Jessica Martin-Howard

Background: The management of type 2 diabetes mellitus (T2DM) includes mastery of complex care activities, self-management skills, and routine health care encounters to optimize glucose control and achieve good health. Given the lifelong course of T2DM, patients are faced with navigating complex medical and disease-specific information. This health-seeking behavior is a driver of health disparities and is associated with hospitalization and readmission. Given that health-seeking behavior is a potentially intervenable social determinant of health, a better understanding of how people navigate these complex systems is warranted. Objective: To address this need, we aimed to develop new patient-reported outcome (PRO) measures that evaluate health-seeking behavior in persons with T2DM. These new PROs were designed to be included in the Re-Engineered Discharge for Diabetes-Computer Adaptive Test (REDD-CAT) measurement system, which includes several other PROs that capture the importance of social determinants of health. Methods: Overall, 225 participants with T2DM completed 56 self-report items that examined health-seeking behaviors. Classical Test Theory and Item Response Theory were used for measurement development. Exploratory factor analysis (EFA; criterion ratio of eigenvalue 1 to eigenvalue 2 being >4; variance for eigenvalue 1 ≥40%) and confirmatory factor analysis (CFA; criterion 1-factor CFA loading <.50; 1-factor CFA residual correlation >.20; comparative fit index ≥0.90; Tucker-Lewis index ≥0.90; root mean square error of approximation 4; variance for eigenvalue 1=41.4%-67.3%) and CFA (fit statistics all exceeded criterion values). This included (1) “Health-Seeking Behavior: PCP-Specific” (6 items); (2) “Health-Seeking Behavior: General Beliefs” (13 items); (3) “Health-Seeking Behavior: Family or Friends-Specific” (5 items); and (4) “Health-Seeking Behavior: Internet-Specific” (4 items). All items were devoid of differential item functioning for age, sex, education, or socioeconomic status factors. “Health-Seeking Behavior: General Beliefs” was developed to include both a computer adaptive test and a 6-item short form version; all other PROs were developed as static short forms. The psychometric reliability of these new PROs was supported; internal consistency ranged from acceptable to excellent (Cronbach α=.78-.91), and measures were free of significant floor or ceiling effects (floor effects range: 0%-8.9%; ceiling effects range: 0%-8.4%). Conclusions: The new REDD-CAT Health-Seeking Behavior PROs provide reliable assessments of health-seeking behaviors among those with T2DM.

BACKGROUND The management of type 2 diabetes mellitus (T2DM) includes mastery of complex care activities, self-management skills, and routine health care encounters to optimize glucose control and achieve good health. Given the lifelong course of T2DM, patients are faced with navigating complex medical and disease-specific information. This health-seeking behavior is a driver of health disparities and is associated with hospitalization and readmission. Given that health-seeking behavior is a potentially intervenable social determinant of health, a better understanding of how people navigate these complex systems is warranted. OBJECTIVE To address this need, we aimed to develop new patient-reported outcome (PRO) measures that evaluate health-seeking behavior in persons with T2DM. These new PROs were designed to be included in the Re-Engineered Discharge for Diabetes-Computer Adaptive Test (REDD-CAT) measurement system, which includes several other PROs that capture the importance of social determinants of health. METHODS Overall, 225 participants with T2DM completed 56 self-report items that examined health-seeking behaviors. Classical Test Theory and Item Response Theory were used for measurement development. Exploratory factor analysis (EFA; criterion ratio of eigenvalue 1 to eigenvalue 2 being >4; variance for eigenvalue 1 ≥40%) and confirmatory factor analysis (CFA; criterion 1-factor CFA loading <.50; 1-factor CFA residual correlation >.20; comparative fit index ≥0.90; Tucker-Lewis index ≥0.90; root mean square error of approximation 4; variance for eigenvalue 1=41.4%-67.3%) and CFA (fit statistics all exceeded criterion values). This included (1) “Health-Seeking Behavior: PCP-Specific” (6 items); (2) “Health-Seeking Behavior: General Beliefs” (13 items); (3) “Health-Seeking Behavior: Family or Friends-Specific” (5 items); and (4) “Health-Seeking Behavior: Internet-Specific” (4 items). All items were devoid of differential item functioning for age, sex, education, or socioeconomic status factors. “Health-Seeking Behavior: General Beliefs” was developed to include both a computer adaptive test and a 6-item short form version; all other PROs were developed as static short forms. The psychometric reliability of these new PROs was supported; internal consistency ranged from acceptable to excellent (Cronbach α=.78-.91), and measures were free of significant floor or ceiling effects (floor effects range: 0%-8.9%; ceiling effects range: 0%-8.4%). CONCLUSIONS The new REDD-CAT Health-Seeking Behavior PROs provide reliable assessments of health-seeking behaviors among those with T2DM.

Background: Medically underserved people with type 2 diabetes mellitus face limited access to group-based diabetes care, placing them at risk for poor disease control and complications. Immersive technology and telemedicine solutions could bridge this gap. Objective: The purpose of this study was to compare the effectiveness of diabetes medical group visits (DMGVs) delivered in an immersive telemedicine platform versus an in-person (IP) setting and establish the noninferiority of the technology-enabled approach for changes in hemoglobin A1c (HbA1c) and physical activity (measured in metabolic equivalent of task [MET]) at 6 months. Methods: This study is a noninferiority randomized controlled trial conducted from February 2017 to December 2019 at an urban safety net health system and community health center. We enrolled adult women (aged ≥18 years) who self-reported African American or Black race or Hispanic or Latina ethnicity and had type 2 diabetes mellitus and HbA1c ≥8%. Participants attended 8 weekly DMGVs, which included diabetes self-management education, peer support, and clinician counseling using a culturally adapted curriculum in English or Spanish. In-person participants convened in clinical settings, while virtual world (VW) participants met remotely via an avatar-driven, 3D VW linked to video teleconferencing. Follow-up occurred 6 months post enrollment. Primary outcomes were mean changes in HbA1c and physical activity at 6 months, with noninferiority margins of 0.7% and 12 MET-hours, respectively. Secondary outcomes included changes in diabetes distress and depressive symptoms. Results: Of 309 female participants (mean age 55, SD 10.6 years; n=195, 63% African American or Black; n=105, 34% Hispanic or Latina; n=151 IP; and n=158 in VW), 207 (67%) met per-protocol criteria. In the intention-to-treat analysis, we confirmed noninferiority for primary outcomes. We found similar improvements in mean HbA1c by group at 6 months (IP: –0.8%, SD 1.9%; VW: –0.5%, SD 1.8%; mean difference 0.3, 97.5% CI –∞ to 0.3; P<.001). However, there were no detectable improvements in physical activity (IP: –6.5, SD 43.6; VW: –9.6, SD 44.8 MET-hours; mean difference –3.1, 97.5% CI –6.9 to ∞; P=.02). The proportion of participants with significant diabetes distress and depressive symptoms at 6 months decreased in both groups. Conclusions: In this noninferiority randomized controlled trial, immersive telemedicine was a noninferior platform for delivering diabetes care, eliciting comparable glycemic control improvement, and enhancing patient engagement, compared to IP DMGVs. Trial Registration: ClinicalTrials.gov NCT02726425; https://clinicaltrials.gov/ct2/show/NCT02726425

Purpose The purpose of this study was to develop a new measure, the Re-Engineered Discharge for Diabetes Computer Adaptive Test (REDD-CAT) Illness Burden item bank, to evaluate the impact that a chronic condition has on independent living, the ability to work (including working at home), social activities, and relationships. Methods Semi-structured interviews were used to inform the development of an item pool (47 items) that captured patients’ beliefs about how a diagnosis of type 2 diabetes interferes with different aspects of their lives. The Illness Burden item bank was developed and tested in 225 people with type 2 diabetes mellitus. Results No items had sparse response option cells or problems with monotonicity; two items were deleted due to low item-rest correlations. Factor analyses supported the retention of 29 items. With those 29 remaining items, a constrained (common slope) graded response model fit assessment indicated that two items had misfit; they were excluded. No items displayed differential item functioning by age, sex, education, or socio-economic status. The final item bank is comprised of 27 items. Preliminary data supported the reliability (internal consistency and test–retest reliability) and validity (convergent, discriminant, and known-groups) of the new bank. Conclusion The Illness Burden item bank can be administered as a computer adaptive test or a 6-item short form. This new measure captures patients’ perceptions of the impact that having type 2 diabetes has on their daily lives; it can be used in conjunction with the REDD-CAT measurement system to evaluate important social determinants of health in persons with type 2 diabetes mellitus.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Medically underserved people with type 2 diabetes mellitus face limited access to group-based diabetes care, placing them at risk for poor disease control and complications. Immersive technology and telemedicine solutions could bridge this gap. Objective: The purpose of this study was to compare the effectiveness of diabetes medical group visits (DMGVs) delivered in an immersive telemedicine platform versus an in-person (IP) setting and establish the noninferiority of the technology-enabled approach for changes in hemoglobin A_1c (HbA_1c) and physical activity (measured in metabolic equivalent of task [MET]) at 6 months. Methods: This study is a noninferiority randomized controlled trial conducted from February 2017 to December 2019 at an urban safety net health system and community health center. We enrolled adult women (aged ≥18 years) who self-reported African American or Black race or Hispanic or Latina ethnicity and had type 2 diabetes mellitus and HbA_1c ≥8%. Participants attended 8 weekly DMGVs, which included diabetes self-management education, peer support, and clinician counseling using a culturally adapted curriculum in English or Spanish. In-person participants convened in clinical settings, while virtual world (VW) participants met remotely via an avatar-driven, 3D VW linked to video teleconferencing. Follow-up occurred 6 months post enrollment. Primary outcomes were mean changes in HbA_1c and physical activity at 6 months, with noninferiority margins of 0.7% and 12 MET-hours, respectively. Secondary outcomes included changes in diabetes distress and depressive symptoms. Results: Of 309 female participants (mean age 55, SD 10.6 years; n=195, 63% African American or Black; n=105, 34% Hispanic or Latina; n=151 IP; and n=158 in VW), 207 (67%) met per-protocol criteria. In the intention-to-treat analysis, we confirmed noninferiority for primary outcomes. We found similar improvements in mean HbA_1c by group at 6 months (IP: –0.8%, SD 1.9%; VW: –0.5%, SD 1.8%; mean difference 0.3, 97.5% CI –∞ to 0.3; P<.001). However, there were no detectable improvements in physical activity (IP: –6.5, SD 43.6; VW: –9.6, SD 44.8 MET-hours; mean difference –3.1, 97.5% CI –6.9 to ∞; P=.02). The proportion of participants with significant diabetes distress and depressive symptoms at 6 months decreased in both groups. Conclusions: In this noninferiority randomized controlled trial, immersive telemedicine was a noninferior platform for delivering diabetes care, eliciting comparable glycemic control improvement, and enhancing patient engagement, compared to IP DMGVs. Trial Registration: ClinicalTrials.gov NCT02726425; https://clinicaltrials.gov/ct2/show/NCT02726425

Background: The development of evidence-based care geared towards Black and Latina women living with uncontrolled type 2 diabetes is contingent upon their active recruitment into clinical interventions. Well-documented impediments to recruitment include a historical mistrust of the research community and socioeconomic factors that limit awareness and access to research studies. Although sociocultural and socioeconomic factors deter minorities from participating in clinical research, it is equally important to consider the role of stigma in chronic disease intervention studies. Objective: We aim to share our discovery of diabetes-related stigma as an underrecognized impediment to recruitment for the Women in Control 2.0 virtual diabetes self-management education study. Methods: Our initial recruitment plan used traditional strategies to recruit minority women with uncontrolled type 2 diabetes, which included letters and phone calls to targeted patients, referrals from clinicians, and posted flyers. After engaging a patient advisory group and consulting with experts in community advocacy, diabetes-related stigma emerged as a prominent barrier to recruitment. The study team reviewed and revised recruitment scripts and outreach material in order to better align with the lived experience and needs of potential enrollees. Results: Using a more nuanced, community-centered recruitment approach, we achieved our target recruitment goal, enrolling 309 participants into the study, exceeding our target of 212. Conclusions: There is a need for updated recruitment methods that can increase research participation of patients who experience internalized diabetes stigma. To address disparities in minority health, further research is needed to better understand diabetes-related stigma and devise strategies to avert or address it.

BACKGROUND The development of evidence-based care geared towards Black and Latina women living with uncontrolled type 2 diabetes is contingent upon their active recruitment into clinical interventions. Well-documented impediments to recruitment include a historical mistrust of the research community and socioeconomic factors that limit awareness and access to research studies. Although sociocultural and socioeconomic factors deter minorities from participating in clinical research, it is equally important to consider the role of stigma in chronic disease intervention studies. OBJECTIVE We aim to share our discovery of diabetes-related stigma as an underrecognized impediment to recruitment for the Women in Control 2.0 virtual diabetes self-management education study. METHODS Our initial recruitment plan used traditional strategies to recruit minority women with uncontrolled type 2 diabetes, which included letters and phone calls to targeted patients, referrals from clinicians, and posted flyers. After engaging a patient advisory group and consulting with experts in community advocacy, diabetes-related stigma emerged as a prominent barrier to recruitment. The study team reviewed and revised recruitment scripts and outreach material in order to better align with the lived experience and needs of potential enrollees. RESULTS Using a more nuanced, community-centered recruitment approach, we achieved our target recruitment goal, enrolling 309 participants into the study, exceeding our target of 212. CONCLUSIONS There is a need for updated recruitment methods that can increase research participation of patients who experience internalized diabetes stigma. To address disparities in minority health, further research is needed to better understand diabetes-related stigma and devise strategies to avert or address it.