Community-based Primary Care Program Effects on Pharmacotherapy of Type 2 Diabetes and Hypertension in Peru

NCT05979142 | Completed

• 1 other identifier: 1912252903
• Study Type: observational
• Target: 131
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to compare usual care to a community-based primary care program (having components of treatment decisions based on clinical guidelines, self-management education, community health workers, and free health care visits and medications) in low-income Peruvians with type 2 diabetes and/or hypertension. The main question\[s\] it aims to answer are:

• Compared to pre-program usual care, does the program result in greater benefits, measured as greater proportions of patients with glucose and blood pressure control or maximal quantities and doses of medications?
• Are there greater benefits when the program was provided at home compared to when the program was provided in a clinic?
• Does longer participation in the program result in greater benefits? Participants will participate in:
• Self-management education provided by community health workers.
• Monitoring of healthy behaviors and glucose, blood pressure, and weight.
• Receipt of free medications for blood pressure, glucose, and heart disease prevention.

Conditions

Type 2 Diabetes; Hypertension

Keywords

low and middle income countries; primary care; chronic care model; community health workers; cohort study; pharmacotherapy

Outcome Measures

Primary Outcomes (5)

• Hypoglycemic agent standard

  Standard was defined as glycemic control or maximum doses of two hypoglycemic agents (metformin and glibenclamide) in eligible patients with type 2 diabetes.

  27 months

• Antihypertensive agent standard

  Standard was defined blood pressure control or maximum doses of three or more antihypertensive agents in eligible patients with elevated blood pressure (\>130/80 mm Hg in diabetics, \>140/90 mm Hg in non-diabetics)

  27 months

• Angiotensin-converting enzyme inhibitor (ACEi) standard

  Standard was defined as any ACEi in eligible patients with diabetes and elevated BP (\>130/80 mm Hg).

  27 months

• Low-dose aspirin standard

  Standard was defined as any low-dose aspirin in eligible patients with 10-year cardiovascular disease (CVD) risk \>10%.

  27 months

• Composite standard

  Coded 'yes' if all treatment standards for which eligible were achieved.

  27 months

Study Arms (2)

program (pre-exposure)

During the pre-exposure period, usual care was provided by two public hospitals, several Ministry of Health clinics, private clinics and pharmacies, and Siempre Salud.

program (post-exposure)

The program had components of four Chronic Care Model (CCM) elements (delivery system design, self-management, decision support, and community resources), community health workers (CHWs), and no out-of-pocket costs for visits and medications.

Other: community-based primary care program

Interventions

community-based primary care program OTHER

See group description

program (post-exposure)

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Three neighborhoods ("the community") in Pueblo Nuevo, Chincha District, Ica, Peru participated in the study. Peru is a middle-income country, but most people in the study community live below the poverty line. Door-to-door surveys identified all persons residing in the study community. Patients 35 years and older were eligible to participate in diabetes and hypertension screening. 83% of all eligible persons participated in mass screenings between September and December 2011. Others participated in later ad hoc screenings. Those with confirmed diagnoses of type 2 diabetes and/or hypertension were eligible to participate in the program.

You may qualify if:

• years or older with confirmed diagnosis of type 2 diabetes and/or hypertension

You may not qualify if:

• None

Sponsors & Collaborators

• Asociación Siempre Salud: lead
• University of Arizona: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• John E Deaver, MD

  Asociación Siempre Salud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 7, 2023
• Study Start: September 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: during submission of manuscript for publication