Achieving Routine Intervention and Screening for Emotional Health
NCT ID: NCT06887049
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1250 participants
INTERVENTIONAL
2026-05-31
2027-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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ARISE Learning Community Arm
Community Health Centers will be given an in-depth training on the ARISE screening and intervention algorithm
ARISE Learning Community Diabetes Distress Screening and Intervention
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
Community Health Centers will be given a brief training on the 7A's model of diabetes distress screening and intervention
ARISE Enhanced Care brief training
Brief training on American Diabetes Association guidelines for screening for diabetes distress using the 7A's model
Interventions
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ARISE Learning Community Diabetes Distress Screening and Intervention
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
Brief training on American Diabetes Association guidelines for screening for diabetes distress using the 7A's model
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes
* Adult (18 years or older)
* A1C \> 8%
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Midwest Clinicians' Network
UNKNOWN
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Arshiya Baig, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Danielle Hessler Jones, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Central Contacts
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References
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Fisher L, Polonsky WH, Hessler D. Addressing diabetes distress in clinical care: a practical guide. Diabet Med. 2019 Jul;36(7):803-812. doi: 10.1111/dme.13967. Epub 2019 May 7.
Chew BH, Vos RC, Metzendorf MI, Scholten RJ, Rutten GE. Psychological interventions for diabetes-related distress in adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2017 Sep 27;9(9):CD011469. doi: 10.1002/14651858.CD011469.pub2.
Shin, P., Sharac, J., Barber, Z., Rosenbaum, S., & Paradise, J. (2015, March). Community Health Centers: A 2013 Profile and Prospects as ACA Implementation Proceeds. The Henry J. Kaiser Family Foundation. Retrieved from http://kff.org/medicaid/issue-brief/community-health-centers-a-2013-profileand-prospects-as-aca-implementation-proceeds/
Health Resources and Services Administration (HRSA). Health Center Program. Table 7. Health Outcomes and Disparities. National Data. Available at: https://data.hrsa.gov/tools/datareporting/program-data/national/table?tableName=7&year=2020.
Schmidt CB, van Loon BJP, Vergouwen ACM, Snoek FJ, Honig A. Systematic review and meta-analysis of psychological interventions in people with diabetes and elevated diabetes-distress. Diabet Med. 2018 Jun 13. doi: 10.1111/dme.13709. Online ahead of print.
Wagner H, Pizzimenti JJ, Daniel K, Pandya N, Hardigan PC. Eye on diabetes: a multidisciplinary patient education intervention. Diabetes Educ. 2008 Jan-Feb;34(1):84-9. doi: 10.1177/0145721707312205.
Nicolucci A, Kovacs Burns K, Holt RI, Comaschi M, Hermanns N, Ishii H, Kokoszka A, Pouwer F, Skovlund SE, Stuckey H, Tarkun I, Vallis M, Wens J, Peyrot M; DAWN2 Study Group. Diabetes Attitudes, Wishes and Needs second study (DAWN2): cross-national benchmarking of diabetes-related psychosocial outcomes for people with diabetes. Diabet Med. 2013 Jul;30(7):767-77. doi: 10.1111/dme.12245.
Fisher L, Hessler D, Glasgow RE, Arean PA, Masharani U, Naranjo D, Strycker LA. REDEEM: a pragmatic trial to reduce diabetes distress. Diabetes Care. 2013 Sep;36(9):2551-8. doi: 10.2337/dc12-2493. Epub 2013 Jun 4.
Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.
Welch GW, Jacobson AM, Polonsky WH. The Problem Areas in Diabetes Scale. An evaluation of its clinical utility. Diabetes Care. 1997 May;20(5):760-6. doi: 10.2337/diacare.20.5.760.
LeBron AM, Valerio MA, Kieffer E, Sinco B, Rosland AM, Hawkins J, Espitia N, Palmisano G, Spencer M. Everyday discrimination, diabetes-related distress, and depressive symptoms among African Americans and Latinos with diabetes. J Immigr Minor Health. 2014 Dec;16(6):1208-16. doi: 10.1007/s10903-013-9843-3.
Sturt J, Dennick K, Hessler D, Hunter BM, Oliver J, Fisher L. Effective interventions for reducing diabetes distress: systematic review and meta-analysis. International Diabetes Nursing. 2015;12(2):40-55.
Skinner TC, Joensen L, Parkin T. Twenty-five years of diabetes distress research. Diabet Med. 2020 Mar;37(3):393-400. doi: 10.1111/dme.14157. Epub 2019 Oct 31.
Dennick K, Sturt J, Speight J. What is diabetes distress and how can we measure it? A narrative review and conceptual model. J Diabetes Complications. 2017 May;31(5):898-911. doi: 10.1016/j.jdiacomp.2016.12.018. Epub 2017 Feb 14.
Snoek FJ, Bremmer MA, Hermanns N. Constructs of depression and distress in diabetes: time for an appraisal. Lancet Diabetes Endocrinol. 2015 Jun;3(6):450-460. doi: 10.1016/S2213-8587(15)00135-7. Epub 2015 May 17.
Indelicato L, Dauriz M, Santi L, Bonora F, Negri C, Cacciatori V, Targher G, Trento M, Bonora E. Psychological distress, self-efficacy and glycemic control in type 2 diabetes. Nutr Metab Cardiovasc Dis. 2017 Apr;27(4):300-306. doi: 10.1016/j.numecd.2017.01.006. Epub 2017 Jan 31.
Dennick K, Sturt J, Hessler D, et al. High rates of elevated diabetes distress in research populations: A systematic review and meta-analysis. International Diabetes Nursing. 2015;12(3):93-107.
Fisher L, Skaff MM, Mullan JT, Arean P, Mohr D, Masharani U, Glasgow R, Laurencin G. Clinical depression versus distress among patients with type 2 diabetes: not just a question of semantics. Diabetes Care. 2007 Mar;30(3):542-8. doi: 10.2337/dc06-1614.
Fisher L, Gonzalez JS, Polonsky WH. The confusing tale of depression and distress in patients with diabetes: a call for greater clarity and precision. Diabet Med. 2014 Jul;31(7):764-72. doi: 10.1111/dme.12428.
Walker RJ, Strom Williams J, Egede LE. Influence of Race, Ethnicity and Social Determinants of Health on Diabetes Outcomes. Am J Med Sci. 2016 Apr;351(4):366-73. doi: 10.1016/j.amjms.2016.01.008.
Hill-Briggs F, Adler NE, Berkowitz SA, Chin MH, Gary-Webb TL, Navas-Acien A, Thornton PL, Haire-Joshu D. Social Determinants of Health and Diabetes: A Scientific Review. Diabetes Care. 2020 Nov 2;44(1):258-79. doi: 10.2337/dci20-0053. Online ahead of print. No abstract available.
Centers for Disease Control and Prevention. National diabetes statistics report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services. 2020:12- 15.
Other Identifiers
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IRB24-0622
Identifier Type: -
Identifier Source: org_study_id
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