Validation of a Novel Patient-Reported Measure of The Burden of Digital Care in Diabetes

Abstract

Background: Patients living with diabetes and chronic conditions may face significant burden managing their health. Many of these patients use digital medicine tools such as continuous glucose monitoring systems. Although measures exist to assess treatment burden from tasks such as managing medications and attending healthcare visits, there is no patient-reported measure that captures the burden of digital care. Therefore, the purpose of this study is to validate the Treatment Burden Questionnaire Plus Digital (TBQ + D), a patient-reported measure of treatment burden that includes using digital tools for adults with diabetes.

Methods: Adult patients with type 1 or type 2 diabetes mellitus completed the 25-item TBQ + D (scored 0 [none] to 10 [maximum] per item; total score range 0-250). We evaluated ease of administration, internal consistency, and tested hypotheses about the relationship between TBQ + D scores and treatment complexity, digital tool use intensity, social risk factors, and digital comfort to assess TBQ + D's validity.

Results: Of 324 patients approached, 300 (93%) consented and completed the TBQ + D (mean age 57 [SD 17]; 50% female; 50% with type 2). The mean TBQ + D score was 53.7 (SD 41.6). Internal consistency was excellent (Cronbach's α = 0.94). As hypothesized, higher TBQ + D scores were reported by patients with type 1 vs. type 2 diabetes mellitus (61.7 vs. 45.7; p = .0008), maximal/moderate vs. minimal to no digital tool use (56.5/60.7 vs. 41.3; p = .001), those on intensive insulin therapy vs. other treatments (61.4 vs. 38.0; p < .0001), and those with greater social vulnerability (p < .0106). TBQ + D scores were not significantly higher in patients with HbA1c ≥ 8% (p = .055) or less comfortable with digital technology (p = .08).

Conclusions: TBQ + D is a novel and valid measure of treatment burden in patients living with diabetes, inclusive of digital burden, that can play a role in fostering minimally disruptive care for patients with diabetes.

Keywords: Burden of Digital Care; Chronic Disease Management; Diabetes Mellitus; Digital Medicine Tools; Patient-Reported Outcome Measures; Self-Management; Treatment Burden; Validation Study.