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NCT02836808Recruiting

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

Source: ClinicalTrials.gov · Last updated 6 Mar 2018 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1200 (estimated)
First submitted
8 Apr 2016
Start date
Oct 2013
Primary completion date
Feb 2018
Lead sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
NCT number
NCT02836808

What you commit to

  • Study type: Interventional
  • Planned participants: 1200
  • From Oct 2013 to the primary completion date, Feb 2018
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • smoking, alcoholism or illegal drug dependence

Other illness

  • 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
  • conditions that require surgical treatment in the short run or which prevent moderated activity.

Who the study is looking for

  • 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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Nacional de Ciencias Medicas y Nutricion
Coordinator of this site? Confirm its status
Mexico CityMexicoRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.