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

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ClinicalTrials.gov Identifier: NCT02836808

Recruitment Status : Recruiting

First Posted : July 19, 2016

Last Update Posted : March 6, 2018

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Sponsor:

Information provided by (Responsible Party):

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Description

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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Detailed Description:

Background: There are major deficiencies in the attention quality provided to people with diabetes in Mexico. The percentage of compliance of therapeutic objectives is noticeably lower than the one informed in developed countries. It is required to have structured management strategies, adapted to traits of our population, which allow improving attention quality in the medium term. The National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ) developed an integrated management program by using the best evidence available. The target population is people with type 2 diabetes, with less than 5 years with the diagnosis, and is free from chronic complications. Selection criteria allow the intervention benefit to diminish incidence of chronic complications.
Hypothesis: "The management strategy applied at the Center of Comprehensive Care for the Patient with Diabetes (CAIPaDi) allows achieving the international treatment standards (proposed by NCQA) in a two-year period".
General and Specific objectives:

General objective: To quantify the results one year after starting the integrated management program oriented to self-care activities applied at CAIPaDi.

Specific objectives:
- To measure the program impact (after 4 months, one and two years) based on the following variables: self-care (measured with standardized questionnaires), efficacy parameters (HbA1c, fasting glycemia, blood lipids, arterial pressure and use of anti-platelet aggregates), execution parameters (compliance of evaluations and preventive measures such as the search for microalbuminuria, ophthalmologic check, influenza vaccination, among others), incidence of micro- and macrovascular complications of diabetes, hospitalizations, use of emergency service or unforeseen expenses related to diabetes.
- To compare the efficacy and execution parameters of the cases attended at the center, with patients with similar characteristics attended at the "Internal Medicine" service of the INCMNSZ.
- To carry out a study of the social-economic impact of the intervention.
Goals: It is intended to validate an intervention that provides integrated attention to people with diabetes, in order to generate in the patient and his/her family, the competencies required for self-care in the long term and the prevention of chronic characteristics. Intervention is low-cost. This characteristic, along with the intervention systematization will allow the model to be exportable to the first-contact units.
Scientific Methodology: CAIPaDi has the mission of improving quality of life of patients with diabetes by means of an intervention adapted to the needs of patients, applying step-by-step action programs".

Intervention consists of four monthly visits, each one being 6 hours long. The visits have individual and group sessions. The nine specialists in the multidisciplinary team are endocrinologists, diabetes educator, nutritionists, psychologist, dentists, psychiatrist, specialist in physical activity, ophthalmologist and foot care. Some of the functions may be fulfilled by the same health professional, previously trained.

At each session, standardized actions are applied, which are assessed with preset indicators. At the initial and at yearly visits the following laboratory tests are taken: glycated hemoglobin, blood chemistry, lipid profile, liver function tests, albumin-creatinine index in an isolated urine sample, and 12-deviation electrocardiogram. At the yearly visits the patients receive reinforcement and treatment modifications as needed.

Contact is kept with patients via phone calls, e-mails and messages on the mobile phone. Patients are asked to send their assessments on preset dates. Materials and tools are developed, which allow measuring information from the study in real time, empowerment of patients and decision-making by the multi-disciplinary team, based on clinical practice guidelines.

There will be information from 1200 patients with 2-year follow-up. Besides having information from 1200 additional cases with follow-up at one year, and other 1200 others with assessments at 6 months. Therefore, the population for assessing execution variables shall be of 3600 participants. Such sample size allows us to detect differences higher than 5% in the percentage of cases that comply with the therapeutic objectives by comparing them with the initial assessment. As a secondary analysis, results will be compared with the population that receives attention the "Internal Medicine" service in the INCMNSZ (n=300 subjects).

Patients will be referred from clinics or first contact physicians outside the Institute.
Expected impacts at medium and long term: This proposal allows validating the intervention designed and applied at CAIPaDi. In case of demonstrating its usefulness and cost-effectiveness, intervention will be exported to first-contact units. Manuals and tools have been developed which will allow the implementation of the program with minimum resources. Such action will allow creating a network of health units that operate with the same quality standards as INCMNSZ.
Infrastructure available at the participating institutions: The INCMNSZ has an area where the center operates.
Deliverable results: Procedure manuals for each of the actions included in the intervention, tools for decision making based on clinical practice guidelines which will be patented, educational materials designed for empowering patients (patentable products), an internet portal, an electronic file, a database, articles in high impact magazines, diploma courses for generating specific competencies related to diabetes treatment and to the center management.

Study Design

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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

MedlinePlus Genetics related topics: Type 2 diabetes

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 :

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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:

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Eligibility Criteria

Information from the National Library of Medicine

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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.

Contacts and Locations

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

More Information

Publications:

Villalpando S, Shamah-Levy T, Rojas R, Aguilar-Salinas CA. Trends for type 2 diabetes and other cardiovascular risk factors in Mexico from 1993-2006. Salud Publica Mex. 2010;52 Suppl 1:S72-9. doi: 10.1590/s0036-36342010000700011.

Aguilar Salinas CA, Gómez Diaz RA, Gomez Perez FJ. Diabetes en Mexico: Principales retos y posibles soluciones. Revista ALAD 2011: 19:146-161

Tricco AC, Ivers NM, Grimshaw JM, Moher D, Turner L, Galipeau J, Halperin I, Vachon B, Ramsay T, Manns B, Tonelli M, Shojania K. Effectiveness of quality improvement strategies on the management of diabetes: a systematic review and meta-analysis. Lancet. 2012 Jun 16;379(9833):2252-61. doi: 10.1016/S0140-6736(12)60480-2. Epub 2012 Jun 9.

Planas LG, Crosby KM, Farmer KC, Harrison DL. Evaluation of a diabetes management program using selected HEDIS measures. J Am Pharm Assoc (2003). 2012;52(6):e130-8. doi: 10.1331/JAPhA.2012.11148.

Hernandez-Jimenez S, Garcia-Ulloa C, Mehta R, Aguilar-Salinas CA, Kershenobich-Stalnikowitz D. Innovative models for the empowerment of patients with type 2 diabetes: the CAIPaDi program. Recent Pat Endocr Metab Immune Drug Discov. 2014;8(3):202-9. doi: 10.2174/1872214808999141110155515.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Garcia-Ulloa AC, Lechuga-Fonseca C, Del Razo-Olvera FM, Aguilar-Salinas CA, Galaviz KI, Narayan KMV, Hernandez-Jimenez S; Group of Study CAIPaDi. Clinician prescription of lipid-lowering drugs and achievement of treatment goals in patients with newly diagnosed type 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2021 Feb;9(1):e001891. doi: 10.1136/bmjdrc-2020-001891.

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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

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