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Re-Engineered Discharge for Diabetes Care Transitions (REDDCAT2)

U

University of Massachusetts, Worcester

Status

Not yet enrolling

Conditions

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

Treatments

Other: Treatment as Usual (TAU)
Behavioral: REDDCAT2 Post-Discharge Navigation

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06869057
R01NR021826 (U.S. NIH Grant/Contract)
STUDY00002129

Details and patient eligibility

About

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.

Full description

The investigators are conducting this research to test a computer-based screening tool and a care coordination protocol to help people with type 2 diabetes who report unmet social determinants of health.

Social determinants of health (SDOH) are the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks. - Office of Disease Prevention and Health Promotion Examples of SDOH include factors such as housing, transportation, education, job opportunities, income, and access to healthy food, clean air and water, and health care services. Participants who join this research will be asked to complete a screening survey about their health. Then, participants will be randomly assigned (like pulling a name out of a hat) to one of two groups:

  • Those in Group 1 will be partnered with a patient navigator whose role will be to review the results of the screening survey and help coordinate care before leaving the hospital and for 90 days after.
  • Those in Group 2 will receive treatment as usual. A list of community-based resources will be provided.

Participants in both groups will complete surveys at the beginning of the study and again at 30 and 90 days after leaving the hospital. The investigators will make reminder calls to participants in both groups about data collection and will collect information from the medical record for as long as 90 days after leaving the hospital.

Enrollment

412 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

412 participants in 2 patient groups

Control
Other group
Description:
Treatment as usual (TAU)
Treatment:
Other: Treatment as Usual (TAU)
Intervention
Experimental group
Description:
REDDCAT2 Intervention
Treatment:
Behavioral: REDDCAT2 Post-Discharge Navigation

Trial documents
1

Trial contacts and locations

0

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Central trial contact

Barbara De La Cruz; Suzanne Mitchell, MD, MS

Data sourced from clinicaltrials.gov

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