Effectiveness of a Diabetes Education Program Based on Tailored Interventions in the Andalusian Public Health and Social System (Edep-Ti Study).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Malaga
- Enrollment
- 410
- Locations
- 1
- Primary Endpoint
- Change from basal glycosylated hemoglobin (HbA1c) at 6 months, change from basal HbA1c at 12 months and change from basal HbA1c at 18 months
Study Overview
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: 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
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.
Intervention: Therapeutic Education Program (Behavioral)
Outcomes
Primary Outcomes
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
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).
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.
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).
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).
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.
Secondary Outcomes
- 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 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)
- Development in smoking habits(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.(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)
Investigators
JOSE MIGUEL MORALES ASENCIO
Professor
University of Malaga