HypertensionNCT04229667
Community Models for Hypertension and Diabetes Care for Refugees
An observational study of Hypertension and Diabetes Mellitus, Type 1, run by International Rescue Committee at 1 site in United States.
Trial summary
The project will investigate and improve a community health worker (CHW) based model for non-communicable disease (NCD) care in a humanitarian emergency. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- Improved Community Health Volunteer (CHV) program
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2020to 28 Feb 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult (≥18 years), Syrian refugee or vulnerable Jordanian patients with type 1 or type 2 diabetes mellitus and/or hypertension and considered to have "high-needs", living in the IRC-clinic catchment areas of Ramtha and Mafraq, Jordan
Who may be able to join
- Adult (≥18 years of age) with clinically-diagnosed hypertension OR type II diabetes AND;
- Poor adherence, defined as:
- Missed ≥2 appointments in the past six months AND/OR;
- Poor disease control:
- Hypertension: Blood pressure >160/90 (EHS/ESC Grade II/III) with or without therapy, on their last measurement in clinic AND/OR; Evidence of hypertensive end organ damage including ischemic heart disease, left ventricular hypertrophy on ECG, eGFR < 60, hypertensive retinopathy, heart failure, myocardial infarction AND/OR; Type II diabetes: HbA1C is >8.5% OR random blood glucose >200 mg/dL with or without insulin/pill therapy AND/OR; Patient has comorbidity and/or evidence of diabetic end organ damage, including ischemic heart disease, left ventricular hypertrophy on ECG, eGFR < 60, retinopathy, heart failure, myocardial infarction, poorly healing wounds (e.g., diabetic foot), amputation, blindness and eye problems.
- Comorbid diabetes and hypertension:
- Disabled (house-bound)
- Type I diabetes (insulin-dependent): all adult cases of insulin-dependent diabetes (likely type I diabetes), due to the nature of treatment interruption which causes rapid decompensations.
Who cannot join
- Pregnancy
- Hospitalization for the majority of the study period
- Patients who leave the study neighborhood or repatriate to Syria
Trial locations and contacts
1 site in 1 country.
United States1 site
International Rescue Committee
New York, New York, 10168
About this study
Official title: Optimising a Community-based Model for Case Identification, Monitoring, and Prevention of Hypertension and Diabetes Among Syrian Refugees in Jordan
The project will investigate and improve a community health worker (CHW) based model for non-communicable disease (NCD) care in a humanitarian emergency.
Read the detailed description
Guidelines for public health approaches for non-communicable disease (NCD) in crises are not well developed. More broadly, NCD management in developing countries focuses on care at the health facility level without a community health worker focus (CHW), which may facilitate continuous care and monitoring.
Since the arrival of refugees from Syria in 2012, the International Rescue Committee (IRC) has provided primary health care, mobile outreach, and community-based empowerment programs for those in need in the northern governorates of Mafraq and Ramtha. The IRC runs health clinics, mobile medical teams, and community health volunteer (CHV) networks to provide care for refugees and Jordanians living in poverty.
This stepped-wedge observational study will follow the implementation of an improved CHV program which focuses on the monitoring of 'high-needs' patients in their households for complications, severe disease, and to avoid interruptions to treatment adherence. The stepped-wedge design will be undertaken to benefit from the phased rollout of the improved CHV intervention over a year-long period. The intervention will be scaled to 20 CHV-neighborhoods across Mafraq and Ramtha.
Primary objectives:
- To evaluate the impact of an improved CHV program that targets high-needs hypertension and diabetes patients on:
- Compliance with routine clinic visits.
- Adherence to medications (self-reported).
- Adherence behaviours (self-reported).
- Disease control outcomes (blood pressure control for hypertension patients; blood sugar control for diabetes patients).
Secondary objectives:
- To document the operations of the improved CHV program in terms of key operational indicators and health indicators.
- To produce lessons learned to improve the CHV program.
Study outcomes:
- Evidence of the effectiveness of the improved CHV strategy on clinic visit compliance, adherence, and patient outcomes.
- Improved guidance for developing and implementing an integrated model of primary care and community health worker networks in crises.
- Conditions
- Hypertension, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Comorbidities and Coexisting Conditions
- Being tested
- Improved Community Health Volunteer (CHV) program
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improved Community Health Volunteer (CHV) programOther
Multi-modal intervention targeting intensive household monitoring of "high-needs" patients using monthly visits to measure blood pressure and blood sugar, adherence to treatments and compliance with clinics visits, and motivational interviewing to facilitate behavior change and psychosocial support.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of diabetes patients at intake (defined as random blood sugar >= 200 mg/dL at intake) demonstrating a change in random blood sugar (mmHg)
As measured by point-of-care glucometer
Measured: Every two months, through study completion (4 to 12 months depending on group)
Proportion of hypertension patients at intake (defined as blood pressure >=140/90 mmHg at intake) demonstrating a change in systolic blood pressure (mmHg)
As measured by electronic blood pressure monitor during household visit
Measured: Every two months, through study completion (4 to 12 months depending on group)
Proportion of patients demonstrating a change in self-reported medication adherence behaviors
As measured by response to questions on adherence behaviors. This measure uses the Center for Adherence Support Evaluation (CASE) Adherence Index, wherein higher values on a scale of 1 to 6 indicate worse outcomes.
Measured: Every two months, through study completion (4 to 12 months depending on group)
Proportion of patients demonstrating a change in self-reported medication adherence actions (5-day)
As measured the number of days during the last 5 days in which medication was not taken (during household visit)
Measured: Every two months, through study completion (4 to 12 months depending on group)
Proportion of patients demonstrating a change in self-reported medication adherence actions (30-day)
As measured the number of days during the last 30 days in which medication was not taken (during household visit)
Measured: Every two months, through study completion (4 to 12 months depending on group)
Secondary outcomes (3)
Proportion of hypertension patients at intake (defined as blood pressure >=140/90 mmHg at intake) demonstrating a change in diastolic blood pressure (mmHg)
As measured by electronic blood pressure monitor during household visit
Measured: Every two months, through study completion (4 to 12 months depending on group)
Proportion of patients demonstrating a change in disease control (defined as blood pressure <140/90 mmHg; <150/90 for patients aged ≥80 years), among patients with hypertension at intake (defined as blood pressure >=140/90 mmHg at intake)
As measured by electronic blood pressure monitor using three measurements during household visit
Measured: Every two months, through study completion (4 to 12 months depending on group)
Proportion of patients demonstrating a change in disease control (defined as random blood sugar <200 mg/dL mmHg), among patients with diabetes at intake (defined as random blood sugar >=200 mg/dL at intake)
As measured with glucometer during household visit
Measured: Every two months, through study completion (4 to 12 months depending on group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start31 Jan 2020
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Why it stopped: As a result of COVID-19, the intervention design changed and an RCT was no longer an appropriate study design for evaluation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Rescue Committee
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, Jordan University of Science and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229667
- Sponsor's protocol ID
- H 1.00.020
- Status last verified
- Jul 2021
- First submitted
- 24 Oct 2019
- Last updated
- 20 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising a Community-based Model for Case Identification, Monitoring, and Prevention of Hypertension and Diabetes Among Syrian Refugees in Jordan
- ClinicalTrials.gov ID
- NCT04229667
- Acronym / sponsor ID
- H 1.00.020
- Conditions
- Hypertension, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Comorbidities and Coexisting Conditions
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: As a result of COVID-19, the intervention design changed and an RCT was no longer an appropriate study design for evaluation.
- Enrolment
- 600 participants (actual)
- Lead sponsor
- International Rescue CommitteeUniversity, hospital or other
- Collaborators
- University of Southern California, Jordan University of Science and Technology
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 18 Jan 2020 (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.
The project will investigate and improve a community health worker (CHW) based model for non-communicable disease (NCD) care in a humanitarian emergency.
Detailed description
Guidelines for public health approaches for non-communicable disease (NCD) in crises are not well developed. More broadly, NCD management in developing countries focuses on care at the health facility level without a community health worker focus (CHW), which may facilitate continuous care and monitoring.
Since the arrival of refugees from Syria in 2012, the International Rescue Committee (IRC) has provided primary health care, mobile outreach, and community-based empowerment programs for those in need in the northern governorates of Mafraq and Ramtha. The IRC runs health clinics, mobile medical teams, and community health volunteer (CHV) networks to provide care for refugees and Jordanians living in poverty.
This stepped-wedge observational study will follow the implementation of an improved CHV program which focuses on the monitoring of 'high-needs' patients in their households for complications, severe disease, and to avoid interruptions to treatment adherence. The stepped-wedge design will be undertaken to benefit from the phased rollout of the improved CHV intervention over a year-long period. The intervention will be scaled to 20 CHV-neighborhoods across Mafraq and Ramtha.
Primary objectives:
- To evaluate the impact of an improved CHV program that targets high-needs hypertension and diabetes patients on:
- Compliance with routine clinic visits.
- Adherence to medications (self-reported).
- Adherence behaviours (self-reported).
- Disease control outcomes (blood pressure control for hypertension patients; blood sugar control for diabetes patients).
Secondary objectives:
- To document the operations of the improved CHV program in terms of key operational indicators and health indicators.
- To produce lessons learned to improve the CHV program.
Study outcomes:
- Evidence of the effectiveness of the improved CHV strategy on clinic visit compliance, adherence, and patient outcomes.
- Improved guidance for developing and implementing an integrated model of primary care and community health worker networks in crises.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (≥18 years), Syrian refugee or vulnerable Jordanian patients with type 1 or type 2 diabetes mellitus and/or hypertension and considered to have "high-needs", living in the IRC-clinic catchment areas of Ramtha and Mafraq, Jordan
Key inclusion criteria (8 listed)
- Adult (≥18 years of age) with clinically-diagnosed hypertension OR type II diabetes AND;
- Poor adherence, defined as:
- Poor disease control:
- Hypertension: Blood pressure >160/90 (EHS/ESC Grade II/III) with or without therapy, on their last measurement in clinic AND/OR; Evidence of hypertensive end organ damage including ischemic heart disease, left ventricular hypertrophy on ECG, eGFR < 60, hypertensive retinopathy, heart failure, myocardial infarction AND/OR; Type II diabetes: HbA1C is >8.5% OR random blood glucose >200 mg/dL with or without insulin/pill therapy AND/OR; Patient has comorbidity and/or evidence of diabetic end organ damage, including ischemic heart disease, left ventricular hypertrophy on ECG, eGFR < 60, retinopathy, heart failure, myocardial infarction, poorly healing wounds (e.g., diabetic foot), amputation, blindness and eye problems.
- Comorbid diabetes and hypertension:
Key exclusion criteria (3 listed)
- Pregnancy
- Hospitalization for the majority of the study period
- Patients who leave the study neighborhood or repatriate to Syria
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 |
|---|---|---|
| Improved Community Health Volunteer (CHV) programMulti-modal intervention targeting intensive household monitoring of "high-needs" patients using monthly visits to measure blood pressure and blood sugar, adherence to treatments and compliance with clinics visits, and motivational interviewing to facilitate behavior change and psychosocial support. | Other | – |
Primary outcome
Proportion of diabetes patients at intake (defined as random blood sugar >= 200 mg/dL at intake) demonstrating a change in random blood sugar (mmHg)
Time frame: Every two months, through study completion (4 to 12 months depending on group)
As measured by point-of-care glucometer
Proportion of hypertension patients at intake (defined as blood pressure >=140/90 mmHg at intake) demonstrating a change in systolic blood pressure (mmHg)
Time frame: Every two months, through study completion (4 to 12 months depending on group)
As measured by electronic blood pressure monitor during household visit
Proportion of patients demonstrating a change in self-reported medication adherence behaviors
Time frame: Every two months, through study completion (4 to 12 months depending on group)
As measured by response to questions on adherence behaviors. This measure uses the Center for Adherence Support Evaluation (CASE) Adherence Index, wherein higher values on a scale of 1 to 6 indicate worse outcomes.
Proportion of patients demonstrating a change in self-reported medication adherence actions (5-day)
Time frame: Every two months, through study completion (4 to 12 months depending on group)
As measured the number of days during the last 5 days in which medication was not taken (during household visit)
Proportion of patients demonstrating a change in self-reported medication adherence actions (30-day)
Time frame: Every two months, through study completion (4 to 12 months depending on group)
As measured the number of days during the last 30 days in which medication was not taken (during household visit)
3 secondary outcomes
Proportion of hypertension patients at intake (defined as blood pressure >=140/90 mmHg at intake) demonstrating a change in diastolic blood pressure (mmHg)
Time frame: Every two months, through study completion (4 to 12 months depending on group)
Proportion of patients demonstrating a change in disease control (defined as blood pressure <140/90 mmHg; <150/90 for patients aged ≥80 years), among patients with hypertension at intake (defined as blood pressure >=140/90 mmHg at intake)
Time frame: Every two months, through study completion (4 to 12 months depending on group)
Proportion of patients demonstrating a change in disease control (defined as random blood sugar <200 mg/dL mmHg), among patients with diabetes at intake (defined as random blood sugar >=200 mg/dL at intake)
Time frame: Every two months, through study completion (4 to 12 months depending on group)
Results and safety
The study was stopped early (reason given: As a result of COVID-19, the intervention design changed and an RCT was no longer an appropriate study design for evaluation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Diabetes Mellitus, Type 1, run by International Rescue Committee at 1 site in United States.
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 8 inclusion and 3 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: stopped early, as of the sponsor's last update on 20 Jul 2021. 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 United States. 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 stopped early (reason given: As a result of COVID-19, the intervention design changed and an RCT was no longer an appropriate study design for evaluation.). Results are not available in the source record.
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?
Proportion of diabetes patients at intake (defined as random blood sugar >= 200 mg/dL at intake) demonstrating a change in random blood sugar (mmHg) (time frame: Every two months, through study completion (4 to 12 months depending on group)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2021.