An interventional study of Multi-level HRSN initiative in Type 2 Diabetes, Hypertension and Hyperlipidemia, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Health services research
Among 21 studies in Diabetes Mellitus, Type 2 by Vanderbilt University Medical Center — 4 open to participants now, 5 under way, none of them phase 3. Diabetes Mellitus, Type 2 · Vanderbilt University Medical Center.
Among the 21 studies in Diabetes Mellitus, Type 2 by Vanderbilt University Medical Center, this one has the largest enrollment of the 18 interventional ones that give a count, is one of 4 that started in 2025, is one of 13 with no phase, and was the 18th registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →4 of the 21 studies in Diabetes Mellitus, Type 2 by Vanderbilt University Medical Center are open now, in 1 country. Recruiting first, the newest first:
Vanderbilt University Medical Center · Sites in United States
Vanderbilt University Medical Center · Sites in United States
Vanderbilt University Medical Center · Sites in United States
Vanderbilt University Medical Center · Sites in United States
By country, each count listing its studies:
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 2 · Phase 3 1
First in 2007; this study’s year is marked. 4 started in 2025.
This study's enrollment of 6,928 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 135 across the 18 interventional studies, 172 across the 3 observational. Of the 15 that completed or were terminated, 11 (73%) have results posted.
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Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
2 of the studies in Diabetes Mellitus, Type 2 by Vanderbilt University Medical Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06852950Vanderbilt University Medical CenterContinuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge | 2027-01 |
| NCT07210593Vanderbilt University Medical CenterSTrong Relationships to Improve DiabEtes Pilot | 2027-03 |
Among the 21 studies in Diabetes Mellitus, Type 2 by Vanderbilt University Medical Center, from their registry updates:
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The goal of this study is to evaluate the effectiveness of a multi-level health-related social needs (HRSN) initiative among adult patients diagnosed with type 2 diabetes, plus hypertension or hyperlipidemia. The multi-level initiative includes HRSN data collection, training and tools for health care professionals, care coordinator support, and community resources. Patients with type 2 diabetes plus hypertension or hyperlipidemia will be screened for HRSN as part of the primary care clinic intake process to assess if patients have any social needs (like difficulty with getting food, housing, or transportation). If patients screen positive for having social needs, then patients will be offered support, which can include help from primary care providers with adjusting a patient's disease management plan, referrals to care coordinators to provide additional assistance in addressing social needs, and information about community organizations that offer resources for social needs. The initiative will be integrated as a system change across VUMC adult primary care practices.
The investigators will use a prospective, single-arm clinical trial to evaluate effects on clinical outcomes for 12 months. Data will be extracted from the EHR on adult patients diagnosed with type 2 diabetes, and either hypertension or hyperlipidemia. The investigators hypothesize that the initiative will reduce the impact of HRSN on clinical outcomes over the study period. The investigators will also administer surveys to a subgroup of patients to examine trends in self-reported psychosocial and behavioral measures over the course of the initiative.
ELIGIBILITY CRITERIA FOR EHR DATA EXTRACTION
Inclusion Criteria:
ELIGIBILITY CRITERIA FOR PATIENT SURVEYS (subset of EHR data)
Inclusion Criteria:
Exclusion Criteria:
Eligible patients will receive the HRSN initiative as part of their primary care appointments
Other: Multi-level HRSN initiative
The multi-level health-related social needs (HRSN) initiative includes multiple components aimed at assessing and addressing HRSN in clinical practice: HRSN screening, EHR tools for clinical decision support, training and tools for health care providers to address HRSN, care coordinator support for patient outreach, and community resources for referral and support.
Change in glycemic control
Hemoglobin A1c extracted from the electronic health record where higher values indicate worse glycemic control.
Time frame: Baseline and 12 months post-baseline
Change in cholesterol
Low-density lipoprotein (LDL) extracted from the electronic health record where higher values indicate worse hyperlipidemia.
Time frame: Baseline and 12 months post-baseline
Change in blood pressure
Systolic blood pressure extracted from the EHR where higher values indicate worse hypertension.
Time frame: Baseline and 12 months post-baseline
Change in medication adherence (survey)
As assessed by the Adherence to Refills and Medications Scale-Diabetes (ARMS-D) with scores ranging from 11-44, where higher scores indicate more problems with medication adherence (worse).
Time frame: Baseline and 6 months post-baseline
Change in dietary behavior (survey)
As assessed by the short version of the Personal Diabetes Questionnaire scale (PDQ-11) Eating Behavior Problems subscale with scores ranging 1-6, where higher scores indicate more problem eating behaviors (worse).
Time frame: Baseline and 6 months post-baseline
Change in dietary behavior (survey)
As assessed by the short version of the Personal Diabetes Questionnaire scale (PDQ-11) Use of Information for Decision Making subscale with scores ranging 1-6, where higher scores indicate more use of dietary information for decision making (better).
Time frame: Baseline and 6 months post-baseline
Change in physical activity (survey)
As assessed by scores on the Exercise Vital Sign (EVS) Tool with scores ranging 0-1,050 minutes or greater per week of moderate to strenuous physical activity.
Time frame: Baseline and 6 months post-baseline
Change in diabetes distress (survey)
As assessed by the Problem Areas in Diabetes-5 (PAID-5) scale with scores ranging from 0 to 20, where higher scores indicate greater diabetes-related emotional distress (worse).
Time frame: Baseline and 6 months post-baseline
Change in diabetes self-efficacy (survey)
As assessed by the Perceived Diabetes Self-Management Scale (PDSMS) with scores ranging 8 to 40, where higher scores indicate more self-efficacy (better).
Time frame: Baseline and 6 months post-baseline
Change in interpersonal processes of care (survey)
As assessed by the Interpersonal Processes of Care (IPC) survey with scores ranging from 1-5 (calculated as the mean of non-missing responses to the corresponding items), where higher scores indicate higher frequency of the labeled interpersonal process (e.g., decided together; lack of clarity). Scoring occurs for 7 interpersonal processes: lack of clarity; elicited concerns, responded; explained results; decided together; emotional support, compassion; discriminated due to race/ethnicity; and disrespectful office staff.
Time frame: Baseline and 6 months post-baseline
Change in perceived discrimination (survey)
As assessed on the Discrimination in Medical Settings scale with scores ranging from 7-35, where higher scores indicate higher frequency of experiences with discrimination in medical settings.
Time frame: Baseline and 6 months post-baseline
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigator.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: After study results are posted on clinical trials and outcomes published in a peer-reviewed journal, until 5 years later
Access criteria: Contact the principal investigator
Ran from Jan 2025 to primary completion in Aug 2026, 18 months.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 18 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: primary completion Sep 2026 → Aug 2026 and completion Sep 2026 → Aug 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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