ClinicalTrials.gov
ClinicalTrials.gov Menu

Reducing Distress And Improving Glycemic Control In Adults With Type 1 Diabetes (T1REDEEM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02175732
Recruitment Status : Active, not recruiting
First Posted : June 26, 2014
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of California, San Francisco

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

Participants in both arms will attend a single, day-long workshop, four hour-long web group meetings and four personal phone calls with the group facilitator during the intervention period. Assessments will be carried out at baseline and at three and nine months.

Hypothesis 1: OnTrack will be superior to KnowIt in the primary and secondary outcomes at follow-up.

Hypothesis 2: Changes in self-efficacy and fear of hypoglycemia over time will mediate the difference between the two study arms and primary outcome.

Hypothesis 3: The differences between the two study arms and changes in the primary outcomes will be qualified by patient characteristics such as age, length of diagnosis, higher baseline distress or HbA1c.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Behavioral: 'KnowIt' Behavioral: 'OnTrack' Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Distress And Improving Glycemic Control In Adults With Type 1 Diabetes
Study Start Date : September 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: KnowIt
Please see the 'KnowIt' intervention description below. Diabetes education, behavioral management
Behavioral: 'KnowIt'

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.


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

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.





Primary Outcome Measures :
  1. Diabetes Distress [ Time Frame: Baseline to 9 months ]
    Distress across several domains will be assessed using the Type 1 Diabetes Distress Scale.

  2. HbA1c [ Time Frame: Baseline to 9 months ]
    Assay


Secondary Outcome Measures :
  1. Self-efficacy [ Time Frame: Baseline to 9 months ]
    Self-efficacy for type 1 diabetes management will be measured using a self-completion validated scale.

  2. Hypoglycemia confidence [ Time Frame: Baseline to 9 months ]
    Hypoglycemia confidence will be assessed using a self-completion scale (unpublished).

  3. Depression [ Time Frame: Baseline to 9 months ]
    Symptoms of depression will be measured using the self-completion Patient Health Questionnaire (PHQ-8).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175732


Locations
United States, California
UC San Francisco, Family and Community Medicine Dept.
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Lawrence Fisher, Ph.D. University of California, San Francisco

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02175732     History of Changes
Other Study ID Numbers: 5R01DK094863 ( U.S. NIH Grant/Contract )
5R01DK094863 ( U.S. NIH Grant/Contract )
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Keywords provided by University of California, San Francisco:
Type 1 Diabetes
Distress

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases