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Implementing HEARTS in Guatemala

Primary Purpose

Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Integrated Diabetes and Hypertension Primary Care Model
Integrated Diabetes and Hypertension Primary Care Model - Providers
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patient participants Inclusion criteria: All non-pregnant adults aged ≥18 years with diagnoses of type 2 diabetes or hypertension who present for routine care at participating MOH primary health facilities between over a 6-month period will be included ("patient participants"). Both previously diagnosed and newly diagnosed patients will be eligible. Previously diagnosed patients will be identified by MOH primary care clinicians who take medical histories as part of routine care. Newly diagnosed patients will be identified by MOH primary care clinicians who apply diabetes and hypertension diagnostic criteria from national guidelines. Diabetes diagnostic criteria for newly diagnosed patients: fasting glucose ≥126 md/dl, two-hour post-prandial glucose ≥200 md/dl, HbA1c ≥6.5%. Hypertension diagnostic criteria for newly diagnosed patients: include systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg. A new hypertension diagnosis must be based on the average of at least two measurements. Exclusion criteria: Participants with confirmed or suspected type 1 diabetes or who are pregnant are not managed at MOH health centers or health posts and thus will be excluded. Other participants All MOH staff (physicians, nurses, auxiliary nurses) and stakeholders on the Technical Advisory Committee will be eligible for participation in the implementation assessment of the pilot ("MOH participants").

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    HEARTS implementation - Patients

    HEARTS implementation - Providers

    Arm Description

    A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in September 2023. This arm consists of the patients whose health markers will be monitored through the study.

    A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in September 2023. This arm consists of the health care providers who will be administering care to the patient participants.

    Outcomes

    Primary Outcome Measures

    Score on Feasibility of Intervention Measure (FIM) Questionnaire
    Feasibility will be assessed among Ministry of Health (MOH) participants through the four-item Feasibility of Intervention Measure (FIM) Questionnaire and semi-structured interviews. A Spanish-language version of the FIM will be adapted for this project. Scores will be on a scale of 1 to 5, with 1 being the worst and 5 being the best. The average score for each participant will be used.
    Number of target health districts that met enrollment goals
    This study will be working with two different health districts, one in the west and the other in the east. This measure is the number of districts that met enrollment goals for patients for patients with diabetes (at least 25) and also for patients with hypertension (at least 25). A given patient may have both diabetes and hypertension and thus count toward each benchmark
    Score on Acceptability of Intervention Measure (AIM) Questionnaire
    Acceptability will be assessed among patients through the four-item Acceptability Intervention Measure (AIM) Questionnaire and semi-structured interviews. A Spanish-language version of the AIM will be adapted for this project. Scores will be on a scale of 1 to 5, with 1 being the worst and 5 being the best. The average score for each participant will be used.
    Proportion of patient participants with subsequent follow-up visit within 3 months
    Proportion of patient participants with subsequent follow-up visit within 3 months in both regions combined.

    Secondary Outcome Measures

    Hypertension treatment rate
    Number of patients receiving hypertension medication treatment per month
    Diabetes treatment rate
    Number of patients receiving diabetes medication treatment per month
    Proportion of participants achieving glycemic control
    Proportion achieving glycemic control (fasting blood glucose <115 mg/dl or random blood glucose <160 mg/dl) among patients with diabetes
    Proportion achieving control of blood pressure
    Proportion achieving control of blood pressure (<130/80 mmHg) among patients with hypertension. This information will be taken from electronic medical records.
    Mean systolic blood pressure
    Mean systolic blood pressure among patients with hypertension
    Mean diastolic blood pressure
    Mean diastolic blood pressure among patients with hypertension
    Adoption
    Number of participating health facilities who enrolled at least one patient with hypertension or diabetes
    Fidelity - health worker training
    Proportion of health workers in each district attending all training sessions
    Fidelity - chart audit
    Proportion of clinical visits that are guideline concordant according to study team's audit of least 25% of patient visits
    Fidelity - team-based care and task sharing
    Proportion of primary health districts conducting at least one care coordination meeting
    Fidelity - access to medicines and diagnostics
    Proportion of primary health facilities that had monthly availability of Ministry of Health medications and diagnostics for diabetes and hypertension. Drugs include antihypertensive medications (hydrochlorothiazide, enalapril, losartan) and oral hypoglycemic agents (metformin and glimepiride). Diagnostics including blood pressure cuffs and monitors, glucometers, lancets, and glucose strips.
    Fidelity - facility-based electronic monitoring tool
    Proportion of patient visits captured in DHIS2 each month compared to comprehensive records in the Ministry of Health's Health Management Information System
    Fidelity - systems monitoring and feedback
    Proportion of quarterly reports viewed by health district administrators
    Usability
    Average score on the System Usability Scale questionnaire. Scores are on a scale of 10 (worst) to 50 (best).
    Sustainability
    Average score on a sustainability questionnaire. Questionnaire was created by combining select questions from the System Usability Scale and the Clinical Sustainability Assessment Tool. Scores are on a scale of 10 (worst) to 70 (best).

    Full Information

    First Posted
    October 6, 2023
    Last Updated
    October 6, 2023
    Sponsor
    University of Michigan
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI), Institute of Nutrition of Central America and Panama, Ministry of Health of Guatemala
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06080451
    Brief Title
    Implementing HEARTS in Guatemala
    Official Title
    Implementing Integrated Diabetes and Hypertension Management in Guatemala Using the HEARTS Model
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    May 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Michigan
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI), Institute of Nutrition of Central America and Panama, Ministry of Health of Guatemala

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The HEARTS Technical Package was developed by the World Health Organization to address the implementation gap of cardiovascular disease prevention in low- and middle-income countries. Guatemala is a middle-income country that is currently implementing HEARTS. National authorities are interested in exploring how hypertension and diabetes management can be integrated in HEARTS implementation. The objective of this study is to conduct a feasibility and acceptability pilot trial of integrated hypertension and diabetes management based on HEARTS in the publicly funded primary care system in Guatemala.
    Detailed Description
    A single-arm pilot trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in September 2023. A planned sample of 100 adult patients diagnosed with diabetes (n=45), hypertension (n=45), or both (n=10) will be enrolled. The intervention will consist of HEARTS-aligned components: Training health workers on Healthy-lifestyle counseling and Evidence-based treatment protocols; strengthening Access to medications and diagnostics; training on Risk-based cardiovascular disease management; Team-based care and task sharing; and Systems monitoring and feedback, including implementation of a facility-based electronic monitoring tool at the individual level. Co-primary outcomes of feasibility and acceptability will be assessed using an explanatory sequential mixed methods design. Secondary outcomes include clinical effectiveness (treatment with medication, glycemic control, and blood pressure control) and key implementation outcomes (adoption, fidelity, usability, and sustainability).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HEARTS implementation - Patients
    Arm Type
    Experimental
    Arm Description
    A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in September 2023. This arm consists of the patients whose health markers will be monitored through the study.
    Arm Title
    HEARTS implementation - Providers
    Arm Type
    Experimental
    Arm Description
    A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in September 2023. This arm consists of the health care providers who will be administering care to the patient participants.
    Intervention Type
    Other
    Intervention Name(s)
    Integrated Diabetes and Hypertension Primary Care Model
    Other Intervention Name(s)
    HEARTS
    Intervention Description
    The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care. Training health workers on diabetes and hypertension treatment protocols Team-based care and task sharing Strengthening access to medications and diagnostics Electronic medical record system and registry Systems monitoring and feedback of key indicators
    Intervention Type
    Other
    Intervention Name(s)
    Integrated Diabetes and Hypertension Primary Care Model - Providers
    Intervention Description
    The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care. Training health workers on diabetes and hypertension treatment protocols Team-based care and task sharing Strengthening access to medications and diagnostics Electronic medical record system and registry Systems monitoring and feedback of key indicators Health care providers will administer this intervention to patient participants and will report on their experience.
    Primary Outcome Measure Information:
    Title
    Score on Feasibility of Intervention Measure (FIM) Questionnaire
    Description
    Feasibility will be assessed among Ministry of Health (MOH) participants through the four-item Feasibility of Intervention Measure (FIM) Questionnaire and semi-structured interviews. A Spanish-language version of the FIM will be adapted for this project. Scores will be on a scale of 1 to 5, with 1 being the worst and 5 being the best. The average score for each participant will be used.
    Time Frame
    6 months
    Title
    Number of target health districts that met enrollment goals
    Description
    This study will be working with two different health districts, one in the west and the other in the east. This measure is the number of districts that met enrollment goals for patients for patients with diabetes (at least 25) and also for patients with hypertension (at least 25). A given patient may have both diabetes and hypertension and thus count toward each benchmark
    Time Frame
    6 months
    Title
    Score on Acceptability of Intervention Measure (AIM) Questionnaire
    Description
    Acceptability will be assessed among patients through the four-item Acceptability Intervention Measure (AIM) Questionnaire and semi-structured interviews. A Spanish-language version of the AIM will be adapted for this project. Scores will be on a scale of 1 to 5, with 1 being the worst and 5 being the best. The average score for each participant will be used.
    Time Frame
    6 months
    Title
    Proportion of patient participants with subsequent follow-up visit within 3 months
    Description
    Proportion of patient participants with subsequent follow-up visit within 3 months in both regions combined.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Hypertension treatment rate
    Description
    Number of patients receiving hypertension medication treatment per month
    Time Frame
    6 months
    Title
    Diabetes treatment rate
    Description
    Number of patients receiving diabetes medication treatment per month
    Time Frame
    6 months
    Title
    Proportion of participants achieving glycemic control
    Description
    Proportion achieving glycemic control (fasting blood glucose <115 mg/dl or random blood glucose <160 mg/dl) among patients with diabetes
    Time Frame
    6 months
    Title
    Proportion achieving control of blood pressure
    Description
    Proportion achieving control of blood pressure (<130/80 mmHg) among patients with hypertension. This information will be taken from electronic medical records.
    Time Frame
    6 months
    Title
    Mean systolic blood pressure
    Description
    Mean systolic blood pressure among patients with hypertension
    Time Frame
    6 months
    Title
    Mean diastolic blood pressure
    Description
    Mean diastolic blood pressure among patients with hypertension
    Time Frame
    6 months
    Title
    Adoption
    Description
    Number of participating health facilities who enrolled at least one patient with hypertension or diabetes
    Time Frame
    6 months
    Title
    Fidelity - health worker training
    Description
    Proportion of health workers in each district attending all training sessions
    Time Frame
    6 months
    Title
    Fidelity - chart audit
    Description
    Proportion of clinical visits that are guideline concordant according to study team's audit of least 25% of patient visits
    Time Frame
    6 months
    Title
    Fidelity - team-based care and task sharing
    Description
    Proportion of primary health districts conducting at least one care coordination meeting
    Time Frame
    6 months
    Title
    Fidelity - access to medicines and diagnostics
    Description
    Proportion of primary health facilities that had monthly availability of Ministry of Health medications and diagnostics for diabetes and hypertension. Drugs include antihypertensive medications (hydrochlorothiazide, enalapril, losartan) and oral hypoglycemic agents (metformin and glimepiride). Diagnostics including blood pressure cuffs and monitors, glucometers, lancets, and glucose strips.
    Time Frame
    6 months
    Title
    Fidelity - facility-based electronic monitoring tool
    Description
    Proportion of patient visits captured in DHIS2 each month compared to comprehensive records in the Ministry of Health's Health Management Information System
    Time Frame
    6 months
    Title
    Fidelity - systems monitoring and feedback
    Description
    Proportion of quarterly reports viewed by health district administrators
    Time Frame
    6 months
    Title
    Usability
    Description
    Average score on the System Usability Scale questionnaire. Scores are on a scale of 10 (worst) to 50 (best).
    Time Frame
    6 months
    Title
    Sustainability
    Description
    Average score on a sustainability questionnaire. Questionnaire was created by combining select questions from the System Usability Scale and the Clinical Sustainability Assessment Tool. Scores are on a scale of 10 (worst) to 70 (best).
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Patient participants Inclusion criteria: All non-pregnant adults aged ≥18 years with diagnoses of type 2 diabetes or hypertension who present for routine care at participating MOH primary health facilities between over a 6-month period will be included ("patient participants"). Both previously diagnosed and newly diagnosed patients will be eligible. Previously diagnosed patients will be identified by MOH primary care clinicians who take medical histories as part of routine care. Newly diagnosed patients will be identified by MOH primary care clinicians who apply diabetes and hypertension diagnostic criteria from national guidelines. Diabetes diagnostic criteria for newly diagnosed patients: fasting glucose ≥126 md/dl, two-hour post-prandial glucose ≥200 md/dl, HbA1c ≥6.5%. Hypertension diagnostic criteria for newly diagnosed patients: include systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg. A new hypertension diagnosis must be based on the average of at least two measurements. Exclusion criteria: Participants with confirmed or suspected type 1 diabetes or who are pregnant are not managed at MOH health centers or health posts and thus will be excluded. Other participants All MOH staff (physicians, nurses, auxiliary nurses) and stakeholders on the Technical Advisory Committee will be eligible for participation in the implementation assessment of the pilot ("MOH participants").
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David Flood, MD
    Phone
    734-647-2892
    Email
    dcflood@umich.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Flood, MD
    Organizational Affiliation
    University of Michigan
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    This project will produce multiple types of data, including patients' clinical information, health facility assessments, and structured and semi-structured interviews. Deidentified data, analytic code, and data dictionaries will be made available on the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) data repository (https://biolincc.nhlbi.nih.gov/) after the study concludes. Semi-structured interview transcripts and structured questionnaire data will not be shared due to privacy concerns and risk for re-identification.

    Learn more about this trial

    Implementing HEARTS in Guatemala

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