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

NCT05011838 | Withdrawn

• 1 other identifier: 1294/19
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Heart Disease Risk Factors; Primary Health Care; Controlled Before-After Studies; Latin America; Colombia

Outcome Measures

Primary Outcomes (1)

• Number of individuals self-reporting a previous diagnosis of hypertension and encountered with uncontrolled hypertension during the study.

  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.

  through the population survey completion, up to 2 months

Secondary Outcomes (3)

• Number of individuals without a previous diagnosis but presenting hypertension during the study.

  through the population survey completion, up to 2 months

• 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

• 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

Study Arms (2)

A multi-component intervention to improve hypertension care and control

EXPERIMENTAL

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.

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

Routine Care

NO INTERVENTION

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

Interventions

1. Health Services Redesign OTHER

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.

A multi-component intervention to improve hypertension care and control

2. Clinical Staff Training OTHER

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.

A multi-component intervention to improve hypertension care and control

3. Patient and Community Engagement OTHER

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.

A multi-component intervention to improve hypertension care and control

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Mental disability
• Unable to answer the questionnaire

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• University Ghent: collaborator
• Facultad Nacional de Salud Publica: collaborator

Study Sites (1)

Unidad Hospitalaria de Santa Cruz

Medellín, Colombia

Location

Related Publications (3)

• 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.

  PMID: 32867605 BACKGROUND

• 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.

  PMID: 33938098 BACKGROUND

• 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.

  PMID: 36002215 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Esteban A Londoño-Agudelo, MD.MPH.

  Institute of Tropical Medicine, Antwerp, Belgium

  PRINCIPAL INVESTIGATOR

• Patrick Van der Stuyft, MD.MPH.PhD

  University Ghent

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are kept unaware of the intervention implementation and its assignment in one commune or another. Furthermore, participants will be randomly recruited in both communes.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 18, 2021
• Study Start: February 14, 2023
• Primary Completion: February 14, 2025
• Study Completion (Estimated): October 18, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The investigators plan to publish the research protocol, which would be available in November 2021. Participant data sets underlying our results would be available starting 2 months after publication.
• Access Criteria: The study protocol and the corresponding statistical analysis plan will be broadly available after its publication planned for November 2021. Other supporting information will be shared only with accredited scientific researchers through an institutional formal request via email and confirmed by phone. Requests for data sharing must comply legal regulations in Colombia and have the endorsement of the Institutional Research Board of the Antwerp Institute of Tropical Medicine.

Locations

CO (1)