JMIR Publications

ABSTRACT

Background:

Diabetes distress (DD), a type of psychological distress specific to people with diabetes, is strongly associated with poor self-care and poor diabetes control. 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.

Objective:

This paper describes the rationale and design of an ongoing clinical trial, Coaching and Education for Diabetes Distress – CEDD Trial, that 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.

Methods:

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).

Results:

Screening and recruitment are ongoing, and the results will be expected by December 2019.

Conclusions:

HC is feasible in primary care and has been successfully applied to improving chronic disease self-management and outcomes. This study will provide evidence as to whether it has significant value in addressing important unmet psychological and behavioral needs of patients with diabetes. Clinical Trial: ClinicalTrials.gov – NCT03617146.