Improving hypertension and diabetes care in Puno, Peru

Addressing HyperteNsion and Diabetes Through Community-Engaged Systems in Puno, Peru (ANDES Study)

This study tests a new approach where health workers visit homes in Puno, Peru, to help people with high blood pressure and diabetes manage their health better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1068 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universidad Peruana Cayetano Heredia (Academic / other)
• Locations: 1 site (Puno)
• Trial ID: NCT05524987 on ClinicalTrials.gov

What this trial studies

This study aims to address the high prevalence of hypertension and diabetes in a vulnerable indigenous population in Puno, Peru, through a community-engaged intervention. The ANDES intervention involves home visits by health agents to provide education and support for managing these conditions. The study will evaluate the effectiveness, acceptability, and sustainability of this multicomponent approach in improving health outcomes. By focusing on a high-risk population, the research seeks to inform health policies in low- and middle-income countries.

Who should consider this trial

Good fit: Ideal candidates for this study are adults diagnosed with hypertension or diabetes who are willing to receive monthly home visits from health agents.

Not a fit: Patients who are not diagnosed with hypertension or diabetes, or those who are unable to provide informed consent, may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve blood pressure control and diabetes management in underserved communities.

How similar studies have performed: Other studies have shown success with community health worker interventions in managing chronic diseases, indicating potential for this approach.

Eligibility criteria

Inclusion Criteria:

1. Diagnosis of HTN, defined as one or more of the following:

   1. Physician-prescribed use of antihypertensive medications, and SBP≥130 mmHg and/or DBP≥80 mmHg
   2. Physician diagnosed hypertension defined as a hypertensive blood pressure measurement (SBP≥140 mmHg and/or DBP≥90 mmHg) documented or measured on two or more separate occasions.
2. Willing and available to receive health agent home visits monthly for the next year.
3. Receiving healthcare through MINSA or EsSalud healthcare systems

Exclusion Criteria:

1. Less than 18 years old;.
2. Has a SBP less than 140 mmHg and DBP less than 90 mmHg and is not currently taking medication;
3. Has a SBP less than 130 mmHg and DBP less than 80 mmHg if currently taking hypertension medication;
4. Unwilling, unable, or or not cognitively capable of providing informed consent;
5. Pregnant or plan to become pregnant in the next 18 months;
6. Plan to move out of the study area in the next 18 months;
7. Are not ambulatory, particularly if bedridden;
8. Currently receives home medical visits;
9. Life expectancy less than 6 months.
10. Lives more than approximately 1 hour from Puno city center;
11. Plan to travel for more than 3 months in the next year;
12. Another ANDES participant already lives in their home;
13. Patients on dialysis or expecting to start dialysis within the next 12 months;
14. Patients with liver failure (meeting Child-Pugh B or C criteria)

Where this trial is running

Puno

• Prisma — Puno, Peru (Recruiting)

Study contacts

• Principal investigator: Stella Hartinger, PhD — Universidad Peruana Cayetano Heredia
• Study coordinator: Stella Hartinger, PhD

Conditions Hypertension; Diabetes; Task shifting; Community Health Worker; Puno-Peru