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Healthcare Intervention Program on Treatment Adherence in People With Newly Diagnosed Type 2 Diabetes Mellitus.

NCT05719675 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-11-29

No results posted yet for this study

Summary

Type 2 Diabetes Mellitus (T2DM) is a group of metabolic disorders characterized by hyperglycemia in the absence of treatment, positioned in the first places of prevalence and mortality in the Mexican population. Adherence to treatment is a central element to prevent complications of the disease, where the active participation of the patient in his or her treatment is fundamental. Despite institutional healthcare efforts to promote this element, there is no clarity in the Clinical Practice Guidelines aimed at the attention of people with T2DM on how to achieve it.

The aim of this project will be to evaluate the effect of an intervention based on Contingency Behavior Analysis on treatment adherence, quality of life and glycemic level in people with newly diagnosed T2DM.

Pre-experimental design with pretest and posttest measurements. The Dependent Variable will be an intervention based on Contingency Behavior Analysis.

The Independent Variables will be adherence to treatment, quality of life and glycemic level.

The power calculation suggests an n = 38, using sequential non-probability sampling.

People older than 18 years with less than 5 years of T2DM diagnosis will be included.

Pretest and posttest differences, effect size and correlations between measurement variables will be analyzed.

It is expected that the intervention based on Contingency Behavior Analysis will encourage the active participation of people with T2DM, improving their adherence to treatment, glycemic level and quality of life.

Considering that the Clinical Practice Guidelines emphasize the importance of therapeutic adherence through the active participation of the patient and his/her environment, it is expected that this project will provide the tools for behavioral change that so far are not included in public health in Mexico.

Conditions

  • Treatment Adherence
  • Quality of Life
  • Glucose Metabolism Disorders (Including Diabetes Mellitus)

Interventions

BEHAVIORAL

Intervention

The general outline of the intervention is divided into three phases: 1. Dispositional alteration, where the aim will be to obtain precise information on the barriers that patients encounter in carrying out their treatment and thus focus the issues to achieve an awareness of the disease by altering some of the factors that give rise to the realization of behaviors that interfere with treatment adherence. 2. Alteration of one's own behavior, focused on the development of healthy habits that are consistent with the indications of the health team for the proper management of the disease. 3. Alteration of the behavior of others, focused on the development of skills in the participants so that they are able to modify the behavior of other people close to them through health promotion strategies.

Sponsors & Collaborators

  • Universidad Nacional Autonoma de Mexico

    lead OTHER

Principal Investigators

  • Georgina E Bazán-Riverón · Universidad Nacional Autonoma de Mexico

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-03-03
Completion
2023-05-17

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05719675 on ClinicalTrials.gov