Search

Purpose: To test the effectiveness and feasibility of a remotely delivered intervention to increase physical activity (walking) in middle-aged and older adults., Design: This study used a personalized (N-of-1) trial design., Setting: This study took place at a major healthcare system from November 2021 to February 2022., Subjects: Sixty adults (45-75 years, 92% female, 80% white) were recruited., Intervention: A 10-week study comprising a 2-week baseline, followed by four 2-week periods where four behavior change techniques (BCTs) - self-monitoring, goal setting, action planning, and feedback - were delivered one at a time in random order., Measures: Activity was measured by a Fitbit, and intervention components delivered by email/text. Average daily steps were compared between baseline and intervention. Participants completed satisfaction items derived from the System Usability Scale and reported attitudes and opinions about personalized trials., Results: Participants rated personalized trial components as feasible and acceptable. Changes in steps between baseline and intervention were not significant, but a large heterogeneity of treatment effects existed, suggesting some participants significantly increased walking while others significantly decreased., Conclusions: Our intervention was well-accepted but use of BCTs delivered individually did not result in a significant increase in steps. Feasibility and heterogeneity of treatment effects support adopting a personalized trial approach to optimize intervention results., (© 2024. International Society of Behavioral Medicine.)

Purpose: To test the feasibility of a remotely-delivered intervention to increase low-intensity physical activity (walking) in middle-aged and older adults., Design: This study used a Personalized (N-of-1) trial design., Setting: This study took place at a major healthcare system from November 2021 to February 2022., Subjects: Sixty adults (45-75 years, 92% female, 80% white) were recruited., Intervention: A 10-week study comprising a 2-week baseline, followed by four 2-week periods where 4 Behavior Change Techniques (BCTs) - self-monitoring, goal setting, action planning and feedback - were delivered one at a time in random order., Measures: Activity was measured by a Fitbit, and intervention components delivered by email/text. Average daily steps were compared between baseline and intervention. Participants completed satisfaction items derived from the System Usability Scale and reported attitudes and opinions about personalized trials., Results: Participants rated personalized trial components as feasible and acceptable. Changes in steps between baseline and intervention were not significant, but a large heterogeneity of treatment effects existed, suggesting some participants significantly increased walking while others significantly decreased., Conclusions: Our intervention was well-accepted but use of BCTs delivered individually did not result in a significant increase in steps. Feasibility and heterogeneity of treatment effects support adopting a personalized trial approach to optimize intervention results., Competing Interests: Conflict of Interest: Authors report no disclosures and no conflicts of interest reported.

Background: Highly effective, short-course, bedaquiline-containing treatment regimens for multidrug-resistant tuberculosis (MDR-TB) and integrase strand transfer inhibitor (INSTI)-containing fixed dose combination antiretroviral therapy (ART) have radically transformed treatment for MDR-TB and HIV. However, without advances in adherence support, we may not realize the full potential of these therapeutics. The primary objective of this study is to compare the effect of adherence support interventions on clinical and biological endpoints using an adaptive randomized platform., Methods: This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of four adherence support strategies on a composite clinical outcome in adults with MDR-TB and HIV initiating bedaquiline-containing MDR-TB treatment regimens and receiving ART in KwaZulu-Natal, South Africa. Trial arms include (1) enhanced standard of care, (2) psychosocial support, (3) mHealth using cellular-enabled electronic dose monitoring, and (4) combined mHealth and psychosocial support. The level of support will be titrated using a differentiated service delivery (DSD)-informed assessment of treatment support needs. The composite primary outcome will include survival, negative TB culture, retention in care, and undetectable HIV viral load at month 12. Secondary outcomes will include individual components of the primary outcome and quantitative evaluation of adherence on TB and HIV treatment outcomes., Discussion: This trial will evaluate the contribution of different modes of adherence support on MDR-TB and HIV outcomes with WHO-recommended all-oral MDR-TB regimens and ART in a high-burden operational setting. We will also assess the utility of a DSD framework to pragmatically adjust levels of MDR-TB and HIV treatment support., Trial Registration: ClinicalTrials.gov NCT05633056. Registered on 1 December 2022., (© 2023. The Author(s).)

Background: Highly effective, short course, bedaquiline-containing treatment regimens for multidrug-resistant tuberculosis (MDR-TB) and integrase strand transfer inhibitor (INSTI)-containing fixed dose combination antiretroviral therapy (ART) have radically transformed treatment for MDR-TB and HIV. However, without advances in adherence support, we may not realize the full potential of these therapeutics. The primary objective of this study is to compare the effect of adherence support interventions on clinical and biological endpoints using an adaptive randomized platform., Methods: This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of four adherence support strategies on a composite clinical outcome in adults with MDR-TB and HIV initiating bedaquiline-containing MDR-TB treatment regimens and receiving ART in KwaZulu-Natal, South Africa. Trial arms include 1) enhanced standard of care; 2) psychosocial support; 3) mHealth using cellular- enabled electronic dose monitoring; 4) combined mHealth and psychosocial support. The level of support will be titrated using a differentiated service delivery (DSD)-informed assessment of treatment support needs. The composite primary outcome will be include survival, negative TB culture, retention in care and undetectable HIV viral load at month 12. Secondary outcomes will include individual components of the primary outcome and quantitative evaluation of adherence on TB and HIV treatment outcomes., Discussion: This trial will evaluate the contribution of different modes of adherence support on MDR-TB and HIV outcomes with WHO recommended all-oral MDR-TB regimens and ART in a high-burden operational setting. We will also assess the utility of a DSD framework to pragmatically adjust levels of MDR-TB and HIV treatment support., Competing Interests: Competing interests The authors declare that they have no competing interests.

Background: Personalized interventions that can be delivered remotely are needed to increase physical activity (PA) in older adults to reduce risk of CV disease and mortality. Prior research indicates that Behavioral Change Techniques (BCTs) (e.g., goal setting, self-monitoring, behavioral repetition) can instill a habit for increasing daily walking. However, past interventions relied on between-subject randomized clinical trials, which can only only be informative about response of the hypothetical average person. Personalized trial designs can identify the benefits of an intervention for a specific individual although extended periods are required for collecting frequent measurements within-subject. Advances in remote, virtual technologies (e.g., text messaging, activity trackers), integrated with automatic platforms, can meet these requirements because they capacitate delivery of BCT interventions, and collection of data during daily life without personal contact. This Stage I-b trial is designed test whether a virtual, personalized intervention is feasible and acceptable to older adults, can elicit participant adherence and exhibit preliminary evidence for efficacy., Methods: A series of up to 60 single-arm, personalized trials, involving no personal contact, will recruit adults, 45-75 years of age, to wear an activity tracker during a 2-week baseline and a 10-week intervention. Five BCT prompts to execute a walking plan will be delivered on a daily basis during the intervention phase. Participants will rate satisfaction with personalized trial components and whether automaticity of the walking plan can be achieved. Step-counts, adherence to the walking plan and self-monitoring of step-count will also be recorded., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 Northwell Health. Published by Elsevier Inc.)

Objective: Personalized trials have the potential to improve the precision of treatment selection and foster patient involvement in clinical decision making. Little is known about the attitudes of patients with multimorbidities. To address this, stakeholders designed and conducted a national survey that determined general attitudes and features of personalized trials that may increase their use among patients with multimorbidities in clinical and research practice., Method: A multistakeholder collaboratory of patients, clinicians, scientists, methodologists, statisticians, and research disseminators designed a survey to determine the conditions, symptoms, and design attributes most applicable to personalized trials according to patients. A sample of U.S. patients with two or more prespecified personalized-trial-amenable chronic conditions completed the online survey., Results: Multimorbid participants (N = 501; M age = 56.1 years) showed that some conditions, symptoms or use cases for personalized trials include pain (57.6%), hypertension (38.8%), diabetes (28.8%), sleep problems (27.4%), and depression (23.0%). Overall, 82.0% of the participants with multimorbidities were interested in participating in personalized trials. The percentage that were interested varied by trial attributes, including physician involvement (86.4%), patient-driven treatment selection (88.0%), clinician blinding (59.2%), placebo treatment options (57.5%), and out-of-pocket costs (41.8%)., Conclusion: Participants with multimorbidities identified prevalent use cases that are suited to personalized trials. Participants also identified design features of such trials, including patient-driven treatment selection, active comparators, and nonblinding. This study demonstrates that eliciting input from a collaboratory and patients with multimorbidities can inform research priorities for this rapidly growing patient population and increase adoption by researchers and clinicians alike. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Importance: Adults who belong to racial/ethnic minority groups are more likely than White adults to receive a diagnosis of chronic disease in the United States., Objective: To evaluate which health indicators have improved or become worse among Black and Hispanic middle-aged and older adults since the Minority Health and Health Disparities Research and Education Act of 2000., Design, Setting, and Participants: In this repeated cross-sectional study, a total of 4 856 326 records were extracted from the Behavioral Risk Factor Surveillance System from January 1999 through December 2018 of persons who self-identified as Black (non-Hispanic), Hispanic (non-White), or White and who were 45 years or older., Exposure: The 1999 legislation to reduce racial/ethnic health disparities., Main Outcomes and Measures: Poor health indicators and disparities including major chronic diseases, physical inactivity, uninsured status, and overall poor health., Results: Among the 4 856 326 participants (2 958 041 [60.9%] women; mean [SD] age, 60.4 [11.8] years), Black adults showed an overall decrease indicating improvement in uninsured status (β = -0.40%; P < .001) and physical inactivity (β = -0.29%; P < .001), while they showed an overall increase indicating deterioration in hypertension (β = 0.88%; P < .001), diabetes (β = 0.52%; P < .001), asthma (β = 0.25%; P < .001), and stroke (β = 0.15%; P < .001) during the last 20 years. The Black-White gap (ie, the change in β between groups) showed improvement (2 trend lines converging) in uninsured status (-0.20%; P < .001) and physical inactivity (-0.29%; P < .001), while the Black-White gap worsened (2 trend lines diverging) in diabetes (0.14%; P < .001), hypertension (0.15%; P < .001), coronary heart disease (0.07%; P < .001), stroke (0.07%; P < .001), and asthma (0.11%; P < .001). Hispanic adults showed improvement in physical inactivity (β = -0.28%; P = .02) and perceived poor health (β = -0.22%; P = .001), while they showed overall deterioration in hypertension (β = 0.79%; P < .001) and diabetes (β = 0.50%; P < .001). The Hispanic-White gap showed improvement in coronary heart disease (-0.15%; P < .001), stroke (-0.04%; P < .001), kidney disease (-0.06%; P < .001), asthma (-0.06%; P = .02), arthritis (-0.26%; P < .001), depression (-0.23%; P < .001), and physical inactivity (-0.10%; P = .001), while the Hispanic-White gap worsened in diabetes (0.15%; P < .001), hypertension (0.05%; P = .03), and uninsured status (0.09%; P < .001)., Conclusions and Relevance: This study suggests that Black-White disparities increased in diabetes, hypertension, and asthma, while Hispanic-White disparities remained in diabetes, hypertension, and uninsured status.

Background: Elevated depressive symptoms among survivors of acute coronary syndromes (ACS) confer recurrent cardiovascular events and mortality, worse quality of life, and higher healthcare costs. While multiple scientific groups advise routine depression screening for ACS survivors, no randomized trials exist to inform this screening recommendation. We aimed to assess the effect of screening for depression on change in quality of life over 18 months among ACS patients., Methods: The Comparison of Depression Identification after Acute Coronary Syndrome on Quality of Life and Cost Outcomes (CODIACS-QoL) trial is a pragmatic, 3-arm trial that randomized ACS patients to 1) systematic depression screening using the 8-item Patient Health Questionnaire (PHQ-8) and if positive screen (PHQ-8 ≥ 10), notification of primary care providers (PCPs) and invitation to participate in centralized, patient-preference, stepped depression care (Screen, Notify, and Treat, N = 499); 2) systematic depression screening and PCP notification only (Screen and Notify, N = 501); and 3) usual care (No Screen, N = 500). Adults hospitalized for ACS in the previous 2-12 months without prior history of depression were eligible for participation. Key outcomes will be quality-adjusted life years (primary), cost of health care utilization, and depression-free days across 18 months., Results: A total of 1500 patients were randomized in the CODIACS-QOL trial (28.3% women; 16.3% Hispanic; mean age 65.9 (11.5) years). Only 7% of ACS survivors had elevated depressive symptoms., Conclusions: Using a novel randomization schema and pragmatic design principles, the CODIACS-QoL trial achieved its enrollment target. Eventual results of this trial will inform future depression screening recommendations in cardiac patients., Trial Registration: ClinicalTrials.gov (NCT01993017)., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background Obtaining out-of-clinic blood pressure ( BP ) measurements to confirm a diagnosis of hypertension is recommended before initiating treatment. There are few empiric data available on the number of measurements required to reliably estimate BP on home BP monitoring ( HBPM ). Methods and Results We analyzed data from 316 community-dwelling adults not taking antihypertensive medication from the IDH (Improving the Detection of Hypertension) study who performed HBPM for 14 days. The reliability of home BP measurements was assessed using the intraclass correlation coefficient and as the percentage of participants with an absolute difference in home BP <10 mm Hg between weeks. The reliability of home hypertension status was assessed by the κ statistic. In the IDH study, 13.6% of participants had clinic hypertension and 18.0% had home hypertension. Mean home systolic and diastolic BP exhibited excellent reliability and sufficient agreement using the average of 2 morning and 2 evening BP readings for a minimum of 2 days of HBPM and a single morning and single evening or 2 morning BP readings for a minimum of 3 days. For diagnosing home hypertension, there was good agreement with a minimum of 3 days of HBPM using the average of 2 morning and 2 evening measurements or a single morning and single evening BP reading. A greater number of days was required for the other HBPM strategies. Conclusions Using the average of morning and evening readings, 3 days of HBPM are needed to reliably estimate mean home BP and diagnose out-of-clinic hypertension.

Objective: Despite their promise for increasing treatment precision, Personalized Trials (i.e., N-of-1 trials) have not been widely adopted. We aimed to ascertain patient preferences for Personalized Trials., Study Design and Setting: We recruited 501 adults with ≥2 common chronic conditions from Harris Poll Online. We used Sawtooth Software to generate 45 plausible Personalized Trial designs comprising combinations of eight key attributes (treatment selection, treatment type, clinician involvement, blinding, time commitment, self-monitoring frequency, duration, and cost) at different levels. Conditional logistic regression was used to assess relative importance of different attributes using a random utility maximization model., Results: Overall, participants preferred Personalized Trials with no costs vs. $100 cost (utility difference 1.52 [standard error 0.07], P < 0.001) and with less vs. more time commitment/day (0.16 [0.07], P < 0.015) but did not hold preferences for the other six attributes. In subgroup analyses, participants ≥65 years, white, and with income ≤$50,000 were more averse to costs than their counterparts (P all <0.05)., Conclusion: To optimize dissemination, Personalized Trial designers should seek to minimize out-of-pocket costs and time burden of self-monitoring. They should also consider adaptive designs that can accommodate subgroup differences in design preferences., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: A summary measure that reflects the global toxicity burden of a treatment is essential for comparing therapies. Current toxicity summaries are ad hoc and do not distinguish among the severities and types of toxicities. Here a clinically feasible method for estimating the toxicity burden, based on a prospective evaluation of the toxicity profile of a randomized clinical trial of 746 prostate cancer patients conducted by SWOG, is proposed., Methods: For 308 patients who experienced severe toxicities, 2 physicians randomly selected from 14 physicians evaluated each toxicity profile and assigned a visual analogue scale score (0-10) based on their impression of the global burden of toxicities. With mixed-effects models, severity scores and a 10-point toxicity burden score (TBS) were derived from 27 predictors accounting for severe (grade 3) and life-threatening (grade 4) toxicities for each organ class of the Common Terminology Criteria for Adverse Events., Results: For most organ classes, grade 3 toxicities had a TBS of 4.14 (95% confidence interval [CI], 3.65-4.63), but infections, cardiovascular events, and pulmonary events had a higher TBS with differences of 0.87 (95% CI, 0.53-1.21), 0.88 (95% CI, 0.51-1.25), and 0.73 (95% CI, 0.22-1.24), respectively. Moreover, most grade 4 events had a higher TBS than grade 3 events, except for hemorrhaging, pain, metabolic events, and musculoskeletal events. The intrarater and interrater correlations were 0.91 and 0.59, respectively., Conclusions: The burden of toxicity grades differs with toxicity types. A TBS provides a toxicity burden summary that incorporates physicians' perspectives and differentiates between severe and life-threatening toxicities and organ classes. Cancer 2018;124:858-64. © 2017 American Cancer Society., (© 2017 American Cancer Society.)