← Back to all trials
Recruiting
NCT05719675
Healthcare Intervention Program on Treatment Adherence in People With Newly Diagnosed Type 2 Diabetes Mellitus.
Conditions: Treatment Adherence, Quality of Life, Glucose Metabolism Disorders (Including Diabetes Mellitus)
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 40
Sponsor: Universidad Nacional Autonoma de Mexico
Location: Mexico
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.
Eligibility Criteria
Inclusion Criteria:Over 18 years of age.Have less than 5 years with the diagnosis of Diabetes Mellitus Type 2.Ability to be present for 60-90 minutes in face-to-face sessions.Additionally, since it is common for people with T2DM to have several comorbidities, this study will include people who also have hypertension, overweight/obesity or dyslipidemia, since in the National Health Survey (INSP, 2021) these were considered to be the comorbidities with the greatest impact at the national level.Exclusion Criteria:Having any present complication derived from poor diabetes control such as neuropathy, retinopathy, nephropathy or lower limb amputations due to poor control of the disease.
This is due to the fact that the intervention is inserted within a secondary prevention scheme, where the aim is for people with T2DM to reduce the risk of developing complications (Seguí et al., 2011).Refusal by the participant to attend the intervention sessions.Having a psychological or psychiatric disorder diagnosed by a health professional that prevents active participation in the workshops.
Source: ClinicalTrials.gov (NCT05719675). StuddyBuddy aggregates publicly available trial information.