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Financial hardship (including financial stress, financial strain, asset depletion, and financial toxicity) is a highly relevant construct among the 6.9 million people living with Alzheimer's disease and related dementias (ADRD) in the United States and their family networks. This scoping review will identify existing measures and approaches for capturing financial strain among these families. This scoping review will be reported in accordance with PRISMA-ScR guidelines. Searches will be conducted in Embase (Embase.com), Medline (Ovid), CINAHLComplete (EbscoHost), AgeLine (EbscoHost), APA PsycInfo (EbscoHost), Scopus, and Web of Science Core Collection databases to identify tools, measures, or approaches for measuring self-reported financial hardship among family members of people living with ADRD. Data elements from both the National Health and Aging Trends Study and the associated National Study of Caregiving will also be considered. Two independent raters will screen the search results and discrepancies with be resolved by a third rater. Extraction will include the use of artificial intelligence-based software and verification by an independent human rater; any changes that are made to the AI-generated extraction will be reviewed by a second independent rater. A frequency analysis will be conducted to analyze the data, and a summary of the psychometric properties of each of the identified measures will be presented. The findings from this review will be disseminated through peer-reviewed publications and conference presentations. Ultimately, this work will inform the development of a new patient-reported outcome measurement system designed to provide a comprehensive assessment of the different aspects of financial hardship for families of people living with ADRD. In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P), the following protocol was registered via https://osf.io on March 14, 2025 (registration DOI: https://doi.org/10.17605/OSF.IO/J26KT).

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 .

IntroductionDementia caregiving is typically provided through a network of multiple individuals, particularly in diverse populations. Although family members of people living with Alzheimer’s disease and Alzheimer’s disease-related dementias, especially spouses and adult children, often assume the role of informal care partner, there is a growing number of non-traditional informal care partners (ie, non-spousal, non-biological child) given societal changes in family structure. The proposed study aims to systematically review the caregiver literature to better understand how caregivers are defined, the approaches and tools commonly used to evaluate the caregiver network and common caregiver outcome assessments that are used in clinical and research settings.Methods and analysisThe following protocol will be conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Searches will be developed by health science library informationists for Medline (Ovid), Cumulative Index to Nursing and Allied Health Literature Complete (EBSCOhost), AgeLine (EBSCOhost) and APA PsycInfo (EBSCOhost) databases to identify tools, measures or approaches to the characterisation of complex caregiver networks that include non-traditional care partners (ie, step-family and non-marital romantic partners, blended families, families of origin, families of choice and family friends). In addition, we will also consider data elements from large-scale cohorts that include caregiver respondents (eg, National Health and Ageing Trends Study; National Study of Caregiving). There will be no limits set on article language, geography or publication date. Articles that are identified in languages other than English will be included if there is an English translation available. Search results will be reviewed by two independent raters for inclusion; in cases where there are discrepancies in inclusion/exclusion recommendations, the two reviewers will meet to establish consensus; a third reviewer will adjudicate when necessary. An artificial-intelligence-based software will be used to aid in extraction; these results will be double-checked by a human, and instances of discrepancies will be reviewed by a second independent rater. A narrative synthesis approach will be used to analyse the data.Ethics and disseminationInformation from this review will be published in peer-reviewed journals and presented at scientific conferences, with the goal of providing future recommendations for how to define a non-traditional caregiver, the systematic assessment of caregiver networks and a summary of the most commonly used outcome measures in the caregiver literature. Given that scoping reviews of published articles are not regulated under federal regulations governing human subject research (45 CFR 46 or 21 CFR 50/56), institutional review board approval is not required.Scoping review registrationIn accordance with the Preferred Reporting Items for Scoping Review and Meta-analysis Protocols, the following protocol has been registered via https://osf.io on 19 December 2023 (registration DOI: https://doi.org/10.17605/OSF.IO/2XGSR).

Importance Although pathological demand avoidance (PDA; also known as “extreme” or “persistent” demand avoidance and persistent drive for autonomy) was first described in 1980 as a distinct behavioral profile among a subgroup of children with autism spectrum disorder, there is limited scientific evidence to support children with PDA or their parents/guardians. Objective To establish the feasibility and acceptability of the Paradigm Shift Program®, a 12‐week educational and training program for parents and guardians of children with PDA. Methods Seventy‐six parents/guardians of children with PDA were enrolled in the study. Prior to the start of the program, the parents/guardians completed a baseline assessment (demographic questions, program expectations, and several patient‐reported outcomes [PROs] and proxy measures). At the end of the program, parents/guardians repeated the PROs and proxy measures, and completed a feasibility and acceptability questionnaire and anchor items. Results A total of 71 parents/guardians completed the pre‐program assessment, and 60 (85%) completed the end‐of‐program assessment. Among those with both assessments, program acceptability was high, and parents/guardians were generally satisfied with the different program elements (level of agreement >70% for agreed or strongly agreed). Parents/guardians reported significant improvement in health‐related quality of life (HRQOL) in 10 of the 13 PROs (all P < 0.05). Parent/guardian proxy reports also indicated significant improvements in demand characteristics (P < 0.05), as well as a trend for significant improvement in conduct problems (P = 0.08), total difficulties (P = 0.05), and externalizing behavior (P = 0.05), in their child with PDA. Interpretation The paradigm shift program was both feasible and acceptable. Furthermore, there was evidence that this program improved the HRQOL of parents/guardians as well as the behavior of children with PDA. The Paradigm Shift Program, a comprehensive training program for parents of neurodivergent children with pathological demand avoidance (PDA), was feasible and acceptable, and there were significant improvements in parents’ well‐being following program completion. As the first examination of a parent‐focused intervention for PDA, results suggest a promising alternative to traditional programs.

Compliance rates for mobile health (mHealth) studies that involve intensive study designs are highly variable. Both person- and study-specific factors likely contribute to this variability. We were interested in understanding the impact that care partner characteristics and demographics have on study engagement, given that engagement is critical to the success of mHealth interventions. The primary objective of this report was to analyze the overall and component-specific completion and compliance rates for an intensive 6-month mHealth intervention (CareQOL app) designed to promote self-awareness and self-care among care partners of individuals with traumatic brain injury. This randomized controlled trial was designed to test the CareQOL app, an mHealth app designed to promote care partner self-awareness (through self-monitoring) and self-care (through personalized self-care push notifications). The study design consisted of a baseline assessment, a 6-month home-monitoring period that included 3 daily ecological momentary assessment (EMA) questions, monthly patient-reported outcome (PRO) surveys, continuous activity and sleep monitoring using a Fitbit, and 2 follow-up PRO surveys at 3 and 6 months posthome monitoring. Three participants withdrew prior to the initiation of the home-monitoring period, resulting in a final analytical sample size of 254. All participants had access to a self-monitoring dashboard (CareQOL app) that included graphical displays of the daily survey scores, as well as daily steps and sleep data from the Fitbit. Overall compliance for the different aspects of the study was high. On average, the full-sample daily EMA PRO completion rate was 84% (SD 19%), Fitbit-based step count compliance was 90% (SD 21%), and Fitbit-based sleep duration compliance was 75% (SD 32%); there was no difference between the study arms for daily EMA PROs and Fitbit compliance rates. Completion rates for monthly and follow-up PRO surveys were even higher, with average end-of-month completion rates ranging from 97% to 100%, and follow-up completion rates of 95% for both time points. Again, these rates did not differ by study arm. The data were represented by 3 engagement groups: high-compliance-all data; high-compliance-PROs and steps only; and moderate PRO compliance-low Fitbit compliance. Group membership was predicted by both race (P<.001) and relationship to the care recipient (P=.001), but not by the other person-specific variables. The compliance rates for this intensive study design are consistent, but at the high end, with what has been reported previously in the literature for studies with shorter time durations. Except for race and relationship to the care recipient, person-specific factors did not appear to be significantly associated with the engagement group. As such, we anticipate that the high compliance rates observed in this study are likely due to several study-specific design elements that were used to encourage study engagement.

Objectives/Goals: To support the growing number of clinical research professionals (CRP) working in behavioral and social science contexts, relevant formative assessments of research skills are needed. This study examines the development of an objective formative assessment designed to assess skills relevant to conducting social and behavioral research. Methods/Study Population: A multidisciplinary group at the University of Michigan was convened to develop the assessment. Case studies depicting clinical and translational research conducted in behavioral and social science contexts were used to measure proficiency in seven of the eight ECRPTQ competencies: Scientific Concepts & Research Design, Ethical & Participant Safety Concerns, Clinical Trial Operations (Good Clinical Practice), Study & Site Management, Data Management & Informatics, Leadership & Professionalism, Communication, and Teamwork & Team Science. Three difficulty levels of questions were developed: basic, intermediate, and advanced. To reinforce knowledge and skill development, the assessment was designed to give respondents formative feedback after responding to each question. Results/Anticipated Results: A preliminary “pre-pilot” test was conducted with three postdoctoral scholars to ensure that the assessment items were understandable. The assessment was then pilot tested with a larger group of 40 clinical research professionals (CRP) to test for the clarity and difficulty level of the items. A smaller group of 20 of these CRPs agreed to participate in focus groups to obtain feedback on their user experience. Data regarding years of experience as a CRP, types of studies engaged with, and information regarding professional certification were collected and used in the analyses. Demographic data collected were not connected to user responses. Results of the pilot test and focus groups were used to revise the questions on the final version of the assessment. Discussion/Significance of Impact: To our knowledge, this is the first objective assessment of research skills for CRP working in behavioral and social science contexts. We will discuss how other institutions can use this instrument to evaluate the training needs of their social and behavioral research workforce.

The management of type 2 diabetes mellitus (T2DM) includes mastery of complex care activities, self-management skills, and routine health care encounters to optimize glucose control and achieve good health. Given the lifelong course of T2DM, patients are faced with navigating complex medical and disease-specific information. This health-seeking behavior is a driver of health disparities and is associated with hospitalization and readmission. Given that health-seeking behavior is a potentially intervenable social determinant of health, a better understanding of how people navigate these complex systems is warranted. To address this need, we aimed to develop new patient-reported outcome (PRO) measures that evaluate health-seeking behavior in persons with T2DM. These new PROs were designed to be included in the Re-Engineered Discharge for Diabetes-Computer Adaptive Test (REDD-CAT) measurement system, which includes several other PROs that capture the importance of social determinants of health. Overall, 225 participants with T2DM completed 56 self-report items that examined health-seeking behaviors. Classical Test Theory and Item Response Theory were used for measurement development. Exploratory factor analysis (EFA; criterion ratio of eigenvalue 1 to eigenvalue 2 being >4; variance for eigenvalue 1 ≥40%) and confirmatory factor analysis (CFA; criterion 1-factor CFA loading <.50; 1-factor CFA residual correlation >.20; comparative fit index ≥0.90; Tucker-Lewis index ≥0.90; root mean square error of approximation <0.15) were used to determine unidimensional sets of items. Items with sparse responses, low-adjusted total score correlations, nonmonotonicity, low factor loading, and high residual correlations of high error modification indices were candidates for exclusion. A constrained graded response model was used to examine item misfit, and differential item functioning was examined to identify item bias. Cronbach α was used to examine internal consistency reliability for the new PROs (criterion ≥0.70), and floor and ceiling effects were examined (criterion ≤20%). Four unidimensional sets of items were supported by EFA (all EFA eigenvalue ratios >4; variance for eigenvalue 1=41.4%-67.3%) and CFA (fit statistics all exceeded criterion values). This included (1) \"Health-Seeking Behavior: PCP-Specific\" (6 items); (2) \"Health-Seeking Behavior: General Beliefs\" (13 items); (3) \"Health-Seeking Behavior: Family or Friends-Specific\" (5 items); and (4) \"Health-Seeking Behavior: Internet-Specific\" (4 items). All items were devoid of differential item functioning for age, sex, education, or socioeconomic status factors. \"Health-Seeking Behavior: General Beliefs\" was developed to include both a computer adaptive test and a 6-item short form version; all other PROs were developed as static short forms. The psychometric reliability of these new PROs was supported; internal consistency ranged from acceptable to excellent (Cronbach α=.78-.91), and measures were free of significant floor or ceiling effects (floor effects range: 0%-8.9%; ceiling effects range: 0%-8.4%). The new REDD-CAT Health-Seeking Behavior PROs provide reliable assessments of health-seeking behaviors among those with T2DM.

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. 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. 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. 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. 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. ClinicalTrials.gov NCT04556591; https://clinicaltrials.gov/ct2/show/NCT04556591.

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. Plain English summary As the complexities of disease management and care needs grow, so does the need for informal caregivers. Providing care for a family member or friend with a significant health condition can have a deleterious impact on caregiver health-related quality of life (HRQOL), as well as the HRQOL of the care recipient. Reliable and valid measures of HRQOL can help us to better understand the treatment needs of these caregiver populations.

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. 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. 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. 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. 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). ClinicalTrials.gov NCT04556591; https://clinicaltrials.gov/ct2/show/NCT04556591. DERR1-10.2196/32842.