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

A Multi-component Intervention to Reduce Gaps in Hypertension Care and Control in Medellin, Colombia

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05011838
Enrollment
0
Registered
2021-08-18
Start date
2023-02-14
Completion date
2026-10-18
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

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

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.

Interventions

OTHER1. 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.

OTHER2. 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.

OTHER3. 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.

Sponsors

University Ghent
CollaboratorOTHER
Facultad Nacional de Salud Publica
CollaboratorOTHER
Institute of Tropical Medicine, Belgium
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Masking description

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.

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.

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 monthsUncontrolled 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

MeasureTime frameDescription
Number of individuals without a previous diagnosis but presenting hypertension during the study.through the population survey completion, up to 2 monthsHypertension: 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 monthsAware 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 monthsPatients 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.

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026