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Diabetes Mellitus Type 2REDDCAT2NCT06869057

Re-Engineered Discharge for Diabetes Care Transitions

A study testing REDDCAT2 Post-Discharge Navigation and Treatment as Usual (TAU) in people with Diabetes Mellitus Type 2 and Social Determinants of Health (SDOH), run by University of Massachusetts, Worcester at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
REDDCAT2 Post-Discharge Navigation and Treatment as Usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
412 participants
Where
1 siteUnited States
Study dates
8 Jun 2026to 30 May 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Suzanne Mitchell, MD, MS contact

774-441-6225

Suzanne.Mitchell2@umassmed.edu

United States1 site, 1 recruiting
  • UMASS Memorial Healthcare System

    Worcester, Massachusetts, 01665

    Suzanne Mitchell, 774-442-3748, REDDCAT2@umassmed.edu

    Recruiting

Other trials in United States

About this study

Official title: Re-Engineered Discharge for Diabetes Care Transitions: Screening and Addressing Social Determinants of Health Needs at Hospital Discharge

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.

Read the detailed 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.

Being tested
REDDCAT2 Post-Discharge Navigation, Treatment as Usual (TAU)
Keywords
diabetes, social determinants of health, hospital readmission
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REDDCAT2 Post-Discharge NavigationBehavioural

    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.

  • 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.

Study groups in NCT06869057
Study groupRoleWhat they receive
ControlOtherTreatment as usual (TAU)
Receives: Other: Treatment as Usual (TAU)
InterventionExperimentalREDDCAT2 Intervention
Receives: Behavioral: REDDCAT2 Post-Discharge Navigation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 90 days

Secondary outcomes (22)
  1. Changes in weight/body mass index (BMI)

    Change in weight/BMI per electronic health record or Research Assistant assessment

    Measured: Baseline, 30, and 90 days

  2. Changes in Pain Management

    Change in Pain and Pain interference scores assessed using two measures from the Patient-Reported Outcomes Measurement Information System (PROMIS).

    1. Pain Severity is scored using a T-score ranging from 20 to 80. T-scores that are 1 or more standard deviations above average are indicative of a poorer outcome (more pain).
    2. Pain Interference, which is a T-score ranging from 20 to 80. T-scores that are 1+ standard deviations above average are indicative of a poorer outcome (more problems with pain hindering activities).

    PROMIS scores have an average of 50 and standard deviation (SD) of 10 in a referent population.

    Measured: Baseline, 30, and 90 days

  3. Changes in Self-Management Adherence

    Change in patient-reported adherence to diabetes regimen from baseline to follow up assessed by administering the Changes in the Summary of Diabetes Self-Care Activities Assessment (SDSCA) \& Re-Engineered Discharge for Diabetes Computer Adaptive Test (REDD-CAT) for Medication Adherence.

    SDSCA - Scores are calculated for each of the five regimen areas assessed: Diet, Exercise, Blood-Glucose Testing, Foot Care, and Smoking Status.

    REDD-CAT Medication Adherence scale is measured using T-scores. Scores greater that 1 standard deviation of 10.0 away from the mean of 50.0 represent a greater or lesser degree of adherence, depending on direction. Higher scores are indicative of a positive outcome (more adherence).

    Measured: Baseline, 30, and 90 days

  4. Changes in Illness Burden perception

    Change in experience of Illness Burden. Illness burden scale generates a T-score, ranging from 20 to 80. The average score is 50 with a standard deviation of 10. T-scores that are 1 or more standard deviations above average are indicative of a poorer outcome (indicate more illness burden).

    Measured: Baseline, 30, and 90 days

  5. Changes in Substance Use

    Change in Substance Use will be assessed using a validated measure from the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS scores have an average of 50 and standard deviation (SD) of 10 in a referent population.

    PROMIS Substance Use - Resulting scores are on a T-score metric ranging from 20 to 80. Scores that are 1 or more standard deviations above average are indicative of poor, self-reported health (greater severity of substance use).

    Measured: Baseline, 30, and 90 days

  6. Changes in Alcohol Use

    Change in Alcohol Use will be assessed using a validated measure from the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS scores have an average of 50 and standard deviation (SD) of 10 in a referent population.

    PROMIS Alcohol Use: Resulting scores are on a T-score metric ranging from 20 to 80. Higher scores are indicative of poor self-reported health (more alcohol consumption, cravings, or difficulty controlling drinking).

    Measured: Baseline, 30, and 90 days

  7. Changes in Diabetes Stigma

    Type 2 Diabetes Stigma Assessment Scale or DSAS-2 is a 19-item measure with three sub-scales: Treated Differently, Blame and Judgement, Self-Stigma. A total scale score can also be calculated. Items are scored 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate worse outcomes (more perceived diabetes stigma).

    Measured: Baseline, 30, and 90 days

  8. Changes in Economic Quality of Life

    Changes in 8-item custom short form from the Economic Quality of Life item bank. Items are related to finances and affordability of living expenses and range from 1 (Never) to 5 (Always). Resulting scores are on a T-score metric, ranging from 20 to 80. Higher scores indicate better economic quality of life.

    Measured: Baseline, 30, and 90 days

  9. Changes in Depressive Symptoms

    Changes in depressive symptom burden are assessed using a measure from the Quality of Life in Neurological Disorders (NeuroQOL) measurement system.

    Neuro-QoL Depression - Resulting scores are on a T-score metric, ranging from 20 to 80. Higher scores indicate poorer self-reported health (a greater presence of depressive symptoms).

    Measured: Baseline, 30, and 90 days

  10. Changes in Anxiety Symptoms

    Changes in anxiety symptom burden are assessed using a measure from the Quality of Life in Neurological Disorders (NeuroQOL) measurement system.

    Neuro-QoL Anxiety - Resulting scores are on a T-score metric, ranging from 20 to 80. Higher scores indicate poorer self-reported health (a greater presence of anxiety symptoms).

    Measured: Baseline, 30, and 90 days

  11. Changes in Emotional Support

    Changes in emotional support scores assessed using measures from the Patient-Reported Outcomes Measurement Information System (PROMIS).

    Resulting scores are on a T-score metric, ranging from 20 to 80. Higher scores indicate worse outcome (a greater degree of social isolation).

    Measured: Baseline, 30, and 90 days

  12. Changes in Health Seeking Behavior

    Changes in Health Seeking Behavior scale, which includes 21 items including subscales related to Primary Care Provider, General, Family/Personal Friends, and Internet. Resulting scores are on a T metric, ranging from 20 to 80. Higher scores indicate a positive outcome (more health-seeking behavior).

    Measured: Baseline, 30, and 90 days

  13. Changes in Medication Adherence

    Medication Adherence scores assessed by administering the Re-Engineered Discharge for Diabetes Computer Adaptive Test (REDD-CAT) for Medication Adherence scale.

    This is measured using T-scores. Scores greater that 1 standard deviation of 10.0 away from the mean of 50.0 reflect a greater or lesser degree of adherence, depending on direction. Higher scores are indicative of a positive outcome (more adherence).

    Measured: Baseline, 30, and 90 days

  14. Changes in Perceived Competence

    Change in Perceived Competence in Diabetes Scale (PCDS) score - items are rated on a scale 1-7. Higher total scores indicate better self-reported health (a greater perceived ability to manage diabetes).

    Measured: Baseline, 30, and 90 days

  15. Changes in Perceived diabetes self-efficacy

    Change in Diabetes Self-Efficacy Scale (DSES) score - items are rated on a scale of 0-10 and summed for a total score. Higher total scores indicate better self-reported health (self-efficacy in managing diabetes).

    Measured: Baseline, 30, and 90 days

  16. Changes in Coping Skills

    Changes in Brief Resilient Coping Scale scores. Items are rated 1 ("does not describe me at all") to 5 ("describes me very well") and summed for a total score. Higher scores indicate better self-reported health (higher coping resiliency).

    Measured: Baseline, 30, and 90 days

  17. Changes in Diabetes Knowledge

    Change in Diabetes Knowledge and diabetes self-care will be assessed using the 23-item Revised Diabetes Knowledge Test (DKT2). DTK2 contains multiple choice questions to assess knowledge, and each question contains 4 responses for the respondent to choose from. Proportion of correct answers over total questions determine scoring.

    Measured: Baseline, 30, and 90 days

  18. Changes in Housing Insecurity

    Change in Housing Insecurity scores, which is a 22-item assessment to evaluate affordability, safety, and home features. Resulting scores use a T-score metric, ranging from 20 to 80. Lower scores indicate poorer outcomes (more significant concerns with housing stability).

    Measured: Baseline, 30, and 90 days

  19. Quantity of unmet social needs

    Absolute change in total number of SDOH domains identified with an unmet need (i.e., food insecurity, housing insecurity, etc.) as reported on Re-Engineered Discharge for Diabetes Computer Adaptive Test (REDD-CAT) screening tool.

    Measured: Baseline, 30, and 90 days

  20. Changes in Glucose Control: HbA1c at point of care

    Change in HbA1c values recorded from point-of-care tests or in the electronic health record at visits.

    Measured: Baseline and 90 days

  21. changes in Diabetes Distress

    The Diabetes Distress Scale is a 17-item self-report instrument. Each item is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem." The scale yields an overall distress score based on the average responses on the 1-6 scale for all 17 items. The scale also yields a score for each of 4 subscales based on the average response on the 1-6 scale on all of the items in that scale.

    An average score of < 2.0 = reflects little or no distress, an average score between 2.0 and 2.9 = reflects moderate distress, and an average score > 3.0 = reflects high distress.

    Measured: Baseline, 30, and 90 days

  22. Time to hospital service use post-discharge

    Time-to-hospital reutilization (defined as any type of hospital service use, e.g., emergency department, observation, or hospital readmissions), at 30-days post-hospital discharge. Source of the data are UMMH electronic health records and participant self-report.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2025
  2. Study start8 Jun 2026
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion30 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
412 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06869057
Sponsor's protocol ID
STUDY00002129
Other IDs
R01NR021826
Acronym
REDDCAT2
Status last verified
Jan 2026
First submitted
25 Feb 2025
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing REDDCAT2 Post-Discharge Navigation and Treatment as Usual (TAU) in people with Diabetes Mellitus Type 2 and Social Determinants of Health (SDOH), run by University of Massachusetts, Worcester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Suzanne Mitchell, MD, MS (774-441-6225, Suzanne.Mitchell2@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to hospital service use post-discharge (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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