Feasibility Study of a Novel mHealth Application to Enable Community Health Workers to Manage
Primary Purpose
Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
Guatemala
Study Type
Interventional
Intervention
Anti-Hypertensive
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension
Eligibility Criteria
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
Sites / Locations
- San Lucas MissionRecruiting
Outcomes
Primary Outcome Measures
Change in systolic blood pressure
Difference in systolic blood pressure from baseline to 6 months
Difference in diastolic blood pressure from baseline to 6 months
Difference in diastolic blood pressure from baseline to 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
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05479097
First Posted
July 26, 2022
Last Updated
March 6, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
Fogarty International Center of the National Institute of Health
1. Study Identification
Unique Protocol Identification Number
NCT05479097
Brief Title
Feasibility Study of a Novel mHealth Application to Enable Community Health Workers to Manage
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Fogarty International Center of the National Institute of Health
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
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Anti-Hypertensive
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in systolic blood pressure
Description
Difference in systolic blood pressure from baseline to 6 months
Time Frame
baseline, 6 months
Title
Difference in diastolic blood pressure from baseline to 6 months
Description
Difference in diastolic blood pressure from baseline to 6 months
Time Frame
baseline, 6 months
Title
Change in the proportion of patients with systolic blood pressure less than or equal to 140
Description
Difference in the proportion of patients with systolic blood pressure less than or equal to 140 from baseline to 6 months
Time Frame
baseline, 6 months
Title
Change in the proportion of patients with systolic blood pressure less than or equal to personalized goal
Description
Difference in the proportion of patients with systolic blood pressure less than or equal to personalized goal from baseline to 6 months
Time Frame
baseline, 6 months
Title
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
Description
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.
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sean Duffy, MD
Phone
+1 608 354 7930
Email
sean.duffy@fammed.wisc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary M Checovich, MS
Phone
608-263-2653
Email
mary.checovich@fammed.wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Duffy, MD
Organizational Affiliation
University of Wisconsin-Madison Department of Family Medicine and Community Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Lucas Mission
City
San Lucas Tolimán
State/Province
Sololá
ZIP/Postal Code
07013
Country
Guatemala
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27502908
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.
Results Reference
background
PubMed Identifier
29153113
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.
Results Reference
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PubMed Identifier
24088093
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.
Results Reference
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PubMed Identifier
25592798
Citation
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.
Results Reference
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PubMed Identifier
27886793
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.
Results Reference
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PubMed Identifier
26890177
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.
Results Reference
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PubMed Identifier
26555199
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.
Results Reference
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PubMed Identifier
27993594
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.
Results Reference
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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
Results Reference
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PubMed Identifier
32370572
Citation
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.
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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.
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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.
Results Reference
background
Links:
URL
https://www.who.int/news-room/fact-sheets/detail/hypertension
Description
World Health Organization. Hypertension Fact Sheet 2019
URL
https://www.who.int/publications/i/item/9789241506236
Description
Global Action Plan for the Prevention and Control of NCDs 2013-2020
URL
https://www.knowledge-action-portal.com/en/content/hearts-technical-package
Description
World Health Organization (WHO) HEARTS Technical Package
URL
https://apps.who.int/iris/bitstream/handle/10665/344424/9789240033986-eng.pdf
Description
World Health Organization. Guideline for the pharmacological treatment of hypertension in adults.
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Feasibility Study of a Novel mHealth Application to Enable Community Health Workers to Manage
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