Achieving Routine Intervention and Screening for Emotional Health (ARISE)

The University of Chicago

Status: Begins enrollment in 2 months

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

Treatments: Behavioral: ARISE Learning Community Diabetes Distress Screening and Intervention; Behavioral: ARISE Enhanced Care brief training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06887049

IRB24-0622

R01DK133603-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnant

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,250 participants in 2 patient groups

ARISE Learning Community Arm

Experimental group

Description:

Community Health Centers will be given an in-depth training on the ARISE screening and intervention algorithm

Treatment:

Behavioral: ARISE Learning Community Diabetes Distress Screening and Intervention

ARISE Enhanced Care

Other group

Description:

Community Health Centers will be given a brief training on the 7A's model of diabetes distress screening and intervention

Treatment:

Behavioral: ARISE Enhanced Care brief training