Multicomponent Integrated Intervention on Metabolic Control and Quality of Life in Type 2 Diabetes: DIABEMPIC Program (DIABEMPIC)

Effect of Multicomponent Integrated Care Intervention on the Metabolic Control and Quality of Life in Patients With Type 2 Diabetes: the Mexico City DIAbetes EMPowerment and Improvement of Care Program

Type 2 diabetes is one of the leading causes of morbidity and mortality rate in Mexico. Although important advances in treatment strategies have been developed in type 2 diabetes mellitus, large gaps exist in achieving quality of care. Few studies have determined the effect of multicomponent interventions in low and middle income countries. The DIABEMPIC program is a quality of care initiative developed by primary care public health services of the Mexico City Government to propitiate diabetes empowerment in people living with type 2 diabetes through an intervention comprised by an interdisciplinary team care, shared medical appointment scheme, patient-centered care approach, structured diabetes education program, promotion of self-management, audit, and guaranteed supply of anti-diabetic medication. The DIABEMPIC program target population consists of patients with type 2 diabetes, without advanced chronic complications, who have regular care in the public primary care services in Mexico city.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: DIABEMPIC

Detailed Description

Background: Diabetes mellitus is a chronic metabolic disease with disabling, deadly, and costly consequences for individuals, families, and national health care systems. Proper diabetes management in people living with type 2 diabetes mellitus focuses on reducing the risks for macrovascular and microvascular complications through controlling blood pressure, lipid levels, and blood glucose levels, and avoiding tobacco. Although important advances in pharmacological and non-pharmacological strategies have been developed, large gaps exist in achieving care goals, particularly in real-world practice and low- and middle- income countries. Barriers to care in T2DM patients may include lack of medical care, poverty, long distances or lack of time to get medical attention, lack of confidence, and inadequate social support, among others. Achievement of diabetes care goals: normal glycated hemoglobin, blood pressure, and LDL cholesterol is associated with better health outcomes, including lower risks of complicating events and death. The DIABEMPIC program is a quality of care initiative developed by primary care public health services of the Mexico City Government to propitiate diabetes empowerment in people living with type 2 diabetes through a 6-months intervention comprised by an interdisciplinary team care, shared medical appointment scheme, patient-centered care approach, structured diabetes education program, promotion of self-management, audit, , and guaranteed supply of anti-diabetic medication. The DIABEMPIC program target population consists of patients with type 2 diabetes, without advanced chronic complications, who have regular care in the public primary care services in Mexico city.

Hypothesis: Participation in the Diabetes Empowerment and Improvement of Care strategy allows reaching diabetes care goals.

General objective: To quantify diabetes care goals achievement at the end of the intervention and one year after finishing the comprehensive care program designed to propitiate diabetes empowerment at Clínica Especializada en el Manejo de la Diabetes of the Mexico City Government.

Specific objectives: To measure the program impact through the following variables: glycated hemoglobin, blood lipids, arterial pressure, self-care activities, diabetes knowledge, health related quality of life, incidence of complications and use of hospital services.

Goals: To improve diabetes care through this multicomponent intervention in order to prevent complications and and enhance quality of life in people with diabetes, but also to expand the care model to primary care health units in Mexico City.

Methodology: The DIABEMPIC program is a quality of care initiative developed by primary care public health services of the Mexico City Government to propitiate diabetes empowerment in people living with type 2 diabetes through an intervention comprised by an interdisciplinary team care, shared medical appointment scheme, patient-centered care approach, structured diabetes education program, promotion of self-management, audit, and guaranteed supply of anti-diabetic medication. Intervention consists of visits at Clínica Especializada en el Manejo de la Diabetes to attend individual and group sessions in a shared medical appointment model by an interdisciplinary case management team. The program last five months and visits occur every 2 weeks according to the needs assessed by the interdisciplinary team. Interdisciplinary team include: endocrinology, diabetes educator, nutritionist, podiatrist, ophthalmologist, psychologist, social worker and dentist. At each visit standardized interventions based in clinical practice guidelines are executed. At the initial, last visit and yearly visit preset indicators are evaluated, including: weight, blood pressure, glycated hemoglobin, lipid profile, creatinine, albumin/creatinin index in urine sample and validated questionaires related to diabetes self-care (Summary of Diabetes Self-care Activities) and Health related quality of life (EuroQOL-5Q-5L). The effect of the intervention will be determined on the improvement on metabolic parameters, as well as in self care activities and quality of life using a "before and after design". As a secondary analysis, results will be compared with the population in the wait-list receiving routine care in primary care units.

Expected results: In case of demonstrating its effectiveness, DIABEMPIC program is considered to be expanded in order to allow more people living with diabetes to receive the benefits of a Multicomponent intervention in Mexico City.

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Iztapalapa
    • Mexico City, Iztapalapa, Mexico, 09060
      • Recruiting
      • Clínica Especializada en el Manejo de la Diabetes de la Ciudad de México from the Ministry of Health of the Mexico City Government
      • Contact: Ruben Silva-Tinoco, MD; Phone Number: 6690 50381700; Email: ruben_ost@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men or Women
• Older than 18 years old, younger than 70 years old
• Having diagnosis of type 2 diabetes
• Acceptance for participation in the program by signing informed consent sheet

Exclusion Criteria:

• Any other type of diabetes, such as Type 1 diabetes, LADA type Diabetes, gestational diabetes, or any other type of diabetes related to genetic syndromes
• advanced diabetes complications such as ischemic heart disease, NYHA III-IV heart failure, KDOQI renal failure ≥4, cerebral vascular disease with functional sequelae
• those who have comorbidities that limit their life expectancy such as malignant tumors in advanced stages
• Dependence of illicit drugs
• Conditions that require short-term surgical treatment.
• Advanced cognitive deficit or serious psychiatric disorders that hinder treatment adherence.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients in the wait-list being attended with the standard model of care for diabetes in primary care units.
Experimental: DIABEMPIC program; Intervention comprised by an interdisciplinary team care, patient-centered care approach, structured diabetes education program, promotion of self-management, audit, and guaranteed supply of anti-diabetic medication.	Behavioral: DIABEMPIC; Patients are attended by 9 diabetes health-care professionals every 2 weeks for 5 months in a shared medical appointment scheme, including individual and group sessions. Patients will be evaluated at the end of the program and 1 year after.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control after the program	HbA1c (%): HbA1c will be compared from the first visit with the last visit (5 months later)	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control after 1 year	HbA1c (%): HbA1c will be compared from the the last visit with the visit 1 year apart	1 year
Lipid control	Total Cholesterol, HDL-Cholesterol and Non-HDL Cholesterol in mg/dL will be compared from the first visit with the last visit (5 months later).	5 months
Weight change	Weight Change (Kg) will be compared from the first visit with the last visit (5 months later).	5 months
Blood pressure	Systolic and diastolic blood pressure (mmHg) will be compared from the first visit with the last visit (5 months later).	5 months
Blood pressure	Systolic and diastolic blood pressure (mmHg) will be compared from the last visit with the visit 1 year apart.	1 year
Lipid control	Total Cholesterol, HDL-Cholesterol and Non-HDL Cholesterol in mg/dL will be compared from the last visit with the visit 1 year apart.	1 year
Weight change	Weight Change in kilograms will be compared from the last visit with the visit 1 year apart.	1 year
Summary of Self-care Activities (0-7, higher score means better self-care)	Summary of Self-care Activities Questionnaire (nutrition, exercise, glucose test, foot care) in days a week (0-7, higuer score means better self-care). Self-care will be compared from the first visit with the last visit (5 months later).	5 months
Summary of Self-care Activities (0-7, higher score means better self-care)	Summary of Self-care Activities Questionnaire (nutrition, exercise, glucose test, foot care) in days a week (0-7, higuer score means better self-care). Self-care will be compared from the last visit with the visit one year apart	1 year
Health-related Quality of Life perception assessed by EQ-5D Visual Analogue Scale questionnaire (0-100, higuer score means better Quality of life perception)	Health-related Quality of life perception with EQ-5D questionnaire visual analogue scale (0-100, higher score means better self-care). Health-related Quality of Life will be compared from the first visit with the last visit (5 months later).	5 months
Health-related Quality of Life perception assessed by EQ-5D Visual Analogue Scale questionnaire (0-100, higher score means better Quality of life perception)	Health-related Quality of life perception with EQ-5D questionnaire visual analogue scale (0-100, higuer score means better quality of life). Health-related Quality of Life will be compared from the last visit with the visit one year apart.	1 year
Health-related Quality of Life perception assessed by EQ-5D Indexed score (0-1, higher score means better Quality of life perception)	Health-related Quality of life perception with EQ-5D questionnaire indexed score (0-100, higuer score means better quality of life). Health-related Quality of Life will be compared from the first visit with the last visit (5 months later)	5 months
Health-related Quality of Life perception assessed by EQ-5D Indexed score (0-1, higher score means better Quality of life perception)	Health-related Quality of life perception with EQ-5D questionnaire indexed score (0-100, higuer score means better quality of life). Health-related Quality of Life will be compared from the last visit with visit one year apart	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control of the patients who attended the program compared with patients attended in primary care units (wait-list)	HbA1c (%). Comparison will be the mean deviation change of patients attending the program and patients with routine care in 5 months follow-up.	5 months
Lipid control of the patients who attended the program compared with patients attended in primary care units (wait-list)	Total Cholesterol, HDL-Cholesterol and Non-HDL Cholesterol in mg/dL . Comparison will be the mean deviation change of patients attending the program and patients with routine care in 5 months follow-up.	5 months
Weight change of the patients who attended the program compared with patients attended in primary care units (wait-list)	Weight change in kilograms. Comparison will be the mean deviation change of patients attending the program and patients with routine care in 5 months follow-up.	5 months
Blood pressure of the patients who attended the program compared with patients attended in primary care units (wait-list)	Systolic and diastolic blood pressure change in mmHg. Comparison will be the mean deviation changes of patients attending the program and patients with routine care in 5 months follow-up.	5 months

Collaborators and Investigators

• Sponsor: Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico
• Investigators: Principal Investigator: Rubén Silva-Tinoco, Clínica Especializada en Manejo de la Diabetes Gobierno de Ciudad de México

Publications and helpful links

General Publications

• Aschner P, Gagliardino JJ, Ilkova H, Lavalle F, Ramachandran A, Mbanya JC, Shestakova M, Chantelot JM, Chan JCN. Persistent poor glycaemic control in individuals with type 2 diabetes in developing countries: 12 years of real-world evidence of the International Diabetes Management Practices Study (IDMPS). Diabetologia. 2020 Apr;63(4):711-721. doi: 10.1007/s00125-019-05078-3. Epub 2020 Jan 4. Erratum In: Diabetologia. 2020 May;63(5):1088-1089.
• Lim LL, Lau ESH, Kong APS, Davies MJ, Levitt NS, Eliasson B, Aguilar-Salinas CA, Ning G, Seino Y, So WY, McGill M, Ogle GD, Orchard TJ, Clarke P, Holman RR, Gregg EW, Gagliardino JJ, Chan JCN. Aspects of Multicomponent Integrated Care Promote Sustained Improvement in Surrogate Clinical Outcomes: A Systematic Review and Meta-analysis. Diabetes Care. 2018 Jun;41(6):1312-1320. doi: 10.2337/dc17-2010.
• Basto-Abreu A, Barrientos-Gutierrez T, Rojas-Martinez R, Aguilar-Salinas CA, Lopez-Olmedo N, De la Cruz-Gongora V, Rivera-Dommarco J, Shamah-Levy T, Romero-Martinez M, Barquera S, Lopez-Ridaura R, Hernandez-Avila M, Villalpando S. [Prevalence of diabetes and poor glycemic control in Mexico: results from Ensanut 2016.]. Salud Publica Mex. 2020 Jan-Feb;62(1):50-59. doi: 10.21149/10752. Spanish.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2017
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: January 24, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; glycemic control; self-care; Diabetes outcomes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DIABEMPIC Mexico City

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data generated is not publicly available due that data used are from patients and are under policies for private confidential information, but will be available at the end of the study on reasonable request and using unidentifiable IDs. Results are planned to be shared through Journal publication.
• IPD Sharing Time Frame: January 2021. Available for 3 years.
• IPD Sharing Access Criteria: Undefined
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No