1250 Participants NeededMy employer runs this trial

Emotional Health Interventions for Diabetes Distress

(ARISE Trial)

AS
Overseen ByAbby Sr. Research Project Manager, MSW
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on helping people with type 2 diabetes who feel overwhelmed or stressed by their condition. Researchers aim to evaluate the effectiveness of a new screening and intervention method, the ARISE Learning Community Diabetes Distress Screening and Intervention, in reducing "diabetes distress." Two groups participate: one receives detailed training on the new method, while the other gets a brief introduction. Suitable candidates have type 2 diabetes, regularly visit a participating clinic, and have an A1C level over 8% (a common blood test indicating blood sugar control over the past 3 months). As an unphased trial, this study offers a unique opportunity to contribute to innovative research focused on improving emotional well-being for those with type 2 diabetes.

What prior data suggests that these interventions are safe for diabetes distress?

Research shows that programs like the ARISE Learning Community, designed to alleviate diabetes distress, are generally safe and manageable. Studies on similar programs indicate they can reduce diabetes distress without major side effects. These programs offer emotional support and coping strategies without involving medical procedures.

The studies report no negative effects from these programs, suggesting they are safe for participants. However, discussing any concerns with a healthcare team before starting is always important.12345

Why are researchers excited about this trial?

Researchers are excited about the Emotional Health Interventions for Diabetes Distress trial because it explores innovative approaches to managing the emotional challenges of living with diabetes. Unlike traditional methods that might focus solely on medication or general counseling, the ARISE Learning Community intervention provides in-depth training for community health centers to use a specialized screening and intervention algorithm tailored for diabetes distress. Meanwhile, the ARISE Enhanced Care arm offers a brief training on the 7A's model, which is a structured yet simplified approach to screening and intervention. These methods aim to directly address the emotional health of patients, potentially improving their overall wellbeing and management of diabetes.

What evidence suggests that this trial's interventions could be effective for diabetes distress?

Research shows that addressing diabetes-related stress can improve health outcomes for people with type 2 diabetes. Studies have found that using tools like the DDS-17 to identify this stress helps lower stress levels and improve blood sugar control. Specifically, one study found that patients took better care of themselves and felt better overall after participating in programs to reduce diabetes stress.

In this trial, the ARISE Learning Community Arm will provide in-depth training for Community Health Centers on the ARISE screening and intervention algorithm. The ARISE Enhanced Care program will offer brief training for healthcare providers. Early results suggest that this brief training helps providers better support patients' emotional health, leading to improved interactions and potentially enhancing patients' emotional well-being. While more information is needed, these programs show promise in helping people manage their diabetes more effectively.12678

Who Is on the Research Team?

AB

Arshiya Baig, MD, MPH

Principal Investigator

University of Chicago

DH

Danielle Hessler Jones, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Inclusion Criteria

I am a patient at a clinic participating in the trial.
I have type 2 diabetes.
My A1C level is above 8%.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Implementation

Community Health Centers receive training on the ARISE screening and intervention algorithm

4-8 weeks

Intervention

Implementation of the ARISE intervention for diabetes distress screening and management

12 months

Follow-up

Participants are monitored for diabetes distress, LDL cholesterol, blood pressure, BMI, depression, anxiety, and A1C levels

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • ARISE Enhanced Care brief training
  • ARISE Learning Community Diabetes Distress Screening and Intervention

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: ARISE Learning Community ArmExperimental Treatment1 Intervention
Group II: ARISE Enhanced CareExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

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

Collaborator

Trials
2,513
Recruited
4,366,000+

Midwest Clinicians' Network

Collaborator

Trials
3
Recruited
2,200+

Citations

Brief Trauma-Informed Care Training to Enhance Health Care ...

This pilot study demonstrated the preliminary effectiveness of a brief TIC training on improving health care provider knowledge and comfort working with ...

Achieving Resilience in Acute Care Nurses (ARISE).

The purpose of the proposed study is to assess the outcomes of a multi-modal intervention and toolkit, ARISE, designed to enhance resilience and promote ...

Brief trauma-informed care training to enhance health care ...

This pilot study demonstrated the preliminary effectiveness of a brief TIC training on improving health care provider knowledge and comfort working with trauma ...

ARISE Network - Stanford Medicine

Our network of physicians evaluate AI outputs and AI solutions against use cases, which enables us to run Randomized Controlled Trials using arms like AI alone, ...

Training for Lasting Change: Trauma-Informed ...

This article describes the effectiveness of a workshop designed to train professionals across disciplines in understanding and implementing TIC in their work ...

Interventions to increase patient and family involvement ... - PMC

This review focuses on one type of involvement in safety ‐ patient and family involvement in escalation of care for serious life‐threatening conditions.

104: A RANDOMIZED CONTROLLED TRIAL OF AN ...

[18] tested the ARISE intervention, designed to support critical care and trauma nurses at a tertiary academic hospital in Toronto, Canada. The intervention ...

Arise the systems physician - Scott - 2014

Using administrative and clinical data on processes and outcomes of care to evaluate care and reconfigure care systems; Ensuring systemic use ...