Clinical trial NCT02804698: Tools And Practices To Decrease CVD And Complications In The Diabetic Population Of Mexico
Official title: Tools And Practices To Decrease CVD And Complications In The Diabetic Population Of Mexico
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Cardiovascular Disease
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: El Colegio de Sonora
First posted: 2016-06-17
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project will look to improve standards of care for diabetic patients by evaluating a program that supports participants in making healthy lifestyle changes.

The program consists of 13 educational sessions that contain information about the prevention and care of diabetes and cardiovascular disease, physical activity, nutrition, community health and emotional well being.

Detailed description: Researchers propose to address extremely high rates of cardiovascular disease morbidity and mortality in Sonora, Mexico through use of an evidence-based community health worker intervention for adult patients with diabetes who receive care at health centers operated by the Secretaría de Salud, an office of the Mexican government. Researchers will conduct a cluster-randomized trial with a total of 400 patients at 20 health centers to understand whether the 13-week educational intervention, Meta Salud Diabetes, can effectively reduce clinical, behavioral, and psychosocial risk for cardiovascular disease among adults with diabetes. Researchers will also conduct an implementation study that will consist of systematic engagement of local, state and national decision makers to identify barriers, facilitators, and strategies to adopt and integrate community health worker-led cardiovascular disease prevention interventions throughout the 209 health centers in Sonora.

Eligibility criteria: Inclusion Criteria:

* adults ≥18 years old
* have been diagnosed with controlled or uncontrolled diabetes

Exclusion Criteria:

* \< than 18 years of age
* not diagnosed with diabetes

Primary outcomes:
measure: Framingham cardiovascular disease risk
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hermosillo
country: Mexico
facility: Ministry of Health
state: Sonora
Study officials:
affiliation: University of Arizona
name: Cecilia B Rosales, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aceves B, Denman CA, Ingram M, Torres JF, Nuno T, Garcia DO, Madhivanan P, Rosales CB. Testing Scalability of a Diabetes Self-Management Intervention in Northern Mexico: An Ecological Approach. Front Public Health. 2021 Aug 18;9:617468. doi: 10.3389/fpubh.2021.617468. eCollection 2021.
citation: Aceves B, Ruiz M, Ingram M, Denman C, Garcia DO, Madhivanan P, Rosales C. Mental health and diabetes self-management: assessing stakeholder perspectives from health centers in Northern Mexico. BMC Health Serv Res. 2021 Feb 25;21(1):177. doi: 10.1186/s12913-021-06168-y.
citation: Bell ML, Rabe BA. The mixed model for repeated measures for cluster randomized trials: a simulation study investigating bias and type I error with missing continuous data. Trials. 2020 Feb 7;21(1):148. doi: 10.1186/s13063-020-4114-9.
citation: Ingram M, Denman CA, Cornejo-Vucovich E, Castro-Vasquez MDC, Aceves B, Ocejo AG, de Zapien JG, Rosales C. The Meta Salud Diabetes Implementation Study: Qualitative Methods to Assess Integration of a Health Promotion Intervention Into Primary Care to Reduce CVD Risk Among an Underserved Population With Diabetes in Sonora, Mexico. Front Public Health. 2019 Nov 15;7:347. doi: 10.3389/fpubh.2019.00347. eCollection 2019.
citation: Sabo S, Denman Champion C, Bell ML, Cornejo Vucovich E, Ingram M, Valenica C, Castro Vasquez MDC, Gonzalez-Fagoaga E, Geurnsey de Zapien J, Rosales CB. Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico. BMJ Open. 2018 Mar 12;8(3):e020762. doi: 10.1136/bmjopen-2017-020762.