NCT07279415

Activate Tennessee: A CHW-Supported Program for Patient Activation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Meharry Medical College · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
BEHAVIORAL	Intervention	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
BEHAVIORAL	Control Group	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.

Timeline

• Start date: 2025-12-20
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-12-12
• Last updated: 2025-12-12