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

March 23, 2020 updated by: JOSE MIGUEL MORALES ASENCIO

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

436

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Málaga, Spain
        • Public Health Service of Andalucía

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic Education Program

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
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.
No Intervention: Usual Care
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from basal glycosylated hemoglobin (HbA1c) at 6 months, change from basal HbA1c at 12 months and change from basal HbA1c at 18 months
Time Frame: 0,6,12 and18 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.
Time Frame: 0,6,12 and18 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.
Time Frame: 0,6,12 and18 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.
Time Frame: 0,6,12 and18 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.
Time Frame: 0,6,12 and18 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.
Time Frame: 0,6,12 and18 months
Determination of diastolic blood pressure measured in millimeters of mercury (mm / Hg), average of 2 determinations.
0,6,12 and18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development in smoking habits
Time Frame: 0,6,12 and18 months
Number of cigarettes consumed per day on average (measured at 0,6,12 and 18 months)
0,6,12 and18 months
Smoking rate
Time Frame: 0,6,12 and18 months
Percentage of smokers of the total of the participants (measured at 0,6,12 and 18 months).
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.
Time Frame: 0,6,12 and18 months
Determination of the body mass index calculated as the weight measured in kilograms (kg) divided by the height measured in meters squared (weight / height2) (Kg /m2) (measured at 0,6,12 and 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.
Time Frame: 0,6,12 and18 months
The Diabetes Quality of Life Questionnaire EuroQol-5D (EQ-5D) in a Spanish version will be implemented at 0, 6, 12 and 18 months. With this questionnaire the individual himself assesses his health status, first in levels of severity (1-without problems, 2-some problems or moderate problems and 3-serious problems) by health dimensions (mobility, personal care, daily activities, pain/discomfort and anxiety / depression). The combination of the values of all dimensions generates 5-digit numbers, with 243 combinations of possible health states. A second part of the questionnaire includes a vertical analog visual scale ranging from 0 (worst imaginable health status) to 100 (best imaginable health status). In it, the individual must mark the point in the vertical line that best reflects his or her subjective assessment of their overall health status.
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.
Time Frame: 0,6,12 and18 months
The International Physical Activity Questionnaire (IPAQ short version) will be implemented at 0, 6, 12 and 18 months. The IPAQ questionnaire in its short version is self-administered and consists of 7 questions that provide information on the time spent doing physical activities of moderate and vigorous intensity, separating time spent walking and time spent in a more passive state. Individuals can be classified into: low level of activity, moderate level (there are 3 criteria to classify a person as active) and high level of activity (there are 2 criteria to classify a person as very active).
0,6,12 and18 months
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.
Time Frame: 0,6,12 and18 months
The Questionnaire of Adherence to the Mediterranean Diet will be implemented at 0, 6, 12 and 18 months. It is a self-administered questionnaire consisting of 14 segments dedicated to eating habits. To estimate the results, the value 1 is assigned to each segment with an affirmative response and 0 to each segment with a non compliant response. From the sum of the values obtained, the degree of adherence is determined, establishing two levels, so that if the total score is greater than or equal to 9 it is considered a diet with a good level of adherence and if the total sum is lower of 9 the diet is considered to be of a low adherence.
0,6,12 and18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 0,6,12 and18 months
The questionnaire of evaluation of self-care barriers in diabetes (EBADE questionnaire) will be implemented at 0, 6, 12 and 18 months. This questionnaire consists of 15 items and 4 structured dimensions according to the Theory of Planned Behavior (behavioral beliefs, subjective norm, behavior of perceived control and behavioral intention), with a minimum score of 15 and a maximum of 105, higher score means better level of self-care behavior. The segments include questions related to diet, physical activity, medication, foot care, control of complications and accessibility to the health system.
0,6,12 and18 months
Participation in the program
Time Frame: 18 months
Number of sessions attended
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JOSE MIGUEL MORALES ASENCIO

Investigators

  • Principal Investigator: Jorge Caro Bautista, Public Health Service of Andalucía

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 17, 2018

First Submitted That Met QC Criteria

February 26, 2018

First Posted (Actual)

March 5, 2018

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP-0005-2015 / PI14-01127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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