DiabetesNCT07279415
Activate Tennessee: A CHW-Supported Program for Patient Activation
A study testing Intervention in people with Diabetes and Hypertension, run by Meharry Medical College.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Hypertension, Cardio Vascular Disease
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Danielle King, PhD contact
About this study
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.
Read the detailed description
Medically underserved persons living with at least two chronic conditions will be recruited for the study.
Participants 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 participants in the intervention group to develop an Individual Patient Health Activation Plan (IHAP) that is informed by the participants individual health conditions and responses to survey questions. CHWs will actively engage in outreach with participants at a minimum of once a month 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 social determinants of health. CHWs will also utilize motivational interviewing to assist participants in making progress on their activation goals. CHWs will follow up with the study participant monthly but remain available to participants as frequently as participants communicate the need and interest. Beyond the minimum frequency of monthly, the length and frequency of visits will be determined collaboratively based on participant needs and goals. Fidelity will be measured by completion of participant's IHAP and monthly completion of CHW documentation including documented use of at least two patient activation interventions.
Participants 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.
Both groups s will meet with the CHWs four times (Baseline, 3 months, 6 months, and 9 months) to complete study surveys and questionnaires, including the patient activation, the primary study outcome.
- Conditions
- Diabetes, Hypertension, Cardio Vascular Disease, Infectious Diseases Morbidity, Chronic Kidney Disease, Hypercholesterolemia
- Being tested
- Intervention, Control Group
- Keywords
- community health worker, co-morbidities
- Medical subject headings
- Diabetes Mellitus, Hypertension, Renal Insufficiency, Chronic, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
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
Control GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Community Health Worker Support - Pre-scheduled sessions | Active comparator | Not described Receives: Behavioral: Intervention |
| Community Health Worker Support - Participant-requested sessions | Active comparator | Not described Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to end of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meharry Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Baptist Memorial Health Care Corporation, National Heart, Lung, and Blood Institute (NHLBI), Cherokee Health Systems
- Responsible party
- Principal investigator, Stephania T. Miller-Hughes, Meharry Medical College
- Investigators
- Stephania M Miller-Hughes, PhD, MS, MSCI, Principal investigator, Meharry Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279415
- Sponsor's protocol ID
- TR72217X5599
- Other IDs
- OT2HL158287
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
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.
PubMed 27965180Crespo 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.
PubMed 3205348121. 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.
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.
PubMed 15491952Liebman 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.
PubMed 18086652Morgan 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.
PubMed 25477284Stupplebeen 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.
PubMed 31285962Bellhouse 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.
PubMed 29080378Gwede 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.
PubMed 22982709Gilmore 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.
PubMed 24034792Kangovi 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.
PubMed 30422224Vasan 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.
PubMed 32643163Kim 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.
PubMed 26890177Swider 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.
PubMed 11841678
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activate Tennessee: A CHW-Supported Program for Patient Activation
- ClinicalTrials.gov ID
- NCT07279415
- Acronym / sponsor ID
- TR72217X5599
- Conditions
- Diabetes, Hypertension, Cardio Vascular Disease, Infectious Diseases Morbidity, Chronic Kidney Disease, Hypercholesterolemia
- Keywords
- community health worker, co-morbidities
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Meharry Medical CollegeUniversity, hospital or other
- Collaborators
- Baptist Memorial Health Care Corporation, National Heart, Lung, and Blood Institute (NHLBI), Cherokee Health Systems
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Medically underserved persons living with at least two chronic conditions will be recruited for the study.
Participants 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 participants in the intervention group to develop an Individual Patient Health Activation Plan (IHAP) that is informed by the participants individual health conditions and responses to survey questions. CHWs will actively engage in outreach with participants at a minimum of once a month 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 social determinants of health. CHWs will also utilize motivational interviewing to assist participants in making progress on their activation goals. CHWs will follow up with the study participant monthly but remain available to participants as frequently as participants communicate the need and interest. Beyond the minimum frequency of monthly, the length and frequency of visits will be determined collaboratively based on participant needs and goals. Fidelity will be measured by completion of participant's IHAP and monthly completion of CHW documentation including documented use of at least two patient activation interventions.
Participants 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.
Both groups s will meet with the CHWs four times (Baseline, 3 months, 6 months, and 9 months) to complete study surveys and questionnaires, including the patient activation, the primary study outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker Support - Pre-scheduled sessions | Active comparator | Behavioral: Intervention |
| Community Health Worker Support - Participant-requested sessions | Active comparator | Behavioral: Control Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionPersons 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 | Behavioural | Community Health Worker Support - Pre-scheduled sessions |
| Control GroupPersons 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. | Behavioural | Community Health Worker Support - Participant-requested sessions |
Primary outcome
Patient Activation Measure
Time frame: From enrollment to end of 9 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Background24. 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: PubMed 27965180Kangovi 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.
- Background: PubMed 32053481Crespo 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.
- Background21. 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: PubMed 15491952Jana 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.
- Background: PubMed 18086652Liebman 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.
- Background: PubMed 25477284Morgan 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.
- Background: PubMed 31285962Stupplebeen 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.
- Background: PubMed 29080378Bellhouse 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.
- Background: PubMed 22982709Gwede 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.
- Background: PubMed 24034792Gilmore 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.
- Background: PubMed 30422224Kangovi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Danielle King, PhD contact
Stephania M Miller-Hughes, PhD, MS, MSCI principal investigator
Meharry Medical College
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Diabetes and Hypertension, run by Meharry Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Briana Jegier, PhD ((312)498-3411, Briana.Jegier@baptistu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Activation Measure (time frame: From enrollment to end of 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07279415, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025; AzTrials last refreshed its copy on 28 Oct 2026.