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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Therapeutic Education Program

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring patient education, self-care, Controlled Trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Public Health Service of Andalucía

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Therapeutic Education Program

Usual Care

Arm 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.

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

Outcomes

Primary Outcome Measures

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

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).

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).

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).

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.

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.

Secondary Outcome Measures

Development in smoking habits

Number of cigarettes consumed per day on average (measured at 0,6,12 and 18 months)

Smoking rate

Percentage of smokers of the total of the participants (measured at 0,6,12 and 18 months).

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

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.

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.

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.

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).

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.

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.

Full Information

NCT ID

NCT03453970

First Posted

January 17, 2018

Last Updated

March 23, 2020

Sponsor

JOSE MIGUEL MORALES ASENCIO

1. Study Identification

Unique Protocol Identification Number

NCT03453970

Brief Title

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

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2018 (Actual)

Primary Completion Date

September 1, 2020 (Anticipated)

Study Completion Date

December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

JOSE MIGUEL MORALES ASENCIO

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

GOALS: PRIMARY: 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: Evaluate the effectiveness of the program on smoking habits and body mass index (weight, height). Analyze the impact of the program on the quality of life related to health. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

patient education, self-care, Controlled Trial

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

436 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Therapeutic Education Program

Arm Type

Experimental

Arm Description

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Therapeutic Education Program

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Determination of HbA1c measured as a percentage

Time Frame

0,6,12 and18 months

Title

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.

Description

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

Time Frame

0,6,12 and18 months

Title

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.

Description

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

Time Frame

0,6,12 and18 months

Title

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.

Description

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

Time Frame

0,6,12 and18 months

Title

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.

Description

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

Time Frame

0,6,12 and18 months

Title

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.

Description

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

Time Frame

0,6,12 and18 months

Secondary Outcome Measure Information:

Title

Development in smoking habits

Description

Number of cigarettes consumed per day on average (measured at 0,6,12 and 18 months)

Time Frame

0,6,12 and18 months

Title

Smoking rate

Description

Percentage of smokers of the total of the participants (measured at 0,6,12 and 18 months).

Time Frame

0,6,12 and18 months

Title

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

Description

Time Frame

0,6,12 and18 months

Title

Description

Time Frame

0,6,12 and18 months

Title

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.

Description

Time Frame

0,6,12 and18 months

Title

Description

Time Frame

0,6,12 and18 months

Other Pre-specified Outcome Measures:

Title

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

Description

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.

Time Frame

0,6,12 and18 months

Title

Participation in the program

Description

Number of sessions attended

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jorge Caro Bautista

Organizational Affiliation

Public Health Service of Andalucía

Official's Role

Principal Investigator

Facility Information:

Facility Name

Public Health Service of Andalucía

City

Málaga

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

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

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