Whole Day Workload: Evaluation of a New Outcome Measure in Occupational Therapy for Adults With Type 1 Diabetes.

IMPORTANCE: Typical whole day workload is a metric with potential relevance to the occupational balance and well-being of individuals with chronic conditions. OBJECTIVE: To examine the reliability and validity of using multiple daily NASA Task Load Index measures (whole day TLX) as an indicator of typical whole day workload experienced by adults with Type 1 diabetes (T1D). DESIGN: Participants with T1D completed cross-sectional measures and 2 wk of ecological momentary assessments (EMA) and daily diaries. Reliability was assessed across subgroups (e.g., workers vs. nonworkers); validity was evaluated with multilevel confirmatory factor analysis and with tests of convergent and divergent validity with patient-reported outcomes and blood glucose measures. SETTING: Three outpatient endocrinology clinics in the United States. PARTICIPANTS: Data from 164 U.S. adults with T1D (42% Latino, 30% White). OUTCOMES AND MEASURES: Measures used included the whole day TLX (assessed via 2 wk of daily diaries), time in target blood glucose range (assessed with a continuous glucose monitor), illness intrusiveness (measured cross-sectionally), and stress (measured cross-sectionally and with EMA). RESULTS: Number of days required for at least 0.70 reliability of the average whole day TLX ranged between 2 and 6 days depending on the subgroup. Results supported convergent and divergent validity of the average of the whole day TLX, including associations with average stress (r = .63, p < .001) and time in target blood glucose range (r = -.25, p = .002). CONCLUSIONS AND RELEVANCE: The whole day TLX was a reliable and valid indicator of typical whole day workload. Plain-Language Summary: The health management responsibilities for Type 1 diabetes can be extremely burdensome. When these responsibilities are experienced, in addition to duties such as work and caregiving, the totality of demands experienced (i.e., whole day workload) can create further issues, such as unhealthy physiological changes and interference with self-care. We tested the psychometric properties of a measurement tool that assesses the typical level of workload people experience. This measure, referred to as the NASA Task Load Index (whole day TLX), was found to be a reliable and valid indicator of typical whole day workload. Occupational therapists may use the whole day TLX to track progress in interventions focused on reducing clients' whole day workload exposure to promote their health and well-being. Occupational therapists' expertise in areas such as activity analysis, task adaptation, and energy conservation makes them especially well-suited to intervene on whole day workload.

Reliability and Validity of Ecological Momentary Assessment Response Time-Based Measures of Emotional Clarity: Secondary Data Analysis.

BACKGROUND: Emotional clarity has often been assessed with self-report measures, but efforts have also been made to measure it passively, which has advantages such as avoiding potential inaccuracy in responses stemming from social desirability bias or poor insight into emotional clarity. Response times (RTs) to emotion items administered in ecological momentary assessments (EMAs) may be an indirect indicator of emotional clarity. Another proposed indicator is the drift rate parameter, which assumes that, aside from how fast a person responds to emotion items, the measurement of emotional clarity also requires the consideration of how careful participants were in providing responses. OBJECTIVE: This paper aims to examine the reliability and validity of RTs and drift rate parameters from EMA emotion items as indicators of individual differences in emotional clarity. METHODS: Secondary data analysis was conducted on data from 196 adults with type 1 diabetes who completed a 2-week EMA study involving the completion of 5 to 6 surveys daily. If lower RTs and higher drift rates (from EMA emotion items) were indicators of emotional clarity, we hypothesized that greater levels (ie, higher clarity) should be associated with greater life satisfaction; lower levels of neuroticism, depression, anxiety, and diabetes distress; and fewer difficulties with emotion regulation. Because prior literature suggested emotional clarity could be valence specific, EMA items for negative affect (NA) and positive affect were examined separately. RESULTS: Reliability of the proposed indicators of emotional clarity was acceptable with a small number of EMA prompts (ie, 4 to 7 prompts in total or 1 to 2 days of EMA surveys). Consistent with expectations, the average drift rate of NA items across multiple EMAs had expected associations with other measures, such as correlations of r=-0.27 (P<.001) with depression symptoms, r=-0.27 (P=.001) with anxiety symptoms, r=-0.15 (P=.03) with emotion regulation difficulties, and r=0.63 (P<.001) with RTs to NA items. People with a higher NA drift rate responded faster to NA emotion items, had greater subjective well-being (eg, fewer depression symptoms), and had fewer difficulties with overall emotion regulation, which are all aligned with the expectation for an emotional clarity measure. Contrary to expectations, the validities of average RTs to NA items, the drift rate of positive affect items, and RTs to positive affect items were not strongly supported by our results. CONCLUSIONS: Study findings provided initial support for the validity of NA drift rate as an indicator of emotional clarity but not for that of other RT-based clarity measures. Evidence was preliminary because the sample size was not sufficient to detect small but potentially meaningful correlations, as the sample size of the diabetes EMA study was chosen for other more primary research questions. Further research on passive emotional clarity measures is needed.

Outcomes of New York City Care Calls: A Prospective Randomized Controlled Effectiveness Trial of Telephone-Delivered Type 2 Diabetes Self-Management Support.

PURPOSE: The purpose of the 12-month randomized controlled trial was to evaluate the effectiveness of a Telephonic Self-Management Support (T-SMS) program among adults with type 2 diabetes (T2D). METHODS: Eight hundred twelve adults with T2D participated in NYC Care Calls (mean age = 59.2, SD = 10.8; female = 57%; mean A1C = 9.3, SD = 1.8; Latino = 86%) and were randomly assigned to T-SMS or enhanced usual care (EUC). A1C (primary outcome), blood pressure, and body mass index (secondary outcomes) were extracted from electronic medical records. Secondary patient-reported outcomes, including depressive symptoms, diabetes distress, medication adherence, and self-management activities, were assessed by telephone in English or Spanish. For T-SMS, the number of assigned phone calls was based on baseline A1C, depressive symptoms, and/or diabetes distress. Analyses were conducted under the intention-to-treat principle. RESULTS: A1C decreased over 12 months in both T-SMS (0.72% percentage points; 95% CI, 0.53-0.91) and EUC (0.66% percentage points; 95% CI, 0.46-0.85; Ps < .001). Diabetes distress and self-management also improved over time in both arms (Ps < .05). Compared to EUC, participants in the T-SMS arm did not differ in outcomes. CONCLUSIONS: The T-SMS and EUC groups were found not to have an appreciable outcome difference. It is unclear whether improvements in A1C across both conditions represent a secular trend or indicate that print-based educational intervention may have a positive impact on self-management and well-being.

Differential Effects of Type 2 Diabetes Treatment Regimens on Diabetes Distress and Depressive Symptoms in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

OBJECTIVE: We evaluated whether adding basal insulin to metformin in adults with early type 2 diabetes mellitus (T2DM) would increase emotional distress relative to other treatments. RESEARCH DESIGN AND METHODS: The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) of adults with T2DM of <10 years' duration, HbA1c 6.8-8.5%, and taking metformin monotherapy randomly assigned participants to add insulin glargine U-100, sulfonylurea glimepiride, the glucagon-like peptide-1 receptor agonist liraglutide, or the dipeptidyl peptidase 4 inhibitor sitagliptin. The Emotional Distress Substudy enrolled 1,739 GRADE participants (mean [SD] age 58.0 [10.2] years, 32% female, 56% non-Hispanic White, 18% non-Hispanic Black, 17% Hispanic) and assessed diabetes distress and depressive symptoms every 6 months. Analyses examined differences at 1 year and over the 3-year follow-up. RESULTS: Across treatments, diabetes distress (-0.24, P < 0.0001) and depressive symptoms (-0.67, P < 0.0001) decreased over 1 year. Diabetes distress was lower at 1 year for the glargine group than for the other groups combined (-0.10, P = 0.002). Diabetes distress was also lower for liraglutide than for glimepiride or sitagliptin (-0.10, P = 0.008). Over the 3-year follow-up, there were no significant group differences in total diabetes distress; interpersonal diabetes distress remained lower for those assigned to liraglutide. No significant differences were observed for depressive symptoms. CONCLUSIONS: Contrary to expectations, this randomized trial found no evidence for a deleterious effect of basal insulin on emotional distress. Glargine lowered diabetes distress modestly at 1 year rather than increasing it. Liraglutide also reduced diabetes distress at 1 year. Results can inform treatment decisions for adults with early T2DM.

Emotional Distress Predicts Reduced Type 2 Diabetes Treatment Adherence in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

OBJECTIVE: We examined longitudinal associations between emotional distress (specifically, depressive symptoms and diabetes distress) and medication adherence in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE), a large randomized controlled trial comparing four glucose-lowering medications added to metformin in adults with relatively recent-onset type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS: The Emotional Distress Substudy assessed medication adherence, depressive symptoms, and diabetes distress in 1,739 GRADE participants via self-completed questionnaires administered biannually up to 3 years. We examined baseline depressive symptoms and diabetes distress as predictors of medication adherence over 36 months. Bidirectional visit-to-visit relationships were also examined. Treatment satisfaction, beliefs about medication, diabetes care self-efficacy, and perceived control over diabetes were evaluated as mediators of longitudinal associations. RESULTS: At baseline, mean ± SD age of participants (56% of whom were White, 17% Hispanic/Latino, 18% Black, and 66% male) was 58.0 ± 10.2 years, diabetes duration 4.2 ± 2.8 years, HbA1c 7.5% ± 0.5%, and medication adherence 89.9% ± 11.1%. Higher baseline depressive symptoms and diabetes distress were independently associated with lower adherence over 36 months (P < 0.001). Higher depressive symptoms and diabetes distress at one visit predicted lower adherence at the subsequent 6-month visit (P < 0.0001) but not vice versa. Treatment assignment did not moderate relationships. Patient-reported concerns about diabetes medications mediated the largest percentage (11.9%-15.5%) of the longitudinal link between emotional distress and adherence. CONCLUSIONS: Depressive symptoms and diabetes distress both predict lower adherence to glucose-lowering medications over time among adults with T2DM. Addressing emotional distress and concerns about anticipated negative effects of taking these treatments may be important to support diabetes treatment adherence.

Does Emotional Distress Predict Worse Glycemic Control Over Time? Results From the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

OBJECTIVE: To evaluate whether baseline levels of depressive symptoms and diabetes-specific distress are associated with glycemic control in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE), a large randomized controlled trial comparing the metabolic effects of four common glucose-lowering medications when combined with metformin in individuals with type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS: The primary and secondary outcomes were defined as an HbA1c value ≥7%, subsequently confirmed, and an HbA1c value >7.5%, subsequently confirmed, respectively. Separate Cox proportional hazards models assessed the association between baseline levels of each exposure of interest (depressive symptoms measured with the eight-item Patient Health Questionnaire and diabetes distress measured with the Diabetes Distress Scale) and the subsequent risk of metabolic outcomes. RESULTS: This substudy included 1,739 participants (56% of whom were non-Hispanic White, 18% non-Hispanic Black, 17% Hispanic, and 68% male; mean [SD] age 58.0 [10.2] years, diabetes duration 4.2 [2.8] years, and HbA1c 7.5% [0.48%]). A total of 1,157 participants reached the primary outcome, with time to event of 2.1 years on average, while 738 participants reached the secondary outcome at 3 years on average. With adjustment for sex, race/ethnicity, treatment group, baseline age, duration of T2DM, BMI, and HbA1c, there were no significant associations between the depressive symptoms or diabetes distress and the subsequent risk of the primary or secondary outcomes. CONCLUSIONS: The current findings suggest that, at least for individuals with diabetes of relatively short duration, baseline levels of emotional distress are not associated with glycemic control over time.

Rethinking dehumanization, empathy, and burnout in healthcare context.

Dehumanization has been characterized as common in medical settings, despite limited work directly examining this. In this context, everyday dehumanization is believed to be largely unconscious and unintentional, resulting from a variety of factors often related to structural and organizational aspects of healthcare. This article adopts the patients' and the healthcare providers' perspective to explore how dehumanization can have helpful and hurtful effects on patient outcomes and provider well-being. Future directions include more direct assessment of dehumanization in healthcare settings, centering the needs and experiences of people with mental illness and comorbid conditions, and improving our understanding of dehumanization relative to emotion regulation processes.

Within-person relationships of sleep duration with next-day stress and affect in the daily life of adults with Type-1 diabetes.

OBJECTIVE: The objective of this study is to examine the within-person relationships between sleep duration and next-day stress and affect in the daily life of individuals with T1D. METHODS: Study participants were recruited in the Function and Emotion in Everyday Life with Type 1 Diabetes (FEEL-T1D) study. Sleep duration was derived by synthesizing objective (actigraphy) and self-report measures. General and diabetes-specific stress and positive and negative affect were measured using ecological momentary assessment. Multilevel regression was used to examine the within-person relationships between sleep duration and next-day stress and affect. Cross-level interactions were used to explore whether gender and baseline depression and anxiety moderated these within-person relationships. RESULTS: Adults with T1D (n = 166) completed measurements for 14 days. The average age was 41.0 years, and 91 participants (54.8%) were female. The average sleep duration was 7.3 h (SD = 1.2 h). Longer sleep was significantly associated with lower general stress (p < 0.001) but not diabetes-specific stress (p = 0.18) on the next day. There were significant within-person associations of longer sleep with lower levels on next-day negative affect (overall, p = 0.002, disappoint, p = 0.05; sad, p = 0.05; tense, p < 0.001; upset, p = 0.008; anxious, p = 0.04). There were no significant associations with positive affect. Examination of the interaction effects did not reveal significant differential relationships for men and women and for individuals with and without depression or anxiety at baseline. CONCLUSION: Findings from this study suggest optimizing sleep duration as an important interventional target for better managing general stress and improving daily emotional wellbeing of individuals with T1D.

Emotional distress and cardiovascular disease risk among participants enrolled in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) study.

AIMS: People with type 2 diabetes (T2DM) have an increased risk of cardiovascular disease (CVD). We examined depressive symptoms (DS) and diabetes distress (DD) in relation to the estimated 10-year risk of CVD in adults with T2DM enrolled in the GRADE Emotional Distress Substudy. METHODS: Linear regression models examined the associations of baseline DS and DD with estimated 10-year risk of CVD using the Atherosclerotic Cardiovascular Disease (ASCVD) risk score, adjusting for age, sex, race/ethnicity, education, income, diabetes duration, diabetes-related complications, and HbA1c. RESULTS: A total of 1,605 GRADE participants were included: 54% Non-Latino (NL) White, 18% Latino, 19% NL-Black, 66% male, mean age 57.5 (SD = 10.25) years, diabetes duration 4.2 (SD = 2.8) years, and HbA1c 7.5% (SD = 0.5%). After incorporating covariates, only DS, especially cognitive-affective symptoms, were associated with ASCVD risk (estimate = 0.15 [95% CI: 0.04, 0.025], p = 0.006). Higher DS remained significantly associated with higher ASCVD risk when adding DD to covariates (estimate = 0.19 [95% CI: 0.07, 0.30], p = 0.002). DD was not associated with ASCVD risk when accounting for covariates. CONCLUSIONS: Depressive symptoms, particularly cognitive-affective symptoms, are associated with increased 10-year predicted ASCVD risk among adults with early T2DM. Diabetes distress is not significantly associated with the predicted ASCVD risk when accounting for covariates.

Reliability and Validity of Noncognitive Ecological Momentary Assessment Survey Response Times as an Indicator of Cognitive Processing Speed in People's Natural Environment: Intensive Longitudinal Study.

BACKGROUND: Various populations with chronic conditions are at risk for decreased cognitive performance, making assessment of their cognition important. Formal mobile cognitive assessments measure cognitive performance with greater ecological validity than traditional laboratory-based testing but add to participant task demands. Given that responding to a survey is considered a cognitively demanding task itself, information that is passively collected as a by-product of ecological momentary assessment (EMA) may be a means through which people's cognitive performance in their natural environment can be estimated when formal ambulatory cognitive assessment is not feasible. We specifically examined whether the item response times (RTs) to EMA questions (eg, mood) can serve as approximations of cognitive processing speed. OBJECTIVE: This study aims to investigate whether the RTs from noncognitive EMA surveys can serve as approximate indicators of between-person (BP) differences and momentary within-person (WP) variability in cognitive processing speed. METHODS: Data from a 2-week EMA study investigating the relationships among glucose, emotion, and functioning in adults with type 1 diabetes were analyzed. Validated mobile cognitive tests assessing processing speed (Symbol Search task) and sustained attention (Go-No Go task) were administered together with noncognitive EMA surveys 5 to 6 times per day via smartphones. Multilevel modeling was used to examine the reliability of EMA RTs, their convergent validity with the Symbol Search task, and their divergent validity with the Go-No Go task. Other tests of the validity of EMA RTs included the examination of their associations with age, depression, fatigue, and the time of day. RESULTS: Overall, in BP analyses, evidence was found supporting the reliability and convergent validity of EMA question RTs from even a single repeatedly administered EMA item as a measure of average processing speed. BP correlations between the Symbol Search task and EMA RTs ranged from 0.43 to 0.58 (P<.001). EMA RTs had significant BP associations with age (P<.001), as expected, but not with depression (P=.20) or average fatigue (P=.18). In WP analyses, the RTs to 16 slider items and all 22 EMA items (including the 16 slider items) had acceptable (>0.70) WP reliability. After correcting for unreliability in multilevel models, EMA RTs from most combinations of items showed moderate WP correlations with the Symbol Search task (ranged from 0.29 to 0.58; P<.001) and demonstrated theoretically expected relationships with momentary fatigue and the time of day. The associations between EMA RTs and the Symbol Search task were greater than those between EMA RTs and the Go-No Go task at both the BP and WP levels, providing evidence of divergent validity. CONCLUSIONS: Assessing the RTs to EMA items (eg, mood) may be a method of approximating people's average levels of and momentary fluctuations in processing speed without adding tasks beyond the survey questions.

Glycemic Risk Index Profiles and Predictors Among Diverse Adults With Type 1 Diabetes.

BACKGROUND: The Glycemia Risk Index (GRI) was introduced as a single value derived from the ambulatory glucose profile that identifies patients who need attention. This study describes participants in each of the five GRI zones and examines the percentage of variation in GRI scores that is explained by sociodemographic and clinical variables among diverse adults with type 1 diabetes. METHODS: A total of 159 participants provided blinded continuous glucose monitoring (CGM) data over 14 days (mean age [SD] = 41.4 [14.5] years; female = 54.1%, Hispanic = 41.5%). Glycemia Risk Index zones were compared on CGM, sociodemographic, and clinical variables. Shapley value analysis examined the percentage of variation in GRI scores explained by different variables. Receiver operating characteristic curves examined GRI cutoffs for those more likely to have experienced ketoacidosis or severe hypoglycemia. RESULTS: Mean glucose and variability, time in range, and percentage of time in high, and very high, glucose ranges differed across the five GRI zones (P values < .001). Multiple sociodemographic indices also differed across zones, including education level, race/ethnicity, age, and insurance status. Sociodemographic and clinical variables collectively explained 62.2% of variance in GRI scores. A GRI score ≥84.5 reflected greater likelihood of ketoacidosis (area under the curve [AUC] = 0.848), and scores ≥58.2 reflected greater likelihood of severe hypoglycemia (AUC = 0.729) over the previous six months. CONCLUSIONS: Results support the use of the GRI, with GRI zones identifying those in need of clinical attention. Findings highlight the need to address health inequities. Treatment differences associated with the GRI also suggest behavioral and clinical interventions including starting individuals on CGM or automated insulin delivery systems.

Impact of Overnight Glucose on Next-Day Functioning in Adults With Type 1 Diabetes: An Exploratory Intensive Longitudinal Study.

OBJECTIVE: While there is evidence that functioning, or ability to perform daily life activities, can be adversely influenced by type 1 diabetes, the impact of acute fluctuations in glucose levels on functioning is poorly understood. RESEARCH DESIGN AND METHODS: Using dynamic structural equation modeling, we examined whether overnight glucose (coefficient of variation[CV], percent time <70 mg/dL, percent time >250 mg/dL) predicted seven next-day functioning outcomes (mobile cognitive tasks, accelerometry-derived physical activity, self-reported activity participation) in adults with type 1 diabetes. We examined mediation, moderation, and whether short-term relationships were predictive of global patient-reported outcomes. RESULTS: Overall next-day functioning was significantly predicted from overnight CV (P = 0.017) and percent time >250 mg/dL (P = 0.037). Pairwise tests indicate that higher CV is associated with poorer sustained attention (P = 0.028) and lower engagement in demanding activities (P = 0.028), time <70 mg/dL is associated with poorer sustained attention (P = 0.007), and time >250 mg/dL is associated with more sedentary time (P = 0.024). The impact of CV on sustained attention is partially mediated by sleep fragmentation. Individual differences in the effect of overnight time <70 mg/dL on sustained attention predict global illness intrusiveness (P = 0.016) and diabetes-related quality of life (P = 0.036). CONCLUSIONS: Overnight glucose predicts problems with objective and self-reported next-day functioning and can adversely impact global patient-reported outcomes. These findings across diverse outcomes highlight the wide-ranging effects of glucose fluctuations on functioning in adults with type 1 diabetes.

Within-person Relationships of Sleep Duration with Next-Day Stress and Affect in the Daily Life of Adults with Type-1 Diabetes.

Objective: The objective of this study is to examine the within-person relationships between sleep duration and next-day stress and affect in the daily life of individuals with T1D. Methods: Study participants were recruited in the Function and Emotion in Everyday Life with Type 1 Diabetes (FEEL-T1D) study. Sleep duration was derived by synthesizing objective (actigraphy) and self-report measures. General and diabetes-specific stress and positive and negative affect were measured using ecological momentary assessment. Multilevel regression was used to examine the within-person relationships between sleep duration and next-day stress and affect. Cross-level interactions were used to explore whether gender and baseline depression and anxiety moderated these within-person relationships. Results: Adults with T1D (n=166) completed measurements for 14 days. The average age was 40.99 years, and 91 participants (54.82%) were female. The average sleep duration was 7.29 hours (SD=1.18 hours). Longer sleep was significantly associated with lower general stress (p<0.001) but not diabetes-specific stress (p=0.18) on the next day. There were significant within-person associations of longer sleep with lower levels on next-day negative affect (overall, p=0.002, disappoint, p=0.05; sad, p=0.05; tense, p<0.001; upset, p=0.008; anxious, p=0.04). There were no significant associations with positive affect. Examination of the interaction effects did not reveal significant differential relationships for men and women and for individuals with and without depression or anxiety at baseline. Conclusion: Findings from this study suggest optimizing sleep duration as an important interventional target for better managing general stress and improving daily emotional wellbeing of individuals with T1D.

Diabetes-Related Quality of Life: Learning From Individuals Making Lifestyle Changes to Improve Type 2 Diabetes Control.

PURPOSE: The purpose of this study was to explore how treatment adherence and lifestyle changes required for glycemic control in type 2 diabetes (T2D) are related to quality of life (QoL) among predominantly ethnic minority and socioeconomically disadvantaged adults engaged in making changes to improve T2D self-management. METHODS: Adults with T2D in New York City were recruited for the parent study based on recent A1C (≥7.5%) and randomly assigned to 1 of 2 arms, receiving educational materials and additional self-management support calls, respectively. Substudy participants were recruited from both arms after study completion. Participants (N = 50; 62% Spanish speaking) were interviewed by phone using a semistructured guide and were asked to define QoL and share ways that T2D, treatment, self-management, and study participation influenced their QoL. Interviews were analyzed using thematic analysis. RESULTS: QoL was described as a multidimensional health-related construct with detracting and enhancing factors related to T2D. Detracting factors included financial strain, symptom progression and burden, perceived necessity to change cultural and lifestyle traditions, and dietary and medical limitations. Enhancing factors included social support, diabetes education, health behavior change, sociocultural connection. CONCLUSION: QoL for diverse and socioeconomically disadvantaged adults with T2D is multifaceted and includes aspects of health, independence, social support, culture, and lifestyle, which may not be captured by existing QoL measures. Findings may inform the development of a novel QoL measure for T2D.

Emotional distress, self-management, and glycemic control among participants enrolled in the glycemia reduction approaches in diabetes: A comparative effectiveness (GRADE) study.

OBJECTIVE: We examined emotional distress in relation to metformin adherence, overall diabetes self-management, and glycemic control among adults with early type 2 diabetes (T2DM) enrolled in the GRADE study. METHODS: Linear regression models examined cross-sectional associations of baseline depression symptoms and diabetes distress with adherence to metformin, self-management, and HbA1c, adjusting for covariates. Cognitive-affective (e.g., sadness) and somatic (e.g., sleep/appetite disturbance) depression symptoms and diabetes distress subscales were also examined. RESULTS: This substudy of 1,739 GRADE participants (56 % Non-Hispanic White, 18 % Non-Hispanic Black, 17 % Hispanic, 68 % male, mean[SD] age = 57.96[10.22] years, diabetes duration = 4.21[2.81] years, and HbA1c = 7.51[0.48]) found that the prevalence of clinically significant depression and diabetes distress was 8.7 % and 25 %, respectively. Fully adjusted models showed that depression symptoms were associated with lower self-management (p < 0.0001); this effect was only significant for somatic symptoms. Diabetes distress was associated with lower adherence (p = 0.0001) and self-management (p < 0.0001); effects were significant for all subscales, except physician-related distress. No significant relationships of total depression symptom severity or diabetes distress with HbA1c were found. CONCLUSIONS: Depression symptoms and diabetes distress were robustly associated with problematic diabetes self-management among participants in GRADE. These findings highlight the need for routine assessment of depression symptoms and diabetes distress early in T2DM care.

Memory complaints moderate the concordance between self-report and electronically monitored adherence in adults with type 2 diabetes.

AIMS: We examined the impact of memory complaints on the concordance between self-report (SR) and electronically monitored (EM) medication adherence, independent of depression symptoms, among adults with type 2 diabetes (T2D). METHODS: Adults (N = 104, age = 56.6 ± 9.2; 64% female) completed a prospective and retrospective memory questionnaire (PRMQ) and a depression symptom interview at baseline. EM was tracked over 3 months and participants rated adherence using SR. Multiple linear regression evaluated PRMQ as a moderator of the relationship between EM and SR, adjusting for depression and other covariates. RESULTS: PRMQ was correlated with lower SR (r = -0.31, p = 0.001), but not with EM. PRMQ moderated the relationship between SR and EM, independent of depression symptoms. At low levels of PRMQ, SR and EM were closely related (ß = 0.76, p < 0.001); at high levels of PRMQ the relationship was weaker (ß = 0.28, p = 0.02). Participants who under-reported their adherence (SR < EM) had higher PRMQ scores than more concordant reporters (p = 0.016). CONCLUSIONS: SR and EM measures were less concordant among adults with T2D who endorsed higher PRMQ scores. Memory complaints may contribute to under-reporting of medication adherence in adults with T2D.

Depressive symptoms mediate the relationship between diabetes and cognitive performance in a community-based sample of older adults.

AIMS: To evaluate whether diabetes and prediabetes are associated with impaired cognitive performance among older adults and examine depressive symptoms as a mediator. METHODS: We used cross-sectional data from the Einstein Aging Study, a systematically recruited, community-based cohort study of diverse older adults (N = 794; Age Mean (SD) = 78.9 (5.3); 64.4% Non-Hispanic White, 28.7% Non-Hispanic Black, 5.7% Hispanic). Diabetes status was established via self-reported diagnosis, prescribed medications, and fasting blood glucose. Depressive symptoms were assessed using the Geriatric Depression Scale. Cognitive tests included Digit Symbol, Trails-B, Free Recall, Category Fluency, Boston Naming, and Block Design. Linear regression and mediation analyses were applied. RESULTS: Compared to those without diabetes, diabetes was associated with worse performance on all cognitive tests (ps < 0.05), except Trails-B (p = 0.53), and increased depressive symptoms (p < 0.01). For diabetes, mediation via increased depressive symptoms was observed for Free Recall (p = 0.044), Category Fluency (p = 0.033), and Boston Naming (p = 0.048). CONCLUSIONS: Diabetes was consistently associated with worse cognitive performance and increased depressive symptoms among this older cohort, while prediabetes was not. Mediation findings suggest depressive symptoms may be a biobehavioral pathway linking diabetes and cognition, though the temporal sequence is unclear. If causal, addressing both diabetes and depressive symptoms among older adults may protect cognitive function.

Function and Emotion in Everyday Life With Type 1 Diabetes (FEEL-T1D): Protocol for a Fully Remote Intensive Longitudinal Study.

BACKGROUND: Although short-term blood glucose levels and variability are thought to underlie diminished function and emotional well-being in people with type 1 diabetes (T1D), these relationships are poorly understood. The Function and Emotion in Everyday Life with T1D (FEEL-T1D) study focuses on investigating these short-term dynamic relationships among blood glucose levels, functional ability, and emotional well-being in adults with T1D. OBJECTIVE: The aim of this study is to present the FEEL-T1D study design, methods, and study progress to date, including adaptations necessitated by the COVID-19 pandemic to implement the study fully remotely. METHODS: The FEEL-T1D study will recruit 200 adults with T1D in the age range of 18-75 years. Data collection includes a comprehensive survey battery, along with 14 days of intensive longitudinal data using blinded continuous glucose monitoring, ecological momentary assessments, ambulatory cognitive tasks, and accelerometers. All study procedures are conducted remotely by mailing the study equipment and by using videoconferencing for study visits. RESULTS: The study received institutional review board approval in January 2019 and was funded in April 2019. Data collection began in June 2020 and is projected to end in December 2021. As of June 2021, after 12 months of recruitment, 124 participants have enrolled in the FEEL-T1D study. Approximately 87.6% (7082/8087) of ecological momentary assessment surveys have been completed with minimal missing data, and 82.0% (82/100) of the participants provided concurrent continuous glucose monitoring data, ecological momentary assessment data, and accelerometer data for at least 10 of the 14 days of data collection. CONCLUSIONS: Thus far, our reconfiguration of the FEEL-T1D protocol to be implemented remotely during the COVID-19 pandemic has been a success. The FEEL-T1D study will elucidate the dynamic relationships among blood glucose levels, emotional well-being, cognitive function, and participation in daily activities. In doing so, it will pave the way for innovative just-in-time interventions and produce actionable insights to facilitate tailoring of diabetes treatments to optimize the function and well-being of individuals with T1D. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30901.

Distress and Type 2 Diabetes Self-Care: Putting the Pieces Together.

BACKGROUND: Conflicting research emphasizes depression, diabetes distress, or well-being in relation to diabetes self-care and risk for poor health outcomes. PURPOSE: The purpose of this study was to test whether a latent variable for general psychological distress derived from shared variance of depression symptoms, diabetes distress, and well-being predicts a latent variable of diabetes self-care and to examine evidence for unique effects once shared effects are adjusted for. METHODS: Adults with suboptimally controlled diabetes were recruited from the South Bronx, NY, for a telephonic diabetes self-management support trial. Baseline diabetes self-care, medication adherence, depression symptoms, diabetes distress, and well-being were measured by validated self-report. Structural equation modeling specified a latent variable for general psychological distress derived from shared variance of depression symptoms, diabetes distress, and well-being. Diabetes self-care was a latent variable indicated by diet, glucose self-monitoring, and medication adherence. RESULTS: Participants (N = 627, 65% female) were predominantly ethnic minority (70% Hispanic; 45% Black) and 77% reported household income <$20K/year. Mean (standard deviation) age = 56 (12) years; A1c = 9.1% (1.9%); body mass index = 32 (8) kg/m2. The latent variable for psychological distress was a robust predictor of poorer diabetes self-care (coefficient = -0.59 [confidence interval = -0.71, -0.46], p < .001) with good model fit. Unique paths from depression symptoms, diabetes distress, and well-being (all ps > .99) to self-care were not observed. CONCLUSIONS: In this population of disadvantaged adults with suboptimally controlled diabetes, general psychological distress was strongly associated with poorer diabetes self-care and fully accounted for the effects of depression, diabetes distress, and positive well-being. This suggests that general distress may underlie previously reported associations between these constructs and diabetes self-care.

Design and methods of NYC care calls: An effectiveness trial of telephone-delivered type 2 diabetes self-management support.

Although problems with type 2 diabetes (T2D) self-management and treatment adherence often co-occur with emotional distress, few translatable intervention approaches are available that can target these related problems in primary care practice settings. The New York City (NYC) Care Calls study is a randomized controlled trial that tests the effectiveness of structured support for diabetes self-management and distress management, delivered via telephone by health educators, in improving glycemic control, self-management and emotional well-being among predominantly ethnic minority and socioeconomically disadvantaged adults with suboptimally controlled T2D. English- and Spanish-speaking adults treated for T2D in NYC primary care practices were recruited based on having an A1C ≥ 7.5% despite being prescribed medications for diabetes. Participants (N = 812) were randomly assigned to a telephonic intervention condition with a stepped protocol of 6-12 phone calls over 1 year, delivered by a health educator, or to a comparison condition of enhanced usual care. The primary outcome is change in A1C over one year, measured at baseline and again approximately 6- and 12-months later. Secondary outcomes measured on the same schedule include blood pressure, patient-reported emotional distress, treatment adherence and self-management behaviors. A comprehensive effectiveness evaluation is guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) to gather data that can inform dissemination and implementation of the intervention, if successful. This paper describes the study rationale, trial design, and methodology.