Coaching and Education for Diabetes Distress

NCT ID: NCT03617146

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-15
• Study Completion Date: 2020-09-17

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.

Conditions

Diabetes Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Health coaching

Intervention Type: BEHAVIORAL

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.

Diabetes Distress-specific Education

Intervention Type: OTHER

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.

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).

Group Type: ACTIVE_COMPARATOR

Diabetes Distress-specific Education

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

Telecoaching

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Charles C Chima

Adjunct Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles Chima

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor Family Medicine

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30938687 (View on PubMed)

Other Identifiers

52960-I

Identifier Type: -

Identifier Source: org_study_id