Coaching and Education for Diabetes Distress (CEDD)

• ClinicalTrials.gov Identifier: NCT03617146
• Recruitment Status: Terminated
• First Posted: August 6, 2018
• Last Update Posted: January 22, 2021
• Sponsor: Baylor College of Medicine
• Information provided by (Responsible Party): Charles C Chima, Baylor College of Medicine

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Distress	Behavioral: Health coaching; Other: Diabetes Distress-specific Education	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two-arm parallel randomized controlled trial
• Masking: Single (Outcomes Assessor)
• Masking Description: Due to the nature of the behavioral intervention, neither participants nor clinic staff can be blinded to allocation. However, to avoid bias in assessing outcomes, the analyst who will abstract the outcomes data from the electronic health record will not have access to information about the allocation. Hence retrieval of data on baseline and follow up diabetes distress scores, HbA1c, and diabetes self-management behaviors, and the creation of the analysis dataset will be done without knowledge or consideration of allocation status.
• Primary Purpose: Supportive Care
• Official Title: Coaching and Education for Diabetes Distress: a Randomized Controlled Trial (CEDD Trial)
• Actual Study Start Date: June 15, 2018
• Actual Primary Completion Date: February 25, 2020
• Actual Study Completion Date: September 17, 2020

Arms and Interventions

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 Name: 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. HbA1c [ Time Frame: 3 months and 6 months from baseline ]
   Change in glycemic control as measured by HbA1c
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

Locations

United States, Texas

Baylor Family Medicine

Houston, Texas, United States, 77098

Sponsors and Collaborators

Baylor College of Medicine

Investigators

• Principal Investigator: Charles Chima; Baylor College of Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chima CC, Salemi JL, Sidani MA, Zoorob RJ. Coaching and Education for Diabetes Distress (CEDD): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Apr 2;8(4):e12166. doi: 10.2196/12166.

• Responsible Party: Charles C Chima, Adjunct Assistant Professor, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT03617146
• Other Study ID Numbers: 52960-I
• First Posted: August 6, 2018
• Last Update Posted: January 22, 2021
• Last Verified: January 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Charles C Chima, Baylor College of Medicine:

Diabetes Distress; Diabetes Mellitus; Diabetes Control; Health Coaching; Diabetes Self-management

Additional relevant MeSH terms:

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases