HypertensionNCT05011838
Evaluation of the Effectiveness of an Intervention to Reduce Gaps in Hypertension Care in Low-income Medellin, Colombia
A study testing 1. Health Services Redesign, 2. Clinical Staff Training and 3. Patient and Community Engagement in people with Hypertension, run by Institute of Tropical Medicine, Belgium at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- 1. Health Services Redesign, 2. Clinical Staff Training and 3. Patient and Community Engagement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteColombia
- Study dates
- 14 Feb 2023to 18 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 35 years or older
- Permanent inhabitant of the selected Communes
- Must be able to provide written informed consent
Who cannot join
- Mental disability
- Unable to answer the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-component Intervention to Reduce Gaps in Hypertension Care and Control in Medellin, Colombia
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- 1. Health Services Redesign, 2. Clinical Staff Training, 3. Patient and Community Engagement
- Keywords
- Heart Disease Risk Factors, Primary Health Care, Controlled Before-After Studies, Latin America, Colombia
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. Health Services RedesignOther
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 TrainingOther
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 EngagementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Hypertension: an average repeat blood pressure measurement equal to or higher than 140/90 mmHg.
Measured: 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.
Aware hypertensive individuals who self-report that they did not attend a follow-up consultation for hypertension during the last year.
Measured: 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.
Patients 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.
Measured: through the population survey completion, up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start14 Feb 2023 (estimated)
- Primary completion14 Feb 2025 (estimated)
- Study completion18 Oct 2026 (estimated)
Why it stopped: Due to the devasting impact of Covid-19 on Colombian health services, the execution of the study was halted shortly after all involved actors had been trained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Facultad Nacional de Salud Publica
- Responsible party
- Sponsor
- Investigators
- Esteban A Londoño-Agudelo, MD.MPH., Principal investigator, Institute of Tropical Medicine, Antwerp, BelgiumPatrick Van der Stuyft, MD.MPH.PhD, Study director, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011838
- Sponsor's protocol ID
- 1294/19
- Status last verified
- Mar 2024
- First submitted
- 6 Aug 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data sets, properly anonymized, underlying our publications of research results, will be shared upon reasonable and formal institutional request.
Publications
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.
PubMed 32867605Londono 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.
PubMed 33938098Londono 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.
PubMed 36002215
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-component Intervention to Reduce Gaps in Hypertension Care and Control in Medellin, Colombia
- ClinicalTrials.gov ID
- NCT05011838
- Acronym / sponsor ID
- 1294/19
- Conditions
- Hypertension
- Keywords
- Heart Disease Risk Factors, Primary Health Care, Controlled Before-After Studies, Latin America, Colombia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the devasting impact of Covid-19 on Colombian health services, the execution of the study was halted shortly after all involved actors had been trained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- University Ghent, Facultad Nacional de Salud Publica
- Study start
- 14 Feb 2023 (estimated)
- Primary completion
- 14 Feb 2025 (estimated)
- Study completion
- 18 Oct 2026 (estimated)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| A multi-component intervention to improve hypertension care and control | Experimental | Other: 1. Health Services Redesign, Other: 2. Clinical Staff Training, Other: 3. Patient and Community EngagementThe 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. |
| Routine Care | No intervention | –The Commune 6 was selected as control area, where routine care will be delivered. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 35 years or older
- Permanent inhabitant of the selected Communes
- Must be able to provide written informed consent
Key exclusion criteria (2 listed)
- Mental disability
- Unable to answer the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1. Health Services Redesign1.1. 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. | Other | A multi-component intervention to improve hypertension care and control |
| 2. Clinical Staff Training2.1. 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. | Other | A multi-component intervention to improve hypertension care and control |
| 3. Patient and Community Engagement3.1. 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. | Other | A multi-component intervention to improve hypertension care and control |
Primary outcome
Number of individuals self-reporting a previous diagnosis of hypertension and encountered with uncontrolled hypertension during the study.
Time frame: through the population survey completion, up to 2 months
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.
3 secondary outcomes
Number of individuals without a previous diagnosis but presenting hypertension during the study.
Time frame: 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.
Time frame: 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.
Time frame: through the population survey completion, up to 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 32867605Londono 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.
- Background: PubMed 33938098Londono 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.
- Derived from this study: PubMed 36002215Londono 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.
- Individual participant dataSharing planned: Yes. All individual participant data sets, properly anonymized, underlying our publications of research results, will be shared upon reasonable and formal institutional request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esteban A Londoño-Agudelo, MD.MPH. principal investigator
Institute of Tropical Medicine, Antwerp, Belgium
Patrick Van der Stuyft, MD.MPH.PhD study director
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1. Health Services Redesign, 2. Clinical Staff Training and 3. Patient and Community Engagement in people with Hypertension, run by Institute of Tropical Medicine, Belgium at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of individuals self-reporting a previous diagnosis of hypertension and encountered with uncontrolled hypertension during the study. (time frame: through the population survey completion, up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05011838, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.