Using Lay Health Advisors to Improve Hypertension Management

NCT ID: NCT03515005

Last Updated: 2021-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-03

Study Completion Date

2019-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hypertension disproportionately affects and is inadequately controlled among African American and poor populations. The investigators propose to determine the impact of using trained lay health advisors to help patients address social contextual factors that influence the management of hypertension.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Hypertension disproportionately affects and is inadequately controlled among African American and poor populations. Health providers generally lack the skills and resources to address social contextual factors (i.e. health and community services, social networks, social stressors, physical environment, and economic resources) that influence management of hypertension. Instead, providers tend to focus on adjusting antihypertensive medication prescriptions and exhorting patients to exercise and eat better. The investigators propose to determine the impact of using trained lay health advisors to help patients address social contextual factors that influence the management of hypertension. Helping patients address these barriers may lead not only to improved blood pressure but also to increased survival, reduced organ damage, and decreased health care costs. This project may also serve as a model of healthcare delivery innovation that could be used to address other health disparity conditions.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lay Health Advisors

Intervention patients will meet monthly in small groups with a trained Lay Health Advisor.

Group Type EXPERIMENTAL

Lay Health Advisor

Intervention Type BEHAVIORAL

Patients will meet regularly Lay Health Advisors who will address the social context of their hypertension.

Usual Care

Control patients will receive usual care from their doctors.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lay Health Advisor

Patients will meet regularly Lay Health Advisors who will address the social context of their hypertension.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* At least 2 outpatient blood pressures with systolic \>140 or diastolic \>90 mm Hg in last 6 months. Separate occurrences at least 1 day apart
* Age 18-59 years
* Non-diabetic
* Preserved kidney function (glomerular filtration rate \>60 ml/min)
* English speaking

Exclusion Criteria

* Mentally incompetent
* Pregnant
* Terminal illness
* Active substance abuse
* Documented coronary, peripheral arterial, or cerebrovascular disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

MetroHealth Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daryl Thornton, MD

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John D Thornton, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

MetroHealth System, Ohio

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The MetroHealth System

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Egan BM, Li J, Hutchison FN, Ferdinand KC. Hypertension in the United States, 1999 to 2012: progress toward Healthy People 2020 goals. Circulation. 2014 Nov 4;130(19):1692-9. doi: 10.1161/CIRCULATIONAHA.114.010676. Epub 2014 Oct 20.

Reference Type BACKGROUND
PMID: 25332288 (View on PubMed)

James SA, Van Hoewyk J, Belli RF, Strogatz DS, Williams DR, Raghunathan TE. Life-course socioeconomic position and hypertension in African American men: the Pitt County Study. Am J Public Health. 2006 May;96(5):812-7. doi: 10.2105/AJPH.2005.076158. Epub 2006 Mar 29.

Reference Type BACKGROUND
PMID: 16571689 (View on PubMed)

Matthews KA, Kiefe CI, Lewis CE, Liu K, Sidney S, Yunis C; Coronary Artery Risk Development in Young Adults Study (CARDIA). Socioeconomic trajectories and incident hypertension in a biracial cohort of young adults. Hypertension. 2002 Mar 1;39(3):772-6. doi: 10.1161/hy0302.105682.

Reference Type BACKGROUND
PMID: 11897761 (View on PubMed)

Cook S, Drum ML, Kirchhoff AC, Jin L, Levie J, Harrison JF, Lippold SA, Schaefer CT, Chin MH. Providers' assessment of barriers to effective management of hypertension and hyperlipidemia in community health centers. J Health Care Poor Underserved. 2006 Feb;17(1):70-85. doi: 10.1353/hpu.2006.0021.

Reference Type BACKGROUND
PMID: 16520513 (View on PubMed)

Mercuri M, Sherbino J, Sedran RJ, Frank JR, Gafni A, Norman G. When guidelines don't guide: the effect of patient context on management decisions based on clinical practice guidelines. Acad Med. 2015 Feb;90(2):191-6. doi: 10.1097/ACM.0000000000000542.

Reference Type BACKGROUND
PMID: 25354075 (View on PubMed)

Borzecki AM, Oliveria SA, Berlowitz DR. Barriers to hypertension control. Am Heart J. 2005 May;149(5):785-94. doi: 10.1016/j.ahj.2005.01.047. No abstract available.

Reference Type BACKGROUND
PMID: 15894958 (View on PubMed)

Hill MN, Bone LR, Hilton SC, Roary MC, Kelen GD, Levine DM. A clinical trial to improve high blood pressure care in young urban black men: recruitment, follow-up, and outcomes. Am J Hypertens. 1999 Jun;12(6):548-54. doi: 10.1016/s0895-7061(99)00007-2.

Reference Type BACKGROUND
PMID: 10371363 (View on PubMed)

Dennison CR, Post WS, Kim MT, Bone LR, Cohen D, Blumenthal RS, Rame JE, Roary MC, Levine DM, Hill MN. Underserved urban african american men: hypertension trial outcomes and mortality during 5 years. Am J Hypertens. 2007 Feb;20(2):164-71. doi: 10.1016/j.amjhyper.2006.08.003.

Reference Type BACKGROUND
PMID: 17261462 (View on PubMed)

Rose LE, Kim MT, Dennison CR, Hill MN. The contexts of adherence for African Americans with high blood pressure. J Adv Nurs. 2000 Sep;32(3):587-94. doi: 10.1046/j.1365-2648.2000.01538.x.

Reference Type BACKGROUND
PMID: 11012800 (View on PubMed)

Russell E, Johnson B, Larsen H, Novilla ML, van Olmen J, Swanson RC. Health systems in context: a systematic review of the integration of the social determinants of health within health systems frameworks. Rev Panam Salud Publica. 2013 Dec;34(6):461-7.

Reference Type BACKGROUND
PMID: 24569976 (View on PubMed)

Wong K, Smalarz A, Wu N, Boulanger L, Wogen J. The association between hypertension-specific care management processes and blood pressure outcomes in US-based physician organizations. J Am Soc Hypertens. 2011 Nov-Dec;5(6):505-12. doi: 10.1016/j.jash.2011.08.002. Epub 2011 Oct 1.

Reference Type BACKGROUND
PMID: 21958468 (View on PubMed)

Jackson EJ, Parks CP. Recruitment and training issues from selected lay health advisor programs among African Americans: a 20-year perspective. Health Educ Behav. 1997 Aug;24(4):418-31. doi: 10.1177/109019819702400403.

Reference Type BACKGROUND
PMID: 9247822 (View on PubMed)

Dye CJ, Williams JE, Evatt JH. Improving hypertension self-management with community health coaches. Health Promot Pract. 2015 Mar;16(2):271-81. doi: 10.1177/1524839914533797. Epub 2014 May 16.

Reference Type BACKGROUND
PMID: 24837989 (View on PubMed)

Margolius D, Bodenheimer T, Bennett H, Wong J, Ngo V, Padilla G, Thom DH. Health coaching to improve hypertension treatment in a low-income, minority population. Ann Fam Med. 2012 May-Jun;10(3):199-205. doi: 10.1370/afm.1369.

Reference Type BACKGROUND
PMID: 22585883 (View on PubMed)

Brownstein JN, Chowdhury FM, Norris SL, Horsley T, Jack L Jr, Zhang X, Satterfield D. Effectiveness of community health workers in the care of people with hypertension. Am J Prev Med. 2007 May;32(5):435-47. doi: 10.1016/j.amepre.2007.01.011.

Reference Type BACKGROUND
PMID: 17478270 (View on PubMed)

Krieger J, Collier C, Song L, Martin D. Linking community-based blood pressure measurement to clinical care: a randomized controlled trial of outreach and tracking by community health workers. Am J Public Health. 1999 Jun;89(6):856-61. doi: 10.2105/ajph.89.6.856.

Reference Type BACKGROUND
PMID: 10358675 (View on PubMed)

Connell P, Wolfe C, McKevitt C. Preventing stroke: a narrative review of community interventions for improving hypertension control in black adults. Health Soc Care Community. 2008 Mar;16(2):165-87. doi: 10.1111/j.1365-2524.2007.00737.x.

Reference Type BACKGROUND
PMID: 18290982 (View on PubMed)

Margolius D, Wong J, Goldman ML, Rouse-Iniguez J, Bodenheimer T. Delegating responsibility from clinicians to nonprofessional personnel: the example of hypertension control. J Am Board Fam Med. 2012 Mar-Apr;25(2):209-15. doi: 10.3122/jabfm.2012.02.100279.

Reference Type BACKGROUND
PMID: 22403202 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB18-00038

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.