Recruiting

Validation of an Integrated Attention Model for Patients With Type 2 Diabetes

ClinicalTrials.gov IDNCT02836808

PhaseNA

Enrollment1200

SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Age18 Years

SexALL

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Conditions studied

Type 2 Diabetes

About this study

Abstract: Empowerment interventions for chronic diseases are an evolving process. No agreement exists regarding the necessary components and methodologies to be applied. Systematic reviews have assessed the effect of self-management interventions. Improvements in illness beliefs, adherence to drug therapy and glucose monitoring have been reported. In the long term, no major changes have been achieved in weight, physical activity, smoking status, and depression scores. There is a need for additional studies. The Center for Comprehensive Care of Patients with Diabetes (CAIPaDi) program is an intervention designed to provide education and empowerment techniques (using simple low-cost interactive tools) over a short period of time followed by at-distance support using internet or cell phone technology. The target population consists of patients with type 2 diabetes, free of chronic complications who are non-smokers. The intervention is composed of four monthly visits followed by a continuous at-distance support system. At each visit, patients stay for six hours in the center. Information is presented in group sessions. Empowerment techniques are applied during individual exchanges with the team or during facilitated group sessions. In summary, empowerment programs are an unmet need in many healthcare services.

Interventions

Behavioral: CAIPaDi — Patients are attended in 1 day by 9 specialists (endocrinologist, diabetes educators, nutritionist, psychologist, dentists, psychiatrist, physical activity specialist, foot care and ophthalmologist). They are attended in 4 monthly visits. After the initial phase, patients come back to the Center at 1 and 2 years for evaluation and reinforcement.

Primary outcomes

Diabetes control after 4 visits in a structured multidisciplinary program for patients with diabetes (3 months)

Eligibility information

Inclusion Criteria: * being over 18 and under 70 years old * having diagnosis of type 2 diabetes in the five previous years, * having family support * free of disabling diabetes complications Exclusion Criteria: * advanced complications of diabetes, such as ischemic heart disease, heart failure NYHA III-IV, KDOQI ≥3 renal failure, amputations, cerebral vascular disease, gastroparesis and muscular atrophy . * type 1 diabetes mellitus, gestational diabetes or some variant of diabetes related to genetic syndromes, hyperlabile diabetes * co-morbidities that limit their life expectancy such as malignant tumors * advanced cognitive impairment or serious psychiatric disorders * smoking, alcoholism or illegal drug dependence * conditions that require surgical treatment in the short run or which prevent moderated activity.

Study locations

Instituto Nacional de Ciencias Medicas y Nutricion, Mexico City, Mexico City 14000 Mexico

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.