Validation of an Integrated Attention Model for Patients With Type 2 Diabetes
CAIPADI
1 other identifier
interventional
1,200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Oct 2013
Longer than P75 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 31, 2013
CompletedFirst Submitted
Initial submission to the registry
April 8, 2016
CompletedFirst Posted
Study publicly available on registry
July 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
ExpectedMarch 6, 2018
July 1, 2016
4.3 years
April 8, 2016
March 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diabetes control after 4 visits in a structured multidisciplinary program for patients with diabetes
HbA1c is measured in percentage (%). HbA1c will be compared from the first visit with the fourth visit.
3 months
Secondary Outcomes (17)
Diabetes control after 1 year in a structured multidisciplinary program for patients with diabetes
1 year
Metabolic parameters are lipid profile after 1 year in a structured multidisciplinary program for patients with diabetes
1 year
Renal function after 1 year in a structured multidisciplinary program for patients with diabetes
1 year
Self-care by SDSCA questionnaire after 1 year in a structured multidisciplinary program for patients with diabetes
1 year
Diabetic complications are eye, renal and foot evaluations after 1 year in a structured multidisciplinary program for patients with diabetes
1 year
- +12 more secondary outcomes
Other Outcomes (11)
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.
2 years
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.
2 years
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.
2 years
- +8 more other outcomes
Study Arms (2)
Control
NO INTERVENTIONPatients attended with the standard model of care for diabetes, as out-patients in the Internal Medicine area
CAIPaDi
EXPERIMENTALPatients attended in the Center of Comprehensive Care for the Patient with Diabetes, where they receive attention from 9 specialists in 1 day
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Nacional de Ciencias Medicas y Nutricion
Mexico City, Mexico City, 14000, Mexico
Related Publications (8)
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.
PMID: 20585732BACKGROUNDAguilar Salinas CA, Gómez Diaz RA, Gomez Perez FJ. Diabetes en Mexico: Principales retos y posibles soluciones. Revista ALAD 2011: 19:146-161
BACKGROUNDTricco 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.
PMID: 22683130BACKGROUNDPlanas 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.
PMID: 23224336BACKGROUNDHernandez-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.
PMID: 25381833BACKGROUNDLanda-Anell MV, Del Razo-Olvera FM, Bodnar I, Cordova-Isidro B, Lagunas-Valdepena D, Arias-Marroquin AT, Garcia-Ulloa AC, Melgarejo-Hernandez MA, Hernandez-Jimenez S; Group of Study CAIPaDi. Nutritional diagnoses in people with type 2 diabetes: association with metabolic, anthropometric, and dietary parameters. Front Nutr. 2024 Oct 18;11:1473429. doi: 10.3389/fnut.2024.1473429. eCollection 2024.
PMID: 39494309DERIVEDGarcia-Ulloa AC, Almeda-Valdes P, Cuatecontzi-Xochitiotzi TE, Ramirez-Garcia JA, Diaz-Pineda M, Garnica-Carrillo F, Gonzalez-Duarte A, Narayan KMV, Aguilar-Salinas CA, Hernandez-Jimenez S; CAIPaDi Study Group. Detection of sudomotor alterations evaluated by Sudoscan in patients with recently diagnosed type 2 diabetes. BMJ Open Diabetes Res Care. 2022 Dec;10(6):e003005. doi: 10.1136/bmjdrc-2022-003005.
PMID: 36521878DERIVEDGarcia-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.
PMID: 33568360DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sergio C Hernández, MD
National Institute of Medical Sciences and Nutrition Salvador Zubirán
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2016
First Posted
July 19, 2016
Study Start
October 31, 2013
Primary Completion
February 9, 2018
Study Completion (Estimated)
December 31, 2028
Last Updated
March 6, 2018
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
- Time Frame
- January 2018. The data will be available for 5 years
- Access Criteria
- Undefined
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.