NCT06869057

Brief Summary

The goal of this project is to test a novel bedside SDOH screening intervention coupled with post-discharge navigation for hospitalized patients with a diabetes diagnosis to reduce unmet social needs, compared to usual care.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
412

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
38mo left

Started May 2026

Longer than P75 for not_applicable diabetes-mellitus-type-2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026May 2029

First Submitted

Initial submission to the registry

February 25, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2029

Last Updated

March 25, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

February 25, 2025

Last Update Submit

March 20, 2026

Conditions

Diabetes Mellitus Type 2Social Determinants of Health (SDOH)Hospital Readmission

Keywords

diabetessocial determinants of healthhospital readmission

Outcome Measures

Primary Outcomes (1)

  • Time to hospital service use post-discharge

    The primary outcome is a composite measure on all types of hospital service use (emergency department, observation, or hospital readmissions), pre-specified as time-to-hospital reutilization, at 90-days post-hospital discharge. Source of the data are UMMH electronic health records and participant self-report.

    90 days

Secondary Outcomes (22)

  • Changes in weight/body mass index (BMI)

    Baseline, 30, and 90 days

  • Changes in Pain Management

    Baseline, 30, and 90 days

  • Changes in Self-Management Adherence

    Baseline, 30, and 90 days

  • Changes in Illness Burden perception

    Baseline, 30, and 90 days

  • Changes in Substance Use

    Baseline, 30, and 90 days

  • +17 more secondary outcomes

Study Arms (2)

Control

OTHER

Treatment as usual (TAU)

Other: Treatment as Usual (TAU)

Intervention

EXPERIMENTAL

REDDCAT2 Intervention

Behavioral: REDDCAT2 Post-Discharge Navigation

Interventions

REDDCAT2 Post-Discharge NavigationBEHAVIORAL

Those in the REDDCAT2 intervention group will be partnered with a patient navigator whose role will be to review the results of the screening survey completed at the beginning of the study. The patient navigator will help coordinate the participant's care before leaving the hospital and for 90 days after. Together, the participant and navigator will form an action plan intended to help address personal, social, or community factors affecting the participant's health. The navigator is expected to contact the participant every 2 weeks, though this can be adjusted based on their preference.

Intervention
Treatment as Usual (TAU)OTHER

TAU participants will receive standard care from the UMass Memorial Healthcare (UMMH) hospitalist team as appropriate. Participants will receive a printed list of community resources. No study-related patient navigation support will be provided. In 2024, Centers for Medicare and Medicaid Services mandated social determinants of health (SDOH) screening for inpatients. UMMH will use a checklist social needs screener. It will be up to the hospitalist teams to act on SDOH screening results. The UMMH hospitalist teams may consult endocrinology and/or inpatient social services to provide support and consultation for all patients regardless of study participation or group assignment. If medically appropriate, the endocrinology service may manage medications and provide referrals for continued treatment post discharge. All services that are normally provided by hospital care teams will remain available.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult aged 18 years or older
  • diagnosed with type 2 diabetes
  • hospitalized at Univ of Massachusetts-affiliated hospital
  • endorsed at least 1 unmet social need via screening survey

You may not qualify if:

  • pregnancy
  • discharge to short or long-term nursing facility or hospital
  • medical contraindication
  • cognitive impairment
  • unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Suzanne Mitchell, MD, MS

CONTACT

774-441-6225Suzanne.Mitchell2@umassmed.edu

Barbara De La Cruz

CONTACT

774-443-2246Barbara.DeLaCruz@umassmed.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 11, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

May 30, 2029

Last Updated

March 25, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

This is a clinical trial. We plan to share data in aggregate according to our data management sharing plan. Sharing individual-level data is beyond the scope of this study.