Diabetes affects between 6.5 and 13 million Americans and is associated with an expenditure of over $44 billion in direct health care costs per year. Prevalence rates for ethnic minorities (African, Asian and Native American, Hispanic) are approximately twice that of non Hispanic Whites (NHW). Depression and elevated distress (D/D) occur as co-morbid conditions in 20% -25% of NHWs with diabetes, but the rates are significantly higher among ethnic minorities. D/D is associated with decreased self-care behavior, poor metabolic control, increased risk for complications, and higher health-care costs. To date, there have been no comprehensive, long-term studies of D/D among patients with diabetes and there have been few practical, evidenced-based interventions that are directed at D/D and diabetes in primary care settings, where most patients receive care. Given the pervasiveness of D/D and the increased behavioral and biological risk that D/D poses for these patients, this competing renewal application (1) expand observation of the interrelationships among D/D, self-care and metabolic control with our existing 3-wave longitudinal cohort from 18 to 42 months to assess the longer term impact of these processes on cardiovascular and other diabetes-related bio-behavioral endpoints (this will be the largest and longest such study to date);(2) gather detailed qualitative data on the subjectively experienced patterns, causes and effects of D/D among these patients;(3) use all of these findings to refine and selectively combine two existing, evidenced-based, interventions (an automated, diabetes-specific self-care program vs. a self-care program plus a live problem solving distress-reduction program vs. enhanced usual care) into a practical, 3-arm clinical trial with a new, highly distressed, multi-ethnic patient sample;and (4) evaluate the intervention using the RE-AIM framework, sharing the results through a comprehensive dissemination package. The proposed research has major implications for clinical care: it will (1) describe the mechanisms and sub group patterns of relationships among D/D, self-care, and metabolic control and their effects on major longer-term diabetes-related outcomes;(2) describe the variety of effects of D/D on diabetes in a diverse patient sample (ethnicity, age, gender);(3) test in an RCT the additive effect of a practical, evidenced-based intervention that specifically targets D/D vs. one that addresses self-care alone;and (4) develop a comprehensive package of practical intervention materials for use in primary care. DESCRIPTION: People with diabetes who experience high levels of D/D are at increased risk for serious disease outcomes. The proposed research will expand the study of D/D, self-care and metabolic control over time from 18 to 42 months to determine their effects on longer-term cardiovascular and other diabetes-related endpoints;will provide valuable subjective information on patients'personal experience of D/D over time;and will test and disseminate the results of two primary care-based interventions that address self-care and D/D in a diverse patient sample.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK061937-07
Application #
7778197
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
Hunter, Christine
Project Start
2002-10-01
Project End
2012-02-29
Budget Start
2010-03-01
Budget End
2011-02-28
Support Year
7
Fiscal Year
2010
Total Cost
$669,671
Indirect Cost
Name
University of California San Francisco
Department
Family Medicine
Type
Schools of Medicine
DUNS #
094878337
City
San Francisco
State
CA
Country
United States
Zip Code
94143
Fisher, Lawrence; Hessler, Danielle; Polonsky, William et al. (2018) Emotion regulation contributes to the development of diabetes distress among adults with type 1 diabetes. Patient Educ Couns 101:124-131
Hessler, Danielle; Fisher, Lawrence; Strycker, Lisa A et al. (2015) Causal and bidirectional linkages over time between depression and diabetes regimen distress in adults with type 2 diabetes. Diabetes Res Clin Pract 108:360-6
Glasgow, Russell E; Fisher, Lawrence; Strycker, Lisa A et al. (2014) Minimal intervention needed for change: definition, use, and value for improving health and health research. Transl Behav Med 4:26-33
Fisher, L; Gonzalez, J S; Polonsky, W H (2014) The confusing tale of depression and distress in patients with diabetes: a call for greater clarity and precision. Diabet Med 31:764-72
Fisher, L; Hessler, D; Masharani, U et al. (2014) Impact of baseline patient characteristics on interventions to reduce diabetes distress: the role of personal conscientiousness and diabetes self-efficacy. Diabet Med 31:739-46
Hessler, Danielle; Fisher, Lawrence; Glasgow, Russell E et al. (2014) Reductions in regimen distress are associated with improved management and glycemic control over time. Diabetes Care 37:617-24
Fisher, Lawrence; Hessler, Danielle; Glasgow, Russell E et al. (2013) REDEEM: a pragmatic trial to reduce diabetes distress. Diabetes Care 36:2551-8
Fisher, Lawrence; Hessler, Danielle M; Polonsky, William H et al. (2012) When is diabetes distress clinically meaningful?: establishing cut points for the Diabetes Distress Scale. Diabetes Care 35:259-64
Fisher, Lawrence; Hessler, Danielle; Naranjo, Diana et al. (2012) AASAP: a program to increase recruitment and retention in clinical trials. Patient Educ Couns 86:372-7
Gonzalez, Jeffrey S; Fisher, Lawrence; Polonsky, William H (2011) Depression in diabetes: have we been missing something important? Diabetes Care 34:236-9

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