Feasibility Study of a Novel mHealth Application to Enable Community Health Workers to Manage

Hypertension Clinical Trial

Official title:

A Feasibility Study of a Novel mHealth Clinical Decision Support Application to Enable Community Health Workers to Manage Hypertension With Remote Physician Supervision

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05479097
• Other study ID #: 2022-0794
• Secondary ID: Approval Date 7/
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: December 30, 2024
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Greater than 18 years old
• Diagnosed with hypertension
• Blood pressure greater than or equal to 140/90 mm Hg OR
• currently taking antihypertensive medication

Exclusion Criteria:

• Pregnancy
• Severe comorbid condition(s) with life expectancy less than 1 year

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Anti-Hypertensive
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.

Locations

Country	Name	City	State
Guatemala	San Lucas Mission	San Lucas Tolimán	Sololá

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Fogarty International Center of the National Institute of Health

Country where clinical trial is conducted

Guatemala, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

Hunter DJ, Reddy KS. Noncommunicable diseases. N Engl J Med. 2013 Oct 3;369(14):1336-43. doi: 10.1056/NEJMra1109345. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic blood pressure	Difference in systolic blood pressure from baseline to 6 months	baseline, 6 months
Primary	Difference in diastolic blood pressure from baseline to 6 months	Difference in diastolic blood pressure from baseline to 6 months	baseline, 6 months
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	baseline, 6 months
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	baseline, 6 months
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.	Up to 12 months

External Links

•   Global Action Plan for the Prevention and Control of NCDs 2013-2020
•   World Health Organization (WHO) HEARTS Technical Package
•   World Health Organization. Guideline for the pharmacological treatment of hypertension in adults.
•   World Health Organization. Hypertension Fact Sheet 2019