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2.10. Statistical Analysis | SPSS (version 28.0; IBM Corp., Armonk, NY, USA) was used for statistical analyses. The distribution of the data was assessed using the Shapiro–Wilk test, and we confirmed that the data followed a normal distribution. To verify the consistency of baseline values (i.e., values in the second postoperative week), the PRE v... | PMC9961826 | ||
4. Discussion | postoperative knee pain, postoperative pain, knee flexion ROM, pain, TKA, knee pain | In this study, we investigated the effects of a 1-week comprehensive FR intervention on pain, knee joint ROM, isometric knee extensor muscle strength, walking speed, and balance function from the second to the third postoperative week in patients with TKA. The results showed that adding one week of FR intervention to r... | PMC9961826 | |
5. Limitation | pain | There were some limitations in this study. We did not investigate FR intensity. Also, FR intervention is typically not self-administered by patients, and this study has not been blinded. Future research should explore the effectiveness of self-administered FR intervention. In addition, all subjects were taking pain med... | PMC9961826 | |
Author Contributions | Conceptualization, M.Y., M.N., A.K. and N.Y.; formal analysis, M.Y. and M.N.; investigation, M.Y., A.I., R.K. and S.W.; methodology, M.Y., M.N., A.K. and N.Y.; supervision, M.N., A.K. and N.Y.; writing—original draft, M.Y., M.N., A.K. and N.Y.; writing—review and editing, M.Y., M.N., A.I., R.K., S.W., A.K. and N.Y. All... | PMC9961826 | ||
Institutional Review Board Statement | This study was approved by the Ethical Review Committee of Takeda General Hospital (approval number: R3-298), and complied with the requirements of the Declaration of Helsinki. | PMC9961826 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC9961826 | ||
Data Availability Statement | All data supporting the conclusions of this study will be fully provided upon request by the authors. | PMC9961826 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC9961826 | ||
References | Flow chart of the study protocol.Foam rolling intervention for anterior thigh, medial thigh, and lateral thigh.Changes in outcome variables before (PRE) and after a 1-week comprehensive foam rolling (FR) program (POST).Data are presented as mean ± standard deviation. Δ Change = Amount of change from PRE to POST. * | PMC9961826 | ||
Methods | psychopathic traits | We revised a previously validated game of prosocial behavior by including a new trial type (i.e., trials where the participant will lose money and the charity will gain money). This version of the game was administered online and participants were randomized to group (exposed to a control stimulus video or a video used... | PMC10115303 | |
Results | Prosocial behavior on the new trial types added in this revised game correlated strongly with prosocial behavior on the old trial type (i.e., trials where the participant will gain money and the charity will lose money; | PMC10115303 | ||
Conclusions | psychopathic traits, psychopathic | Choices on this revised game of prosocial behavior, which can be administered online, are associated with psychopathic traits scores. The game appears to have high immediate test-retest reliability. Exposure to the moral elevation stimulus did not affect prosocial behavior or impact the relationship between psychopathi... | PMC10115303 | |
Data Availability | Administered | Sakai, J., Chintaluru, Y., Raymond, K. M., McWilliams, S., Carter, R. M., Winters, D. E., & Mikulich, S. (2022, January 8). A Revised Prosocial Behavior Game Administered Online: Testing Associations with Psychopathic Traits and the Effects of a Moral Elevation Stimulus on Game Behavior. | PMC10115303 | |
1. Introduction | psychopathic traits | Prosocial behavior, “behavior which the actor expects will benefit the person or persons to whom it is directed” [Prior studies have utilized multiple approaches to measure prosocial behavior. These include self-report, categorical measures (e.g., offered the opportunity to volunteer or donate–with outcomes being yes/n... | PMC10115303 | |
2. Materials and methods | The Colorado Multiple Institutions Review Board (COMIRB #17–0182) approved the study protocol and the study protocol was registered with ClinicalTrials.gov (NCT03834467). | PMC10115303 | ||
2.1 Recruitment, randomization and study procedures | Subjects (n = 500) were recruited via advertising on Craigslist (some subjects contacted the study team via review of the ClinicalTrials.gov database), were assessed for meeting the study age requirement (18–25 years; note we sought to recruit a general population sample of young adults and therefore had minimal inclus... | PMC10115303 | ||
Consort flow diagram. | PMC10115303 | |||
Comparisons of subject characteristics by study group. | CROSS | Mean (standard deviation) or Count (%). For testing, race was collapsed into 3 categories: white, non-white, and other/no answer. MW = Mann-Whitney U test; LSRPS = Levenson Self Report Psychopathy Scale; RCVAS = Red Cross Visual Analog Score (0–100, higher scores indicate a more positive view of the Red Cross). | PMC10115303 | |
2.2 AlAn’s short game version 2 | CROSS | The AlAn’s short game version 2 is programmed in REDCap. Subjects start with $2.50 and the Red Cross donation starts at $2.50. There are three trial types in the game. (1) | PMC10115303 | |
2.3 Elevation stimulus and control videos | Subjects were randomized to either view a moral elevation stimulus video (Group 1; available here ( | PMC10115303 | ||
2.4 Levenson Self Report Psychopathy Scale (LSRPS) | impulsive aggression, psychopathic | Prior to watching the assigned video, subjects completed the LSRPS, a self-report 26-item questionnaire, which provides a two-factor measure of psychopathic traits. We examined Factor 1 score (callousness; derived from 16 questions, range of scores 16–64), Factor 2 score (impulsive aggression; derived from 10 questions... | PMC10115303 | |
2.5 Data analyses and study hypotheses | Using estimates from our prior work (standard deviation = 6.3) [Distributions of outcomes were assessed for approximate normality. Demographic characteristics were compared between Groups using independent t-tests and chi-square tests or their nonparametric equivalents as appropriate. Despite some directional hypothese... | PMC10115303 | ||
Examining performance of new trials where the player will lose money and the charity donation will increase | REGRESSION, CROSS | Using data from Run 1 only (prior to moral elevation stimulus vs. control exposure), we tested internal consistency (Kuder-Richardson 20) within and across Active Trial Type and examined the relationship between Active Trial Type A and Active Trial Type B using Pearson correlations initially. Then, a multiple regressio... | PMC10115303 | |
Testing for a negative association between psychopathy trait scores and game behavior in Run 1 | psychopathic | REGRESSION, CROSS | We first graphed trial acceptance rates by trial characteristics (i.e., the relative amounts to “You” and the Red Cross) and then examined acceptance rates for those with higher psychopathic trait scores (top 20%; note: this does not represent a clinical cut off but instead was an avenue through which to visualize beha... | PMC10115303 |
Testing the effects of moral elevation on game behavior | CROSS | We compared Groups over Run using a mixed model analysis of covariance (ANCOVA) adjusting for age, race, and Red Cross visual analog scale score with fixed effects of Group (moral elevation vs. nature video), Run (1 vs. 2), sex (female vs. not female; as well as potential interactions with other fixed effects) and Grou... | PMC10115303 | |
Testing whether type of stimulus (moral elevation vs. Control) moderates the relationship between psychopathic traits and prosocial behavior | psychopathic | CROSS | We hypothesized that the relationship between psychopathic trait score and prosocial behavior would be moderated by the type of video viewed in between Runs. We evaluated the influence of moral elevation video condition exposure in comparison to control video condition, using a mixed model ANCOVA adjusting for age, rac... | PMC10115303 |
3. Results | PMC10115303 | |||
Examining performance of new trials where player loses money and the charity donation increases | We calculated internal consistency (Kuder-Richardson 20) within Run 1 for Active Trial Type A (0.83), for Active Trial Type B (0.81), and with appropriate reverse scoring of all Active Trial Type B, across Trial Types A and B (0.89). Behavior on the prior version game trials (the number of rejected Active Trial Type A)... | PMC10115303 | ||
Testing the effects of moral elevation on game behavior | As shown in | PMC10115303 | ||
Testing for pre-stimulus to post-stimulus change in prosocial behavior among those receiving the moral elevation video stimulus (n = 237) vs. those receiving the Control (nature) video stimulus (n = 248) after adjusting for participant characteristics using a mixed model ANCOVA). | A Group by Run interaction was non-significant ( | PMC10115303 | ||
Testing whether moral elevation moderates the relationship between psychopathic traits and prosocial behavior | psychopathic traits, psychopathy, psychopathic | SENSITIVITY | Analyses examining whether type of stimulus exposure moderated the negative association between psychopathic traits and prosocial behavior were non-significant, indicating that moral elevation exposure did not explain this relationship. In a mixed model ANCOVA evaluating effects of psychopathy, group, Run and sex after... | PMC10115303 |
4. Discussion | internalizing disorders | CROSS | This revised version of the AlAn’s game provides useful information about self-other considerations and allows mapping of acceptance rates by self-other valuations (see Both Active Trial Type A and new Active trial Type B suggest that on average there is a bias toward over-valuing oneself over the charity. For example,... | PMC10115303 |
5. Conclusions | prosocial behavior, psychopathic | Behavior on the AlAn’s game v.2 is related to psychopathic trait scores. The game also shows high correlations between runs. Utilizing a randomized, controlled design, we were unable to demonstrate that exposure to a moral elevation stimulus video changes performance on a previously validated game of prosocial behavior... | PMC10115303 | |
Supporting information | (DOCX)Click here for additional data file.(DOCX)Click here for additional data file.(PPTX)Click here for additional data file.(DOC)Click here for additional data file. | PMC10115303 | ||
References | PMC10115303 | |||
Background | cardiometabolic diseases | ELEVATED BLOOD PRESSURE, HYPERTENSION | Short sleep duration, defined as < 7 h sleep on weeknights, affects 40% of the US adult population, contributing to the increased risk for cardiometabolic diseases, decreased safety, and poorer mental health. Despite the prevalence of short sleep duration, few studies have tested interventions to extend sleep duration.... | PMC10566182 |
Methods | hypertension | ELEVATED BLOOD PRESSURE, SECONDARY, HYPERTENSION | This is a single-blind, randomized controlled trial to determine the impact of a behavioral sleep extension intervention on sleep duration and cardiometabolic health among individuals with short sleep duration (< 7 h per night) and elevated blood pressure or hypertension (SBP 120–150 mmHg or DBP 80–90 mmHg). After comp... | PMC10566182 |
Discussion | The results of this study will determine the effects of behavioral sleep extension on sleep and cardiometabolic health among adults with short sleep duration and elevated BP/hypertension. The results will inform the feasibility and efficacy of behavioral sleep extension and provide information needed for future multi-s... | PMC10566182 | ||
Trial registration | ClinicalTrials.gov NCT04766424. Registered on 21 February 2021. | PMC10566182 | ||
Keywords | PMC10566182 | |||
Introduction | PMC10566182 | |||
Background and rationale {6a} | CMD | INSULIN RESISTANCE | According to data from the National Health Interview Survey,70.1 million US adults (29.2%) sleep < 6 h per 24-h period [Despite the well-known negative effects of short sleep duration, surprisingly little attention has been paid to the development of sleep extension interventions and testing whether such treatments can... | PMC10566182 |
Objectives {7} | sleepiness, CMD | INFLAMMATION | The goal of this proposed study is to conduct a randomized controlled trial to test the efficacy of our behavioral sleep extension intervention on 24-h ambulatory BP (ABP) and other key biological and behavioral CMD risk factors among participants with short sleep duration and elevated BP/hypertension. The intervention... | PMC10566182 |
Hypotheses | CMD | Compared to the education control group, we predict greater improvements in sleep duration in the intervention group in sleep duration (aim 1), 24-h ABP, and other measures of BP and CMD risk (aim 2) and health behaviors and patient-reported outcomes (aim 3). We predict improvements will persist at the 12-month follow-... | PMC10566182 | |
Trial design {8} | SECONDARY | This is a single-blind, parallel-group, randomized controlled trial with a 1:1 allocation ratio and superiority framework. The study will test a behavioral sleep extension intervention compared to an education control group. The primary endpoint is 8 weeks and the secondary endpoint is 12 months. A CONSORT-style flow c... | PMC10566182 | |
Methods: participants, interventions, and outcomes | PMC10566182 | |||
Study setting {9} | hypertension | HYPERTENSION | This study will recruit participants with elevated BP/stage I hypertension and sleep duration < 7 h from community settings in Salt Lake City, Utah, and the surrounding area. | PMC10566182 |
Participant timeline {13} | BLOOD | The schedule of time points, study assessments, and interventions is listed in Fig. Schedule of time points, study assessments, and interventionsAfter web or telephone screening, participants will complete a baseline/screening visit. Participants will undergo standardized BP screening to determine BP eligibility. The B... | PMC10566182 | |
Eligibility criteria {10} | cognitive or neurological disorders, comorbid sleep disorders, schizophrenia,, dementia, apnea, bipolar disorder, overnight obstructive sleep, alcohol abuse, insomnia, cancer, renal disease, depressive symptoms, Parkinson’s, hypertension, weight loss | OBSTRUCTIVE SLEEP APNEA, RESTLESS LEGS SYNDROME, HYPERTENSION, DISORDERS | The following are the inclusion criteria:Age 18–65 years.In-office BP readings indicating elevated BP/stage I/II hypertension (SBP of 120–150 mmHg or DBP of 80–90 mmHg). Note that participants taking antihypertensive medications will be permitted if stable dose for > 8 weeks and willing to maintain their dose for the 8... | PMC10566182 |
Who will take informed consent? {26a} | Participants will attend a screening visit, and prior to consent, the research staff will take their resting blood pressure using a standardized protocol. Participants who are eligible based on their blood pressure readings will complete informed consent. Consent will be completed by the trained study staff (the resear... | PMC10566182 | ||
Additional consent provisions for collection and use of participant data and biological specimens {26b} | This study includes blood draws for cardiometabolic risk markers (e.g., lipids, glycated hemoglobin (HbA1c)) as well as Alzheimer’s-related biomarkers (targeted metabolomics, lipidomics) and the genetic risk gene apolipoprotein E4 testing (APOE4). In the consent process, participants will have the opportunity to opt ou... | PMC10566182 | ||
Interventions | PMC10566182 | |||
Intervention description {11a} | TED | The behavioral sleep extension intervention consists of a wearable sleep tracker, a weekly educational email, and one weekly phone call from a coach. The maintenance intervention consists of monthly email and phone calls.Self-monitoring (wearable sleep tracker): Participants receive a Fitbit wearable sleep tracker to a... | PMC10566182 | |
Control group description | Participants assigned to the health education control group will be provided with weekly health education emails with content written at < 4th grade level. Participants in this group will also receive brief weekly scripted telephone calls from the coach (< 5 min) to determine if they received the health information and... | PMC10566182 | ||
Measures of intervention fidelity | All coaching sessions will be recorded for training and fidelity monitoring. All coaches will be trained until they reach a criterion of adherence to the treatment protocol before being assigned study participants. In each quarter, Dr. Duffecy (co-PI) will review approximately 10 sessions quarterly in year 1 and 10 ses... | PMC10566182 | ||
Criteria for discontinuing or modifying allocated interventions {11b} | injury or major change | Participants may be removed from the study if the participant requests withdrawal or the principal investigators consider it necessary to stop the intervention (e.g., significant change that would significantly affect study participations such as pregnancy or a critical injury or major change in health, beginning a shi... | PMC10566182 | |
Strategies to improve adherence to interventions {11c} | HOLIDAY | Retention during the intervention and maintenance periods will be handled by the coaches (e.g., coach will attempt to contact participants via their preferred contact method and reschedule missed sessions when possible). The study staff will also send quarterly study newsletters and birthday and holiday cards to partic... | PMC10566182 | |
Relevant concomitant care permitted or prohibited during the trial {11d) | hypertension | HYPERTENSION | For the intervention period (weeks 1–8), we will use a constrained usual care model (requesting participants to keep antihypertensive medications constant if possible) to reduce non-study-related variability in the acute intervention phase. For the maintenance and no intervention periods (months 2–12), we will track th... | PMC10566182 |
Provisions for post-trial care {30} | This trial does not include provisions for post-trial care. If participants inquire about additional sleep interventions after the trial, they will be provided with information about local sleep centers. | PMC10566182 | ||
Outcomes {12} | sleepiness, sleep disturbance, sleep-related impairment | SECONDARY | Study outcomes and assessment time points are listed in Fig. Primary outcome: The primary outcome is a change in sleep duration from baseline to 8 weeks. Sleep duration at baseline and 8 weeks will each be calculated as averages over 10-day periods. Sleep duration will be measured by 8–10 days of actigraphy at baseline... | PMC10566182 |
Participant timeline {13} | A description of the participant timeline is listed in Fig. A description of the participant timeline | PMC10566182 | ||
Sample size {14} | Our power calculations are based on the assumption that the standard deviation (SD) for change in sleep duration from baseline to 8 weeks will not exceed 37.4 min, which is 10% higher than the SD for change in sleep duration of 34 min reported after 40 days in our previous study [If we also assume that (1) the SD for b... | PMC10566182 | ||
Recruitment {15} | EVENTS, RECRUITMENT | The study will use both active and passive recruitment methods. For active recruitment, patients from the University of Utah Health (UU Health) primary care practices who meet the initial criteria (age, BP) will be sent letters explaining the study and providing information for online screening. The study staff will fo... | PMC10566182 | |
Assignment of interventions: allocation | PMC10566182 | |||
Sequence generation {16a} | Randomization will be performed using random permuted blocks with stratification by sex and antihypertensive medication use. | PMC10566182 | ||
Concealment mechanism {16b} | The randomization allocation will be completed by the biostatistician and loaded into the REDCap system, where it will be concealed from the study investigators and staff. | PMC10566182 | ||
Implementation {16c} | After the screening is completed, the study staff will enter data into a REDCap form including the inclusion/exclusion criteria and stratification information. The interventionist only will have access to the randomization module in REDCap and will complete the randomization and notify the participant of his or her ass... | PMC10566182 | ||
Assignment of interventions: blinding | PMC10566182 | |||
Who will be blinded {17a} | The study staff, the PI, and the co-Is who are not directly responsible for delivering the intervention will be blinded. Participants and the interventionist will be unblinded. The interventionist will not be involved in the collection of outcome measures. The statistician, who creates the randomization table and is co... | PMC10566182 | ||
Procedure for unblinding if needed {17b} | ADVERSE EVENTS | The study has appointed an independent safety monitor, a primary care physician, who is unaffiliated with the study and is available to review the adverse events. He will be unblinded if necessary and will recommend to the study team if a situation arises that unblinding is critical to addressing the situation. | PMC10566182 | |
Data collection and management | PMC10566182 | |||
Plans for assessment and collection of outcomes {18a} | PMC10566182 | |||
Screening measures | sleep disorders, restless legs, insomnia, Insomnia, depressive symptoms | RESTLESS LEGS, RESTLESS LEGS | Participants will complete self-report measures to evaluate for the presence of elevated depressive symptoms and symptoms of common sleep disorders on the web/phone prescreening. Participants who demonstrate elevated depressive symptoms (score ≥ 15) on the PHQ-8, moderate severity of restless legs (score ≥ 11) on the I... | PMC10566182 |
Outcome measures | inflammation, sleep disturbance, sleep-related impairment | INFLAMMATION, SECONDARY | Primary outcome: Sleep duration at 8 weeks. Sleep will be measured by 8–10 days of actigraphy at baseline/screening, week 8, and 6 and 12 months with the Actiwatch Spectrum device (Philips Respironics Inc.). Devices will be configured using default settings and scored using the Acitware Software (Philips Respironics, I... | PMC10566182 |
Plans to promote participant retention and complete follow-up {18b} | Retention for the assessment visits will be handled by the study staff. During informed consent, the staff will discuss with the participants the differences between intervention and assessment as well as the impact of dropout on the validity of study results, while also highlighting voluntary participation. For partic... | PMC10566182 | ||
Data management {19} | SLEEP APNEA | This study will use the secure, web-based Research Electronic Data Capture (REDCap) for data input. Case report forms will be designed to flag out-of-range values. When possible, participants will enter data directly into REDCap. For forms that need to be manually entered (e.g., blood test results, sleep apnea screenin... | PMC10566182 | |
Confidentiality {27} | All investigators and staff will have up-to-date certification on confidentiality and privacy throughout the Collaborative Institutional Training Initiative (CITI) and will have completed additional HIPAA training through The University of Utah. Physical documents will be kept in folders within locked file cabinets in ... | PMC10566182 | ||
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} | Alzheimer’s disease | We will collect and store serum for targeted metabolomics analyses to evaluate whether changes in sleep affect biomarkers related to Alzheimer’s disease risk. | PMC10566182 | |
Statistical methods | PMC10566182 | |||
Statistical methods for primary and secondary outcomes {20a} | REGRESSION, SECONDARY | The primary outcome of the proposed study is the change in the mean sleep duration from baseline to 8 weeks. The study sample size has been determined based on the primary analysis of covariance (ANCOVA) that will compare mean sleep duration at 8 weeks, with statistical adjustment for the baseline sleep duration and th... | PMC10566182 | |
Interim analyses {21b} | There are no interim analyses planned for this study. | PMC10566182 | ||
Methods for additional analyses (e.g., subgroup analyses) {20b} | mild obstructive sleep apnea | OBSTRUCTIVE SLEEP APNEA, EVENTS | In addition to our primary analyses, we plan to analyze the results of participants who completed the intervention per protocol, in that they attended all the coaching or health education sessions. We will also conduct exploratory analyses based on clinically significant improvements in sleep and analyze the results am... | PMC10566182 |
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} | We plan to apply multiple imputation to impute missing outcome data, using comprehensive imputation models that include both non-missing measurements from the variables included in the data analysis as well as additional auxiliary variables that are considered to be predictive either of the risk of missingness or the v... | PMC10566182 | ||
Plans to give access to the full protocol, participant-level data, and statistical code {31c} | De-identified data and a codebook will be provided upon written request to the contact PI (Dr. Baron). | PMC10566182 | ||
Oversight and monitoring | PMC10566182 | |||
Composition of the coordinating centre and trial steering committee {5d} | RECRUITMENT | This study does not have a coordinating centre or trial steering committee. Dr. Baron and Dr. Duffecy (co-PIs) are jointly responsible for the conduct of the study. Dr. Baron is the contact PI and is responsible for the day-to-day study operations, overseeing the local study staff who are conducting recruiting and data... | PMC10566182 | |
Composition of the data monitoring committee, its role, and reporting structure {21a} | ADVERSE EVENTS | Due to the low-risk nature of the study, there is no data monitoring committee. The study team has appointed an independent safety monitor to review any potential adverse events during the study. | PMC10566182 | |
Adverse event reporting and harms {22} | ADVERSE EVENTS, ADVERSE EVENT, EVENTS | Given the non-invasive nature of the intervention, no new adverse events are expected. Adverse events will be assessed at each study visit and between visits if reported during the study period. Adverse events will be reported according to the standard procedures. The team will review such events and rate them as | PMC10566182 | |
Frequency and plans for auditing trial conduct {23} | The study investigators will submit an annual report to the study sponsor (National Institute of Nursing) including details of enrollment in the past year, progress on the study aims, and any barriers to completing the study. The study progress will be reviewed by NIH via the yearly progress report. The team will also ... | PMC10566182 | ||
Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25} | Plans for protocol modifications will first be approved by the sponsor (NIH). Then, any modifications will be approved by the IRB and updated in ClinicalTrials.gov. Participants will be notified of the protocol changes, if applicable, at their next study visit, where they will complete an updated informed consent form ... | PMC10566182 | ||
Dissemination plans {31a} | The study team will share updates to the participants approximately quarterly and will send a result summary at the end of the study. The results of the study will be presented at international conferences and publications in peer-reviewed journals. The team will work with their institutions and use social media to hig... | PMC10566182 | ||
Discussion | hypertension, insomnia, cardiometabolic disease | HYPERTENSION | This study aims to test the effects of a real-world behavioral sleep extension intervention on sleep and cardiometabolic health among adults with elevated BP/stage I/II hypertension and short sleep duration. Despite the effectiveness of other behavioral sleep medicine treatments, such as cognitive behavioral therapy fo... | PMC10566182 |
Trial status | RECRUITMENT | Protocol ver 1.0 (date 06/28/23).Recruitment began: 3/15/2021.Anticipated recruitment completion date: 1/1/2024. | PMC10566182 | |
Acknowledgements | The authors thank Max Byck for assistance in drafting this manuscript. | PMC10566182 | ||
Authors’ contributions {31b} | TG | All authors have read and approved of this manuscript. KB and JD are co-PI for this study and jointly conceived the study and designed the protocol and study-related processes. KB is the contact PI and is primarily responsible for daily study operations. JD is primarily responsible for the execution of the coaching int... | PMC10566182 | |
Funding {4} | The research reported in this publication was supported (in part or in full) by the National Institute on Nursing and the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number(s) 1R01HL141706-01A1, 3R01NR018891-01A1S1, UL1TR002538, UM1TR004409, 5R01HL139837-04, 5R0... | PMC10566182 | ||
Availability of data and materials {29} | De-identified data and a study codebook will be made available at the end of the study upon request to the contact PI (KB). | PMC10566182 | ||
Declarations | PMC10566182 | |||
Ethics approval and consent to participate {24} | This study was approved by the University of Utah Institutional Review Board (IRB_00130332), and written informed consent will be obtained from all participants. | PMC10566182 | ||
Consent for publication {32} | Not applicable, no identifiable images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. Informed consent materials are attached as supplementary materials. | PMC10566182 |
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