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1.
PLoS One ; 19(5): e0302582, 2024.
Article in English | MEDLINE | ID: mdl-38722831

ABSTRACT

Sedentary behavior, a key modifiable risk factor for cardiovascular disease, is prevalent among cardiovascular disease patients. However, few interventions target sedentary behavior in this group. This paper describes the protocol of a parallel two-group randomized controlled trial for a novel multi-technology sedentary behavior reduction intervention for cardiovascular disease patients (registered at Clinicaltrial.gov, NCT05534256). The pilot trial (n = 70) will test a 12-week "Sit Less" program, based on Habit Formation theory. The 35 participants in the intervention group will receive an instructional goal-setting session, a Fitbit for movement prompts, a smart water bottle (HidrateSpark) to promote hydration and encourage restroom breaks, and weekly personalized text messages. A control group of 35 will receive the American Heart Association's "Answers by Heart" fact sheets. This trial will assess the feasibility and acceptability of implementing the "Sit Less" program with cardiovascular disease patients and the program's primary efficacy in changing sedentary behavior, measured by the activPAL activity tracker. Secondary outcomes include physical activity levels, cardiometabolic biomarkers, and patient-centered outcomes (i.e. sedentary behavior self-efficacy, habit strength, and fear of movement). This study leverages commonly used mobile and wearable technologies to address sedentary behavior in cardiovascular disease patients, a high-risk group. Its findings on the feasibility, acceptability and primary efficacy of the intervention hold promise for broad dissemination.


Subject(s)
Cardiovascular Diseases , Exercise , Sedentary Behavior , Humans , Cardiovascular Diseases/prevention & control , Male , Female , Middle Aged , Adult , Pilot Projects
2.
J Behav Med ; 47(3): 389-404, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38127174

ABSTRACT

For individuals living with a chronic illness who require use of long-term medications, adherence is a vital aspect of successful symptom management and outcomes. This study investigated the effect of a smartphone app on adherence, self-efficacy, knowledge, and medication social support in a medically underserved adult population with various chronic illnesses. Participants were randomized to a group who used the app for one month or a control group provided with a printed medication list. Compared to the control group, participants receiving the intervention had significantly greater medication adherence (Cohen's d = -0.52, p = .014) and medication self-efficacy (Cohen's d = 0.43, p = .035). No significant effects were observed related to knowledge or social support. The findings suggest use of the app could positively impact chronic disease management in a medically underserved population in the United States.


Subject(s)
Mobile Applications , Adult , Humans , Medically Underserved Area , Medication Adherence , Chronic Disease , Self Efficacy
3.
Birth ; 2023 Nov 15.
Article in English | MEDLINE | ID: mdl-37968839

ABSTRACT

INTRODUCTION: Although current recommendations support vaginal breech birth as a reasonable option, access to breech birth in US hospitals is limited. This study explored the experiences of decision-making and perceptions of access to care in people who transferred out of the hospital system to pursue home breech birth. METHODS: We conducted a mixed methods study of people with a singleton, term breech fetus who transferred out of the US hospital system to pursue home breech birth. Twenty-five people completed an online demographic and psychosocial survey, and 23 (92%) participated in semi-structured interviews. We used an interpretive description approach informed by situational analysis to analyze qualitative data about participants' experiences and perceived access to care. RESULTS: Of 25 individuals who left the hospital system to pursue a home breech birth, most felt denied informed choice (64%) and threatened or coerced into cesarean (68%). The majority reported low or very low autonomy in decision-making (n = 20, 80%) and high decisional satisfaction using validated measures. Many participants felt safer in a hospital setting but were not able to access care for planned vaginal breech hospital birth, despite extensive efforts. Participants felt "backed into a corner" and "forced into homebirth," perceiving a lack of access to safe and respectful care in the hospital system. CONCLUSION: Some service users believe that home birth is their only option when they cannot access hospital-based care for vaginal breech birth. Current barriers to care for breech birth limit birthing people's autonomy and may be placing them and their infants at increased risk.

4.
JMIR Pediatr Parent ; 6: e41779, 2023 Oct 13.
Article in English | MEDLINE | ID: mdl-37831486

ABSTRACT

BACKGROUND: Goal setting and tracking are well established behavior change techniques. Little is known about the extent to which commercially available mobile apps are designed to guide parents in using these strategies, their evidence base, and their quality. OBJECTIVE: This study aims to review commercially available apps that target parents in relation to setting and tracking behavioral goals for their children. The objectives were to classify the apps' general characteristics, features, evidence base, and target behaviors and assess app quality overall and separately for apps that target health-related behaviors (HRBs) and apps without a health-related behavior (WHRB). METHODS: Apps were identified using keyword searches in the Apple App Store and Google Play in the United States. Apps were included if their primary purpose was to assist with setting goals, tracking goals, tracking behaviors, or giving feedback pertaining to goals for children by parents. App characteristics and common features were documented and summarized. Two reviewers assessed app quality using the Mobile App Rating Scale (MARS). Descriptive statistics summarized the MARS total score, 4 quality subscales, and 6 app-specific items that reflect the perceived impact of the app on goal setting and tracking, overall and with subgroup analysis for HRB and WHRB apps. RESULTS: Of the 21 apps identified, 16 (76%) met the review criteria. Overall, 9 apps defined and targeted the following HRBs: nutrition and mealtime (6/16, 38%), physical activity and screen time (5/16, 31%), sleep (7/16, 44%), and personal hygiene (6/16, 38%). Three apps targeted specific age groups (2 apps were for children aged 6-13 years and 1 app was for children aged ≥4 years). None of the apps provided tailored assessments or guidance for goal setting. None of the apps indicated that they were intended for the involvement of a health professional or had been tested for efficacy. The MARS total score indicated moderate app quality overall (mean 3.42, SD 0.49) and ranged from 2.5 to 4.2 out of 5 points. The Habitz app ranked highest on the MARS total score among HRB apps (score=4.2), whereas Thumsters ranked highest (score=3.9) among the WHRB apps. Subgroup analysis revealed a pattern of higher quality ratings in the HRB group than the WHRB group, including the mean MARS total score (mean 3.67, SD 0.34 vs mean 3.09, SD 0.46; P=.02); the engagement and information subscales; and the app-specific items about perceived impact on knowledge, attitudes, and behavior change. CONCLUSIONS: Several high-quality commercially available apps target parents to facilitate goal setting and tracking for child behavior change related to both health and nonhealth behaviors. However, the apps lack evidence of efficacy. Future research should address this gap, particularly targeting parents of young children, and consider individually tailored guided goal setting and involvement of health professionals.

5.
Curr Diab Rep ; 23(4): 43-58, 2023 04.
Article in English | MEDLINE | ID: mdl-36749452

ABSTRACT

PURPOSE OF REVIEW: Diabetes is a chronic condition that requires consistent self-management for optimal health outcomes. People with diabetes are prone to burnout, cognitive burden, and sub-optimal performance of self-management tasks. Interventions that focus on habit formation have the potential to increase engagement by facilitating automaticity of self-management task performance. The purpose of this review is to (1) clarify the conceptualizations of habit formation and behavioral automaticity in the context of health behavior interventions, (2) review the evidence of habit in relation to behaviors relevant to diabetes self-management, and (3) discuss opportunities for incorporating habit formation and automaticity into diabetes self-management interventions. RECENT FINDINGS: Modern habit research describes a habit as a behavior that results over time from an automatic mental process. Automatic behaviors are experienced as cue-dependent, goal-independent, unconscious, and efficient. Habit formation requires context-dependent repetition to form cue-behavior associations. Results of diabetes habit studies are mixed. Observational studies have shown positive associations between habit strength and target self-management behaviors such as taking medication and monitoring blood glucose, as well as glycemic outcomes such as HbA1c. However, intervention studies conducted in similar populations have not demonstrated a significant benefit of habit-forming interventions compared to controls, possibly due to varying techniques used to promote habit formation. Automaticity of self-management behaviors has the potential to minimize the burden associated with performance of self-management tasks and ultimately improve outcomes for people with diabetes. Future studies should focus on refining interventions focused on context-dependent repetition to promote habit formation and better measurement of habit automaticity in diabetes self-management.


Subject(s)
Diabetes Mellitus , Self-Management , Humans , Health Behavior , Diabetes Mellitus/therapy , Habits
6.
JMIR Form Res ; 6(11): e39357, 2022 Nov 21.
Article in English | MEDLINE | ID: mdl-36409541

ABSTRACT

BACKGROUND: Advances in medical treatments in recent years have contributed to an overall decline in HIV-related opportunistic infections and deaths in youth; however, mortality and morbidity rates in perinatally and nonperinatally infected adolescents and young adults (AYA) living with HIV remain relatively high today. OBJECTIVE: The goal of this project was to assess the use, utility, and cost-effectiveness of PlusCare, a digital app for HIV case management in AYA living with HIV. The app supports routine case management tasks, such as scheduling follow-up visits, sharing documents for review and signature, laboratory test results, and between-visit communications (eg, encouraging messages). METHODS: We conducted a single-group mixed methods pre-post study with HIV case management programs in 2 large urban hospitals in the Boston metro area. Case management staff (case managers [CMs], N=20) and AYA living with HIV participants (N=45) took part in the study with access to PlusCare for up to 15 and 12 months, respectively. RESULTS: The CMs and AYA living with HIV reported mean System Usability Scale scores of 51 (SD 7.9) and 63 (SD 10.6), respectively. Although marginally significant, total charges billed at 1 of the 2 sites compared with the 12 months before app use (including emergency, inpatient, and outpatient charges) decreased by 41% (P=.046). We also observed slight increases in AYA living with HIV self-reported self-efficacy in chronic disease management and quality of life (Health-Related Quality of Life-4) from baseline to the 12-month follow-up (P=.02 and P=.03, respectively) and increased self-efficacy from the 6- to 12-month follow-up (P=.02). There was no significant change in HIV viral suppression, appointment adherence, or medication adherence in this small-sample pilot study. CONCLUSIONS: Although perceived usability was low, qualitative feedback from CMs and use patterns suggested that direct messaging and timely, remote, and secure sharing of laboratory results and documents (including electronic signatures) between CMs and AYA living with HIV can be particularly useful and have potential value in supporting care coordination and promoting patient self-efficacy and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT03758066; https://clinicaltrials.gov/ct2/show/NCT03758066.

7.
JMIR Mhealth Uhealth ; 10(3): e21959, 2022 03 03.
Article in English | MEDLINE | ID: mdl-35238791

ABSTRACT

BACKGROUND: For adolescents living with type 1 diabetes (T1D), completion of multiple daily self-management tasks, such as monitoring blood glucose and administering insulin, can be challenging because of psychosocial and contextual barriers. These barriers are hard to assess accurately and specifically by using traditional retrospective recall. Ecological momentary assessment (EMA) uses mobile technologies to assess the contexts, subjective experiences, and psychosocial processes that surround self-management decision-making in daily life. However, the rich data generated via EMA have not been frequently examined in T1D or integrated with machine learning analytic approaches. OBJECTIVE: The goal of this study is to develop a machine learning algorithm to predict the risk of missed self-management in young adults with T1D. To achieve this goal, we train and compare a number of machine learning models through a learned filtering architecture to explore the extent to which EMA data were associated with the completion of two self-management behaviors: mealtime self-monitoring of blood glucose (SMBG) and insulin administration. METHODS: We analyzed data from a randomized controlled pilot study using machine learning-based filtering architecture to investigate whether novel information related to contextual, psychosocial, and time-related factors (ie, time of day) relate to self-management. We combined EMA-collected contextual and insulin variables via the MyDay mobile app with Bluetooth blood glucose data to construct machine learning classifiers that predicted the 2 self-management behaviors of interest. RESULTS: With 1231 day-level SMBG frequency counts for 45 participants, demographic variables and time-related variables were able to predict whether daily SMBG was below the clinical threshold of 4 times a day. Using the 1869 data points derived from app-based EMA data of 31 participants, our learned filtering architecture method was able to infer nonadherence events with high accuracy and precision. Although the recall score is low, there is high confidence that the nonadherence events identified by the model are truly nonadherent. CONCLUSIONS: Combining EMA data with machine learning methods showed promise in the relationship with risk for nonadherence. The next steps include collecting larger data sets that would more effectively power a classifier that can be deployed to infer individual behavior. Improvements in individual self-management insights, behavioral risk predictions, enhanced clinical decision-making, and just-in-time patient support in diabetes could result from this type of approach.


Subject(s)
Diabetes Mellitus, Type 1 , Self-Management , Adolescent , Blood Glucose Self-Monitoring , Diabetes Mellitus, Type 1/psychology , Diabetes Mellitus, Type 1/therapy , Humans , Machine Learning , Retrospective Studies , Young Adult
8.
Diabetes Res Clin Pract ; 180: 109048, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34534592

ABSTRACT

AIMS: The purpose of this study was to explore preferences that adults with type 1 diabetes (T1D) have for training and support to initiate and sustain optimal use of continuous glucose monitoring (CGM) technology. METHODS: Twenty-two adults with T1D (M age 30.95 ± 8.32; 59.1% female; 90.9% Non-Hispanic; 86.4% White; diabetes duration 13.5 ± 8.42 years; 72.7% insulin pump users) who had initiated CGM use in the past year participated in focus groups exploring two overarching questions: (1) What helped you learn to use your CGM? and (2) What additional support would you have wanted? Focus groups used a semi-structured interview guide and were recorded, transcribed and analyzed. RESULTS: Overarching themes identified were: (1) "I got it going by myself": CGM training left to the individual; (2) Internet as diabetes educator, troubleshooter, and peer support system; and (3) domains of support they wanted, including content and format of this support. CONCLUSION: This study identifies current gaps in training and potential avenues for enhancing device education and CGM onboarding support for adults with T1D. Providing CGM users with relevant, timely resources and attending to the emotional side of using CGM could alleviate the burden of starting a new device and promote sustained device use.


Subject(s)
Diabetes Mellitus, Type 1 , Adult , Blood Glucose , Blood Glucose Self-Monitoring , Diabetes Mellitus, Type 1/drug therapy , Female , Humans , Insulin Infusion Systems , Male , Young Adult
9.
Diabetes Technol Ther ; 23(12): 818-827, 2021 12.
Article in English | MEDLINE | ID: mdl-34270351

ABSTRACT

Background: Continuous glucose monitoring (CGM) can improve glycemic control for adults with type 1 diabetes (T1D) but certain barriers interfere with consistent use including cost, data overload, alarm fatigue, physical discomfort, and unwanted social attention. This pilot study aimed to examine feasibility and acceptability of a behavioral intervention, ONBOARD (Overcoming Barriers and Obstacles to Adopting Diabetes Devices) to support adults with T1D in optimizing CGM use. Methods: Adults (18-50 years) with T1D in their first year of CGM use were invited to participate in a tailored, multicomponent telehealth-based intervention delivered over four 60-min sessions every 2-3 weeks. Participants completed surveys (demographics; diabetes distress, Diabetes Distress Scale for adults with type 1 diabetes; satisfaction with program) and provided CGM data at baseline and postintervention (3 months). Data were analyzed using paired t-tests and Wilcoxon signed-rank tests. Results: Twenty-two participants (age = 30.95 ± 8.32 years; 59% women; 91% non-Hispanic; 86% White, 5% Black, 9% other; 73% pump users) completed the study. ONBOARD demonstrated acceptability and a high rate of retention. Moderate effect sizes were found for reductions in diabetes distress (P = 0.01, r = -0.37) and increases in daytime spent in target range (70-180 mg/dL: P = 0.03, r = -0.35). There were no significant increases in hypoglycemia. Conclusions: Findings show preliminary evidence of feasibility, acceptability, and efficacy of ONBOARD for supporting adults with T1D in optimizing CGM use while alleviating diabetes distress. Further research is needed to examine ONBOARD in a larger sample over a longer period.


Subject(s)
Diabetes Mellitus, Type 1 , Telemedicine , Adult , Blood Glucose , Blood Glucose Self-Monitoring , Diabetes Mellitus, Type 1/drug therapy , Feasibility Studies , Female , Humans , Hypoglycemic Agents , Male , Pilot Projects , Young Adult
10.
JMIR Form Res ; 5(7): e30450, 2021 Jul 30.
Article in English | MEDLINE | ID: mdl-34328432

ABSTRACT

BACKGROUND: The Special Supplemental Nutrition Assistance Program for Women, Infants, and Children (WIC) is a federal nutrition program that provides nutritious food, education, and health care referrals to low-income women, infants, and children up to the age of 5 years. Although WIC is associated with positive health outcomes for each participant category, modernization and efficiency are needed at the clinic and shopping levels to increase program satisfaction and participation rates. New technologies, such as electronic benefits transfer (EBT), online nutrition education, and mobile apps, can provide opportunities to improve the WIC experience for participants. OBJECTIVE: This formative study applies user-centered design principles to inform the layout and prioritization of features in mobile apps for low-income families participating in the WIC program. METHODS: To identify and prioritize desirable app features, caregivers (N=22) of the children enrolled in WIC participated in individual semistructured interviews with a card sorting activity. Interviews were transcribed verbatim and analyzed using constant comparative analysis for themes. App features were ranked and placed into natural groupings by each participant. The sum and average of the rankings were calculated to understand which features were prioritized by the users. Natural groupings of features were labeled according to participant descriptions. RESULTS: Natural groupings focused on the following categories: clinics/appointments, shopping/stores, education/assessments, location, and recipes/food. Themes from the interviews triangulated the results from the ranking activity. The priority app features were balance checking, an item scanner, and appointment scheduling. Other app features discussed and ranked included appointment reminders, nutrition training and quizzes, shopping lists, clinic and store locators, recipe gallery, produce calculator, and dietary preferences/allergies. CONCLUSIONS: This study demonstrates how a user-centered design process can aid the development of an app for low-income families participating in WIC to inform the effective design of the app features and user interface.

11.
Can J Diabetes ; 45(5): 411-416, 2021 Jul.
Article in English | MEDLINE | ID: mdl-33722492

ABSTRACT

OBJECTIVES: Our aim was to evaluate self-reported depressive symptoms and clinical outcomes during routine screening for adolescents and young adults with type 2 diabetes (T2D), and examine associations among depressive symptoms and demographic and clinical characteristics. METHODS: The Patient Health Questionnaire (PHQ) was administered to 197 adolescents and young adults with T2D using the PHQ-2 or PHQ-9 in routine pediatric diabetes care at 4 academic medical centres. Data from electronic health records were extracted from the screening date and 12 months earlier. RESULTS: Adolescents and young adults with T2D (mean age, 16.85 years; 57% male; 77.2% non-Caucasian) completed the PHQ as part of routine diabetes care. On the PHQ, 19.3% of adolescents and young adults endorsed elevated depressive symptoms (PHQ score ≥10) and, among a subsample with item-level data (n=53), 18.9% endorsed thoughts of self-harm. Subsequently, 50.0% of those with depressive symptoms had a documented referral for mental health treatment in the electronic health record after the positive screening outcome. Older age, shorter diabetes duration, higher glycated hemoglobin level, being non-Hispanic white, more blood glucose checks per day and being prescribed oral medications were significantly associated with more depressive symptoms. CONCLUSIONS: Screening for depressive symptoms identifies individuals in need of referral for mental health treatment. A focus on self-harm assessment, standardized methods for documentation of symptoms and mental health referrals and increased referral resources are needed.


Subject(s)
Depression/diagnosis , Diabetes Mellitus, Type 2/psychology , Mass Screening/statistics & numerical data , Adolescent , Female , Humans , Male , Patient Health Questionnaire , Risk Factors , Young Adult
12.
Transl Behav Med ; 11(1): 122-131, 2021 02 11.
Article in English | MEDLINE | ID: mdl-31764981

ABSTRACT

Psychosocial guidelines recommend routine screening of depressive symptoms in adolescents and young adults (AYA) with diabetes. Best practices for screening in routine care and patient characteristics associated with depressive symptoms require further investigation. The purpose of this study was to examine psychometric properties of the Patient Health Questionnaire (PHQ-2 and PHQ-9); document rates of depressive symptoms and related clinical actions; and evaluate associations with patient characteristics. The Patient Health Questionnaire (PHQ-2 or PHQ-9) was administered at five pediatric academic medical centers with 2,138 youth with type 1 diabetes. Screening was part of routine clinical care; retrospective data from electronic health records were collected for the first screening date as well as 12 months prior. The PHQ demonstrated good psychometric properties. Evaluation of item-level PHQ-9 data identified 5.0% of AYA with at least moderate depressive symptoms who would not have been flagged for further screening using the PHQ-2 only. On the PHQ-9, 10.0% of AYA with type 1 diabetes endorsed elevated depressive symptoms and 7.0% endorsed thoughts of self-harm. Patients with moderate or greater depressive symptoms had a 43.9% documented referral rate for mental health treatment. Higher BMI, older age, public insurance, shorter diabetes duration, higher HbA1C, and a diabetic ketoacidosis (DKA) event in the past year were associated with depressive symptoms. The PHQ-9 identified AYA with elevated depressive symptoms that would not have been identified using the PHQ-2. Depressive symptoms were associated with negative diabetes indicators. To improve referral rates, standardized methods for provision and documentation of referrals are needed.


Subject(s)
Depression , Diabetes Mellitus, Type 1 , Adolescent , Aged , Child , Depression/diagnosis , Diabetes Mellitus, Type 1/complications , Diabetes Mellitus, Type 1/diagnosis , Humans , Mass Screening , Psychometrics , Retrospective Studies , Surveys and Questionnaires , Young Adult
13.
Clin J Oncol Nurs ; 24(5): E57-E64, 2020 10 01.
Article in English | MEDLINE | ID: mdl-32945801

ABSTRACT

BACKGROUND: Researchers have estimated that about 50% of pediatric patients with chronic illness adhere to tacrolimus therapy, a medication responsible for preventing critical side effects in patients undergoing hematopoietic stem cell transplantation (HSCT). OBJECTIVES: The purpose of this study was to describe patient adherence to tacrolimus by reviewing documentation from the electronic health record and therapeutic drug levels. METHODS: This retrospective descriptive study examined 357 clinic visits by 57 patients undergoing HSCT. Direct (tacrolimus levels) and indirect (subjective reporting) measures were evaluated. FINDINGS: The authors found that, in 51% of visits, adherence was not documented. The overall nontherapeutic drug level rate was 60%. Because of the small sample size, nonadherence did not statistically correlate with nontherapeutic levels. The findings highlight the need for adherence awareness, assessment, and documentation in clinical practice.


Subject(s)
Hematopoietic Stem Cell Transplantation , Immunosuppressive Agents , Neoplasms , Tacrolimus , Child , Humans , Immunosuppressive Agents/therapeutic use , Medication Adherence , Neoplasms/drug therapy , Retrospective Studies , Tacrolimus/therapeutic use
14.
J Am Med Inform Assoc ; 26(12): 1627-1631, 2019 12 01.
Article in English | MEDLINE | ID: mdl-31529065

ABSTRACT

Effective diabetes problem solving requires identification of risk factors for inadequate mealtime self-management. Ecological momentary assessment was used to enhance identification of factors hypothesized to impact self-management. Adolescents with type 1 diabetes participated in a feasibility trial for a mobile app called MyDay. Meals, mealtime insulin, self-monitored blood glucose, and psychosocial and contextual data were obtained for 30 days. Using 1472 assessments, mixed-effects between-subjects analyses showed that social context, location, and mealtime were associated with missed self-monitored blood glucose. Stress, energy, mood, and fatigue were associated with missed insulin. Within-subjects analyses indicated that all factors were associated with both self-management tasks. Intraclass correlations showed within-subjects accounted for the majority of variance. The ecological momentary assessment method provided specific targets for improving self-management problem solving, phenotyping, or integration within just-in-time adaptive interventions.


Subject(s)
Blood Glucose Self-Monitoring , Diabetes Mellitus, Type 1/psychology , Ecological Momentary Assessment , Meals , Mobile Applications , Self-Management , Adolescent , Blood Glucose , Diabetes Mellitus, Type 1/therapy , Female , Humans , Hypoglycemic Agents/administration & dosage , Insulin/administration & dosage , Male
15.
Pediatr Transplant ; 23(5): e13451, 2019 08.
Article in English | MEDLINE | ID: mdl-31066981

ABSTRACT

The purpose of this study was to examine the potential predictive value of the Medication Level Variability Index (MLVI) biomarker with graft-versus-host disease (GVHD) in the pediatric hematopoietic stem cell transplant (HSCT) patient during the acute phase post-transplant. This retrospective descriptive study evaluated a total of 406 tacrolimus levels in 64 patients over a varying number of weeks per participant (median = 8, min = 3, max = 11). Patients were followed until Day 100 post-transplant or tacrolimus taper began. A total of 72 episodes of non-therapeutic levels occurred during the acute phase. Of those, 40 (56%) were <5, while 32 (44%) were >15. Approximately 39% (n = 25 of 64) of the participants in the study developed GVHD post-discharge. Those with GVHD had a statistically significantly higher MLVI than those that did not (median = 3.1, IQR = 2.5-4.7 vs 2.3, IQR = 1.6-3.4, respectively, P = 0.024). Using a criterion of MLVI > 3, there was a statistically significant increased likelihood of GVHD (OR = 3.82, 95% CI=1.32 = 11.04, P = 0.013). Area under the curve (AUC) calculation for the sensitivity and specificity of using the MLVI for GVHD was also conducted. The AUC of 0.67 was statistically significant (95% CI 0.53-0.81, P = 0.024). This is the first-known study to report the use of the MLVI in HSCT patients. The MLVI is associated with a main adverse outcome related to HSCT, GVHD. These results are encouraging of a new potential biomarker to evaluate tacrolimus serum assay levels and identify patients at risk for developing GVHD.


Subject(s)
Biomarkers/blood , Graft vs Host Disease/blood , Hematopoietic Stem Cell Transplantation , Immunosuppressive Agents/pharmacokinetics , Tacrolimus/pharmacokinetics , Adolescent , Child , Child, Preschool , Dose-Response Relationship, Drug , Female , Humans , Immunosuppressive Agents/administration & dosage , Infant , Male , Predictive Value of Tests , Retrospective Studies , Sensitivity and Specificity , Tacrolimus/administration & dosage , Young Adult
16.
J Diabetes Sci Technol ; 13(1): 128-139, 2019 01.
Article in English | MEDLINE | ID: mdl-30394807

ABSTRACT

Diabetes Technology Society (DTS) convened a meeting about the US Food and Drug Administration (FDA) Digital Health Software Precertification Program on August 28, 2018. Forty-eight attendees participated from clinical and academic endocrinology (both adult and pediatric), nursing, behavioral health, engineering, and law, as well as representatives of FDA, National Institutes of Health (NIH), National Telecommunications and Information Administration (NTIA), and industry. The meeting was intended to provide ideas to FDA about their plan to launch a Digital Health Software Precertification Program. Attendees discussed the four components of the plan: (1) excellence appraisal and certification, (2) review pathway determination, (3) streamlined premarket review process, and (4) real-world performance. The format included (1) introductory remarks, (2) a program overview presentation from FDA, (3) roundtable working sessions focused on each of the Software Precertification Program's four components, (4) presentations reflecting the discussions, (5) questions to and answers from FDA, and (6) concluding remarks. The meeting provided useful information to the diabetes technology community and thoughtful feedback to FDA.


Subject(s)
Certification , Diabetes Mellitus/therapy , Medical Informatics/standards , Software/standards , United States Food and Drug Administration , Artificial Intelligence , Humans , Machine Learning , Medical Informatics Applications , Models, Organizational , Product Surveillance, Postmarketing , Program Development , Societies, Medical , Software Validation , United States
17.
Diabetes Technol Ther ; 20(7): 465-474, 2018 07.
Article in English | MEDLINE | ID: mdl-29882677

ABSTRACT

BACKGROUND: Integration of momentary contextual and psychosocial factors within self-management feedback may provide more specific, engaging, and personalized targets for problem solving. METHODS: Forty-four youth ages 13-19 with type 1 diabetes (T1D) were provided a Bluetooth meter and completed the 30-day protocol. Participants were randomized to "app + meter" or "meter-only" groups. App + meter participants completed mealtime and bedtime assessment each day. Assessments focused on psychosocial and contextual information relevant for self-management. Graphical feedback integrated self-monitored blood glucose (SMBG), insulin, and Bluetooth-transmitted blood glucose data with the psychosocial and contextual data. App + meter participants completed an interview to identify data patterns. RESULTS: The median number of momentary assessments per participant was 80.0 (range 32-120) with 2.60 per day. By 2 weeks participants had an average of 40.77 (SD 12.23) assessments. Dose-response analyses indicated that the number of app assessments submitted were significantly related to higher mean daily SMBG (r = -0.44, P < 0.05) and to lower% missed mealtime SMBG (r = -0.47, P < 0.01). Number of feedback viewing sessions was also significantly related to a lower% missed mealtime SMBG (r = -0.44, P < 0.05). Controlling for baseline variables, mixed-effects analyses did not indicate group × time differences in mean daily SMBG. Engagement analyses resulted in three trajectory groups distinguished by assessment frequencies and rates of decline. Engagement group membership was significantly related to gender, mean daily SMBG, and HbA1c values. CONCLUSIONS: Momentary assessment combined with device data provided a feasible means to provide novel personalized biobehavioral feedback for adolescents with T1D. A 2-week protocol provided sufficient data for self-management problem identification. In addition to feedback, more intensive intervention may need to be integrated for those patients with the lowest self-management at baseline.


Subject(s)
Diabetes Mellitus, Type 1/blood , Feedback, Psychological/physiology , Adolescent , Blood Glucose Self-Monitoring/methods , Diabetes Mellitus, Type 1/drug therapy , Ecological Momentary Assessment , Feasibility Studies , Female , Humans , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Male , Patient Compliance , Young Adult
18.
J Am Med Inform Assoc ; 25(2): 135-141, 2018 02 01.
Article in English | MEDLINE | ID: mdl-28575462

ABSTRACT

Objective: Sharing personal information about type 1 diabetes (T1D) can help adolescents obtain social support, enhance social learning, and improve self-care. Diabetes technologies, online communities, and health interventions increasingly feature data-sharing components. This study examines factors underlying adolescents' willingness to share personal T1D information with peers. Materials and Methods: Participants were 134 adolescents (12-17 years of age; 56% female) who completed an online survey regarding experiences helping others with T1D, perceived social resources, beliefs about the value of sharing information and helping others, and willingness to share T1D information. Hemoglobin A1c values were obtained from medical records. Results: Adolescents were more willing to share how they accomplished T1D tasks than how often they completed them, and least willing to share glucose control status. In multivariate analyses, sharing/helping beliefs (ß = 0.26, P < .01) and glucose control (HbA1c value; ß = -0.26, P < .01) were related to greater willingness to share personal health information. Glucose control moderated relationships such that adolescents with worse A1c values had stronger relationships between sharing/helping beliefs and willingness to share (ß = 0.18, P < .05) but weaker relationships between helping experience and willingness to share (ß = -0.22, P = .07). Discussion: Many adolescents with T1D are willing to share personal health information, particularly if they have better diabetes health status and a stronger belief in the benefits of sharing. Conclusion: Social learning and social media components may improve intervention participation, engagement, and outcomes by boosting adolescents' beliefs about the benefits of sharing information and helping others.


Subject(s)
Diabetes Mellitus, Type 1 , Health Records, Personal , Information Dissemination , Adolescent , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/therapy , Female , Glycated Hemoglobin/analysis , Health Status , Humans , Male , Social Media , Social Support , Socioeconomic Factors , Surveys and Questionnaires
20.
JMIR Mhealth Uhealth ; 5(8): e102, 2017 Aug 02.
Article in English | MEDLINE | ID: mdl-28768611

ABSTRACT

BACKGROUND: The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in the United States provides free supplemental food and nutrition education to low-income mothers and children under age 5 years. Childhood obesity prevalence is higher among preschool children in the WIC program compared to other children, and WIC improves dietary quality among low-income children. The Children Eating Well (CHEW) smartphone app was developed in English and Spanish for WIC-participating families with preschool-aged children as a home-based intervention to reinforce WIC nutrition education and help prevent childhood obesity. OBJECTIVE: This paper describes the development and beta-testing of the CHEW smartphone app. The objective of beta-testing was to test the CHEW app prototype with target users, focusing on usage, usability, and perceived barriers and benefits of the app. METHODS: The goals of the CHEW app were to make the WIC shopping experience easier, maximize WIC benefit redemption, and improve parent snack feeding practices. The CHEW app prototype consisted of WIC Shopping Tools, including a barcode scanner and calculator tools for the cash value voucher for purchasing fruits and vegetables, and nutrition education focused on healthy snacks and beverages, including a Yummy Snack Gallery and Healthy Snacking Tips. Mothers of 63 black and Hispanic WIC-participating children ages 2 to 4 years tested the CHEW app prototype for 3 months and completed follow-up interviews. RESULTS: Study participants testing the app for 3 months used the app on average once a week for approximately 4 and a half minutes per session, although substantial variation was observed. Usage of specific features averaged at 1 to 2 times per month for shopping-related activities and 2 to 4 times per month for the snack gallery. Mothers classified as users rated the app's WIC Shopping Tools relatively high on usability and benefits, although variation in scores and qualitative feedback highlighted several barriers that need to be addressed. The Yummy Snack Gallery and Healthy Snacking Tips scored higher on usability than benefits, suggesting that the nutrition education components may have been appealing but too limited in scope and exposure. Qualitative feedback from mothers classified as non-users pointed to several important barriers that could preclude some WIC participants from using the app at all. CONCLUSIONS: The prototype study successfully demonstrated the feasibility of using the CHEW app prototype with mothers of WIC-enrolled black and Hispanic preschool-aged children, with moderate levels of app usage and moderate to high usability and benefits. Future versions with enhanced shopping tools and expanded nutrition content should be implemented in WIC clinics to evaluate adoption and behavioral outcomes. This study adds to the growing body of research focused on the application of technology-based interventions in the WIC program to promote program retention and childhood obesity prevention.

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