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| ID | Type | Description | Link |
|---|---|---|---|
| Approval Date 7/2/2022 | Other Identifier | UW Madison | |
| A532050 | Other Identifier | UW Madison | |
| 1R21TW011891-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
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This is a single group study assessing the feasibility of hypertension management by community health workers (CHWs) equipped with a mobile clinical decision support (CDS) application and working with remote physician supervision.
An estimated 1.13 billion people worldwide are currently living with hypertension, the leading preventable cause of death and disability. Two thirds of these patients live in low- and middle-income countries (LMIC). Treatment of hypertension has been found to be cost-effective in reducing morbidity and mortality across a broad range of settings. Despite this, less than 10% of patients with hypertension in LMIC have good control of their blood pressure. Health systems in LMIC, which are often focused on providing episodic care for acute illnesses and suffer from inadequate and poorly distributed health care infrastructure and workforce, are ill-equipped to address the rise in chronic non-communicable diseases (NCDs) such as hypertension. Governments and NGOs are increasingly turning to community health workers (CHWs) - lay people trained to carry out a variety of tasks and who often are from or have a close connection to the communities they serve - to help fill care gaps for hypertension and other NCDs in LMIC. In most cases, CHWs have played supportive (e.g. providing patient education) rather than direct care roles. While such programs have led to improved chronic disease outcomes, they still rely on clinic-based physicians, mid-level providers or nurses to directly provide medical management, and therefore do not address the essential problem of inadequate primary care infrastructure and workforce, particularly in rural areas. Overcoming this problem is key to reducing the growing burden of untreated hypertension in LMIC.
To solve this problem, the investigators are developing an innovative mobile application to assist CHWs in the treatment of hypertension in adults with remote physician supervision. This application is built on the widely-used CommCare platform and will provide clinical decision support (CDS) to CHWs based on protocols from the WHO and the International Society of Hypertension for antihypertensive medication initiation and titration, lifestyle counseling, and identification of patients requiring a higher level of care. The investigators will develop and test this approach in a rural area of Guatemala with poor primary care infrastructure and where the team has worked extensively in the past and has an ongoing collaboration with a local NGO, the San Lucas Mission, and affiliated CHWs. Through this collaboration, the investigators have developed and implemented a CHW-led rural diabetes program enabled by a CDS mobile application and have demonstrated that CHWs can safely and effectively manage diabetes using the application. The hypothesis is that the investigators will be able to adapt the model to hypertension management and are evaluating the feasibility of this approach with this pilot study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-Hypertensive | Drug | Based on information entered by the CHWs into the CommCare application designed for this study, the application will provide recommendations (and underlying rationale for these recommendations) for prescription of antihypertensives (amlodipine and/or losartan OR enalapril) and medications to reduce cardiovascular risk (aspirin and atorvastatin) if indicated, lifestyle modification, and referral to the supervising physician if indicated for potential complications of hypertension. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure | Difference in systolic blood pressure from baseline to 6 months | baseline, 6 months |
| Difference in Diastolic Blood Pressure From Baseline to 6 Months | Difference in diastolic blood pressure from baseline to 6 months | baseline, 6 months |
| Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to 140 | Difference in the proportion of patients with systolic blood pressure less than or equal to 140 from baseline to 6 months | baseline, 6 months |
| Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to Personalized Goal | Difference in the proportion of patients with systolic blood pressure less than or equal to personalized goal from baseline to 6 months | baseline, 6 months |
| Proportion of Visits for Which Both the CHW Conducting the Visit and the Physician Reviewing Post-visit Data Agreed With the Antihypertensive Recommendations Provided by the CDS Application | This measure will be calculated as the proportion of visits for which both the CHW conducting the visit and the physician reviewing post-visit data agreed with the antihypertensive recommendations provided by the application. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean Duffy, MD | University of Wisconsin-Madison Department of Family Medicine and Community Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Lucas Mission | San Lucas Tolimán | Departamento de Sololá | 07013 | Guatemala |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27502908 | Background | Mills KT, Bundy JD, Kelly TN, Reed JE, Kearney PM, Reynolds K, Chen J, He J. Global Disparities of Hypertension Prevalence and Control: A Systematic Analysis of Population-Based Studies From 90 Countries. Circulation. 2016 Aug 9;134(6):441-50. doi: 10.1161/CIRCULATIONAHA.115.018912. | |
| 29153113 | Background | Zhang D, Wang G, Joo H. A Systematic Review of Economic Evidence on Community Hypertension Interventions. Am J Prev Med. 2017 Dec;53(6S2):S121-S130. doi: 10.1016/j.amepre.2017.05.008. |
| Label | URL |
|---|---|
| World Health Organization. Hypertension Fact Sheet 2019 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Participants | All study participants were enrolled in a single arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Participants | All study participants were enrolled in a single arm. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Systolic Blood Pressure | Difference in systolic blood pressure from baseline to 6 months | All participants who completed the 6 month follow-up visit | Posted | Median | 95% Confidence Interval | mmHg | baseline, 6 months |
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Six months.
Vitals were measured and participants were assessed for medication side effects and potential complications of hypertension at monthly visits using a standardized data collection application. Laboratory testing, including serum creatinine, electrolytes, lipid profile, blood glucose, and ALT was conducted for participants at the enrollment visit and at the 6 month visit, as well as in other points for selected subjects per the medical judgement of the supervising physician.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Participants | All study participants were enrolled in a single arm. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sean Duffy | University of Wisconsin School of Medicine and Public Health | 608-263-3111 | sean.duffy@fammed.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 2, 2023 | Jun 14, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2022 | Jun 14, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 27, 2023 | Jul 11, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000959 | Antihypertensive Agents |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| 24088093 | Background | Hunter DJ, Reddy KS. Noncommunicable diseases. N Engl J Med. 2013 Oct 3;369(14):1336-43. doi: 10.1056/NEJMra1109345. No abstract available. |
| 25592798 | Background | Checkley W, Ghannem H, Irazola V, Kimaiyo S, Levitt NS, Miranda JJ, Niessen L, Prabhakaran D, Rabadan-Diehl C, Ramirez-Zea M, Rubinstein A, Sigamani A, Smith R, Tandon N, Wu Y, Xavier D, Yan LL; GRAND South Network, UnitedHealth Group/National Heart, Lung, and Blood Institute Centers of Excellence. Management of NCD in low- and middle-income countries. Glob Heart. 2014 Dec;9(4):431-43. doi: 10.1016/j.gheart.2014.11.003. |
| 27886793 | Background | Vedanthan R, Bernabe-Ortiz A, Herasme OI, Joshi R, Lopez-Jaramillo P, Thrift AG, Webster J, Webster R, Yeates K, Gyamfi J, Ieremia M, Johnson C, Kamano JH, Lazo-Porras M, Limbani F, Liu P, McCready T, Miranda JJ, Mohan S, Ogedegbe O, Oldenburg B, Ovbiagele B, Owolabi M, Peiris D, Ponce-Lucero V, Praveen D, Pillay A, Schwalm JD, Tobe SW, Trieu K, Yusoff K, Fuster V. Innovative Approaches to Hypertension Control in Low- and Middle-Income Countries. Cardiol Clin. 2017 Feb;35(1):99-115. doi: 10.1016/j.ccl.2016.08.010. |
| 26890177 | Background | Kim K, Choi JS, Choi E, Nieman CL, Joo JH, Lin FR, Gitlin LN, Han HR. Effects of Community-Based Health Worker Interventions to Improve Chronic Disease Management and Care Among Vulnerable Populations: A Systematic Review. Am J Public Health. 2016 Apr;106(4):e3-e28. doi: 10.2105/AJPH.2015.302987. Epub 2016 Feb 18. |
| 26555199 | Background | Mishra SR, Neupane D, Preen D, Kallestrup P, Perry HB. Mitigation of non-communicable diseases in developing countries with community health workers. Global Health. 2015 Nov 10;11:43. doi: 10.1186/s12992-015-0129-5. |
| 27993594 | Background | Khetan AK, Purushothaman R, Chami T, Hejjaji V, Madan Mohan SK, Josephson RA, Webel AR. The Effectiveness of Community Health Workers for CVD Prevention in LMIC. Glob Heart. 2017 Sep;12(3):233-243.e6. doi: 10.1016/j.gheart.2016.07.001. Epub 2016 Dec 16. |
| Background | Svoronos T, Mjungu P, Dhadialla R, Luk R, Zue C, Jackson J, et al. CommCare: Automated quality improvement to strengthen community-based health. Weston: D-Tree International 2010 |
| 32370572 | Background | Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, Ramirez A, Schlaich M, Stergiou GS, Tomaszewski M, Wainford RD, Williams B, Schutte AE. 2020 International Society of Hypertension Global Hypertension Practice Guidelines. Hypertension. 2020 Jun;75(6):1334-1357. doi: 10.1161/HYPERTENSIONAHA.120.15026. Epub 2020 May 6. No abstract available. |
| 30858263 | Background | Duffy S, Svenson J, Chavez A, Kelly M, Wise P. Empowering Community Health Workers With Mobile Technology to Treat Diabetes. Ann Fam Med. 2019 Mar;17(2):176. doi: 10.1370/afm.2361. No abstract available. |
| 33361237 | Background | Duffy S, Norton D, Kelly M, Chavez A, Tun R, Ramirez MNG, Chen G, Wise P, Svenson J. Using Community Health Workers and a Smartphone Application to Improve Diabetes Control in Rural Guatemala. Glob Health Sci Pract. 2020 Dec 23;8(4):699-720. doi: 10.9745/GHSP-D-20-00076. Print 2020 Dec 23. |
| Global Action Plan for the Prevention and Control of NCDs 2013-2020 | View source |
| World Health Organization (WHO) HEARTS Technical Package | View source |
| World Health Organization. Guideline for the pharmacological treatment of hypertension in adults. | View source |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Systolic blood pressure | Median | Inter-Quartile Range | mmHg |
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| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
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| Primary | Difference in Diastolic Blood Pressure From Baseline to 6 Months | Difference in diastolic blood pressure from baseline to 6 months | Participants who completed the 6 month visit | Posted | Mean | 95% Confidence Interval | mmHg | baseline, 6 months |
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|
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| Primary | Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to 140 | Difference in the proportion of patients with systolic blood pressure less than or equal to 140 from baseline to 6 months | Study participants who completed the 6 month visit. | Posted | Count of Participants | Participants | baseline, 6 months |
|
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| Primary | Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to Personalized Goal | Difference in the proportion of patients with systolic blood pressure less than or equal to personalized goal from baseline to 6 months | Participants who completed the 6 month visit. Note that this outcome is the same as outcome #3 (change in proportion of patients with systolic blood pressure <=140 mmHg) because no patients had a personalized goal different than <=140 mmHg. | Posted | Count of Participants | Participants | baseline, 6 months |
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| Primary | Proportion of Visits for Which Both the CHW Conducting the Visit and the Physician Reviewing Post-visit Data Agreed With the Antihypertensive Recommendations Provided by the CDS Application | This measure will be calculated as the proportion of visits for which both the CHW conducting the visit and the physician reviewing post-visit data agreed with the antihypertensive recommendations provided by the application. | Posted | Count of Units | Patient visits | 6 months | Patient visits | Patient visits |
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| 32 |
| 0 |
| 32 |
| 16 |
| 32 |
| Non-cardiac chest pain | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment | Asymptomatic systolic blood pressure <90 mmHg |
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| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE (5.0) | Systematic Assessment |
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| Syncope | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
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| Heart failure | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
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| Systolic blood pressure not controlled (>140 mmHg) |
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| Systolic blood pressure greater than personalized goal |
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