectives.

Treatment:

Behavioral: Therapeutic Education Program

Usual Care

No Intervention group

Description:

The conventional intervention consists of the usual care that is followed in the nursing consultations in primary care to patients with type 2 DM, based on the recommendations of the Clinical Practice Guide of the National Health System