Evaluation of the Effectiveness of an Intervention to Reduce Gaps in Hypertension Care in Low-income Medellin, Colombia
NCT ID: NCT05011838
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-02-14
2026-10-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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A multi-component intervention to improve hypertension care and control
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.
1. Health Services Redesign
1.1. Healthy Hearts service: a nursing station providing blood pressure measurement, cardiovascular risk assessment, preventive counselling and effective follow-up in extended opening hours.
1.2. Hypertension screening: All adults attending health care facilities who did not have their blood pressure measured in the previous year will be referred to the Healthy Hearts Service for screening.
1.3. Clinical management: 1.3.1. Creation of the cardiovascular risk team: a group of doctors supervising hypertension management and coordinating improvement.
1.3.2. Guideline-based standardized diagnostic and treatment protocols: a simplified diagnostic and treatment algorithm will identify a core set of primary and secondary antihypertensive medications.
1.3.3. Availability of antihypertensive medications: it will be assured through procurement mechanisms and its availability will be communicated to clinicians at the beginning of each week and ad hoc in case of stock-outs.
2. Clinical Staff Training
2.1. Training on good clinical management of hypertension: focused on correct blood pressure measurement, use of evidence-based guidelines, cardiovascular risk assessment, use of a standardized diagnostic and treatment algorithm, correct prescription of pharmacological and non-pharmacological treatment, patient counselling, and how to tackle clinical inertia.
2.2. Training on communication skills and patients' needs assessment for all health workers involved in hypertension care. This training will be designed under the "patient-centred medicine" framework, aiming at equipping health providers with tools for understanding patients' feelings and experience of illness, and to improve their capacity to address social, psychological, and behavioural dimensions of hypertension care.
3. Patient and Community Engagement
3.1. Patient empowerment: "expert hypertensive patients" , under the supervision of a social worker, will provide support and transmit their know-how to other patients in need, particularly those newly diagnosed or non-adherent to treatment or presenting uncontrolled hypertension.
3.2. Community engagement: a Community Hypertension Outreach Group will be set up, composed of existing voluntary community health workers, who will be trained and certified. This group will conduct blood pressure measurements in selected public areas of the commune, referring those with positive screening to the nearest health facility for diagnosis confirmation. It will also provide health information with emphasis on healthy lifestyles. Existing local communication channels such as the community radio and the local newspaper will be engaged.
Routine Care
The Commune 6 was selected as control area, where routine care will be delivered.
No interventions assigned to this group
Interventions
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1. Health Services Redesign
1.1. Healthy Hearts service: a nursing station providing blood pressure measurement, cardiovascular risk assessment, preventive counselling and effective follow-up in extended opening hours.
1.2. Hypertension screening: All adults attending health care facilities who did not have their blood pressure measured in the previous year will be referred to the Healthy Hearts Service for screening.
1.3. Clinical management: 1.3.1. Creation of the cardiovascular risk team: a group of doctors supervising hypertension management and coordinating improvement.
1.3.2. Guideline-based standardized diagnostic and treatment protocols: a simplified diagnostic and treatment algorithm will identify a core set of primary and secondary antihypertensive medications.
1.3.3. Availability of antihypertensive medications: it will be assured through procurement mechanisms and its availability will be communicated to clinicians at the beginning of each week and ad hoc in case of stock-outs.
2. Clinical Staff Training
2.1. Training on good clinical management of hypertension: focused on correct blood pressure measurement, use of evidence-based guidelines, cardiovascular risk assessment, use of a standardized diagnostic and treatment algorithm, correct prescription of pharmacological and non-pharmacological treatment, patient counselling, and how to tackle clinical inertia.
2.2. Training on communication skills and patients' needs assessment for all health workers involved in hypertension care. This training will be designed under the "patient-centred medicine" framework, aiming at equipping health providers with tools for understanding patients' feelings and experience of illness, and to improve their capacity to address social, psychological, and behavioural dimensions of hypertension care.
3. Patient and Community Engagement
3.1. Patient empowerment: "expert hypertensive patients" , under the supervision of a social worker, will provide support and transmit their know-how to other patients in need, particularly those newly diagnosed or non-adherent to treatment or presenting uncontrolled hypertension.
3.2. Community engagement: a Community Hypertension Outreach Group will be set up, composed of existing voluntary community health workers, who will be trained and certified. This group will conduct blood pressure measurements in selected public areas of the commune, referring those with positive screening to the nearest health facility for diagnosis confirmation. It will also provide health information with emphasis on healthy lifestyles. Existing local communication channels such as the community radio and the local newspaper will be engaged.
Eligibility Criteria
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Inclusion Criteria
* Permanent inhabitant of the selected Communes
* Must be able to provide written informed consent
Exclusion Criteria
* Unable to answer the questionnaire
35 Years
ALL
Yes
Sponsors
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University Ghent
OTHER
Facultad Nacional de Salud Publica
OTHER
Institute of Tropical Medicine, Belgium
OTHER
Responsible Party
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Principal Investigators
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Esteban A Londoño-Agudelo, MD.MPH.
Role: PRINCIPAL_INVESTIGATOR
Institute of Tropical Medicine, Antwerp, Belgium
Patrick Van der Stuyft, MD.MPH.PhD
Role: STUDY_DIRECTOR
University Ghent
Locations
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Unidad Hospitalaria de Santa Cruz
Medellín, , Colombia
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1294/19
Identifier Type: -
Identifier Source: org_study_id
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