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

NCT03453970 | Completed

• 1 other identifier: AP-0005-2015 / PI14-01127
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

Brief Summary

GOALS: PRIMARY:

1. 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).
2. 2.Evaluate the effectiveness of the program on smoking habits and body mass index (weight, height).
3. 3.Analyze the impact of the program on the quality of life related to health.
4. 4.Check the effect on lifestyles: compliance levels of physical exercise and adherence to diet mediterranean.

Conditions

Diabetes Mellitus, Type 2

Keywords

patient education; self-care; Controlled Trial

Outcome Measures

Primary Outcomes (6)

• Change from basal glycosylated hemoglobin (HbA1c) at 6 months, change from basal HbA1c at 12 months and change from basal HbA1c at 18 months

  Determination of HbA1c measured as a percentage

  0,6,12 and18 months

• 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.

  Determination of total cholesterol (TC) values measured in milligrams per deciliter (mg/dl).

  0,6,12 and18 months

• 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.

  Determination of LDLc measured in milligrams per deciliter (mg/dl).

  0,6,12 and18 months

• 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.

  Determination of TG measured in milligrams per deciliter (mg/dl).

  0,6,12 and18 months

• 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.

  Determination of systolic blood pressure measured in millimeters of mercury (mm / Hg), average of 2 determinations.

  0,6,12 and18 months

• 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.

  Determination of diastolic blood pressure measured in millimeters of mercury (mm / Hg), average of 2 determinations.

  0,6,12 and18 months

Secondary Outcomes (6)

• Development in smoking habits

  0,6,12 and18 months

• Smoking rate

  0,6,12 and18 months

• Change from baseline weight at 6 months, change from baseline weight at 12 months and change from baseline weight at 18 months.

  0,6,12 and18 months

• 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.

  0,6,12 and18 months

• 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.

  0,6,12 and18 months

Other Outcomes (2)

• 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

  0,6,12 and18 months

• Participation in the program

  18 months

Study Arms (2)

Therapeutic Education Program

EXPERIMENTAL

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.

Behavioral: Therapeutic Education Program

Usual Care

NO INTERVENTION

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

Interventions

Therapeutic Education Program BEHAVIORAL

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.

Therapeutic Education Program

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Public Health Service of Andalucía

Málaga, Spain

Location

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jorge Caro Bautista, PhD

  University of Malaga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: March 5, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)