Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment (HABIT) efficacy trial: Community health worker support may increase hydroxyurea adherence of youth with sickle cell disease.

Despite disease-modifying effects of hydroxyurea on sickle cell disease (SCD), poor adherence among affected youth commonly impedes treatment impact. Following our prior feasibility trial, the "Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment (HABIT)" multi-site randomized controlled efficacy trial aimed to increase hydroxyurea adherence for youth with SCD ages 10-18 years. Impaired adherence was identified primarily through flagging hydroxyurea-induced fetal hemoglobin (HbF) levels compared to prior highest treatment-related HbF. Eligible youth were enrolled as dyads with their primary caregivers for the 1-year trial. This novel semi-structured supportive, multidimensional dyad intervention led by community health workers (CHW), was augmented by daily tailored text message reminders, compared to standard care during a 6-month intervention phase, followed by a 6-month sustainability phase. Primary outcomes from the intervention phase were improved Month 6 HbF levels compared to enrollment and proportion of days covered (PDC) for hydroxyurea versus pre-trial year. The secondary outcome was sustainability of changes up to Month 12. The 2020-2021 peak coronavirus disease 2019 (COVID-19) pandemic disrupted enrollment and clinic-based procedures; CHW in-person visits shifted to virtual scheduled interactions. We enrolled 50 dyads, missing target enrollment. Compared to enrollment levels, both HbF level and PDC significantly - but not sustainably - improved within the intervention group (p = .03 and .01, respectively) with parallel increased mean corpuscular volume (MCV) (p = .05), but not within controls. No significant between-group differences were found at Months 6 or 12. These findings suggest that our community-based, multimodal support for youth-caregiver dyads had temporarily improved hydroxyurea usage. Durability of impact should be tested in a trial with longer duration of CHW-led and mobile health support.

Impact of driving cessation on health-related quality of life trajectories.

BACKGROUND: Trajectories of health-related quality of life (HRQoL) after driving cessation (DC) are thought to decline steeply, but for some, HRQoL may improve after DC. Our objective is to examine trajectories of HRQoL for individuals before and after DC. We hypothesize that for urban drivers, volunteers and those who access alternative transportation participants' health may remain unchanged or improve. METHODS: This study uses data from the AAA Longitudinal Research on Aging Drivers (LongROAD) study, a prospective cohort of 2,990 older drivers (ages 65-79 at enrollment). The LongROAD study is a five-year multisite study and data collection ended October 31, 2022. Participants were recruited using a convenience sample from the health centers roster. The number of participants approached were 40,806 with 7.3% enrolling in the study. Sixty-one participants stopped driving permanently by year five and had data before and after DC. The PROMIS®-29 Adult Profile was utilized and includes: 1) Depression, 2) Anxiety, 3) Ability to Participate in Social Roles and Activities, 4) Physical Function, 5) Fatigue, 6) Pain Interference, 7) Sleep Disturbance, and 8) Numeric Pain Rating Scale. Adjusted (age, education and gender) individual growth models with 2989 participants with up to six observations from baseline to year 5 in the models (ranging from n = 15,041 to 15,300) were utilized. RESULTS: Ability to participate in social roles and activities after DC improved overall. For those who volunteered, social roles and activities declined not supporting our hypothesis. For those who accessed alternative transportation, fatigue had an initial large increase immediately following DC thus not supporting our hypothesis. Urban residents had worse function and more symptoms after DC compared to rural residents (not supporting our hypothesis) except for social roles and activities that declined steeply (supporting our hypothesis). CONCLUSIONS: Educating older adults that utilizing alternative transportation may cause initial fatigue after DC is recommended. Accessing alternative transportation to maintain social roles and activities is paramount for rural older adults after DC especially for older adults who like to volunteer.

Relative importance of selected predictors of health-related quality-of-life (HRQOL) among U.S. adults.

PURPOSE: Many factors have been associated with health-related quality of life (HRQOL), and researchers often have tried to rank these contributing factors. Variable importance quantifies the net independent contribution of each individual predictor in a set of predictors to the prediction accuracy of the outcome. This study assessed relative importance (RI) of selected contributing factors to respondents' physically unhealthy days (PUD), mentally unhealthy days (MUD), activity limitation days (ALD), and EuroQol EQ-5D index derived from the Healthy Days measures (dEQ-5D). METHODS: Using data from the 2021 Behavioral Risk Factor Surveillance Systems (BRFSS), we estimated the RI of seven socio-demographics and seventeen chronic conditions and risk behaviors. A variable's importance was measured as the average increase in the coefficient of determination after adding the variable to all possible sub-models. RESULTS: After controlling for socio-demographics, arthritis and no physical activity were the most important variables for PUD with a RI of 10.5 and 10.4, respectively, followed by depression (RI = 8.5) and COPD (RI = 8.3). Depression was the most important variable for MUD with RI = 23.0 while all other 16 predictors had a RI < 7.0. Similar results were observed for ALD and dEQ-5D: depression was the most important predictor (RI = 16.3 and 15.2, respectively), followed by no physical activity, arthritis, and COPD (RI ranging from 7.1 to 9.2). CONCLUSION: This study quantified and ranked selected contributing factors of HRQOL. Results of this analysis also can be used to validate HRQOL measures based on domain knowledge of HRQOL.

A randomized controlled trial of the dissemination of an mHealth intervention for improving health outcomes: the WiseApp for Spanish-speakers living with HIV study protocol.

BACKGROUND: While there is no cure for HIV, adherence to antiretroviral therapy can extend the lifespan and improve the quality of life of people with HIV. Despite the global reduction of HIV infection rates in recent years, New York City and La Romana, Dominican Republic, continue to report high infection rates among Latino populations. Many people with HIV remain virally unsuppressed in these geographic hotspots, suggesting a need for additional interventions to overcome medication adherence barriers. Tailored and culturally appropriate mobile health (mHealth) technology can be an engaging way to improve adherence. The primary objective of this trial is to test the effectiveness of an mHealth tool to improve HIV medication adherence among Spanish-speaking people living in New York City and the Dominican Republic. METHODS: The WiseApp study is a two-arm randomized controlled trial among 248 people with HIV across the New York and Dominican Republic sites over the course of 12 months. Participants are randomly assigned to either receive a CleverCap pill bottle that is linked to the WiseApp (intervention) or standard of care (control). All participants complete surveys at baseline, 3-month, 6-month, and 12-month follow-up visits and the study team obtains HIV-1 viral load and CD4 count results through blood draw at each study timepoint. DISCUSSION: The use of mHealth technologies to improve medication adherence among people with HIV has been implemented in recent years. Although some studies have found improvement in adherence to antiretroviral therapy in the short term, there is limited information about how these interventions improve adherence among Spanish-speaking populations. Disproportionate rates of HIV infection among Latinos in New York City suggest an existing inequitable approach in reaching and treating this population. Due to a lack of mHealth studies with Latino populations, and apps tailored to Spanish-speakers, the WiseApp study will not only demonstrate the effectiveness of this particular mHealth app but will also contribute to the mHealth research community as a whole. TRIAL REGISTRATION: This trial was registered with Clinicaltrials.gov (NCT05398185) on 5/31/2022.

A community health worker and mobile health app intervention to improve adherence to HIV medication among persons with HIV: the CHAMPS study protocol.

BACKGROUND: Persons with HIV (PWH) can now achieve a near-normal life expectancy due to antiretroviral therapy (ART). Despite widespread availability of ART in the United States (US), many of the country's approximate 1.1 million PWH are not achieving viral suppression due to poor ART adherence. Viral suppression rates are particularly low in Alabama (AL, 62%) and New York City (NYC, 67%). There is mixed evidence on the efficacy of community health workers (CHW) and mHealth interventions for improving ART adherence and viral suppression in PWH thus, we sought to combine these interventions and test the efficacy for improving health outcomes in PWH. METHODS: The CHAMPS study is a two-arm randomized controlled trial among 300 PWH with suboptimal primary care appointment adherence (n = 150 in AL and 150 in NYC) over the course of 12 months. Participants are randomly assigned to CHAMPS (intervention) or a standard-of-care (control) arm. Participants in the intervention arm are given a CleverCap pill bottle that syncs to the WiseApp to track medication adherence, reminds users to take their medication at a set time, and enables communication with CHW. All participants complete baseline, 6-month, and 12-month follow-up visits where surveys are administered and, CD4 and HIV-1 viral load are obtained through blood draw. DISCUSSION: Maintaining ART adherence has significant implications in HIV management and transmission. mHealth technologies have been shown to optimize the provision of health services, produce positive changes in health behavior, and significantly improve health outcomes. CHW interventions also provide personal support to PWH. The combination of these strategies may provide the necessary intensity to increase ART adherence and clinic attendance among PWH at highest risk for low engagement. Delivering care remotely enables CHW to contact, assess, and support numerous participants throughout the day, reducing burden on CHW and potentially improving intervention durability for PWH. The adoption of the WiseApp coupled with community health worker sessions in the CHAMPS study has the potential to improve HIV health outcomes, and will add to the growing knowledge of mHealth and CHW efforts to improve PWH medication adherence and viral suppression. TRIAL REGISTRATION: This trial was registered with Clinicaltrials.gov (NCT04562649) on 9/24/20.

Escalating costs of self-injury mortality in the 21st century United States: an interstate observational study.

BACKGROUND: Estimating the economic costs of self-injury mortality (SIM) can inform health planning and clinical and public health interventions, serve as a basis for their evaluation, and provide the foundation for broadly disseminating evidence-based policies and practices. SIM is operationalized as a composite of all registered suicides at any age, and 80% of drug overdose (intoxication) deaths medicolegally classified as 'accidents,' and 90% of corresponding undetermined (intent) deaths in the age group 15 years and older. It is the long-term practice of the United States (US) Centers for Disease Control and Prevention (CDC) to subsume poisoning (drug and nondrug) deaths under the injury rubric. This study aimed to estimate magnitude and change in SIM and suicide costs in 2019 dollars for the United States (US), including the 50 states and the District of Columbia. METHODS: Cost estimates were generated from underlying cause-of-death data for 1999/2000 and 2018/2019 from the US Centers for Disease Control and Prevention's (CDC's) Wide-ranging ONline Data for Epidemiologic Research (WONDER). Estimation utilized the updated version of Medical and Work Loss Cost Estimation Methods for CDC's Web-based Injury Statistics Query and Reporting System (WISQARS). Exposures were medical expenditures, lost work productivity, and future quality of life loss. Main outcome measures were disaggregated, annual-averaged total and per capita costs of SIM and suicide for the nation and states in 1999/2000 and 2018/2019. RESULTS: 40,834 annual-averaged self-injury deaths in 1999/2000 and 101,325 in 2018/2019 were identified. Estimated national costs of SIM rose by 143% from $0.46 trillion to $1.12 trillion. Ratios of quality of life and work losses to medical spending in 2019 US dollars in 2018/2019 were 1,476 and 526, respectively, versus 1,419 and 526 in 1999/2000. Total national suicide costs increased 58%-from $318.6 billion to $502.7 billion. National per capita costs of SIM doubled from $1,638 to $3,413 over the observation period; costs of the suicide component rose from $1,137 to $1,534. States in the top quintile for per capita SIM, those whose cost increases exceeded 152%, concentrated in the Great Lakes, Southeast, Mideast and New England. States in the bottom quintile, those with per capita cost increases below 70%, were located in the Far West, Southwest, Plains, and Rocky Mountain regions. West Virginia exhibited the largest increase at 263% and Nevada the smallest at 22%. Percentage per capita cost increases for suicide were smaller than for SIM. Only the Far West, Southwest and Mideast were not represented in the top quintile, which comprised states with increases of 50% or greater. The bottom quintile comprised states with per capita suicide cost increases below 24%. Regions represented were the Far West, Southeast, Mideast and New England. North Dakota and Nevada occupied the extremes on the cost change continuum at 75% and - 1%, respectively. CONCLUSION: The scale and surge in the economic costs of SIM to society are large. Federal and state prevention and intervention programs should be financed with a clear understanding of the total costs-fiscal, social, and personal-incurred by deaths due to self-injurious behaviors.

Five-Year Community Surveillance Study for Acute Respiratory Infections Using Text Messaging: Findings From the MoSAIC Study.

BACKGROUND: Acute respiratory infections (ARI) are the most common infectious diseases globally. Community surveillance may provide a more comprehensive picture of disease burden than medically attended illness alone. METHODS: In this longitudinal study conducted from 2012 to 2017 in the Washington Heights/Inwood area of New York City, we enrolled 405 households with 1915 individuals. Households were sent research text messages twice weekly inquiring about ARI symptoms. Research staff confirmed symptoms by follow-up call. If ≥2 criteria for ARI were met (fever/feverish, cough, congestion, pharyngitis, myalgias), staff obtained a mid-turbinate nasal swab in participants' homes. Swabs were tested using the FilmArray reverse transcription polymerase chain reaction (RT-PCR) respiratory panel. RESULTS: Among participants, 43.9% were children, and 12.8% had a chronic respiratory condition. During the 5 years, 114 724 text messages were sent; the average response rate was 78.8% ± 6.8%. Swabs were collected for 91.4% (2756/3016) of confirmed ARI; 58.7% had a pathogen detected. Rhino/enteroviruses (51.9%), human coronaviruses (13.9%), and influenza (13.2%) were most commonly detected. The overall incidence was 0.62 ARI/person-year, highest (1.73) in <2 year-olds and lowest (0.46) in 18-49 year-olds. Approximately one-fourth of those with ARI sought healthcare; percents differed by pathogen, demographic factors, and presence of a chronic respiratory condition. CONCLUSIONS: Text messaging is a novel method for community-based surveillance that could be used both seasonally as well as during outbreaks, epidemics and pandemics. The importance of community surveillance to accurately estimate disease burden is underscored by the findings of low rates of care-seeking that varied by demographic factors and pathogens.

Association between self-reported body mass index and active life expectancy in a large community-dwelling sample of older U.S. adults.

BACKGROUND: Obesity may have a protective effect (greater survival) in older adults, a finding known as the "obesity paradox." This study examined the association between self-reported body mass index (BMI) and active life expectancy (ALE) among older U.S. adults. METHODS: Using the Medicare Health Outcomes Survey Cohort 15 (2012 baseline, 2014 follow-up), we estimated life expectancy and ALE by participants' baseline BMI and age using multi-state models. A participant was classified as in an active state if this person reported having no difficulty for any of these six activities of daily living (ADLs). RESULTS: Small differences in life expectancy were noted among persons in normal weight (BMI 18.5-24.9 kg/m2), overweight (BMI 25-29.9 kg/m2), and obesity ranges (BMI 30 kg/m2 and higher). However, persons with obesity had a significantly lower ALE. ALE at age 65 was 11.1 (11.0-11.2) years for persons with obesity, 1.2 (1.1-1.3) years less than that for the normal weight and overweight persons (12.3 years for both, 12.2-12.4). Persons with class III obesity had a significantly lower life expectancy and ALE than normal weight persons. Although persons with class I or II obesity had a similar life expectancy as normal weight persons, they have a shorter ALE. CONCLUSIONS: Although older adults with obesity have a similar life expectancy as normal weight persons, they have a significantly shorter ALE. Given the complex relationship of BMI and ALE, a "one size fits all" approach to weight management is not advisable.

National and State Trends in Anxiety and Depression Severity Scores Among Adults During the COVID-19 Pandemic - United States, 2020-2021.

Recent studies indicate an increase in the percentage of adults who reported clinically relevant symptoms of anxiety and depression during the COVID-19 pandemic (1-3). For example, based on U.S. Census Bureau Household Pulse Survey (HPS) data, CDC reported significant increases in symptoms of anxiety and depressive disorders among adults aged ≥18 years during August 19, 2020-February 1, 2021, with the largest increases among adults aged 18-29 years and among those with less than a high school education (1). To assess more recent national trends, as well as state-specific trends, CDC used HPS data (4) to assess trends in reported anxiety and depression among U.S. adults in all 50 states and the District of Columbia (DC) during August 19, 2020-June 7, 2021 (1). Nationally, the average anxiety severity score increased 13% from August 19-31, 2020, to December 9-21, 2020 (average percent change [APC] per survey wave = 1.5%) and then decreased 26.8% from December 9-21, 2020, to May 26-June 7, 2021 (APC = -3.1%). The average depression severity score increased 14.8% from August 19-31, 2020, to December 9-21, 2020 (APC = 1.7%) and then decreased 24.8% from December 9-21, 2020, to May 26-June 7, 2021 (APC = -2.8%). State-specific trends were generally similar to national trends, with both anxiety and depression scores for most states peaking during the December 9-21, 2020, or January 6-18, 2021, survey waves. Across the entire study period, the frequency of anxiety and depression symptoms was positively correlated with the average number of daily COVID-19 cases. Mental health services and resources, including telehealth behavioral services, are critical during the COVID-19 pandemic.

Efficacy, Use, and Usability of the VIP-HANA App for Symptom Self-management in PLWH with HANA Conditions.

The purpose of this study was to evaluate the efficacy of the VIP-HANA application (app) for improving symptom burden in a randomized control trial of 100 people living with HIV (PLWH) who have non-AIDS conditions associated with HIV. The intervention group received the VIP-HANA app which allowed them to report their symptoms every week and receive self-management strategies tailored to their symptoms. The control arm received an app to report their symptoms every week but did not receive any strategies. The results of our study suggest that symptom burden improved in the participants of both study arms. Although these findings do not support the efficacy of VIP-HANA in improving symptom burden in PLWH who have HIV-associated non-AIDS (HANA) conditions, this could be a function of the study design. Findings suggest that PLWH are interested in monitoring their symptoms, which could have implications for the wider use of digital health for patient surveillance.

RESUMEN: El propósito de este estudio fue evaluar la eficacia de la aplicación VIP-HANA para mejorar la carga de síntomas en una prueba controlada aleatorizada de 100 personas que viven con VIH con condiciones no de SIDA asociadas al VIH. El grupo de intervención recibió la aplicación VIP-HANA que les permitió reportar sus síntomas cada semana y recibir estrategias de autogestión personalizadas. El brazo de control recibió una aplicación para reportar sus síntomas cada semana, pero no recibió ninguna estrategia. Los resultados de nuestro estudio sugieren que la carga general de los síntomas mejoro entre los participantes en ambos brazos del estudio. Aunque estos hallazgos no apoyan la eficacia de la aplicación VIP-HANA para mejorar la carga de síntomas en PVVS con condiciones de HANA, esto puede ser una función del diseño del estudio. Estos hallazgos sugieren que PVVS están interesados en monitorear sus síntomas, lo que puede tener implicaciones para el uso más amplio de salud digital para la vigilancia de pacientes.

Group-randomized trial of tailored brief shared decision-making to improve asthma control in urban black adults.

AIMS: To assess the intervention effects of BREATHE (BRief intervention to Evaluate Asthma THErapy), a novel brief shared decision-making intervention and evaluate feasibility and acceptability of intervention procedures. DESIGN: Group-randomized longitudinal pilot study. METHODS: In total, 80 adults with uncontrolled persistent asthma participated in a trial comparing BREATHE (N = 40) to a dose-matched attention control intervention (N = 40). BREATHE is a one-time shared decision-making intervention delivered by clinicians during routine office visits. Ten clinicians were randomized and trained on BREATHE or the control condition. Participants were followed monthly for 3 months post-intervention. Data were collected from December 2017 - May 2019 and included surveys, lung function tests, and interviews. RESULTS: Participants were Black/multiracial (100%) mostly female (83%) adults (mean age 45). BREATHE clinicians delivered BREATHE to all 40 participants with fidelity based on expert review of audiorecordings. While the control group reported improvements in asthma control at 1-month and 3-month follow-up, only BREATHE participants had better asthma control at each timepoint (ß = 0.77; standard error (SE)[0.17]; p ≤ 0.0001; ß = 0.71; SE[0.16]; p ≤ 0.0001; ß = 0.54; SE[0.15]; p = .0004), exceeding the minimally important difference. BREATHE participants also perceived greater shared decision-making occurred during the intervention visit (ß = 7.39; SE[3.51]; p = .03) and fewer symptoms at follow-up (e.g., fewer nights woken, less shortness of breath and less severity of symptoms) than the controls. Both groups reported improved adherence and fewer erroneous medication beliefs. CONCLUSION: BREATHE is a promising brief tailored intervention that can be integrated into office visits using clinicians as interventionists. Thus, BREATHE offers a pragmatic approach to improving asthma outcomes and shared decision-making in a health disparity population. IMPACT: The study addressed the important problem of uncontrolled asthma in a high-risk vulnerable population. Compared with the dose-matched attention control condition, participants receiving the novel brief tailored shared decision-making intervention had significant improvements in asthma outcomes and greater perceived engagement in shared decision-making. Brief interventions integrated into office visits and delivered by clinicians may offer a pragmatic approach to narrowing health disparity gaps. Future studies where other team members (e.g., office nurses, social workers) are trained in shared decision-making may address important implementation science challenges as it relates to adoption, maintenance, and dissemination. TRAIL REGISTRATION: clinicaltrials.gov # NCT03300752.

Development and validation of early warning score system: A systematic literature review.

OBJECTIVES: This review aims to: 1) evaluate the quality of model reporting, 2) provide an overview of methodology for developing and validating Early Warning Score Systems (EWSs) for adult patients in acute care settings, and 3) highlight the strengths and limitations of the methodologies, as well as identify future directions for EWS derivation and validation studies. METHODOLOGY: A systematic search was conducted in PubMed, Cochrane Library, and CINAHL. Only peer reviewed articles and clinical guidelines regarding developing and validating EWSs for adult patients in acute care settings were included. 615 articles were extracted and reviewed by five of the authors. Selected studies were evaluated based on the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) checklist. The studies were analyzed according to their study design, predictor selection, outcome measurement, methodology of modeling, and validation strategy. RESULTS: A total of 29 articles were included in the final analysis. Twenty-six articles reported on the development and validation of a new EWS, while three reported on validation and model modification. Only eight studies met more than 75% of the items in the TRIPOD checklist. Three major techniques were utilized among the studies to inform their predictive algorithms: 1) clinical-consensus models (n = 6), 2) regression models (n = 15), and 3) tree models (n = 5). The number of predictors included in the EWSs varied from 3 to 72 with a median of seven. Twenty-eight models included vital signs, while 11 included lab data. Pulse oximetry, mental status, and other variables extracted from electronic health records (EHRs) were among other frequently used predictors. In-hospital mortality, unplanned transfer to the intensive care unit (ICU), and cardiac arrest were commonly used clinical outcomes. Twenty-eight studies conducted a form of model validation either within the study or against other widely-used EWSs. Only three studies validated their model using an external database separate from the derived database. CONCLUSION: This literature review demonstrates that the characteristics of the cohort, predictors, and outcome selection, as well as the metrics for model validation, vary greatly across EWS studies. There is no consensus on the optimal strategy for developing such algorithms since data-driven models with acceptable predictive accuracy are often site-specific. A standardized checklist for clinical prediction model reporting exists, but few studies have included reporting aligned with it in their publications. Data-driven models are subjected to biases in the use of EHR data, thus it is particularly important to provide detailed study protocols and acknowledge, leverage, or reduce potential biases of the data used for EWS development to improve transparency and generalizability.

Unrecognised self-injury mortality (SIM) trends among racial/ethnic minorities and women in the USA.

AIM: To assess whether an enhanced category combining suicides with nonsuicide drug self-intoxication fatalities more effectively captures the burden of self-injury mortality (SIM) in the USA among US non-Hispanic black and Hispanic populations and women irrespective of race/ethnicity. METHODS: This observational study used deidentified national mortality data for 2008-2017 from the CDC's Web-based Injury Statistics Query and Reporting System. SIM comprised suicides by any method and age at death plus estimated nonsuicide drug self-intoxication deaths at age ≥15 years. Measures were crude SIM and suicide rates; SIM-to-suicide rate ratios; and indices of premature mortality. RESULTS: While the suicide rate increased by 29% for blacks, 36% for Hispanics and 25% for non-Hispanic whites between 2008 and 2017, corresponding SIM rate increases were larger at 109%, 69% and 55% (p<0.0001). SIM:suicide rate ratio gaps were widest among blacks but similar for the other two groups. Gaps were wider for females than males, especially black females whose ratios measured ≥3.71 across the observation period versus <3.00 for white and Hispanic counterparts. Total lost years of life for Hispanic, white and black SIM decedents in 2017 were projected to be 42.6, 37.1 and 32.4, respectively. CONCLUSION: Application of SIM exposed substantial excess burdens from substance poisoning relative to suicide for minorities, particularly non-Hispanic blacks and for women generally. Results underscored the need to define, develop, implement and evaluate comprehensive strategies to address common antecedents of self-injurious behaviours.

Protocol of the randomized control trial: the WiseApp trial for improving health outcomes in PLWH (WiseApp).

BACKGROUND: Poor adherence to antiretroviral therapy (ART) is one of the primary barriers to viral load suppression. mHealth technology can help overcome challenges with ART adherence. This paper outlines the protocol for the WiseApp randomized control trial. The WiseApp contains real-time medication monitoring linking an electronic pill bottle and fitness tracker to the app, helping persons living with HIV (PLWH) self-manage their medication adherence and improve their overall quality of life. The primary objective of the trial is to test the effect of the WiseApp's medication adherence features on antiretroviral adherence in underserved PLWH in New York City. METHODS: This ongoing study is a two-arm randomized control trial. Participants are randomized 1:1 to the WiseApp intervention arm or the control arm at baseline and followed for 6 months. Eligibility criteria include: 18 years of age, have a diagnosis of HIV, speak and understand English or Spanish, live in the United States, own a smartphone, currently taking ART medications, and report the past 30 days adherence of 80% or less as measured using the Visual Analogue Scale (VAS), or have a viral load of over 400 copies/mL. The sample size for the trial is 200 people. All study participants receive the WiseApp, a CleverCap electronic pill bottle, and a fitness tracker. The intervention group also receives videos and health surveys centered on medication adherence and managing living with HIV as well as medication reminders. In contrast, the control group receives walk step reminders, videos, and surveys focused on overall wellness. DISCUSSION: The WiseApp Trial has the potential to improve HIV self-management applications, being one of the few randomized controlled trials of a mHealth medication adherence and HIV self-management application in the United States. The trial could also bring new opportunities for advancement in reaching economically disenfranchised and underserved populations in the United States. The real-time monitoring of the WiseApp has the potential to help providers initiate interventions to help patients resume treatment before drug resistance begins. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov ( NCT03205982 ) on July 2, 2017.

A randomized controlled efficacy trial of an mHealth HIV prevention intervention for sexual minority young men: MyPEEPS mobile study protocol.

BACKGROUND: Young sexual minority men in the United States have a high incidence rate of HIV infection. Early intervention among this group, that is timed to precede or coincide with sexual initiation, is of critical importance to prevent HIV infection. Despite this, there are very few published randomized controlled efficacy trials testing interventions to reduce sexual vulnerability for HIV acquisition among racially/ethnically diverse, very young, sexual minority men (aged ≤18 years). This paper describes the design of a mobile app-based intervention trial to reduce sexual risk for HIV acquisition and promote health protection in this group. METHODS: This study is a randomized controlled trial of an mHealth-based HIV prevention intervention, MyPEEPS Mobile, among diverse sexual minority cisgender young men, aged 13-18 years. The mobile intervention was adapted from a prior group-based intervention curriculum with evidence of efficacy, designed to be specific to the risk contexts and realities of young sexual minority men, and to include psychoeducational and skill-building components with interactive games and activities. Participants are recruited locally within four regional hubs (Birmingham, AL, Chicago, IL, New York City, NY, Seattle, WA) and nationwide via the Internet, enrolled in-person or remotely (via videoconference), and randomized (1:1) to either the MyPEEPS Mobile intervention or delayed intervention condition. Post-hoc stratification by age, race/ethnicity, and urban/suburban vs. rural statuses is used to ensure diversity in the sample. The primary outcomes are number of male anal sex partners and frequency of sexual acts with male partners (with and without condoms), sex under the influence of substances, and uptake of pre-and post-exposure prophylaxis, as well as testing for HIV and other sexually transmitted infections at 3-, 6- and 9-month follow-up. DISCUSSION: Behavioral interventions for very young sexual minority men are needed to prevent sexual risk early in their sexual development and maturation. This study will provide evidence to determine feasibility and efficacy of a mobile app-based HIV prevention intervention to reduce sexual risk among this very young group. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT03167606, registered May 30, 2017.

Mobile Electrocardiogram Monitoring and Health-Related Quality of Life in Patients With Atrial Fibrillation: Findings From the iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology (iHEART) Study.

BACKGROUND: Atrial fibrillation (AF) is associated with high recurrence rates and poor health-related quality of life (HRQOL) but few effective interventions to improve HRQOL exist. OBJECTIVE: The aim of this study was to examine the impact of the "iPhone Helping Evaluate Atrial Fibrillation Rhythm through Technology" (iHEART) intervention on HRQOL in patients with AF. METHODS: We randomized English- and Spanish-speaking adult patients with AF to receive either the iHEART intervention or usual care for 6 months. The iHEART intervention used smartphone-based electrocardiogram monitoring and motivational text messages. Three instruments were used to measure HRQOL: the Atrial Fibrillation Effect on Quality of Life (AFEQT), the 36-item Short-Form Health survey, and the EuroQol-5D. We used linear mixed models to compare the effect of the iHEART intervention on HRQOL, quality-adjusted life-years, and AF symptom severity. RESULTS: A total of 238 participants were randomized to the iHEART intervention (n = 115) or usual care (n = 123). Of the participants, 77% were men and 76% were white. More than half (55%) had an AF recurrence. Both arms had improved scores from baseline to follow-up for AFEQT and AF symptom severity scores. The global AFEQT score improved 18.5 and 11.2 points in the intervention and control arms, respectively (P < .05). There were no statistically significant differences in HRQOL, quality-adjusted life-years, or AF symptom severity between groups. CONCLUSIONS: We found clinically meaningful improvements in AF-specific HRQOL and AF symptom severity for both groups. Additional research with longer follow-up should examine the influence of smartphone-based interventions for AF management on HRQOL and address the unique needs of patients diagnosed with different subtypes of AF.

Prevalence, risk factors, and burden of disease for falls and balance or walking problems among older adults in the U.S.

This study assesses the prevalence of falls, factors predicting future falls, and health impacts of falls and balance or walking problems for U.S. older adults. Data were from participants ≥65 years in the Medicare Health Outcomes Survey Cohort 15 (baseline survey in 2012; follow-up survey in 2014; n = 164,597). We examined baseline factors predicting falls at follow-up and estimated the impact of falls and balance/walking problems on health-related quality of life (HRQOL), mortality, and quality-adjusted life years (QALYs). About 23% reported falls and 34% reported balance/walking problems in the past 12 months. The strongest predictors of falls were previous falls [adjusted odds ratio (OR) = 2.9] and balance/walking problems (OR = 1.7). Many self-reported chronic conditions (e.g., depression, stroke, and diabetes), geriatric symptoms (e.g., urine leakage), and limitations of activities of daily living (e.g., transferring and walking) also predicted falls, but at a smaller magnitude (ORs = 1.1-1.3). Having balance/walking problems was associated with a greater decrease in HRQOL scores (0.195 points) than falls (0.077 points), while falls were associated with a greater increase in mortality [adjusted hazard ratio (HR) = 1.5] than balance/walking problems (HR = 1.1). Falls were associated with a 4.6-year (48%) decrease in QALYs, while balance/walking problems was associated with a 7.3-year (62%) decrease in QALYs. Falls are a major problem for U.S. elderly and will continue to have an even greater impact as the population ages. The nearly 50% decrease in QALYs for falls and >60% decrease for balance or walking problems demonstrates the substantial burden associated with these problems among older Americans.

HABIT efficacy and sustainability trial, a multi-center randomized controlled trial to improve hydroxyurea adherence in youth with sickle cell disease: a study protocol.

BACKGROUND: Hydroxyurea (HU) is recommended as standard practice for youth with sickle cell disease (SCD). Yet, despite its efficacy, HU adherence in adolescents and young adults is often poor. Poor medication adherence increases disease burden, healthcare cost and widens health disparities. Adolescence is a critical time to improve adherence through improved chronic disease self-management. This study aims to test the efficacy of an intervention delivered to youth/parent dyads by community health workers (CHWs), augmented by tailored text messages on HU adherence (primary outcome). Secondary outcomes are intervention sustainability, youth health-related quality of life, self-management responsibility concordance, acute hospital use and self-reported disease symptoms. METHODS: Hydroxyurea Adherence for Personal Best in Sickle Cell Disease, "HABIT," is a 12 month multi-center randomized controlled trial. One hundred four youth, 10 to 18 years of age prescribed HU who meet eligibility criteria, enrolled with their parent as dyads, will be randomized 1:1 to either the HABIT intervention or to usual clinical care plus education handouts. All subjects will complete clinic visits at months 0, 2, 4, 6 (efficacy component), 9 and 12 (sustainability component) for assessment of HbF biomarker, other hematologic parameters, and to complete questionnaires. In addition, dyads assigned to the HABIT intervention will work with CHWs to identify a daily habit (e.g., brushing teeth) on which to build a HU adherence habit. Tailored daily text message reminders to support the habit will be developed by the dyad in collaboration with the CHWs and sent to parent and youth. At the 6 month visit, the intervention will end and the sustainability portion of the trial will begin. All data analyses will be based on intention to treat with all randomized subjects included in the analyses. DISCUSSION: Prior retrospective studies demonstrate that a majority of adolescents are poorly adherent to HU. If efficacious, the HABIT intervention has the potential to improve the lives of youth with SCD. TRIAL REGISTRATION: Clinicaltrials.gov NCT03462511 . Registered March 6, 2018, last updated July 26, 2019.

Shared decision-making in the BREATHE asthma intervention trial: A research protocol.

AIM: To evaluate the preliminary effectiveness of the BRief Evaluation of Asthma THerapy intervention, a 7-min primary care provider-delivered shared decision-making protocol that uses motivational interviewing to address erroneous asthma disease and medication beliefs. DESIGN: A multi-centre masked two-arm group-randomized clinical trial. METHODS: This 2-year pilot study is funded (September 2016) by the National Institute of Nursing Research. Eight providers will be randomized to one of two arms: the active intervention (N = 4) or a dose-matched attention control (N = 4). Providers will deliver the intervention to which they were randomized to 10 Black adult patients with uncontrolled asthma (N = 80). Patients will be followed three months postintervention to test the preliminary intervention effects on asthma control (primary outcome) and on medication adherence, lung function, and asthma-related quality of life (secondary outcomes). DISCUSSION: This study will evaluate the preliminary impact of a novel shared decision-making intervention delivered in a real world setting to address erroneous disease and medication beliefs as a means of improving asthma control in Black adults. Results will inform a future, large-scale randomized trial with sufficient power to test the intervention's effectiveness. IMPACT: Shared decision-making is an evidence-based intervention with proven effectiveness when implemented in the context of labour- and time-intensive research protocols. Medication adherence is linked with the marked disparities evident in poor and minority adults with asthma. Addressing this requires a novel multifactorial approach as we have proposed. To ensure sustainability, shared decision-making interventions must be adapted to and integrated into real-world settings. TRIAL REGISTRATION: Registered at clincialtrials.gov as NCT03036267 and NCT03300752.

HABIT, a Randomized Feasibility Trial to Increase Hydroxyurea Adherence, Suggests Improved Health-Related Quality of Life in Youths with Sickle Cell Disease.

OBJECTIVES: To examine the effect of a community health worker (CHW) intervention, augmented by tailored text messages, on adherence to hydroxyurea therapy in youths with sickle cell disease, as well as on generic and disease-specific health-related quality of life (HrQL) and youth-parent self-management responsibility concordance. STUDY DESIGN: We conducted a 2-site randomized controlled feasibility study (Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment [HABIT]) with 2:1 intervention allocation. Youths and parents participated as dyads. Intervention dyads received CHW visits and text message reminders. Data were analyzed using descriptive statistics, the Wilcoxon signed-rank test, and growth models adjusting for group assignment, time, and multiple comparisons. Changes in outcomes from 0 to 6 months were compared with their respective minimal clinically important differences. RESULTS: A total of 28 dyads (mean age of youths, 14.3 ± 2.6 years; 50% Hispanic) participated (18 in the intervention group, 10 in the control group), with 10.7% attrition. Accounting for group assignment, time, and multiple comparisons, at 6 months intervention youths reported improved generic HrQL total score (9.8 points; 95% CI, 0.4-19.2) and Emotions subscale score (15.0 points; 95% CI, 1.6-28.4); improved disease-specific subscale scores for Worry I (30.0 points; 95% CI, 8.5-51.5), Emotions (37.0 points, 95% CI, 9.4-64.5), and Communication I (17.8 points; 95% CI, 0.5-35.1); and 3-month dyad self-management responsibility concordance (3.5 points; 95% CI, -0.2 to 7.1). There were no differences in parent proxy-reported HrQL measures at 6 months. CONCLUSIONS: These findings add to research examining effects of behavioral interventions on HrQL outcomes in youths with sickle cell disease. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02029742.