Activate Tennessee: A CHW-Supported Program for Patient Activation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention, Control Group.
- Who it may be relevant to
- Registry conditions: Diabetes, Hypertension, Cardio Vascular Disease, Infectious Diseases Morbidity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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 a - 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.
Primary outcome measures
- Patient Activation Measure [Time frame: From enrollment to end of 9 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 27965180
- 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 32053481
- 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.
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- 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 31285962
Identifiers
NCT: NCT07279415 · TR72217X5599 · OT2HL158287