Reducing Distress And Improving Glycemic Control In Adults With Type 1 Diabetes

NCT02175732 | Completed DMC

• 1 other identifier: 5R01DK094863
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes Distress (DD) refers to the emotional and behavioral challenges and burdens that arise through living with and managing diabetes. High DD is characterized by feeling frustrated, overwhelmed and discouraged by the demands of diabetes, and high DD may have a negative impact on disease management and glycemic control; poor glycemic control can also have a negative effect on DD. Few interventions have been assessed that directly target DD or mood in adults with Type 1 diabetes. In this study the investigators will compare two active, evidence-based behavioral interventions to reduce high DD and improve glycemic control and disease management:

1. 1.A Type 1 diabetes education protocol ('KnowIt') that brings together new advances in diabetes education and behavioral management.
2. 2.A DD-reduction protocol ('OnTrack') that helps identify and address the personal stresses and strains of having diabetes.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes; Distress

Outcome Measures

Primary Outcomes (2)

• Diabetes Distress

  Distress across several domains will be assessed using the Type 1 Diabetes Distress Scale.

  Baseline to 9 months

• HbA1c

  Assay

  Baseline to 9 months

Secondary Outcomes (3)

• Self-efficacy

  Baseline to 9 months

• Hypoglycemia confidence

  Baseline to 9 months

• Depression

  Baseline to 9 months

Study Arms (2)

KnowIt

EXPERIMENTAL

Please see the 'KnowIt' intervention description below. Diabetes education, behavioral management

Behavioral: 'KnowIt'

OnTrack

EXPERIMENTAL

Please see the 'OnTrack' intervention description below. Diabetes Distress Reduction, Problem Solving Therapy

Behavioral: 'OnTrack'

Interventions

'KnowIt' BEHAVIORAL

Participants in the 'KnowIt' group will participate in a single, day-long group workshop led by a trained facilitator. Content covered during the program will focus on recent advances in diabetes care and self-management. During the three months following the initial workshop, participants will receive four telephone calls with their group facilitator to address any questions and challenges. One week after each phone call participants will take part in a 60 minute web meetings with their facilitator and other group members to review program content and discuss any challenges. Finally, participants will receive two further phone calls from their facilitator during months four to nine.

KnowIt

'OnTrack' BEHAVIORAL

Participants in the 'OnTrack' group will participate in a single, day-long group workshop led by a trained facilitator. Content covered during the program will utilize an emotion-based adaptation of Problem Solving Therapy to target and reduce diabetes distress. During the three months following the initial workshop, participants will receive four telephone calls with their group facilitator to address any questions and challenges. One week after each phone call participants will take part in a 60 minute web meetings with their facilitator and other group members to review program content and discuss any challenges. Finally, participants will receive two further phone calls from their facilitator during months four to nine.

OnTrack

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19 or older
• Type 1 diabetes
• Diagnosed at least 12 months
• Intensive insulin use
• Recent HbA1c result of 7.5 or higher
• At least moderate diabetes distress (score 2.0 or higher on T1 Diabetes Distress scale)
• Able to speak/read English fluently

You may not qualify if:

• Severe complications or disorders (e.g. heart attack in past 12 months, psychosis, blindness, end-stage dialysis).

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UC San Francisco, Family and Community Medicine Dept.

San Francisco, California, 94143, United States

Location

Related Publications (8)

• 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.

  PMID: 23735726 BACKGROUND

• Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754.

  PMID: 7555499 BACKGROUND

• 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.

  PMID: 17327318 BACKGROUND

• Glasgow RE, Fisher L, Skaff M, Mullan J, Toobert DJ. Problem solving and diabetes self-management: investigation in a large, multiracial sample. Diabetes Care. 2007 Jan;30(1):33-7. doi: 10.2337/dc06-1390.

  PMID: 17192329 BACKGROUND

• Hessler D, Strycker L, Fisher L. Reductions in Management Distress Following a Randomized Distress Intervention Are Associated With Improved Diabetes Behavioral and Glycemic Outcomes Over Time. Diabetes Care. 2021 Jul;44(7):1472-1479. doi: 10.2337/dc20-2724. Epub 2021 May 14.

  PMID: 33990376 DERIVED

• Shumway M, Fisher L, Hessler D, Bowyer V, Polonsky WH, Masharani U. Economic costs of implementing group interventions to reduce diabetes distress in adults with type 1 diabetes mellitus in the T1-REDEEM trial. J Diabetes Complications. 2019 Nov;33(11):107416. doi: 10.1016/j.jdiacomp.2019.107416. Epub 2019 Aug 15.

  PMID: 31473079 DERIVED

• Hessler D, Fisher L, Polonsky W, Strycker L, Parra J, Bowyer V, Dedhia M, Masharani U. There is value in treating elevated levels of diabetes distress: the clinical impact of targeted interventions in adults with Type 1 diabetes. Diabet Med. 2020 Jan;37(1):71-74. doi: 10.1111/dme.14082. Epub 2019 Aug 5.

  PMID: 31314907 DERIVED

• Fisher L, Hessler D, Polonsky WH, Masharani U, Guzman S, Bowyer V, Strycker L, Ahmann A, Basina M, Blumer I, Chloe C, Kim S, Peters AL, Shumway M, Weihs K, Wu P. T1-REDEEM: A Randomized Controlled Trial to Reduce Diabetes Distress Among Adults With Type 1 Diabetes. Diabetes Care. 2018 Sep;41(9):1862-1869. doi: 10.2337/dc18-0391. Epub 2018 Jul 5.

  PMID: 29976567 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lawrence Fisher, Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 26, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 25, 2019

Record last verified: 2019-03

Locations

US (1)