Evaluation of the Effectiveness of an Intervention to Reduce Gaps in Hypertension Care in Low-income Medellin, Colombia

Not Applicable

Withdrawn

• Conditions: Hypertension
• Interventions: Other: 1. Health Services Redesign; Other: 2. Clinical Staff Training; Other: 3. Patient and Community Engagement

• Registration Number: NCT05011838
• Lead Sponsor: Institute of Tropical Medicine, Belgium

Brief Summary

This study evaluates the effectiveness of a multi-component intervention to reduce the gaps in hypertension care and control at a population level in low-income Communes of Medellin, Colombia, and assess the process and fidelity of the intervention's implementation.

Detailed Description

A multi-component intervention was designed based on international guidelines, a cross-sectional population survey results, and consultation with the community and institutional stakeholders. Three main components integrate activities related to (I) Health services redesign, (II) Clinical staff training (III) Patient and community engagement. The effectiveness of the intervention will be evaluated in a controlled before-after quasi-experimental study, with two deprived Communes of the city selected as intervention and control arms. Two representative population-based surveys of adults aged 35 years or older will be undertaken in the intervention and the control Communes two years apart, one before the intervention implementation and the other after. The surveys will include different adults. The main outcomes assessed will be the gaps in hypertension diagnosis, treatment, follow-up and control. Effectiveness will be evaluated with "difference in difference" measures. Generalized estimation equations models will be fitted considering the clustered nature of data and adjusting for potential confounding variables. The implementation process will be studied with mixed methods. Finally, implementation fidelity will be documented to assess to which degree the components of the intervention were implemented as intended.

Study Timeline

• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-13
• Study First Posted: 2021-08-18
• Study Start: 2023-02-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-02-14
• Study Completion: 2026-10-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 35 years or older
• Permanent inhabitant of the selected Communes
• Must be able to provide written informed consent

Exclusion Criteria

• Mental disability
• Unable to answer the questionnaire

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A multi-component intervention to improve hypertension care and control	3. Patient and Community Engagement	The intervention will be implemented in Commune 2. It will integrate activities related to 1) Health services redesign, 2) Clinical staff training and 3) Patient and community engagement. The intervention activities will be implemented by health services staff with technical assistance from the investigation team.
A multi-component intervention to improve hypertension care and control	1. Health Services Redesign	The intervention will be implemented in Commune 2. It will integrate activities related to 1) Health services redesign, 2) Clinical staff training and 3) Patient and community engagement. The intervention activities will be implemented by health services staff with technical assistance from the investigation team.
A multi-component intervention to improve hypertension care and control	2. Clinical Staff Training	The intervention will be implemented in Commune 2. It will integrate activities related to 1) Health services redesign, 2) Clinical staff training and 3) Patient and community engagement. The intervention activities will be implemented by health services staff with technical assistance from the investigation team.

Primary Outcome Measures

Name	Time	Method
Number of individuals self-reporting a previous diagnosis of hypertension and encountered with uncontrolled hypertension during the study.	through the population survey completion, up to 2 months	Uncontrolled hypertension: an average blood pressure measurement higher than 140/90 mmHg for aware hypertensive patients between 35 and 59 years old or for diabetic patients regardless of age, and higher than 150/90 mmHg for aware hypertensive patients aged 60 years or older.

Secondary Outcome Measures

Name	Time	Method
Number of individuals without a previous diagnosis but presenting hypertension during the study.	through the population survey completion, up to 2 months	Hypertension: an average repeat blood pressure measurement equal to or higher than 140/90 mmHg.
Number of individuals self-reporting a previous diagnosis of hypertension who did not attend a follow-up consultation during the last year.	through the population survey completion, up to 2 months	Aware hypertensive individuals who self-report that they did not attend a follow-up consultation for hypertension during the last year.
Number of aware hypertensive individuals who received a prescription of antihypertensive medication but either do not take the drugs or are non-adherent.	through the population survey completion, up to 2 months	Patients with a prescription of antihypertensive medication who self-report that they do not take the drugs or, assessed by mean of the 4-item Medication Adherence Questionnaire, are non-adherent.

Trial Locations

Locations (1)

Unidad Hospitalaria de Santa Cruz; 🇨🇴 Medellín, Colombia