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

Abstract

Background Diabetes distress (DD), a type of psychological distress specific to people with diabetes, is strongly associated with difficulties in performing self-care and inability to meet glycemic targets. 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 The aim of this study is to describe the rationale and design of an ongoing clinical trial, Coaching and Education for Diabetes Distress 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 2-arm randomized controlled trial 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 8 HC sessions over a 5-month period. The primary outcome measure is reduction in DD over a 6-month period. Additional outcome measures include changes in hemoglobin A 1c and self-care practices (medication-taking, dietary, and physical activity behaviors). Results As of March 2019, screening and recruitment are ongoing, and the results are expected by July 2020. 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. Trial Registration ClinicalTrials.gov NCT03617146; https://clinicaltrials.gov/ct2/show/NCT03617146 (Archived by WebCite at http://www.webcitation.org/76Va37dbO) International Registered Report Identifier (IRRID) DERR1-10.2196/12166

Perceptions of diabetes distress during pregnancy in women with type 1 and type 2 diabetes: a qualitative interpretive description study

“…A nurse-coaching pilot intervention that used educational, behavioral and affective strategies resulted in lower DD scores from baseline to 6 months in a sample of women with T2D ( F = 7.5, p < 0.01) [ 50 ]. A randomized controlled trial of health coaching that is underway will utilize a behavioral and psychological management intervention that includes diabetes self-management education and support and a DD-specific education program delivered over the telephone for non-pregnant adults with T2D who screen positive for DD [ 51 ].…”

A diabetes, a stressz és az alvásproblémák kapcsolata a Hungarostudy 2013 kutatás adatainak fényében

“…Az utóbbi évtizedekben megalapozottá vált az a feltételezés is, miszerint a diabetesszel összefüggő distressz (amelyet elkülönítenek az esetenként jellemző klinikailag jelentős depressziótól) jelentős, negatív hatást gyakorol a betegek életminőségére és adherenciájára [25], ezért első lépésként ennek szűrése, majd kezelése hazánkban is szükséges lenne, ahogy az alvásprobléma azonosítása és kezelése is. Különös tekintettel arra, hogy mindkét problémakör kezelésére elérhetők [26], illetve várhatóan a közeljövőben elérhetővé válnak [27] hatékony magatartásorvoslási módszerek.…”