What is ARISE studying for type 2 diabetes?

ARISE is studying how screening for diabetes-related emotional distress and providing support can affect health outcomes in adults with type 2 diabetes. The study compares two training programs for health center staff to better identify and address emotional challenges in diabetes management. It is sponsored by the University of Chicago.

Who may be eligible for this type 2 diabetes clinical trial?

Adults aged 18 years or older with type 2 diabetes and an A1C level over 8% may be eligible. Patients must receive care at a participating clinic and not be pregnant. Please review eligibility criteria for more details.

Is there any cost to participate in this type 2 diabetes clinical trial?

Study-related care, including the training programs and all trial visits, is provided at no cost. However, personal travel or other expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06887049

ARISE Study Comparing Diabetes Distress Screening and Intervention Approaches for Adults with Type 2 Diabetes in Community Health Centers

Led by University of Chicago · Updated on 2026-07-08

1250

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the effectiveness of screening for diabetes distress DD and providing interventions for adults with type 2 diabetes mellitus T2DM. Diabetes distress is the emotional stress related to managing diabetes, which affects medication adherence, lifestyle habits, and overall quality of life. The study focuses on populations disproportionately affected by T2DM and DD, including African-Americans and Hispanics, and seeks to improve emotional health screening and support within real-world primary care settings. Participants care centers will be randomly assigned to either receive an in-depth training on the ARISE screening and intervention program or a brief training on the 7As model for diabetes distress screening. The ARISE program trains community health center staff to screen patients using validated tools to identify diabetes distress levels and their sources, then provide tailored support and referrals. The other group receives an enhanced usual care training. This pragmatic study uses a cluster randomized design to compare these approaches. During the study, participants will be regularly assessed over 12 months for outcomes including A1C levels, diabetes distress scores, cholesterol levels, blood pressure, body mass index, depression and anxiety screening results, and healthcare referrals. The study tracks these measures to understand the impact of the screening and intervention programs on diabetes management and emotional health. The total participation spans the intervention and follow-up periods to monitor changes in health and distress.

CONDITIONS

Brief Title

Achieving Routine Intervention and Screening for Emotional Health

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	ARISE Learning Community Screening & Intervention	ARISE Enhanced Care Guideline Training	ADA Guideline-Based Usual Care
What it is	A structured program offering in-depth staff training at community clinics to implement the ARISE algorithm for diabetes distress screening and intervention, including use of T2-DDAS Core and Sources, followed by patient discussion and appropriate referrals.	A brief education and training for clinic staff on ADA guideline-based diabetes distress screening using the 7A's model.	Usual care per ADA standards involves guideline-recommended screening for diabetes distress and referral for psychosocial support as needed. The screening typically uses validated tools and the 7A's care model.
Primary use	To systematically identify and address sources of diabetes distress in adults with uncontrolled T2DM, providing targeted discussion and referrals aimed at improving emotional health and diabetes outcomes.	To increase awareness and screening for diabetes distress through brief guideline-based staff training, helping identify patients in need of psychosocial support.	To provide consistent, guideline-based screening for diabetes distress in clinical practice, enabling appropriate referral for psychological interventions among patients with T2DM.
How it is given or performed	Clinic staff receive thorough training on ARISE protocols, regularly screen patients with T2DDAS questionnaires, discuss distress sources with each patient, and offer direct referrals per positive screening results.	Clinic staff get brief guideline training on the 7A's screening process, then screen patients for distress and refer those who screen positive.	Usual care involves clinic staff using standardized ADA protocols for regular distress screening, most commonly with brief validated questionnaires and the 7A's model.
Evidence status	The ARISE Learning Community program is currently being evaluated in a large, randomized trial; evidence for efficacy across settings and populations is not yet published.	Brief guideline-based training has not been tested as a standalone intervention for diabetes distress in adults with uncontrolled T2DM outside this trial.	Systematic reviews show psychological interventions for diabetes distress improve emotional wellbeing and self-management in T2DM, but effectiveness depends on implementation depth and setting.
Important limitations	In-depth training and multi-step workflow may require more resources than most clinics can provide. Long-term outcome data is not yet available.	Brief training may not fully address complex sources of distress or ensure follow-up for emotional health needs.	While ADA guidelines recommend screening, real-world adoption is inconsistent and many patients may not receive referrals or interventions for distress. Effectiveness varies based on clinic resources and patient engagement.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patient at a participating clinic
Diagnosed with type 2 diabetes
Adult aged 18 years or older
A1C blood sugar level greater than 8%

You will not qualify if you...

Currently pregnant

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit

Intervention

Duration - 12 months

Participants receive training at their community health centers on diabetes distress screening and intervention using either the ARISE program or a brief training on the 7A's model.

Multiple visits as part of routine care and study assessments

Follow-up

Duration - Up to 12 months

Researchers monitor participants' diabetes-related health measures and emotional distress over time to assess the impact of the interventions.

Regular assessments during the intervention period