Effectiveness of an Immersive Telemedicine Platform for Delivering Diabetes Medical Group Visits for African American, Black and Hispanic, or Latina Women With Uncontrolled Diabetes: The Women in Control 2.0 Noninferiority Randomized Clinical Trial.

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.

Development of a New Measure of Housing Security: The REDD-CAT Housing Security Measure.

BACKGROUND: Housing security is a key social determinant of behavior related to health outcomes. OBJECTIVE: The purpose of this study was to develop a new patient-reported outcome measure that evaluates aspects of housing security for use in the Re-Engineered Discharge for Diabetes-Computer Adaptive Test (REDD-CAT) measurement system. DESIGN: Qualitative data, literature reviews, and cross-sectional survey study. PARTICIPANTS: A total of 225 people with T2DM provided responses to the items in this item pool. MAIN MEASURES: A new item pool that evaluates important aspects of housing security was developed using stakeholder data from focus groups of persons with T2DM. KEY RESULTS: For the Housing Affordability scale, factor analysis (both exploratory and confirmatory) supported the retention of six items. Of these items, none exhibited sparse cells or problems with monotonicity; no items were deleted due to low item-adjusted total score correlations. For the six affordability items, a constrained graded response model indicated no items exhibited misfit; thus, all were retained. No items indicated differential item functioning (examined for age, sex, education, race, and socioeconomic status). Thus, the final Affordability item bank comprised six items. A Housing Safety index (three items) and a Home Features index (eight items) were also developed. Reliability (i.e., internal consistency and test-retest reliability) and validity (i.e., convergent, discriminant, and known-groups) of the new measures were also supported. CONCLUSIONS: The REDD-CAT Housing Security Measure provides a reliable and valid assessment of housing affordability, safety, and home features in people with type 2 diabetes mellitus. Future work is needed to establish the clinical utility of this measure in other clinical populations.

Development and calibration data for the Illness Burden item bank: a new computer adaptive test for persons with type 2 diabetes mellitus.

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.

Development and calibration data for the Medication Adherence Item Bank: a new computer adaptive test for persons with type 2 diabetes mellitus.

PURPOSE: To develop a new computer adaptive test that evaluates important aspects of medication adherence for persons with type 2 diabetes mellitus. METHODS: Two hundred and twenty-five people with type 2 diabetes mellitus completed 41 items related to medication adherence. RESULTS: Exploratory analysis supported the essential unidimensionality of the initial item pool. Five items were deleted due to low item-adjusted total score correlations (resulting in 36 items). Confirmatory factor analysis supported the retention of 27 items. A graded response model identified no items for exclusion, based on misfit. No items were flagged for meaningful differential item functioning (DIF). The final item bank is comprised of 27 items; an associated 6-item short form was constructed that balanced both psychometric factors (e.g., item information values) and clinical input. Initial analysis of the simulated CAT and static short form supported both the reliability (i.e., internal consistency and test-retest reliability) and validity (i.e., convergent, discriminant, and known groups) of both administration formats. CONCLUSIONS: The new medication adherence item bank provides a reliable and valid assessment of the ability to take medications accurately among people with T2DM; it will be available in early 2023 through healthmeasures.net.

Development and calibration data for the Healthcare Access Item Bank: a new computer adaptive test for persons with type 2 diabetes mellitus.

PURPOSE: The purpose of this study was to develop a new measure to evaluate the ability to receive medical services when needed among persons with type 2 diabetes mellitus. METHODS: The Healthcare Access measure was developed using data from 225 persons with type 2 diabetes mellitus who completed an item pool comprised of 54 questions pertaining to their experience accessing healthcare services. RESULTS: Exploratory and confirmatory factor analyses supported the retention of 45 items. In addition, a constrained graded response model (GRM), as well as analyses that examined item misfit and differential item functioning (investigated for age, sex, education, race, and socioeconomic status), supported the retention of 44 items in the final item bank. Expert review and GRM item calibration products were used to inform the selection of a 6-item static short form and to program the Healthcare Access computer adaptive test (CAT). Preliminary data supported the reliability (i.e., internal consistency and test-retest reliability) and validity (i.e., convergent, discriminant, and known-groups) of the new measure. CONCLUSIONS: The new Healthcare Access item bank can be used to examine the experiences that persons with type 2 diabetes mellitus have with healthcare access, to better target treatment improvements and mitigate disparities; it will be available as a part of the Neuro-Qol measurement system through healthmeasures.net and the PROMIS Application Programmable Interface (API) in early 2023.

The Physical Activity Assessment of Adults With Type 2 Diabetes Using Accelerometer-Based Cut Points: Scoping Review.

BACKGROUND: Incorporating physical activity into lifestyle routines is recommended for individuals with type 2 diabetes. Accelerometers offer a promising method for objectively measuring physical activity and for assessing interventions. However, the existing literature for accelerometer-measured physical activity among middle-aged and older adults with type 2 diabetes is lacking. OBJECTIVE: This study aims to identify research studies in which accelerometer-based cut points were used to classify the physical activity intensity of middle-aged to older adults with type 2 diabetes as sedentary, light, moderate, vigorous, and very vigorous, and to determine if validated accelerometer cut points specifically for this population exist. METHODS: We followed the Joanna Briggs Institute methodology for scoping reviews. Between June 23 and July 12, 2020, two reviewers independently screened records from four databases (PubMed, Web of Science, Embase, Engineering Village) and the ActiGraph Corp web site for eligible studies that included patients with type 2 diabetes with a sample mean age ≥50 years, used research-grade accelerometers, applied cut points to categorize objectively measured physical activity, and were available in English. We excluded studies reporting exclusively steps or step counts measured by accelerometers or pedometers and conference abstracts or other sources that did not have a full text available. Data extraction was completed using Microsoft Excel. Data for the following variables were tabulated based on frequency distributions: study design, accelerometer type, device placement, epoch length, total wear time, and cut points used. Study aims and participant demographic data were summarized. RESULTS: A total of 748 records were screened at the abstract level, and 88 full-text articles were assessed for eligibility. Ultimately, 46 articles were retained and analyzed. Participants' mean ages ranged from 50 to 79.9 years. The ActiGraph accelerometer and the Freedson et al and Troiano et al counts-per-minute cut points were the most frequently used across the literature. Freedson et al and Troiano et al counts-per-minute cut points for light, moderate, and vigorous activity correspond to <1952, 1952-5724, and ≥5725, and 100-2019, 2020-5998, and ≥5999, respectively. The Lopes et al cut points were developed by calibrating the ActiGraph in middle-aged and older adults with overweight/obesity and type 2 diabetes. These counts-per-minute thresholds are ≥200 (light), ≥1240 (moderate), and ≥2400 (vigorous), and were applied in 1 interventional study. CONCLUSIONS: An assortment of accelerometer cut points have been used by researchers to categorize physical activity intensity for middle-aged and older adults with diabetes. Only one set of cut points was validated and calibrated in our population of interest. Additional research is warranted to address the need for diabetes-specific cut points to inform public health recommendations. This includes confirmation that the Lopes et al cut points reflect clinically meaningful changes in physical activity for adults with diabetes who have comorbidities other than overweight/obesity and the development of relative intensity cut points that may be more suitable for those with suboptimal physical functioning.

Reducing Readmission of Hospitalized Patients With Depressive Symptoms: A Randomized Trial.

PURPOSE: To determine if hospitalized patients with depressive symptoms will benefit from post-discharge depression treatment with care transition support. METHODS: This is a randomized controlled trial of hospitalized patients with patient health questionnaire-9 score of 10 or more. We delivered the Re-Engineered Discharge (RED) and randomized participants to groups receiving RED-only or RED for Depression (RED-D), a 12-week post-discharge telehealth intervention including cognitive behavioral therapy, self-management support, and patient navigation. Primary outcomes were hospital readmission and reutilization rates at 30 and 90 days post discharge. RESULTS: We randomized 709 participants (353 RED-D, 356 RED-only). At 90 days, 265 (75%) intervention participants had received at least 1 RED-D session (median 4). At 30 days, the intention-to-treat analysis showed no differences between RED-D vs RED-only in hospital readmission (9% vs 10%, incidence rate ratio [IRR] 0.92 [95% CI, 0.56-1.52]) or reutilization (27% vs 24%, IRR 1.14 [95% CI, 0.85-1.54]). The intention-to-treat analysis also showed no differences at 90 days in readmission (28% vs 21%, IRR 1.30 [95% CI, 0.95-1.78]) or reutilization (70% vs 57%, IRR 1.22 [95% CI, 1.01-1.49]). In the as-treated analysis, each additional RED-D session was associated with a decrease in 30- and 90-day readmissions. At 30 days, among 104 participants receiving 3 or more sessions, there were fewer readmissions (3% vs 10%, IRR 0.30 [95% CI, 0.07-0.84]) compared with the control group. At 90 days, among 109 participants receiving 6 or more sessions, there were fewer readmissions (11% vs 21%, IRR 0.52 [95% CI, 0.27-0.92]). Intention-to-treat analysis showed no differences between study groups on secondary outcomes. CONCLUSIONS: Care transition support and post-discharge depression treatment can reduce unplanned hospital use with sufficient uptake of the RED-D intervention.

Patient engagement and presence in a virtual world world diabetes self-management education intervention for minority women.

OBJECTIVE: We aim to explore how users' experience of presence in a virtual world (VW) learning environment enhanced patient engagement in DSME/S programs conducted in an online VW platform with minority women with type 2 diabetes. METHODS: We conducted an embedded, mixed methods study, using a convergent study design to analyze qualitative field notes and interview data and quantitative survey data gathered from the Women in Control 2.0 (WIC2) clinical trial participants. The WIC2 clinical trial compared a diabetes group visit program delivered using an online VW platform versus an in-person approach. RESULT: We enrolled 158 VW participants, of which 144 completed baseline data, 124 completed the post-intervention follow up survey, and 30 participated in key informant and focus group interviews. Overall, participants reported a sense of social (63.7%, mean 3.7/5.0), physical (63.1%, mean 3.6/5.0), and self (49.0%, mean 3.3/5.0) presence while engaged in VW group DSME/S. Three themes emerged from mixed methods analysis including, 1) Participants' identification with their avatars enhances a sense of self presence in a VW, 2) physical presence enables visualization and imaginative play modalities of social learning, and 3) social presence cultivates meaningful social support and psychological safety. CONCLUSION: Our research empirically supports the premise that participants' experience of three domains of presence (self, physical and social) in a VW environment enhances participant engagement in DSME/S programs. PRACTICE IMPLICATIONS: Further research is warranted to study optimal approaches to implementation and dissemination of this novel approach to patient education and engagement.

Stigma as a Barrier to Participant Recruitment of Minority Populations in Diabetes Research: Development of a Community-Centered Recruitment Approach.

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.