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

NCT05719675 | Completed

• 3 other identifiers: 522006894CE/FESI/052022/15191012331
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Health Psychology; Behavioral Contingencial Analysis; Treatment Adherence; Glycemic Control; Health-Related Quality of Life

Outcome Measures

Primary Outcomes (3)

• Treatment adherence

  The Therapeutic Adherence scale for patients with chronic diseases based on explicit behaviors (Soria et al., 2009) will be used. The instrument has 21 items where the answers are presented on a scale of 0 to 100 points, considering that a person presents good adherence to treatment the closer to 100. Originally, the total scale was constructed and validated in the Mexican population, where it presented a Cronbach's Alpha of .919, and this reliability coefficient ranged between .883 and .902 for each of its items. Regarding the dimensions that make up the scale, the authors report three factors: Control over medication and food intake (α= .877), Behavioral medical follow-up (α= .798) and Self-efficacy (α= .850). The first refers to monitoring medication intake and adherence to diet; the second refers to long-term health care behaviors, such as attendance at follow-up visits; and the third factor measures the person's belief that what he does has a positive impact on his or her health.

  3 months

• Fasting glucose

  An Accu-Chek Active capillary glucose kit calibrated for plasma measurements and designed to be used on the outside of the body (finger, palm or forearm) will be used.

  3 months

• Health-related quality of life

  The validated version of the Diabetes-39 questionnaire (López-Carmona and Rodríguez-Moctezuma, 2006) will be used in Mexican patients. The questionnaire contains 39 items grouped into five sections: Energy and Mobility (α = .92), Diabetes Control (α = .83), Anxiety-Concern (α = .80), Social Burden (α = .83), and Sexual Functioning (α = .93). For its part, the total questionnaire had a high reliability (α = .95). Participants answer on a scale of 1 to 7 how much, in the last month, their quality of life has been affected based on the activities posed along each item, where a higher score reflects a greater affectation. In addition, it contains two final items where the patient's perception of his or her overall quality of life and the severity of diabetes is rated. The minimum values of the scale start with 0 points and reach a maximum of 100 points, where higher values indicate a greater affectation to the quality of life.

  3 months

Study Arms (1)

Intervention

EXPERIMENTAL

A healthcare model for people with Type 2 Diabetes Mellitus, based on Contingency Behavioral Analysis (CBA). The CCA model was constructed in a Mexican population by Ribes et al. (1986), and later operationalized in manuals by Rodriguez (2002). It has proven to be a suitable alternative for working with people with T2DM (Ocampo et al., 2017; Rodriguez et al., 2015; Rodriguez et al., 2016; Rivera et al., 2008; Rodriguez et al., 2013; Rosales et al., 2021). For this intervention, an application manual aimed at the intervention facilitator was developed and evaluated by a panel of experts in the field of nursing, endocrinology, diabetology and social work with experience in the care of people with T2DM. In general, they were asked to evaluate the congruence and adequacy of the activities proposed in the sessions to improve adherence to treatment in people with T2DM. Additionally, they evaluated whether the number of sessions was adequate for the objectives of the research project.

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

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.

Also known as: Contingency Behavioral Analysis

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead

Study Sites (1)

Facultad de Estudios Superiores Iztacala, Universidad Nacional Autónoma de México.

Estado de México, Mexico

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance; Glucose Metabolism Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Georgina E Bazán-Riverón

  Universidad Nacional Autonoma de Mexico

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The intervention will focus on three phases: (1) Dispositional alteration, where the aim will be to achieve an awareness of the disease by altering any of the factors that give rise to the performance of behaviors that interfere with adherence to treatment; (2) Alteration of one's own behavior, which would be focused on the development of healthy habits consistent with the indications of the health team for the proper management of the disease; and (3) Alteration of others' behaviors, focused on the development of skills in participants so they can alter the behaviors of significant others by means of health promotion strategies.

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 9, 2023
• Study Start: March 1, 2023
• Primary Completion: March 3, 2023
• Study Completion: May 17, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact j\ fmora@hotmail.com

Locations

ME (1)