Achieving Routine Intervention and Screening for Emotional Health

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM); Diabetes Distress

• Registration Number: NCT06887049
• Lead Sponsor: University of Chicago

Brief Summary

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

Detailed Description

Diabetes mellitus (DM) affects 30 million people in the U.S.1 The prevalence of diabetes is higher among Hispanics (12.5%) and African Americans (11.7%) compared to non-Hispanic whites (7.5%). Managing type 2 DM (T2DM) can be complex and burdensome; patients must modify their diet and exercise habits, take medications, check their blood sugars, visits their healthcare providers regularly, and navigate work and family life. Financial insecurity and social risks (e.g., transportation access) also disproportionately affect persons of color in the U.S. and in turn impede patients' ability to adhere to diabetes self-care recommendations. Diabetes distress (DD) is the stress, fear, and guilt in having to manage diabetes and is distinct from depression and anxiety. A meta-analysis of 58 international studies noted one in five adults with diabetes had elevated DD.6 DD has well documented associations with poor medication adherence, dietary and exercise behaviors, quality of life, and glycosylated hemoglobin (A1C). African-Americans and Hispanics have higher levels of DD compared to non-Hispanic whites.

The American Diabetes Association published guidelines promoting screening for and addressing DD as a critical part of clinical care. Multiple studies have tested standardized screening instruments for DD and intervention studies have demonstrated reductions in DD. However, only 24% of adults with diabetes report their health care team asked them how diabetes affected their lives and far fewer currently receive structured DD screening and follow-up. Efforts to systematically identify and address DD could be an important strategy to improve diabetes outcomes and address diabetes disparities. Community health centers (CHCs) can be important partners in this effort. CHCs provide primary care for 2.5 million adults with diabetes, of whom 30% have A1C \>9% and 57% are racial ethnic minorities.

No studies have systematically implemented DD screening and treatment interventions into a real-world primary care setting or used a guideline based approach. To fill this gap, we developed the ARISE (Achieving Routine Intervention and Screening for Emotional health) intervention. ARISE is a primary care training and implementation program for clinicians and allied health professionals to support screening for and address DD in T2DM. ARISE utilizes a standardized process for screening adult patients with T2DM for DD using validated instruments, provides training and support for CHC staff applying evidence-based strategies on how to address DD in the encounter, and an algorithm for action steps and referrals based on individualized sources of DD (e.g. hypoglycemia, access based on social needs). This pragmatic study will compare ARISE to enhanced usual care (didactic lecture for clinical staff on emotional health of persons with diabetes) using a type I hybrid effectiveness-implementation design via a cluster randomized controlled trial. This study provides the opportunity to optimize T2DM care for populations with health disparities concordant with evidence-based guidelines to aid in the attainment of optimal glycemic control.

Study Timeline

• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Study First Posted: 2025-03-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Study Start: 2026-05
• Primary Completion: 2026-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

• Patient at a participating clinic
• Type 2 diabetes
• Adult (18 years or older)
• A1C > 8%

Exclusion Criteria

• Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of A1C across time	12 months	Rate of A1C from Baseline to follow-up

Secondary Outcome Measures

Name	Time	Method
Average diabetes distress score	12 months	Rate of diabetes distress at each community health center based on average of patients' "core" and "sources" screening scores (based on T2-DDAS screening)
Average of low density lipoproteins (LDL Cholesterol) measure	12 months	Rate of average measure of patients' cholesterol in the blood
Average systolic blood pressure across time	12 months	Average of patients' systolic blood pressure (measures the arterial pressure)
Average Body mass index at baseline and follow-up	12 months	Average of patients' BMI (a measure of height and weight)
Average depression screening (PHQ)	12 months	Average of patients' degree of depression based on survey
Average score of anxiety screening (GAD)	12 months	Average of patients' degree of anxiety based on survey
Average number of referrals across patients over time	12 months	Average of patients' number of referrals to other providers or resources, and frequencies of different types of referrals made (e.g., rate of patients sent to OBGYN, Ophthalmology, etc.)