Health TrialsbyHealthPanel

Achieving Routine Intervention and Screening for Emotional Health

ConditionsType 2 Diabetes Mellitus (T2DM)Diabetes Distress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

The purpose of this project is to evaluate the effectiveness of diabetes distress screening and intervention on patients with type 2 diabetes mellitus (T2DM).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient at a participating clinic

Type 2 diabetes

Adult (18 years or older)

A1C > 8%

Disqualifiers

Pregnant

Trial design

Design model

Parallel

Treatments tested in this trial

  • ARISE Learning Community Diabetes Distress Screening and Intervention

    Behavioral

    In-depth training for frontline community health center staff on ARISE algorithm to screen for degree of diabetes distress using T2-DDAS Core. If positive, screen for sources of diabetes distress using T2-DDAS Sources. Discuss results with patient and make any relevant referrals.

  • ARISE Enhanced Care brief training

    Behavioral

    Brief training on American Diabetes Association guidelines for screening for diabetes distress using the 7A's model

Treatment groups

1,250 Participants
are divided into 2 treatment groups
Group A: ARISE Learning Community ArmExperimental treatment 1 intervention
Group B: ARISE Enhanced CareOther 1 intervention

Trial outcomes

Primary outcomes

1

Rate of A1C across time

Rate of A1C from Baseline to follow-up

Time frame
12 months

Secondary outcomes

1

Average diabetes distress score

Rate of diabetes distress at each community health center based on average of patients' "core" and "sources" screening scores (based on T2-DDAS screening)

Time frame
12 months
2

Average of low density lipoproteins (LDL Cholesterol) measure

Rate of average measure of patients' cholesterol in the blood

Time frame
12 months
3

Average systolic blood pressure across time

Average of patients' systolic blood pressure (measures the arterial pressure)

Time frame
12 months
4

Average Body mass index at baseline and follow-up

Average of patients' BMI (a measure of height and weight)

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

University of California, San Francisco

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Midwest Clinicians' Network

Collaborator

Source ClinicalTrials.gov
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