Clinical trial NCT05011838: Evaluation of the Effectiveness of an Intervention to Reduce Gaps in Hypertension Care in Low-income Medellin, Colombia
Official title: A Multi-component Intervention to Reduce Gaps in Hypertension Care and Control in Medellin, Colombia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertension
Keywords: Heart Disease Risk Factors
Primary Health Care
Controlled Before-After Studies
Latin America
Colombia
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: University Ghent
name: Facultad Nacional de Salud Publica
First posted: 2021-08-18
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two deprived Communes of the city have been selected as intervention and control arms. All the intervention components will be implemented in Commune 2, located in the northeast of Medellin. Commune 6, located northwest of Medellin, has been selected as the control area to deliver routine care. Two representative population 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 randomly include different individuals. The main outcomes assessed will be the gaps in hypertension diagnosis, treatment, follow-up and control.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of individuals self-reporting a previous diagnosis of hypertension and encountered with uncontrolled hypertension during the study.
timeFrame: through the population survey completion, up to 2 months
Secondary outcomes:
measure: Number of individuals without a previous diagnosis but presenting hypertension during the study.
timeFrame: through the population survey completion, up to 2 months
measure: Number of individuals self-reporting a previous diagnosis of hypertension who did not attend a follow-up consultation during the last year.
timeFrame: through the population survey completion, up to 2 months
measure: Number of aware hypertensive individuals who received a prescription of antihypertensive medication but either do not take the drugs or are non-adherent.
timeFrame: through the population survey completion, up to 2 months
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Unidad Hospitalaria de Santa Cruz
Study officials:
affiliation: Institute of Tropical Medicine, Antwerp, Belgium
name: Esteban A Londoño-Agudelo, MD.MPH.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Patrick Van der Stuyft, MD.MPH.PhD
role: STUDY_DIRECTOR
References:
citation: Londono Agudelo E, Garcia Farinas A, Perez Ospina V, Taborda Perez C, Villacres Landeta T, Battaglioli T, Gomez Arias R, Van der Stuyft P. Out-of-pocket expenditure for hypertension care: a population-based study in low-income urban Medellin, Colombia. Glob Health Action. 2020 Dec 31;13(1):1806527. doi: 10.1080/16549716.2020.1806527.
citation: Londono Agudelo E, Perez Ospina V, Battaglioli T, Taborda Perez C, Gomez-Arias R, Van der Stuyft P. Gaps in hypertension care and control: a population-based study in low-income urban Medellin, Colombia. Trop Med Int Health. 2021 Aug;26(8):895-907. doi: 10.1111/tmi.13599. Epub 2021 May 22.
citation: Londono Agudelo EA, Battaglioli T, Soto A, Vasquez Gomez J, Aguilar Ramirez H, Perez Ospina V, Rodriguez Salva A, Ortiz Solorzano P, Perez D, Gomez-Arias R, Van Der Stuyft P. Protocol for a controlled before-after quasi-experimental study to evaluate the effectiveness of a multi-component intervention to reduce gaps in hypertension care and control in low-income communes of Medellin, Colombia. BMJ Open. 2022 Aug 24;12(8):e056262. doi: 10.1136/bmjopen-2021-056262.