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

Institute of Tropical Medicine, Belgium

Status: Withdrawn

Conditions: Hypertension

Treatments: Other: 1. Health Services Redesign; Other: 3. Patient and Community Engagement; Other: 2. Clinical Staff Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05011838

1294/19

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 2 patient groups

A multi-component intervention to improve hypertension care and control

Experimental group

Description:

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.

Treatment:

Other: 3. Patient and Community Engagement

Other: 1. Health Services Redesign

Other: 2. Clinical Staff Training

Routine Care

No Intervention group

Description:

The Commune 6 was selected as control area, where routine care will be delivered.