NCT07279415

Brief Summary

The research project will involve community health workers (CHWs) that will help participants to better understand their medical conditions and to responsibly manage their medical needs. The project will focus on participants with the greatest medical needs and those that have many different illnesses at the same time. CHWs will help guide participants in focusing on improving their knowledge and confidence to manage their health conditions and to improve their ability to understand how the healthcare system works. This will give participants the opportunity to take charge of their illnesses and possibly improve their health conditions over time. The CHWs will work together with participants to develop a health plan focused on their specific health needs.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
16mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Dec 2025Sep 2027

First Submitted

Initial submission to the registry

November 18, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

December 20, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

November 18, 2025

Last Update Submit

December 9, 2025

Conditions

Keywords

community health worker, co-morbidities

Outcome Measures

Primary Outcomes (1)

  • Patient Activation Measure

    Scored from 0 to 100 with higher scores denoting higher levels of patient activation, it measures participant knowledge, skills, and confidence to manage their own health and healthcare, navigate the healthcare system, and address social barriers that create challenges in their ability to achieve optimal health.

    From enrollment to end of 9 months

Study Arms (2)

Community Health Worker Support - Pre-scheduled sessions

ACTIVE COMPARATOR
Behavioral: Intervention

Community Health Worker Support - Participant-requested sessions

ACTIVE COMPARATOR
Behavioral: Control Group

Interventions

Control GroupBEHAVIORAL

Persons in the comparator group will receive support to complete an IHAP and access to an interactive community resource website. CHWs will remain available to comparator group participants in response to communicated need and interest but will not provide active outreach to participants.

Community Health Worker Support - Participant-requested sessions
InterventionBEHAVIORAL

Persons assigned to the intervention group will receive strategic and intentional outreach and support from a CHW for 9 months to carry out the patient activation intervention. CHWs will work with persons in the intervention group to develop an Individual Patient Health Activation Plan (IHAP) that is informed by the participants individual health conditions. The IHAP will address priorities and barriers to obtaining optimal health, access to care, and adherence to a health care plan. CHWs will actively outreach the study participant a minimum of monthly to see how they are doing and to update or modify the IHAP, as needed. They will assist the participant in understanding medical advice, developing chronic disease self-management skills, accessing health care, making appointments, and addressing challenges arising from SDoH. CHWs will also utilize motivational interviewing to assist participants in making

Community Health Worker Support - Pre-scheduled sessions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older,
  • Able to speak and understand English
  • Have been told by a health care provider that they have two or more, chronic health conditions
  • Are classified as medically underserved or socially vulnerable person

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (24)

  • 24. Association of State and Territorial Health Officials. (n.d.). Community health workers: evidence of their effectiveness. Association of State and Territorial Health Officials. Accessed on April 10, 2025: https://www.astho.org/globalassets/pdf/community-health-workers-summary-evidence.pdf

    BACKGROUND
  • Kangovi S, Mitra N, Turr L, Huo H, Grande D, Long JA. A randomized controlled trial of a community health worker intervention in a population of patients with multiple chronic diseases: Study design and protocol. Contemp Clin Trials. 2017 Feb;53:115-121. doi: 10.1016/j.cct.2016.12.009. Epub 2016 Dec 10.

    PMID: 27965180BACKGROUND
  • Crespo R, Christiansen M, Tieman K, Wittberg R. An Emerging Model for Community Health Worker-Based Chronic Care Management for Patients With High Health Care Costs in Rural Appalachia. Prev Chronic Dis. 2020 Feb 13;17:E13. doi: 10.5888/pcd17.190316.

    PMID: 32053481BACKGROUND
  • 21. Patel MI, Kapphahn K, Salava D, et al. The effect of a multilevel community health worker-led intervention on health-related quality of life, patient activation, acute care use, and total costs of care: A randomized controlled trial. Journal of Clinical Oncology. 2022;40(16_suppl):6500-6500.

    BACKGROUND
  • Jana S, Basu I, Rotheram-Borus MJ, Newman PA. The Sonagachi Project: a sustainable community intervention program. AIDS Educ Prev. 2004 Oct;16(5):405-14. doi: 10.1521/aeap.16.5.405.48734.

    PMID: 15491952BACKGROUND
  • Liebman AK, Juarez PM, Leyva C, Corona A. A pilot program using promotoras de salud to educate farmworker families about the risk from pesticide exposure. J Agromedicine. 2007;12(2):33-43. doi: 10.1300/J096v12n02_04.

    PMID: 18086652BACKGROUND
  • Morgan K, Lee J, Sebar B. Community health workers: a bridge to healthcare for people who inject drugs. Int J Drug Policy. 2015 Apr;26(4):380-7. doi: 10.1016/j.drugpo.2014.11.001. Epub 2014 Nov 13.

    PMID: 25477284BACKGROUND
  • Stupplebeen DA, Barnett-Sherrill AT, Sentell TL. Community Health Workers in Hawai'i: A Scoping Review and Framework Analysis of Existing Evidence. Hawaii J Med Public Health. 2019 Jun;78(6 Suppl 1):6-14.

    PMID: 31285962BACKGROUND
  • Bellhouse S, McWilliams L, Firth J, Yorke J, French DP. Are community-based health worker interventions an effective approach for early diagnosis of cancer? A systematic review and meta-analysis. Psychooncology. 2018 Apr;27(4):1089-1099. doi: 10.1002/pon.4575. Epub 2017 Nov 23.

    PMID: 29080378BACKGROUND
  • Gwede CK, Ashley AA, McGinnis K, Montiel-Ishino FA, Standifer M, Baldwin J, Williams C, Sneed KB, Wathington D, Dash-Pitts L, Green BL. Designing a community-based lay health advisor training curriculum to address cancer health disparities. Health Promot Pract. 2013 May;14(3):415-24. doi: 10.1177/1524839912458675. Epub 2012 Sep 14.

    PMID: 22982709BACKGROUND
  • Gilmore B, McAuliffe E. Effectiveness of community health workers delivering preventive interventions for maternal and child health in low- and middle-income countries: a systematic review. BMC Public Health. 2013 Sep 13;13:847. doi: 10.1186/1471-2458-13-847.

    PMID: 24034792BACKGROUND
  • Kangovi S, Mitra N, Norton L, Harte R, Zhao X, Carter T, Grande D, Long JA. Effect of Community Health Worker Support on Clinical Outcomes of Low-Income Patients Across Primary Care Facilities: A Randomized Clinical Trial. JAMA Intern Med. 2018 Dec 1;178(12):1635-1643. doi: 10.1001/jamainternmed.2018.4630.

    PMID: 30422224BACKGROUND
  • Vasan A, Morgan JW, Mitra N, Xu C, Long JA, Asch DA, Kangovi S. Effects of a standardized community health worker intervention on hospitalization among disadvantaged patients with multiple chronic conditions: A pooled analysis of three clinical trials. Health Serv Res. 2020 Oct;55 Suppl 2(Suppl 2):894-901. doi: 10.1111/1475-6773.13321. Epub 2020 Jul 8.

    PMID: 32643163BACKGROUND
  • 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: 26890177BACKGROUND
  • Swider SM. Outcome effectiveness of community health workers: an integrative literature review. Public Health Nurs. 2002 Jan-Feb;19(1):11-20. doi: 10.1046/j.1525-1446.2002.19003.x.

    PMID: 11841678BACKGROUND
  • Covert H, Sherman M, Miner K, Lichtveld M. Core Competencies and a Workforce Framework for Community Health Workers: A Model for Advancing the Profession. Am J Public Health. 2019 Feb;109(2):320-327. doi: 10.2105/AJPH.2018.304737. Epub 2018 Dec 20.

    PMID: 30571307BACKGROUND
  • Knowles M, Crowley AP, Vasan A, Kangovi S. Community Health Worker Integration with and Effectiveness in Health Care and Public Health in the United States. Annu Rev Public Health. 2023 Apr 3;44:363-381. doi: 10.1146/annurev-publhealth-071521-031648.

    PMID: 37010928BACKGROUND
  • Hill-Briggs F, Adler NE, Berkowitz SA, Chin MH, Gary-Webb TL, Navas-Acien A, Thornton PL, Haire-Joshu D. Social Determinants of Health and Diabetes: A Scientific Review. Diabetes Care. 2020 Nov 2;44(1):258-79. doi: 10.2337/dci20-0053. Online ahead of print. No abstract available.

    PMID: 33139407BACKGROUND
  • Novilla MLB, Goates MC, Leffler T, Novilla NKB, Wu CY, Dall A, Hansen C. Integrating Social Care into Healthcare: A Review on Applying the Social Determinants of Health in Clinical Settings. Int J Environ Res Public Health. 2023 Oct 2;20(19):6873. doi: 10.3390/ijerph20196873.

    PMID: 37835143BACKGROUND
  • Shahid R, Shoker M, Chu LM, Frehlick R, Ward H, Pahwa P. Impact of low health literacy on patients' health outcomes: a multicenter cohort study. BMC Health Serv Res. 2022 Sep 12;22(1):1148. doi: 10.1186/s12913-022-08527-9.

    PMID: 36096793BACKGROUND
  • Coughlin SS, Vernon M, Hatzigeorgiou C, George V. Health Literacy, Social Determinants of Health, and Disease Prevention and Control. J Environ Health Sci. 2020;6(1):3061. Epub 2020 Dec 16. No abstract available.

    PMID: 33604453BACKGROUND
  • DE Hert M, Correll CU, Bobes J, Cetkovich-Bakmas M, Cohen D, Asai I, Detraux J, Gautam S, Moller HJ, Ndetei DM, Newcomer JW, Uwakwe R, Leucht S. Physical illness in patients with severe mental disorders. I. Prevalence, impact of medications and disparities in health care. World Psychiatry. 2011 Feb;10(1):52-77. doi: 10.1002/j.2051-5545.2011.tb00014.x.

    PMID: 21379357BACKGROUND
  • Woolf SH, Braveman P. Where health disparities begin: the role of social and economic determinants--and why current policies may make matters worse. Health Aff (Millwood). 2011 Oct;30(10):1852-9. doi: 10.1377/hlthaff.2011.0685.

    PMID: 21976326BACKGROUND
  • Shadmi E. Disparities in multiple chronic conditions within populations. J Comorb. 2013 Dec 24;3(Spec Issue):45-50. doi: 10.15256/joc.2013.3.24. eCollection 2013.

    PMID: 29090147BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusHypertensionRenal Insufficiency, ChronicHypercholesterolemia

Interventions

MethodsControl Groups

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperlipidemiasDyslipidemiasLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Investigative TechniquesEpidemiologic Research DesignEpidemiologic MethodsResearch Design

Study Officials

  • Stephania M Miller-Hughes, PhD, MS, MSCI

    Meharry Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle King, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 12, 2025

Study Start

December 20, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

December 12, 2025

Record last verified: 2025-12