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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836808
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: CAIPaDi Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Validation of an Integrated Attention Model for Patients With Type 2 Diabetes
Actual Study Start Date : October 31, 2013
Actual Primary Completion Date : February 9, 2018
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Patients attended with the standard model of care for diabetes, as out-patients in the Internal Medicine area
Experimental: CAIPaDi
Patients attended in the Center of Comprehensive Care for the Patient with Diabetes, where they receive attention from 9 specialists in 1 day
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 Outcome Measures :
  1. Diabetes control after 4 visits in a structured multidisciplinary program for patients with diabetes [ Time Frame: 3 months ]
    HbA1c is measured in percentage (%). HbA1c will be compared from the first visit with the fourth visit.


Secondary Outcome Measures :
  1. Diabetes control after 1 year in a structured multidisciplinary program for patients with diabetes [ Time Frame: 1 year ]
    HbA1c is measured in percentage (%). HbA1c will be compared from the fourth visit with the visit 1 year apart.

  2. Metabolic parameters are lipid profile after 1 year in a structured multidisciplinary program for patients with diabetes [ Time Frame: 1 year ]
    Metabolic parameters are lipid profile (cholesterol, HDL cholesterol LDL cholesterol and triglycerides) in mg/dl. All of them will be compared from the fourth visit with the visit 1 year apart.

  3. Renal function after 1 year in a structured multidisciplinary program for patients with diabetes [ Time Frame: 1 year ]
    Renal function in mg/g (albumin/creatinine ratio). Renal function will be compared from the fourth visit with the visit 1 year apart.

  4. Self-care by SDSCA questionnaire after 1 year in a structured multidisciplinary program for patients with diabetes [ Time Frame: 1 year ]
    Self-care evaluation will be determined by SDSCA questionnaire and an objective examination of the patient doing the activities. This will be compared from the fourth visit with the visit 1 year apart.

  5. Diabetic complications are eye, renal and foot evaluations after 1 year in a structured multidisciplinary program for patients with diabetes [ Time Frame: 1 year ]
    Diabetic complications are eye, renal and foot evaluations. All of them will be compared from the fourth visit with the visit 1 year apart.

  6. Quality of life after 1 year in a structured multidisciplinary program for patients with diabetes [ Time Frame: 1 year ]
    Quality of life will be assessed with the DQoL (Diabetes Quality of Life) questionnaire. This will be compared from the fourth visit with the visit 1 year apart.

  7. Diabetes control after 2 years in a structured multidisciplinary program for patients with diabetes [ Time Frame: 2 years ]
    HbA1c is measured in percentage (%). HbA1c to be compared will be from fourth visit, 1 and 2 years apart.

  8. Metabolic parameters are lipid profile after 2 years in a structured multidisciplinary program for patients with diabetes [ Time Frame: 2 years ]
    Metabolic parameters are lipid profile (cholesterol, HDL cholesterol LDL cholesterol and triglycerides) in mg/dl. The parameters to be compared will be from fourth visit, 1 and 2 years apart.

  9. Renal function after 2 years in a structured multidisciplinary program for patients with diabetes [ Time Frame: 2 years ]
    Renal function in mg/g (albumin/creatinine ratio). The parameters to be compared will be from fourth visit, 1 and 2 years apart.

  10. Self-care by SDSCA questionnaire after 2 years in a structured multidisciplinary program for patients with diabetes [ Time Frame: 2 years ]
    Self-care evaluation will be determined by SDSCA questionnaire and an objective examination of the patient doing the activities. The parameters to be compared will be from fourth visit, 1 and 2 years apart.

  11. Diabetic complications are eye, renal and foot after 2 years in a structured multidisciplinary program for patients with diabetes [ Time Frame: 2 years ]
    Diabetic complications are eye, renal and foot evaluations. All of them will be compared from the fourth visit with the visit 1 year apart. The parameters to be compared will be from fourth visit, 1 and 2 years apart.

  12. Quality of life after 2 years in a structured multidisciplinary program for patients with diabetes [ Time Frame: 2 years ]
    Quality of life will be assessed with the DQoL (Diabetes Quality of Life) questionnaire. The parameters to be compared will be from fourth visit, 1 and 2 years apart.

  13. Metabolic parameters are lipid profile after 4 visits in a structured multidisciplinary program for patients with diabetes [ Time Frame: 3 months ]
    Metabolic parameters are lipid profile (cholesterol, HDL cholesterol LDL cholesterol and triglycerides) in mg/dl. All of them will be compared from the first visit with the fourth visit.

  14. Renal function after 4 visits in a structured multidisciplinary program for patients with diabetes [ Time Frame: 3 months ]
    Renal function in mg/g (albumin/creatinine ratio). Renal function will be compared from the first visit with the fourth visit.

  15. Self-care by SDSCA questionnaire after 4 visits in a structured multidisciplinary program for patients with diabetes [ Time Frame: 3 months ]
    Self-care evaluation will be determined by SDSCA questionnaire and an objective.

  16. Diabetic complications are eye, renal and foot evaluations after 4 visits in a structured multidisciplinary program for patients with diabetes [ Time Frame: 3 months ]
    Diabetic complications are eye, renal and foot evaluations. All of them will be compared from the first visit with the fourth visit.

  17. Quality of life after 4 visits in a structured multidisciplinary program for patients with diabetes [ Time Frame: 3 months ]
    Quality of life will be assessed with the DQoL (Diabetes Quality of Life) questionnaire. This will be compared from the first visit with the fourth visit.


Other Outcome Measures:
  1. Glucose control of the cases attended at the Center compared with those of patients with similar characteristics attended in the "Internal Medicine" service of the INCMNSZ. [ Time Frame: 2 years ]
    HbA1c is measured in percentage (%). Comparison will be with patients from the Internal Medicine ward, who meet the same clinical characteristics as the patients from the Center.

  2. Lipid parameters of the cases attended at the Center compared with those of patients with similar characteristics attended in the "Internal Medicine" service of the INCMNSZ. [ Time Frame: 2 years ]
    Metabolic parameters are lipid profile (cholesterol, HDL cholesterol LDL cholesterol and triglycerides) in mg/dl. Comparison will be with patients from the Internal Medicine ward, who meet the same clinical characteristics as the patients from the Center.

  3. Renal function evaluation of the cases attended at the Center compared with those of patients with similar characteristics attended in the "Internal Medicine" service of the INCMNSZ. [ Time Frame: 2 years ]
    Renal function in mg/g (albumin/creatinine ratio). Comparison will be with patients from the Internal Medicine ward, who meet the same clinical characteristics as the patients from the Center.

  4. Self-care evaluation of the cases attended at the Center compared with those of patients with similar characteristics attended in the "Internal Medicine" service of the INCMNSZ. [ Time Frame: 2 years ]
    Self-care evaluation will be determined by SDSCA questionnaire and an objective examination of the patient doing the activities. Comparison will be with patients from the Internal Medicine ward, who meet the same clinical characteristics as the patients from the Center.

  5. Evaluation of complications of the cases attended at the Center compared with those of patients with similar characteristics attended in the "Internal Medicine" service of the INCMNSZ. [ Time Frame: 2 years ]
    Diabetic complications are eye, renal and foot evaluations. Comparison will be with patients from the Internal Medicine ward, who meet the same clinical characteristics as the patients from the Center.

  6. Quality of life of the cases attended at the Center compared with those of patients with similar characteristics attended in the "Internal Medicine" service of the INCMNSZ. [ Time Frame: 2 years ]
    Quality of life will be assessed with the DQoL (Diabetes Quality of Life) questionnaire. Comparison will be with patients from the Internal Medicine ward, who meet the same clinical characteristics as the patients from the Center.

  7. Social-economic impact of expenses on food of a multidisciplinary intervention for patients with diabetes [ Time Frame: 2 years ]
    Patients will be asked about expenses on food. It will be included an evaluation of visits to emergency service related to diabetes complications and costs generated from this visit.

  8. Social-economic impact of exercising facilities and usage of a multidisciplinary intervention for patients with diabetes [ Time Frame: 2 years ]
    Patients will be asked about the expense for the use of facilities for exercise at the beginning and at the fourth visit.

  9. Social-economic impact of drug treatment of a multidisciplinary intervention for patients with diabetes [ Time Frame: 2 years ]
    Patients will be asked about the expense drug treatment at the beginning and at the fourth visit. It will be included an evaluation of visits to emergency service related to diabetes complications and costs generated from this visit.

  10. Social-economic impact of transportation of a multidisciplinary intervention for patients with diabetes [ Time Frame: 2 years ]
    Patients will be asked about the expense transportation at the beginning and at the fourth visit. It will be included an evaluation of visits to emergency service related to diabetes complications and costs generated from this visit.

  11. Social-economic impact of living and eating expenses of a multidisciplinary intervention for patients with diabetes [ Time Frame: 2 years ]
    Patients will be asked about the expense living and eating at the beginning and at the fourth visit. It will be included an evaluation of visits to emergency service related to diabetes complications and costs generated from this visit.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836808


Contacts
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Contact: Sergio Hernández, MD 57870900 ext 5045 sergiohdzj@hotmail.com
Contact: Carlos A Aguilar-Salinas, MD 57870900 ext 2405 caguilarsalinas@yahoo.com

Locations
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Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Recruiting
Mexico City, DF, Mexico, 14000
Contact: Carlos A Aguilar-Salinas, MD    52-55-56554523    caguilarsalinas@yahoo.com   
Principal Investigator: Sergio Hernández, MD         
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
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Principal Investigator: Sergio C Hernández, MD National Institute of Medical Sciences and Nutrition Salvador Zubirán
Publications:
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Responsible Party: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT02836808    
Other Study ID Numbers: dia-1190
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Journal publication. The information to be shared will be metabolic parameters and questionaire results. The data will be available on 2016. Metabolic parameters will be obtained from blood samples and the questionnaires results from those self-applied or applied during praxis.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: January 2018. The data will be available for 5 years
Access Criteria: Undefined
Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Multidisciplinary interventions
Long term control
Empowerment
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases