Using Lay Health Advisors to Improve Hypertension Management

NCT03515005 | Terminated

• 1 other identifier: IRB18-00038
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Hypertension; Community Health Workers; Community-Based Participatory Research; Health Equity

Outcome Measures

Primary Outcomes (1)

• Change in systolic and diastolic blood pressure

  Difference between final and initial systolic and diastolic blood pressure readings

  1 year

Secondary Outcomes (1)

• Change in quality of life.

  1 year

Study Arms (2)

Lay Health Advisors

EXPERIMENTAL

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

Behavioral: Lay Health Advisor

Usual Care

NO INTERVENTION

Control patients will receive usual care from their doctors.

Interventions

Lay Health Advisor BEHAVIORAL

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

Lay Health Advisors

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Mentally incompetent
• Pregnant
• Terminal illness
• Active substance abuse
• Documented coronary, peripheral arterial, or cerebrovascular disease

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

The MetroHealth System

Cleveland, Ohio, 44109, United States

Location

Related Publications (18)

• 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.

  PMID: 25332288 BACKGROUND

• 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.

  PMID: 16571689 BACKGROUND

• 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.

  PMID: 11897761 BACKGROUND

• 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.

  PMID: 16520513 BACKGROUND

• 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.

  PMID: 25354075 BACKGROUND

• 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.

  PMID: 15894958 BACKGROUND

• 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.

  PMID: 10371363 BACKGROUND

• 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.

  PMID: 17261462 BACKGROUND

• 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.

  PMID: 11012800 BACKGROUND

• 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.

  PMID: 24569976 BACKGROUND

• 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.

  PMID: 21958468 BACKGROUND

• 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.

  PMID: 9247822 BACKGROUND

• 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.

  PMID: 24837989 BACKGROUND

• 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.

  PMID: 22585883 BACKGROUND

• 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.

  PMID: 17478270 BACKGROUND

• 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.

  PMID: 10358675 BACKGROUND

• 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.

  PMID: 18290982 BACKGROUND

• 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.

  PMID: 22403202 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• John D Thornton, MD, MPH

  MetroHealth System, Ohio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: May 3, 2018
• Study Start: December 3, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)