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

NCT05479097 | Completed Results

• 4 other identifiers: 2022-0794Approval Date 7/2/2022A5320501R21TW011891-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (5)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

San Lucas Mission

San Lucas Tolimán, Departamento de Sololá, 07013, Guatemala

Location

Related Publications (12)

• 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.

  PMID: 27502908 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.

  PMID: 29153113 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.

  PMID: 24088093 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.

  PMID: 25592798 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.

  PMID: 27886793 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.

  PMID: 26890177 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.

  PMID: 26555199 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.

  PMID: 27993594 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

  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.

  PMID: 32370572 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.

  PMID: 30858263 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.

  PMID: 33361237 BACKGROUND

Related Links

• World Health Organization. Hypertension Fact Sheet 2019
• 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.

MeSH Terms

Conditions

Hypertension

Interventions

Antihypertensive Agents

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Dr. Sean Duffy
• Organization: University of Wisconsin School of Medicine and Public Health

sean.duffy@fammed.wisc.edu

608-263-3111

Study Officials

• Sean Duffy, MD

  University of Wisconsin-Madison Department of Family Medicine and Community Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 29, 2022
• Study Start: February 6, 2023
• Primary Completion: August 15, 2023
• Study Completion: December 31, 2023
• Last Updated: July 16, 2024
• Results First Posted: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)