Coaching and Education for Diabetes Distress (CEDD)

January 20, 2021 updated by: Charles C Chima, Baylor College of Medicine

Coaching and Education for Diabetes Distress: a Randomized Controlled Trial (CEDD Trial)

Diabetes distress (DD) is a negative emotional reaction to a diagnosis of diabetes and concerns about the burden of managing diabetes, the risk of complications, and inadequate support system. DD is common among people with diabetes and is strongly associated with poor diabetes self-care and poor diabetes control. Reducing DD should thus be an important component of diabetes management. In line with the growing evidence, the American Diabetes Association now recommends that providers "routinely monitor people with diabetes for diabetes distress, particularly when treatment targets are not met". Despite increased recognition of the need to manage DD, interventions that are both feasible and effective for reducing DD in routine care settings are not yet known. A pilot study showed that health coaching (HC) has some efficacy in addressing DD but no adequately powered study has implemented a pragmatic research design capable of assessing the real-world effectiveness of HC in reducing DD.

This study seeks to assess whether HC effectively reduces DD among primary care patients with diabetes, and whether HC is more effective than an educational program targeting DD. The investigators hypothesize that over a 6-month period, patients with poorly controlled diabetes and DD who enroll in and complete at least five HC sessions will achieve higher and clinically significant reductions in DD and HbA1c, and greater compliance with diabetes self-care recommendations than those who receive only an educational program targeting DD as part of usual diabetes care.

The two-arm randomized controlled trial for patients with poorly-controlled diabetes is taking place at an academic family medicine practice in Houston, Texas. Both arms will receive usual care, which includes education about DD. In addition, the intervention arm will receive eight HC sessions over a five-month period. The primary outcome measure is reduction in DD over a six month period. Additional outcome measures include changes in glycemic control (HbA1C) and self-care practices (medication adherence, dietary, and physical activity behaviors). The study will also measure satisfaction and willingness-to-pay for HC to determine the extent to which HC, if effective for reducing DD, can be operationalized in similar healthcare settings.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77098
        • Baylor Family Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has had a diagnosis of type 2 diabetes for at least 6 months
  • Aged 18 to 75 years
  • Most recent HbA1c taken within 30 days was ≥ 8.0
  • At least moderate diabetes distress (a mean score ≥ 2.0 on the 17-item Diabetes Distress Scale).

Exclusion Criteria:

  • Moderately-severe to severe depression: Patient Health Questionnaire (PHQ9) score ≥15
  • Other severe mental health disorder (e.g. Alzheimer's, schizophrenia)
  • Current pregnancy
  • Severe diabetes complications or functional deficits (e.g. kidney failure requiring dialysis, amputation, blindness).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm

Participants in the intervention arm will receive the following interventions:

Month 1: Diabetes Distress-specific Education.

Months 1 to 3: Six 30 to 45-minute telephone-based health coaching sessions targeting diabetes distress reduction and self-care improvement.

Month 3: Follow up distress-specific education.

Months 4 and 5: Two 30 to 45 minute telephone-based health coaching sessions targeting diabetes distress reduction and self-care improvement.
Behavioral: Health coaching
The intervention will seek to help participants express their diabetes emotional needs and to work with them to figure out what can be done to meet those needs. Depending on the unique needs of each participant, the coaching approach for this study will include: improving motivation and self-efficacy for diabetes management using motivational interviewing and appreciative inquiry; building trust and rapport through mindful listening, open-ended inquiry, and perceptive reflections; and expressing empathy through nonviolent communication. Each participant will receive eight individual coaching sessions over a five month period. All coaching sessions will be delivered over the phone (i.e. telecoaching). The coaching intervention will be done by a certified health and wellness coach.
Other Names:
  • Telecoaching
Other: Diabetes Distress-specific Education
A diabetes distress-specific education that explains what diabetes distress is, why it matters, and its four domains. In addition, the participant is given feedback on his or her distress score and advised on ways to deal with the areas of greatest distress. Participant is linked with resources to overcome any expressed needs. The education is provided by a trained medical assistant.
Active Comparator: Control Arm

Participants in the control arm will receive the following interventions:

Month 1: Diabetes Distress-specific Education (same as for the intervention arm).

Month 3: Follow up distress-specific education (same as for the intervention arm).
Other: Diabetes Distress-specific Education
A diabetes distress-specific education that explains what diabetes distress is, why it matters, and its four domains. In addition, the participant is given feedback on his or her distress score and advised on ways to deal with the areas of greatest distress. Participant is linked with resources to overcome any expressed needs. The education is provided by a trained medical assistant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes distress score
Time Frame: 3 months and 6 months from baseline
Change in diabetes distress score as measured by the diabetes distress scale (DDS). DDS scores range from 1 to 6, with scores that are less than 2.0 being indicative of little or no distress. Hence scores of 2.0 and above are significant and higher values are indicative of worse outcome.
3 months and 6 months from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 3 months and 6 months from baseline
Change in glycemic control as measured by HbA1c
3 months and 6 months from baseline
Self-care behaviors (medication adherence, dietary practices, and physical activity behaviors)
Time Frame: 3 months and 6 months from baseline
Change in medication adherence, dietary practices, and physical activity behaviors, as measured by the respective medication, diet, and exercise subscales of the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire.
3 months and 6 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: Charles Chima, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2018

Primary Completion (Actual)

February 25, 2020

Study Completion (Actual)

September 17, 2020

Study Registration Dates

First Submitted

July 27, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (Actual)

August 6, 2018

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 52960-I

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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