An interventional study of Community Health Worker intervention and Usual Care in Social Determinants of Health (SDOH), Hypertension and Diabetes Mellitus, sponsored by Sairam Parthasarathy. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Sairam Parthasarathy · Not applicable, Interventional, and Health services research
The goal of the Arizona Community Engagement Alliance (AZ-CEAL) will be to combine social care with healthcare programs. The study will be connecting selected patients from clinics with trained community health workers (CHW) who will assist participants in getting the help that is needed for their health such as transportation needs, accessing healthy food, health information, accessing good health care, job opportunities, and housing. The study will collect information from both the patients and the health care systems to test how effectively the care plan works over time.
Social drivers of health contribute significantly to disparities in health outcomes for many chronic diseases in low income populations. Social drivers of health and health related social needs exacerbate stress, allostatic load, chronic pain, and cardiovascular outcomes. And in recent years, the consistent and compelling evidence regarding how Social drivers of health influences health has led to growing recognition within healthcare systems of the need to addressing health-related factors upstream of the clinical encounter. Whilst health systems have started collecting patient-level Social drivers of health, most front-line healthcare workers have little time, skill, or resources to address Social drivers of health challenges (Implementation Gap). And, in the health systems we serve, social worker positions employed and embedded within healthcare systems -- the key clinician professional group skilled at addressing SDOH -- are being cut for short term financial performance, leaving vulnerable patient populations disconnected from existing community resources and professional support. Community Health Workers (CHWs) are entry-level paraprofessionals known to provide robust support to link high risk populations with health and social services that could help high risk patient-clients cope with or mitigate the effects of Social drivers of health. Yet, despite their known effectiveness and the prevalent identification of Social drivers of health within healthcare systems, CHWs largely operate outside of healthcare systems and are not effectively linked to those systems in a manner to help patient-clients address identified Social drivers of health challenges and health related social needs. The key research questions that pertain to addressing Social drivers of health elements within healthcare systems are: (a) How to integrate social care (i.e., services that address health-related social risk factors and needs) into clinical practice settings? and (b) what kind of infrastructure is needed to facilitate such activities?
To address these important questions, the overarching goal of the Arizona Community Engagement Alliance (AZ-CEAL) will be to disseminate and implement social care integration within healthcare systems by connecting healthcare providers within systems with trained community health workers within the communities while studying process-level (implementation) and client-level (patient outcome) metrics in a stepped wedge design approach within a large statewide healthcare system. This 4-year project proposal will address the overarching overall goal by continuing to leverage our community based participatory research relationship with the Arizona Community Health Worker (AzCHOW) Association representing 1500 CHWs and 200 CHW employers statewide to refine and train CHWs in interventions aimed at addressing Social drivers of health within healthcare delivery settings. We propose an initial planning phase (9 months) that will enable refinement of the evidence-based CHWs and their core competency trainings that are tailored to address care within Arizona healthcare settings and build the linkage infrastructure to connect them with healthcare providers and their patients within healthcare settings. In the implementation phase (39 months), we will undertake a stepped wedge cluster randomized trial to evaluate the process-level (implementation) and client-level (patient outcome) metrics. We will conduct this study within a statewide large healthcare system with 10 clusters per step. We will collect implementation outcomes data consistent with the RE-AIM framework. We will measure effects on process-level outcomes (SDOH elements) measured by patient reports (CEAL Common survey) and healthcare system-data ("No-show" rates) as well as patient-level (client) outcomes (blood pressure, HbA1C, lipid profile, stress, healthcare utilization [i.e., composite outcome of unplanned office visits, urgent care visits, emergency room visits, and hospitalization] and even death). The conceptual framework for our proposal is based upon the five activities to better integrate social care into health care delivery that was advocated by the National Academy of Sciences. The activities are to improve awareness, adjustment, assistance, alignment, and advocacy for social care within healthcare systems with multi-level interventions at the community- and systems-level.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 740 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Sairam Parthasarathy is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Must meet at least one of the three criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be assigned to CHWs with knowledge of the local community resources based upon participant's residential area. The CHWs will assist the patient participant by systematically assessing and addressing the social drivers of health and Health Related Social Needs (HRSNs). A standardized assessment tool will be implemented to systematically identify baseline drivers of health. The CHWs will set long term goals and create an action plan with the patient. Through CHW core competencies of coaching, advocacy, and individual capacity building, the CHWs will use an adapted Goal Setting and Action Planning tool to prioritize short and long term goals to ensure patient self-sufficiency, self-determination and ensure patient navigation and mediation are people-centered.
Other: Community Health Worker intervention
Comparator (Description of usual care): Participants receiving care in clinics at the same time of a stepped-wedge design in a different clinic cluster but before the rolling in of the CHW-intervention described in the active comparator. These participants (patients) do not have CHWs addressing social issues and HRSNs within the healthcare system. The social drivers of health are assessed by phone interview as part of annual population health assessments and entered into the Electronic Medical Records system.
Other: Usual Care
CHWs with knowledge of local community resources will address social needs through through a IVR platform. Both CHWs and participants can access each other through the IVR system. Patients are observed repeatedly so that measurements are nested within members. We will recruit participants into the closed cohort prior to the sequential roll-out of the intervention to ensure individual-level informed consent and patient-reported data. Recruiting individuals before the intervention is rolled into the clinic (cluster) enables both concurrent comparisons of participants receiving care across clinics as well as pre-post comparisons of individual level (patient-reported) data in addition to passive data collection at a system or clinic level. Primary Data collected through patient reported surveys and passive EMR collection will occur at baseline and 6 months. Patients may opt-in to additional data collection at 12, 18, 24, 36 month time points.
Participants (patients) do not have CHWs addressing social issues and HRSNs within the healthcare system. The healthcare personnel act upon the identified social issues independently or with assistance from local clinic resources as usual. The social drivers of health are assessed by phone interview as part of annual population health assessments and entered into the Electronic Medical Records system and that in turn informs the healthcare provider.
Change in Healthcare utilization
Composite outcome of unplanned office visits, urgent care visits, emergency room visits, and hospitalizations. Data is passively collected through the EMR system. The data is expressed as a rate (events/year) that is calculated from 6 months of data
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Change in Patient No-Show Rate
Missed clinic appointment (numerator) compared to total clinic appointments (denominator). Data is passively collected through the EMR system. This is calculated as a rate (No-shows/year) from 6-months of data
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Change in Social Determinants of Health Risk Burden Assessed Using PRAPARE
Participant-reported social determinants of health will be assessed using the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE). The instrument evaluates social and economic factors potentially affecting health, including housing, transportation, financial strain, employment, education, access to resources, and social support. The outcome will be assessed as the change from baseline in the number of identified social risk factors, with higher counts indicating greater social risk burden.
Time frame: Baseline, 6 months, 12 months, 18 months, and/or end of treatment
Change in Systolic blood pressure
Passively collect systolic blood pressure data from the EMR systems. It will be adjusted for number of anti-hypertensive medications and dosage.
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Change in Diastolic blood pressure
Passively collect diastolic blood pressure data from the EMR systems. It will be adjusted for number of anti-hypertensive medications and dosage.
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Change in HBA1C
Passively collect HBA1C data from the EMR systems. It will be adjusted for number of anti-diabetic medications and dosage.
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Change in Lipid panel level
Passively collectlppid panel data from the EMR systems (Total cholesterol, HDL, VLDL, and TGL). It will be adjusted for number of anti-lipidemic medications and dosage.
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Change in Patient Telemedicine Availability
Assess patient utilization of telemedicine visits (numerator) compared to total clinic visits (denominator). Data is passively collected through the EMR system and expressed as a proportion of the total visits in the same time period.
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Change From Baseline in Patient Satisfaction as Measured by the CAHPS Overall Provider Rating at 6 Months
Patient satisfaction is measured by the Clinician \& Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Adult Visit Survey 3.0 overall provider rating item ("Using any number from 0 to 10...rate this provider"). Scores range from 0 to 10, with higher scores indicating greater satisfaction. Change is calculated as the 6-month score minus the baseline score; possible change scores range from -10 to +10, with positive values indicating improved satisfaction.
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Change From Baseline in Health Literacy as Measured by the Brief Health Literacy Screen at 6 Months
Health literacy is assessed using the 3-item Brief Health Literacy Screen (BHLS; Chew items), a self-report measure of subjective health literacy comprising: (1) confidence completing medical forms independently; (2) frequency of needing help reading health materials; and (3) frequency of difficulty understanding written health information. Each item is rated on a 5-point scale scored 1 to 5. Items are coded so that higher values reflect greater health literacy \[state which item(s) are reverse-scored under your coding\] and summed to yield a total score ranging from 3 to 15, with higher scores indicating higher subjective health literacy. Change is calculated as the 6-month score minus the baseline score (range -12 to +12); positive values indicate improved health literacy.
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Change From Baseline in Sleep Disturbance as Measured by the PROMIS Sleep Disturbance Short Form 8a T-Score at 6 Months
Sleep disturbance is assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8a, an 8-item self-report measure with a 7-day recall period. Each item is rated on a 5-point scale, yielding a raw score of 8 to 40. Raw scores are converted to a standardized T-score using the PROMIS Sleep Disturbance scoring manual conversion table. T-scores are calibrated to the US general population, with a mean of 50 and a standard deviation of 10; the observed T-score range for this form is approximately 28.9 to 76.5. Higher T-scores indicate greater sleep disturbance (worse sleep). Change is calculated as the 6-month T-score minus the baseline T-score; negative values indicate improvement in sleep.
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Change From Baseline in Sleep-Related Impairment as Measured by the PROMIS Sleep-Related Impairment Short Form 8a T-Score at 6 Months
Sleep-related impairment is assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Short Form 8a v1.0, an 8-item self-report measure with a 7-day recall period assessing perceived alertness, sleepiness, and functional impairment during waking hours associated with sleep problems. Each item is rated on a 5-point scale (1=Not at all to 5=Very much), yielding a raw score of 8 to 40. Raw scores are converted to a standardized T-score using the PROMIS Sleep-Related Impairment scoring manual conversion table. T-scores are calibrated to the US general population, with a mean of 50 and a standard deviation of 10; higher T-scores indicate greater sleep-related impairment (worse daytime functioning). Change is calculated as the 6-month T-score minus the baseline T-score; negative values indicate improvement.
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Plan to share: Undecided
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Started Dec 2024 (actual). Primary completion is estimated for Apr 2028, 39 months after the start.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 39 months is above that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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Sairam Parthasarathy