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Activate Tennessee: A CHW-Supported Program for Patient Activation

M

Meharry Medical College

Status

Not yet enrolling

Conditions

Chronic Kidney Disease
Hypertension
Diabetes
Hypercholesterolemia
Cardio Vascular Disease
Infectious Diseases Morbidity

Treatments

Behavioral: Intervention
Behavioral: Control Group

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT07279415
TR72217X5599
OT2HL158287 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

  • 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

300 participants in 2 patient groups

Community Health Worker Support - Pre-scheduled sessions
Active Comparator group
Treatment:
Behavioral: Intervention
Community Health Worker Support - Participant-requested sessions
Active Comparator group
Treatment:
Behavioral: Control Group

Trial contacts and locations

0

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Central trial contact

Danielle King, PhD; Briana Jegier, PhD

Data sourced from clinicaltrials.gov

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