Implementing a mentoring program for clinical research professionals: A novel professional development initiative for university health research staff.

Clinical and translational research relies on a well-trained workforce, but mentorship programs designed expressly for this workforce are lacking. This paper presents the development of a mentoring program for research staff and identifies key programmatic outcomes. Research staff participating in this program were matched with a senior mentor. Focus groups were conducted to identify key program outcomes. Surveys were administered throughout the program period to assess participants' experience, gains in skill, and subsequent careers. Analysis of the resultant qualitative and quantitative data are used to characterize the implementation and impact of the program. A total of 47 mentees and 30 mentors participated in program between 2018 and 2023. A comprehensive logic model of short-, intermediate- and long-term outcomes was developed. Participants reported positive valuations of every programmatic outcome assessed including their program experience, learning and research careers. The pool of available mentors also grew as new mentors were successfully recruited for each cohort. This mentorship program developed and implemented by senior research staff successfully provided junior research staff with professional development support, mentorship, and professional development opportunities. Junior and senior health research staff built mentoring relationships that advanced their clinical and translational research careers.

Identifying Design Opportunities for Adaptive mHealth Interventions That Target General Well-Being: Interview Study With Informal Care Partners.

BACKGROUND: Mobile health (mHealth) interventions can deliver personalized behavioral support to users in daily contexts. These interventions have been increasingly adopted to support individuals who require low-cost and low-burden support. Prior research has demonstrated the feasibility and acceptability of an mHealth intervention app (CareQOL) designed for use with informal care partners. To further optimize the intervention delivery, we need to investigate how care partners, many of whom lack the time for self-care, react and act in response to different behavioral messages. OBJECTIVE: The goal of this study was to understand the factors that impact care partners' decision-making and actions in response to different behavioral messages. Insights from this study will help optimize future tailored and personalized behavioral interventions. METHODS: We conducted semistructured interviews with participants who had recently completed a 3-month randomized controlled feasibility trial of the CareQOL mHealth intervention app. Of the 36 participants from the treatment group of the randomized controlled trial, 23 (64%) participated in these interviews. To prepare for each interview, the team first selected representative behavioral messages (eg, targeting different health dimensions) and presented them to participants during the interview to probe their influence on participants' thoughts and actions. The time of delivery, self-reported perceptions of the day, and user ratings of a message were presented to the participants during the interviews to assist with recall. RESULTS: The interview data showed that after receiving a message, participants took various actions in response to different messages. Participants performed suggested behaviors or adjusted them either immediately or in a delayed manner (eg, sometimes up to a month later). We identified 4 factors that shape the variations in user actions in response to different behavioral messages: uncertainties about the workload required to perform suggested behaviors, concerns about one's ability to routinize suggested behaviors, in-the-moment willingness and ability to plan for suggested behaviors, and overall capability to engage with the intervention. CONCLUSIONS: Our study showed that care partners use mHealth behavioral messages differently regarding the immediacy of actions and the adaptation to suggested behaviors. Multiple factors influence people's perceptions and decisions regarding when and how to take actions. Future systems should consider these factors to tailor behavioral support for individuals and design system features to support the delay or adaptation of the suggested behaviors. The findings also suggest extending the assessment of user adherence by considering the variations in user actions on behavioral support (ie, performing suggested or adjusted behaviors immediately or in a delayed manner). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/32842.

The Dosing of Mobile-Based Just-in-Time Adaptive Self-Management Prompts for Caregivers: Preliminary Findings From a Pilot Microrandomized Study.

BACKGROUND: Caregivers of people with chronic illnesses often face negative stress-related health outcomes and are unavailable for traditional face-to-face interventions due to the intensity and constraints of their caregiver role. Just-in-time adaptive interventions (JITAIs) have emerged as a design framework that is particularly suited for interventional mobile health studies that deliver in-the-moment prompts that aim to promote healthy behavioral and psychological changes while minimizing user burden and expense. While JITAIs have the potential to improve caregivers' health-related quality of life (HRQOL), their effectiveness for caregivers remains poorly understood. OBJECTIVE: The primary objective of this study is to evaluate the dose-response relationship of a fully automated JITAI-based self-management intervention involving personalized mobile app notifications targeted at decreasing the level of caregiver strain, anxiety, and depression. The secondary objective is to investigate whether the effectiveness of this mobile health intervention was moderated by the caregiver group. We also explored whether the effectiveness of this intervention was moderated by (1) previous HRQOL measures, (2) the number of weeks in the study, (3) step count, and (4) minutes of sleep. METHODS: We examined 36 caregivers from 3 disease groups (10 from spinal cord injury, 11 from Huntington disease, and 25 from allogeneic hematopoietic cell transplantation) in the intervention arm of a larger randomized controlled trial (subjects in the other arm received no prompts from the mobile app) designed to examine the acceptability and feasibility of this intensive type of trial design. A series of multivariate linear models implementing a weighted and centered least squares estimator were used to assess the JITAI efficacy and effect. RESULTS: We found preliminary support for a positive dose-response relationship between the number of administered JITAI messages and JITAI efficacy in improving caregiver strain, anxiety, and depression; while most of these associations did not meet conventional levels of significance, there was a significant association between high-frequency JITAI and caregiver strain. Specifically, administering 5-6 messages per week as opposed to no messages resulted in a significant decrease in the HRQOL score of caregiver strain with an estimate of -6.31 (95% CI -11.76 to -0.12; P=.046). In addition, we found that the caregiver groups and the participants' levels of depression in the previous week moderated JITAI efficacy. CONCLUSIONS: This study provides preliminary evidence to support the effectiveness of the self-management JITAI and offers practical guidance for designing future personalized JITAI strategies for diverse caregiver groups. TRIAL REGISTRATION: ClinicalTrials.gov NCT04556591; https://clinicaltrials.gov/ct2/show/NCT04556591.

The reliability and validity of the TBI-CareQOL system in four diverse caregiver groups.

PURPOSE: Establishing the psychometric reliability and validity of new measures is an ongoing process. More work is needed in to confirm the clinical utility of the TBI-CareQOL measurement development system in both an independent cohort of caregivers of traumatic brain injury (TBI), as well as in additional caregiver groups. METHODS: An independent cohort of caregivers of people with TBI (n = 139), as well as three new diverse caregiver cohorts (n = 19 caregivers of persons with spinal cord injury, n = 21 caregivers for persons with Huntington disease, and n = 30 caregivers for persons with cancer), completed 11 TBI-CareQOL measures (caregiver strain; caregiver-specific anxiety; anxiety; depression; anger; self-efficacy; positive affect and well-being; perceived stress; satisfaction with social roles and activities; fatigue; sleep-related impairment), as well as two additional measures to examine convergent and discriminant validity (PROMIS Global Health; the Caregiver Appraisal Scale). RESULTS: Findings support the internal consistency reliability (all alphas > 0.70 with the vast majority being > 0.80 across the different cohorts) of the TBI-CareQOL measures. All measures were free of ceiling effects, and the vast majority were also free of floor effects. Convergent validity was supported by moderate to high correlations between the TBI-CareQOL and related measures, while discriminant validity was supported by low correlations between the TBI-CareQOL measures and unrelated constructs. CONCLUSION: Findings indicate that the TBI-CareQOL measures have clinical utility in caregivers of people with TBI, as well as in other caregiver groups. As such, these measures should be considered as important outcome measures for clinical trials aiming to improve caregiver outcomes.

Development of a New Measure of Housing Security: The REDD-CAT Housing Security Measure.

BACKGROUND: Housing security is a key social determinant of behavior related to health outcomes. OBJECTIVE: The purpose of this study was to develop a new patient-reported outcome measure that evaluates aspects of housing security for use in the Re-Engineered Discharge for Diabetes-Computer Adaptive Test (REDD-CAT) measurement system. DESIGN: Qualitative data, literature reviews, and cross-sectional survey study. PARTICIPANTS: A total of 225 people with T2DM provided responses to the items in this item pool. MAIN MEASURES: A new item pool that evaluates important aspects of housing security was developed using stakeholder data from focus groups of persons with T2DM. KEY RESULTS: For the Housing Affordability scale, factor analysis (both exploratory and confirmatory) supported the retention of six items. Of these items, none exhibited sparse cells or problems with monotonicity; no items were deleted due to low item-adjusted total score correlations. For the six affordability items, a constrained graded response model indicated no items exhibited misfit; thus, all were retained. No items indicated differential item functioning (examined for age, sex, education, race, and socioeconomic status). Thus, the final Affordability item bank comprised six items. A Housing Safety index (three items) and a Home Features index (eight items) were also developed. Reliability (i.e., internal consistency and test-retest reliability) and validity (i.e., convergent, discriminant, and known-groups) of the new measures were also supported. CONCLUSIONS: The REDD-CAT Housing Security Measure provides a reliable and valid assessment of housing affordability, safety, and home features in people with type 2 diabetes mellitus. Future work is needed to establish the clinical utility of this measure in other clinical populations.

A pilot intervention of using a mobile health app (ONC Roadmap) to enhance health-related quality of life in family caregivers of pediatric patients with cancer.

Background: The Roadmap mobile health (mHealth) app was developed to provide health-related quality of life (HRQOL) support for family caregivers of patients with cancer. Methods: Eligibility included: family caregivers (age ≥18 years) who self-reported as the primary caregiver of their pediatric patient with cancer; patients (age ≥5 years) who were receiving cancer care at the University of Michigan. Feasibility was calculated as the percentage of caregivers who logged into ONC Roadmap and engaged with it at least twice weekly for at least 50% of the 120-day study duration. Feasibility and acceptability was also assessed through a Feasibility and Acceptability questionnaire and the Mobile App Rating Scale to specifically assess app-quality. Exploratory analyses were also conducted to assess HRQOL self- or parent proxy assessments and physiological data capture. Results: Between September 2020-September 2021, 100 participants (or 50 caregiver-patient dyads) consented and enrolled in the ONC Roadmap study for 120-days. Feasibility of the study was met, wherein the majority of caregivers (N=32; 65%) logged into ONC Roadmap and engaged with it at least twice weekly for at least 50% of the study duration (defined a priori in the Protocol). The Feasibility and Acceptability questionnaire responses indicated that the study was feasible and acceptable with the majority (>50%) reporting Agree or Strongly Agree with positive Net Favorability [(Agree + Strongly Agree) - (Disagree + Totally Disagree)] in each of the domains (e.g., Fitbit use, ONC Roadmap use, completing longitudinal assessments, engaging in similar future study, study expectations). Improvements were seen across the majority of the mental HRQOL domains across all groups; even though underpowered, there were significant improvements in caregiver-specific aspects of HRQOL and anxiety and in depression and fatigue for children (ages 8-17 years), and a trend toward improvement in depression for children ages 8-17 years and in fatigue for adult patients. Conclusions: This study supports that mHealth technology may be a promising platform to provide HRQOL support for caregivers of pediatric patients with cancer. Importantly, the findings suggest that the study protocol was feasible, and participants were favorable to participate in future studies of this intervention alongside routine cancer care delivery.

Development and calibration data for the Illness Burden item bank: a new computer adaptive test for persons with type 2 diabetes mellitus.

PURPOSE: The purpose of this study was to develop a new measure, the Re-Engineered Discharge for Diabetes Computer Adaptive Test (REDD-CAT) Illness Burden item bank, to evaluate the impact that a chronic condition has on independent living, the ability to work (including working at home), social activities, and relationships. METHODS: Semi-structured interviews were used to inform the development of an item pool (47 items) that captured patients' beliefs about how a diagnosis of type 2 diabetes interferes with different aspects of their lives. The Illness Burden item bank was developed and tested in 225 people with type 2 diabetes mellitus. RESULTS: No items had sparse response option cells or problems with monotonicity; two items were deleted due to low item-rest correlations. Factor analyses supported the retention of 29 items. With those 29 remaining items, a constrained (common slope) graded response model fit assessment indicated that two items had misfit; they were excluded. No items displayed differential item functioning by age, sex, education, or socio-economic status. The final item bank is comprised of 27 items. Preliminary data supported the reliability (internal consistency and test-retest reliability) and validity (convergent, discriminant, and known-groups) of the new bank. CONCLUSION: The Illness Burden item bank can be administered as a computer adaptive test or a 6-item short form. This new measure captures patients' perceptions of the impact that having type 2 diabetes has on their daily lives; it can be used in conjunction with the REDD-CAT measurement system to evaluate important social determinants of health in persons with type 2 diabetes mellitus.

Development and calibration data for the Medication Adherence Item Bank: a new computer adaptive test for persons with type 2 diabetes mellitus.

PURPOSE: To develop a new computer adaptive test that evaluates important aspects of medication adherence for persons with type 2 diabetes mellitus. METHODS: Two hundred and twenty-five people with type 2 diabetes mellitus completed 41 items related to medication adherence. RESULTS: Exploratory analysis supported the essential unidimensionality of the initial item pool. Five items were deleted due to low item-adjusted total score correlations (resulting in 36 items). Confirmatory factor analysis supported the retention of 27 items. A graded response model identified no items for exclusion, based on misfit. No items were flagged for meaningful differential item functioning (DIF). The final item bank is comprised of 27 items; an associated 6-item short form was constructed that balanced both psychometric factors (e.g., item information values) and clinical input. Initial analysis of the simulated CAT and static short form supported both the reliability (i.e., internal consistency and test-retest reliability) and validity (i.e., convergent, discriminant, and known groups) of both administration formats. CONCLUSIONS: The new medication adherence item bank provides a reliable and valid assessment of the ability to take medications accurately among people with T2DM; it will be available in early 2023 through healthmeasures.net.

Initial Evidence for Reliable and Valid Use of Scores on the 8-Item Econ-QOL Short Form to Measure Economic Quality of Life in Caregivers of Persons With Traumatic Brain Injury.

OBJECTIVE: To provide reliability and validity data to support the clinical utility of Economic Quality of Life Measure (Econ-QOL) scores in caregivers of civilians and service members/veterans with traumatic brain injury (TBI). DESIGN: Cross-sectional survey study. SETTING: Three academic medical centers and a Veterans Affairs treatment facility. PARTICIPANTS: 376 caregivers of civilians (n=213) and service members/veterans (n=163) with TBI (N=376). INTERVENTIONS: N/A. MAIN OUTCOME MEASURES: Econ-QOL and several patient-reported outcome measures (Traumatic Brain Injury Caregiver Quality of Life Caregiver-Specific Anxiety and Caregiver Strain, Patient-Reported Outcomes Measurement Information System sleep-related impairment, Neurological Quality of Life Measurement System positive affect and well-being) and measures of financial status (self-reported income). RESULTS: Internal consistency reliability of the Econ-QOL Short Form scores were excellent (all Cronbach's alphas ≥.92). There were no floor or ceiling effects for scores. There was evidence of convergent and discriminant validity, with the Econ-QOL scores having the strongest relationships with self-reported income (convergent validity evidence) and weak relationships with the other measures (discriminant validity evidence). Individuals with scores that were "below or possibly below" the poverty line (according to 2016 federal government poverty level thresholds) reported worse economic quality of life relative to those individuals who were definitely above the poverty line, supporting known-groups validity. CONCLUSIONS: This article establishes the clinical utility of scores on the Econ-QOL Short Form in caregivers of persons with TBI and provides evidence that it is valid and appropriate to use such scores not only in a variety of different disability populations (eg, spinal cord injury, stroke) but also in caregivers.

Development and calibration data for the Healthcare Access Item Bank: a new computer adaptive test for persons with type 2 diabetes mellitus.

PURPOSE: The purpose of this study was to develop a new measure to evaluate the ability to receive medical services when needed among persons with type 2 diabetes mellitus. METHODS: The Healthcare Access measure was developed using data from 225 persons with type 2 diabetes mellitus who completed an item pool comprised of 54 questions pertaining to their experience accessing healthcare services. RESULTS: Exploratory and confirmatory factor analyses supported the retention of 45 items. In addition, a constrained graded response model (GRM), as well as analyses that examined item misfit and differential item functioning (investigated for age, sex, education, race, and socioeconomic status), supported the retention of 44 items in the final item bank. Expert review and GRM item calibration products were used to inform the selection of a 6-item static short form and to program the Healthcare Access computer adaptive test (CAT). Preliminary data supported the reliability (i.e., internal consistency and test-retest reliability) and validity (i.e., convergent, discriminant, and known-groups) of the new measure. CONCLUSIONS: The new Healthcare Access item bank can be used to examine the experiences that persons with type 2 diabetes mellitus have with healthcare access, to better target treatment improvements and mitigate disparities; it will be available as a part of the Neuro-Qol measurement system through healthmeasures.net and the PROMIS Application Programmable Interface (API) in early 2023.

An app-based just-in-time-adaptive self-management intervention for care partners: The CareQOL feasibility pilot study.

PURPOSE/OBJECTIVE: The primary objective of this study was to establish the feasibility and acceptability of an intensive data collection protocol that involves the delivery of a personalized just-in-time adaptive intervention (JITAI) in three distinct groups of care partners (care partners of persons with spinal cord injury [SCI], Huntington's disease [HD], or hematopoietic cell transplantation [HCT]). RESEARCH METHOD/DESIGN: Seventy care partners were enrolled in this study (n = 19 SCI; n = 21 HD, n = 30 HCT). This three-month (90 day) randomized control trial involved wearing a Fitbit to track sleep and steps, providing daily reports of health-related quality of life (HRQOL), and completing end of month HRQOL surveys. Care partners in the JITAI group also received personalized pushes (i.e., text-based phone notifications that include brief tips or suggestions for improving self-care). At the end of three-months, care partners in both groups completed a feasibility and acceptability questionnaire. RESULTS: Most (98.6%) care partners completed the study, average compliance was 88% for daily HRQOL surveys, 96% for daily steps, and 85% for daily sleep (from wearing the Fitbit), and all monthly surveys were completed with the exception of one missed 3-month assessment. The acceptability of the protocol was high; ratings exceeded 80% agreement for the different elements of the study. Improvements were seen for the majority of the HRQOL measures. There was no evidence of measurement reactivity. CONCLUSIONS/IMPLICATIONS: Findings provide strong support for the acceptability and feasibility of an intensive data collection protocol that involved the administration of a JITAI. Although this trial was not powered to establish efficacy, findings indicated improvements across a variety of different HRQOL measures (~1/3 of which were statistically significant). (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Improving outcomes for care partners of persons with traumatic brain injury: Protocol for a randomized control trial of a just-in-time-adaptive self-management intervention.

Informal family care partners of persons with traumatic brain injury (TBI) often experience intense stress resulting from their caregiver role. As such, there is a need for low burden, and easy to engage in interventions to improve health-related quality of life (HRQOL) for these care partners. This study is designed to evaluate the effectiveness of a personalized just-in-time adaptive intervention (JITAI) aimed at improving the HRQOL of care partners. Participants are randomized either to a control group, where they wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback), or the JITAI group, where they wear the Fitbit®, provide daily reports of HRQOL and receive personalized self-management pushes for 6 months. 240 participants will be enrolled (n = 120 control group; n = 120 JITAI group). Outcomes are collected at baseline, 1-, 2-, 3-, 4-, 5- & 6-months, as well as 3- and 6-months post intervention. We hypothesize that the care partners who receive the intervention (JITAI group) will show improvements in caregiver strain (primary outcome) and mental health (depression and anxiety) after the 6-month (180 day) home monitoring period. Participant recruitment for this study started in November 2020. Data collection efforts should be completed by spring 2025; results are expected by winter 2025. At the conclusion of this randomized control trial, we will be able to identify care partners at greatest risk for negative physical and mental health outcomes, and will have demonstrated the efficacy of this JITAI intervention to improve HRQOL for these care partners. Trial registration: ClinicalTrial.gov NCT04570930; https://clinicaltrials.gov/ct2/show/NCT04570930.

The association between sleep and cognitive function in people with spinal cord injury (SCI).

PURPOSE/OBJECTIVE: While there is evidence in other clinical groups to suggest that sleep problems can negatively impact cognitive performance, this relationship has not yet been examined in people with spinal cord injury (SCI). Thus, we sought to examine the association between sleep and cognitive function in people with SCI. RESEARCH METHOD/DESIGN: Over the course of 7 days, 167 individuals with SCI completed daily subjective ratings of sleep (sleep quality, number of hours slept per night, and bedtime variability) and wore a wrist-worn device that continuously monitored autonomic nervous system (ANS) activity (i.e., blood volume pulse [BVP] signal and electrodermal activity [EDA] signal). At the end of this home monitoring period, participants completed a subjective rating of cognition and six objective cognitive tests. A series of multivariable linear regressions were used to examine associations between eight measures of sleep/ANS activity during sleep and eight cognitive variables. RESULTS: Subjective ratings of sleep were not related to either objective cognitive performance or self-reported cognitive function. However, there were some relationships between ANS activity during sleep and objective cognitive performance: lower BVP signal was associated with poorer performance on measures of processing speed, working memory, learning and long-term memory, and EDA signals were associated with poorer performance on a measure of executive function. CONCLUSIONS/IMPLICATIONS: Future work is needed to better understand the relationship of sleep, especially sleep physiology, and cognitive functioning for individuals with SCI, and how that may be similar or different to relationships in the general population. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Daily Variation in Sleep Quality is Associated With Health-Related Quality of Life in People With Spinal Cord Injury.

OBJECTIVE: Although sleep difficulties are common after spinal cord injury (SCI), little is known about how day-to-day fluctuations in sleep quality affects health-related quality of life (HRQOL) among these individuals. We examined the effect of sleep quality on same-day HRQOL using ecological momentary assessment methods over a 7-day period. DESIGN: Repeated-measures study involving 7 days of home monitoring; participants completed HRQOL measures each night and ecological momentary assessment ratings 3 times throughout the day; multilevel models were used to analyze data. SETTING: Two academic medical centers. PARTICIPANTS: A total of 170 individuals with SCI (N=170). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Daily sleep quality was rated on a scale of 0 (worst) to 10 (best) each morning. Participants completed end-of-day diaries each night that included several HRQOL measures (Sleep Disturbance, Sleep-related Impairment, Fatigue, Cognitive Abilities, Pain Intensity, Pain Interference, Ability to Participate in Social Roles and Activities, Depression, Anxiety) and ecological momentary assessment ratings of HRQOL (pain, fatigue, subjective thinking) 3 times throughout each day. RESULTS: Multilevel models indicated that fluctuations in sleep quality (as determined by end-of-day ratings) were significantly related to next-day ratings of HRQOL; sleep quality was related to other reports of sleep (Sleep Disturbance; Sleep-related Impairment; Fatigue) but not to other aspects of HRQOL. For ecological momentary assessment ratings, nights of poor sleep were related to worse pain, fatigue, and thinking. Generally, sleep quality showed consistent associations with fatigue and thinking across the day, but the association between sleep quality and these ecological momentary assessment ratings weakened over the course of the day. CONCLUSIONS: Findings highlight the important association between sleep and HRQOL for people with SCI. Future work targeting sleep quality improvement may have positive downstream effects for improving HRQOL in people with SCI.

An App-Based Just-in-Time Adaptive Self-management Intervention for Care Partners (CareQOL): Protocol for a Pilot Trial.

BACKGROUND: Care partners (ie, informal family caregivers) of individuals with health problems face considerable physical and emotional stress, often with a substantial negative impact on the health-related quality of life (HRQOL) of both care partners and care recipients. Given that these individuals are often overwhelmed by their caregiving responsibilities, low-burden self-management interventions are needed to support care partners to ensure better patient outcomes. OBJECTIVE: The primary objective of this study is to describe an intensive data collection protocol that involves the delivery of a personalized just-in-time adaptive intervention that incorporates passive mobile sensor data feedback (sleep and activity data from a Fitbit [Fitbit LLC]) and real time self-reporting of HRQOL via a study-specific app called CareQOL (University of Michigan) to provide personalized feedback via app alerts. METHODS: Participants from 3 diverse care partner groups will be enrolled (care partners of persons with spinal cord injury, care partners of persons with Huntington disease, and care partners of persons with hematopoietic cell transplantation). Participants will be randomized to either a control group, where they will wear the Fitbit and provide daily reports of HRQOL over a 3-month (ie, 90 days) period (without personalized feedback), or the just-in-time adaptive intervention group, where they will wear the Fitbit, provide daily reports of HRQOL, and receive personalized push notifications for 3 months. At the end of the study, participants will complete a feasibility and acceptability questionnaire, and metrics regarding adherence and attrition will be calculated. RESULTS: This trial opened for recruitment in November 2020. Data collection was completed in June 2021, and the primary results are expected to be published in 2022. CONCLUSIONS: This trial will determine the feasibility and acceptability of an intensive app-based intervention in 3 distinct care partner groups: care partners for persons with a chronic condition that was caused by a traumatic event (ie, spinal cord injury); care partners for persons with a progressive, fatal neurodegenerative disease (ie, Huntington disease); and care partners for persons with episodic cancer conditions that require intense, prolonged inpatient and outpatient treatment (persons with hematopoietic cell transplantation). TRIAL REGISTRATION: ClinicalTrials.gov NCT04556591; https://clinicaltrials.gov/ct2/show/NCT04556591. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32842.

Association of physical and mental symptoms with cognition in people with spinal cord injury.

PURPOSE/OBJECTIVE: To examine the association between physical and mental symptoms and cognition in people with spinal cord injury. Research Method/Design: One hundred seventy-four community-dwelling adults with spinal cord injury completed several self-reported measures of health-related quality of life (Patient-Reported Outcomes Measurement Information System [PROMIS] Cognitive Abilities, Anxiety, Depression, Fatigue, and Pain Intensity) as well as a traditional neuropsychological assessment (six tests that included assessments of processing speed, working memory, memory, executive function, and attention). A series of multivariable linear regressions were used to test for associations between physical and mental symptoms and the seven ratings of cognition (i.e., scores on PROMIS Cognitive Abilities, as well as the six scores from the neuropsychological tests) after controlling for age, gender, education, and injury classification. RESULTS: There was generally no association between symptom measures and neuropsychological test performance with one exception: Greater pain was associated with poorer performance on attention. However, anxiety and fatigue were associated with lower self-perceived cognitive function. Among those individuals with evidence of cognitive impairment in at least one cognitive domain, anxiety was also associated with lower working memory score, and fatigue was associated with lower delayed memory performance. CONCLUSIONS/IMPLICATIONS: While the associations between pain and cognitive performance are consistent with general literature, the absence of a relationship between other symptoms (i.e., depression and fatigue) and cognitive performance was somewhat more surprising. Similarly, the associations between anxiety and fatigue with perceived cognitive function are consistent with the general literature, yet the absence of a relationship with depression was somewhat more surprising. Future work is needed to replicate these findings. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

The association between medication use and cognitive performance in people with SCI.

PURPOSE/OBJECTIVE: Polypharmacy is common in people with spinal cord injury (SCI). Given the high rates of medication use, and the complicated side effect profile of many of the medications that are regularly prescribed in people with SCI, we were interested in the association between the use of different classes of medications and cognitive function in these individuals. Research Method/Design: One-hundred and 73 people with SCI participated in an observational study. Self-reported medications were provided by participants. Participants also completed several cognitive tests designed to capture multiple aspects of cognition (processing speed, attention, working memory, learning, free-recall memory, delayed free recall memory, executive function), as well as a self-report measure that captures participant perceptions of cognitive function. A series of multivariable linear regressions were used to test for associations between medications and the seven measures of cognition. RESULTS: In general, there was not a robust relationship between medication use and cognitive function; the sole exception was an association between opioid use and subjective cognitive function. There was some preliminary support for an association between medication use, especially benzodiazepine and opioid analgesic use, and poorer cognitive performance. Specifically: Opioid analgesic use was associated with slowed processing speed, worse attention, poorer working memory, poorer executive function and more subjective cognitive complaints; benzodiazepine use was associated with slower processing speed, poorer working memory, and worse executive function; anticonvulsant use was related to worse delayed free recall memory; and the number of medication categories a person with SCI was taking was related to slower processing speed, and worse subjective cognitive function. Antidepressant, cannabis, skeletal muscle relaxant, sedative and stimulant use were not significantly related to cognitive performance, nor to subjective reports of cognitive function. CONCLUSIONS/IMPLICATIONS: Findings did not support a strong relationship between medication use and cognitive function in people with SCI. There is some preliminary support for an association between benzodiazepine use and cognitive performance, but this needs to be confirmed in future research. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Health-Related Quality of Life in Focal Segmental Glomerular Sclerosis and Minimal Change Disease: A Qualitative Study of Children and Adults to Inform Patient-Reported Outcomes.

RATIONALE & OBJECTIVE: Assessment of how patients feel and function is needed for clinical care and research for focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD). The objective of this study was to develop a patient-reported outcome assessment appropriate for use in children and adults with FSGS and MCD. STUDY DESIGN: Qualitative study using semi-structured interviews. SETTING & PARTICIPANTS: 48 semi-structured interviews with children aged 8 to 17 years (n = 11) and adults (n = 10) with FSGS and children aged 8 to 17 (n = 11) and adults (n = 16) with MCD recruited from 3 academic medical centers. ANALYTICAL APPROACH: Latent content analysis. RESULTS: FSGS and MCD have a pervasive and comparable impact on physical, social, and mental health-related quality of life regardless of age or diagnosis. Physical symptoms of swelling, fatigue, and pain were articulated by most participants. Disease management was also a frequent topic of discussion; participants described their experiences with medication and associated side effects, as well as lifestyle changes made to manage their disease (ie, dietary changes and frequent medical appointments). These discussions often identified a profound impact on physical abilities and life participation. In many instances, participants described the negative impact these symptoms had on their mood and sense of self, with most participants reporting feelings of anxiety. LIMITATIONS: Participants were primarily non-Hispanic White and English speaking, which may limit generalizability. CONCLUSIONS: Our results suggest that there are commonalities to the FSGS-MCD patient experience of health-related quality of life that will enable the generation of a disease-specific FSGS-MCD patient-reported outcomes instrument for use in children and adults. The development of this tool is intended to facilitate better care and support clinical research for these individuals.

Understanding speech and swallowing difficulties in individuals with Huntington disease: Validation of the HDQLIFE Speech Difficulties and Swallowing Difficulties Item Banks.

PURPOSE: As Huntington disease (HD) progresses, speech and swallowing difficulties become more profound. These difficulties have an adverse effect on health-related quality of life (HRQOL), thus psychometrically robust measures of speech and swallowing are needed to better understand the impact of these domains across the course of the disease. Therefore, the purpose of this study is to establish the clinical utility of two new patient-reported outcome measures (PROs), HDQLIFE Speech Difficulties and HDQLIFE Swallowing Difficulties. METHODS: Thirty-one participants with premanifest or manifest HD, and 31 age- and sex-matched healthy control participants were recruited for this study. Participants completed several PROs [HDQLIFE Speech Difficulties, HDQLIFE Swallowing Difficulties, Communication Participation Item Bank (CPIB)], as well as several clinician-rated assessments of speech and functioning. A computational algorithm designed to detect features of spoken discourse was also examined. Analyses were focused on establishing the reliability and validity of these new measures. RESULTS: Internal consistency was good for Swallowing (Cronbach's alpha = 0.89) and excellent for Speech and the CPIB (both Cronbach's alpha ≥ 0.94), and convergent/discriminant validity was supported. Known groups validity for the PROs was supported by significant group differences among control participants and persons with different stages of HD (all p < 0.0001). All PROs were able to distinguish those with and without clinician-rated dysarthria (likelihood ratios far exceeded the threshold for clinical decision making [all ≥ 3.28]). CONCLUSIONS: Findings support the clinical utility of the HDQLIFE Speech and Swallowing PROs and the CPIB for use across the HD disease spectrum. These PROs also have the potential to be clinically useful in other populations.

Responsiveness to change over time and test-retest reliability of the PROMIS and Neuro-QoL mental health measures in persons with Huntington disease (HD).

BACKGROUND: The majority of persons with Huntington disease (HD) experience mental health symptoms. Patient-reported outcome (PRO) measures are capable of capturing unobservable behaviors and feelings relating to mental health. The current study aimed to test the reliability and responsiveness to self-reported and clinician-rated change over time of Neuro-QoL and PROMIS mental health PROs over the course of a 24-month period. METHODS: At baseline, 12-months, and 24-months, 362 participants with premanifest or manifest HD completed the Neuro-QoL Depression computer adaptive test (CAT), PROMIS Depression short form (SF), Neuro-QoL Anxiety CAT, PROMIS Anxiety SF, PROMIS Anger CAT and SF, Neuro-QoL Emotional/Behavioral Dyscontrol CAT and SF, Neuro-QoL Positive Affect and Well-Being CAT and SF, and Neuro-QoL Stigma CAT and SF. Participants completed several clinician-administered measures at each time point, as well as several global ratings of change at 12- and 24-months. Reliability (test-retest reliability and measurement error) and responsiveness (using standardized response means and general linear models) were assessed. RESULTS: Test-retest reliability and measurement error were excellent for all PROs (all ICC ≥ .90 for test-retest reliability and all SEM percentages ≤ 6.82%). In addition, 12- and 24-month responsiveness were generally supported for the Neuro-QoL and PROMIS mental health PROs; findings relative to clinician-rated anchors of change (e.g., SRMs for the group with declines ranged from .38 to .91 for 24-month change and .09 to .45, with the majority above .25 for 12-month change) were generally more robust than those relative to self-reported anchors of change (e.g., SRMs for the group with declines ranged from .02 to .75, with the majority above .39 for 24-month change and .09 to .45, with the majority above .16 for 12-month change). CONCLUSIONS: The Neuro-QoL and PROMIS mental health PROs demonstrated strong psychometric reliability, as well as responsiveness to self-reported and clinician-rated change over time in people with HD.