Theoretically Based Factors Associated With Stroke Family Caregiver Health.

PURPOSE: Most persons who have had strokes are cared for at home by family members-many of whom experience depressive symptoms and quality of life changes as a result of providing care. The objective of this study is to determine theoretically based factors associated with unhealthy days in stroke family caregivers. RESEARCH DESIGN AND METHODS: Secondary data analysis was conducted using baseline data from a large randomized controlled clinical trial testing the Telephone Assessment and Skill-Building Kit program with 254 family caregivers of persons who have had strokes. Guided by a conceptual model derived from Lazarus' transactional approach to stress, data were analyzed using multiple regression with unhealthy days as the dependent variable and theoretically based factors as independent variables. RESULTS: Caregivers were mostly female (78%), White (71%), spouses (47%), or adult children (29%). Caregivers reported nine unhealthy days on average within the past month. A total of 37.8% of the variance in unhealthy days was explained by caregiver task difficulty, level of optimism, threat appraisal, depressive symptoms, and life changes with depressive symptoms being the strongest individual predictor because of shared variance. CLINICAL RELEVANCE: Unhealthy days is an important part of stroke family caregiver health. Factors associated with unhealthy days in this study provide areas to consider in future intervention development.

Accuracy and Feasibility of Using a Smartphone Application for Carbohydrate Counting Versus Traditional Carbohydrate Counting for Adults With Insulin-Treated Diabetes.

BACKGROUND: Patients with insulin-treated diabetes struggle with performing accurate carbohydrate counting for proper blood glucose control. Little is known about the comparative accuracy and feasibility of carbohydrate counting methods. PURPOSE: The purpose of this study was to determine whether carbohydrate counting using a smartphone application is more accurate and feasible than a traditional method. THEORETICAL/CONCEPTUAL FRAMEWORK: Based on a conceptual model derived from the Technology Acceptance Model, feasibility was defined as usefulness, ease of use, and behavioral intention to use each method. METHODS: A standardized meal was presented to 20 adults with insulin-treated diabetes who counted carbohydrates using traditional and smartphone methods. Accuracy was measured by comparing carbohydrate counting estimates with the standardized meal values. Perceived feasibility (usefulness, ease of use, behavioral intention) was measured using rating forms derived from the Technology Acceptance Model. RESULTS: The number of training and estimation minutes were significantly higher for the traditional method than the smartphone method (Z = -3.83, P < .05; Z = -2.30, P < .05). The traditional method took an additional 1.4 minutes for estimation and 12.5 minutes for training. There were no significant differences in accuracy between traditional and smartphone methods for carbohydrate counting (Wilcoxon signed-rank test, Z = -1.10, P = .28). There were no significant differences between traditional and smartphone methods for feasibility (usefulness, Z = -.10, P = .95; ease of use, Z = -.36, P = .72; or behavioral intention, Z = -.94, P = .35). CONCLUSION: While both traditional and smartphone methods were found to be similar in terms of accuracy and feasibility, the smartphone method took less time for training and for carbohydrate estimation.

Loneliness in older primary care patients and its relationship to physical and mental health-related quality of life.

BACKGROUND: Loneliness is a significant public health challenge in the United States, especially among older adults. The epidemiology of loneliness among older adults in primary care is lacking, and specific research is needed on how loneliness impacts older primary patients' physical, mental, and cognitive health. A large sample of older primary care patients were recruited for a trial during the COVID-19 pandemic to measure the relationship between loneliness and physical and mental quality of life (QOL). METHODS: Baseline data come from the Caregiver Outcomes of Alzheimer's Disease Screening (COADS) study, an ongoing randomized controlled trial evaluating benefits and risks of Alzheimer's disease and related dementias screening among primary care patients ages 65 and older, collected April 2020 to September 2021. Loneliness was measured with the 5-item, Loneliness Fixed Form Ages 18+ from The NIH Toolbox Emotion Battery, physical and mental health-related QOL was measured with the SF-36v2, and depression and anxiety severity were measured with the PHQ-9 and GAD-7, respectively. RESULTS: Spearman correlation analyses revealed that loneliness was moderately correlated with mental health QOL (r[601] = -0.43, p < 0.001), anxiety severity (r[601] = 0.44, p < 0.001), and depression severity (r[601] = 0.42, p < 0.001), while weakly correlated with physical health QOL (r[601] = -0.15, p < 0.001). After conducting unadjusted and adjusted linear regression models, we found that loneliness was significantly associated with both lower mental (p < 0.001) and physical (p < 0.001) QOL. Furthermore, loneliness remained significantly associated with worse mental QOL after adjusting for age, gender, race, ethnicity, educational level, perceived income status, neighborhood disadvantage, severity of comorbidities, and comorbid depression and anxiety. CONCLUSION: Primary care providers should discuss loneliness with their older adult patients and provide resources to help patients develop and maintain meaningful social relationships.

Family Management Skills Reported by Parents of Preterm Infants in the NICU Using the Self- and Family Management Framework (SFMF).

BACKGROUND: Across the globe, family-integrated care (FICare) has become an evidence-based standard in which parents deliver the majority of infant care in the neonatal intensive care unit (NICU). Because of extensive barriers to parent presence, adaptations to FICare may be required for successful implementation. Family management theory may provide structure to the Parent Education of FICare and help nurses guide parents' skill development as equal care members. PURPOSE: To identify family management skills employed by NICU parents using the Self- and Family Management Framework (SFMF). METHODS: We conducted secondary analyses of qualitative interview data from NICU parents (n = 17) who shared their experiences of using family management skills to care for their infant. We categorized skills according to 3 main self- and family management processes: Focusing on Infant Illness Needs; Activating Resources; and Living With Infant Illness. RESULTS: Parents reported several family management skills currently identified in the SFMF, as well as new skills such as conflict management, power brokerage, and addressing resources related to social determinants of health. Parent activation of resources was critical to sustaining parent focus on the infant's illness needs. IMPLICATIONS FOR PRACTICE AND RESEARCH: By teaching skills that parents reported as helping them manage infant care, neonatal nurses may better facilitate parent integration into the care team. Future researchers can incorporate the skills identified in this study into the design of family management interventions that facilitate FICare implementation in the United States.

Participant Satisfaction in a Cardiovascular Disease Prevention Intervention for Midlife Black Women.

BACKGROUND: Midlife Black women suffer disproportionately from cardiovascular disease and are 65% more likely to die following a cardiac event compared with White women. Recruitment and retention of midlife Black women in clinical trials has been historically low. The culturally tailored Midlife Black Women's Stress Reduction and Wellness (B-SWELL) intervention was codeveloped with the community and designed to lower cardiovascular disease risk in midlife Black women. OBJECTIVES: We sought to assess participant satisfaction in the randomized feasibility trial of the B-SWELL intervention. METHODS: A feasibility trial comparing the B-SWELL to a wellness intervention was conducted in the winter and spring of 2021 in compliance with pandemic research protocols. An adapted survey tool was used to rate satisfaction with the intervention and its technology using a Likert-type scale (1 [strongly disagree] to 5 [strongly agree]). Survey subscales assessed usefulness, ease, and acceptability of the intervention(s). RESULTS: Randomization yielded no statistical demographic differences (N = 48). Satisfaction for the interventions was high in both the B-SWELL and Wellness intervention groups with mean scores of 4.57 and 4.56, respectively. Mean scores for technology were 4.49 for the B-SWELL and 4.47 for the Wellness group. Subscales were also rated highly. Narrative responses were positively aligned with satisfaction scores. CONCLUSIONS: Results support use of cultural adaptation and community participatory methods to develop and deliver interventions targeted to at-risk populations. Culturally adapted interventions designed in collaboration with the community have greater authenticity, increasing the potential for higher recruitment, retention, and participant satisfaction of underrepresented populations. The trial is registered in ClinicalTrials.gov (NCT04404478).

Relationship between health-related quality of life, depression, and anxiety in older primary care patients and their family members.

OBJECTIVES: Patient-family member dyads experience transitions through illness as an interdependent team. This study measures the association of depression, anxiety, and health-related quality of life (HRQOL) of older adult primary care patient-family member dyads. METHODS: Baseline data from 1,808 patient-family member dyads enrolled in a trial testing early detection of Alzheimer's disease and related dementias in primary care. Actor-Partner Independence Model was used to analyze dyadic relationships between patients' and family members' depression (PHQ-9), anxiety (GAD-7), and HRQOL (SF-36 Physical Component Summary score and Mental Component Summary score). RESULTS: Family member mean (SD) age is 64.2 (13) years; 32.2% male; 84.6% White; and 64.8% being the patient's spouse/partner. Patient mean (SD) age is 73.7 (5.7) years; 47% male; and 85.1% White. For HRQOL, there were significant actor effects for patient and family member depression alone and depression and anxiety together on their own HRQOL (p < 0.001). There were significant partner effects where family member depression combined with anxiety was associated with the patient's physical component summary score of the SF-36 (p = 0.010), and where the family member's anxiety alone was associated with the patient's mental component summary score of the SF-36 (p = 0.031). CONCLUSION: Results from this study reveal that many dyads experience covarying health status (e.g. depression, anxiety) even prior to entering a caregiving situation.

Merits and Pitfalls of Social Media as a Platform for Recruitment of Study Participants.

Efficient and effective methods of recruiting participants for studies have characteristically come with many challenges. The unprecedented rise of social media platforms such as Facebook and Instagram has revolutionized the ease of recruiting participants as compared to more traditional methods such as newspaper or radio advertisements. While these new advancements may seem to increase the success of recruitment, they are not without their own faults and limitations. In this paper, we intend to dissect the advantages and disadvantages of social media platforms in recruiting participants. Specifically, we will discuss the advantages of targeted and rapid recruitment, engagement, and cost reduction as well as the disadvantages of representativeness, privacy concerns, limited control, and limited access.

Psychometric Testing of the Oncology Nurses Health Behaviors Determinants Scale: A Cross-Sectional Study.

OBJECTIVES: Adherence by oncology nurses to chemotherapy safe handling guidelines is essential to prevent hazards of chemotherapy exposure. A review of the literature revealed the need for an instrument with evidence of reliability and validity to measure factors influencing adherence to safe chemotherapy-handling guidelines among oncology nurses. The purpose of this study was to psychometrically test the Oncology Nurses' Health Behaviors Determinants Scale (HBDS-ON) that measures the mentioned factors. DATA SOURCES: Methodological research of a quantitative cross-sectional survey design was used. The study surveys were administered by email to a sample of 108 oncology nurses. Cronbach alpha, item analysis, exploratory factor analysis using principal axis factoring, and convergence validity testing were used to test reliability and validity. CONCLUSION: Factor analysis yielded six subscales, each having acceptable internal consistency reliability (Cronbach alpha between 0.70 and 0.88). The subscales included four oncology nurse health beliefs (perceived threat, benefits, barriers, and self-efficacy), cues to action, and personal protective equipment availability and accessibility. Convergence validity testing results support the Oncology Nurses Health Behaviors Determinant Scale (HBDS-ON) construct validity. Oncology nurses' self-efficacy to adherence to chemotherapy-handling guidelines, the perceived barriers to adhere to chemotherapy-handling guidelines, and cues to action are associated with adherence to chemotherapy-handling guidelines. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses' health beliefs, the cues to action, and personal protection equipment availability and accessibility are important determinants of nurses' adherence to chemotherapy-handling guidelines. The HBDS-ON is an instrument that has evidence of reliability and validity and could be used in practice to measure these determinants.

Patient motivators to use opioids for acute pain after emergency care.

Introduction: Patients are stakeholders in their own pain management. Factors motivating individuals to seek or use opioids therapeutically for treatment of acute pain are not well characterized but could be targeted to reduce incident iatrogenic opioid use disorder (OUD). Emergency departments (EDs) commonly encounter patients in acute pain for whom decisions regarding opioid therapy are required. Decision-making is necessarily challenged in episodic, unscheduled care settings given time pressure, limited information, and lack of pre-existing patient provider relationship. Patients may decline to take prescribed opioids or conversely seek opioids from other providers or non-medical sources. Methods: Using a framework analysis approach, we qualitatively analyzed transcripts from 29 patients after discharge from an ED visit for acute pain at a large, urban, academic hospital in the midwestern United States to describe motivating factors influencing patient decisions regarding opioid use for acute pain. A semi-structured interview guide framed participant discussion in either a focus group or interview transcribed and analyzed with conventional content analysis. Results: Four major themes emerged from our analysis including a) pain management literacy, b) control preferences, c) risk tolerance, and d) cues to action. Discussion: Our findings suggest targets for future intervention development and a framework to guide the engagement of patients as stakeholders in their own acute pain management.

Development and Validation of the Lewy Body Disease Caregiver Activities Scale.

Background and Purpose: Caring for someone with Lewy body disease (LBD) is difficult. This study describes the development and validity testing of the LBD Caregiver Activities Scale (LBD-CAS). Methods: Caregiver interviews informed the development of the LBD-CAS. Experts estimated the content validity of items (I-CVI) and provided feedback about the scale. Family caregivers evaluated items for face validity. Results: Expert I-CVI ratings yielded 49 items with scores of 0.83 or higher. Four items with I-CVI scores <.83 were retained due to conceptual significance. The overall scale CVI was 0.86. Items evaluated by caregivers for face validity showed excellent variability in responses, with no major ceiling or floor effects. Conclusions: LBD-CAS showed evidence of content and face validity for the assessment of activities performed by LBD caregivers. Further psychometric testing is recommended.

Iterative Development of the Caregiver Wellness After Traumatic Brain Injury Program (CG-Well).

OBJECTIVES: (1) To iteratively design a web/phone-based intervention to support caregivers of adults acutely following traumatic brain injury (TBI), Caregiver Wellness (CG-Well), and (2) to obtain qualitative and quantitative feedback on CG-Well from experts and caregivers to refine the intervention. SETTING: A level I trauma and tertiary medical center. PARTICIPANTS: Convenience sample of a total of 19 caregivers and 25 experts. DESIGN: Multistep prospective study with iterative changes to CG-Well: (1) developed intervention content based on qualitative feedback from a prior study and literature review; (2) obtained qualitative feedback from 10 experts; (3) refined content using a modified Delphi approach involving 4 caregivers and 6 experts followed by qualitative interviews with 9 caregivers; (4) designed CG-Well website and videos; and (5) obtained feedback on program acceptability, appropriateness, and feasibility from 6 caregivers and 9 experts. INTERVENTIONS: CG-Well included content on TBI, self-care and support, and skill-building strategies delivered through a website and telephone calls. MAIN OUTCOME MEASURES: Qualitative data were analyzed using content analysis. Caregivers and experts completed Likert-type scales to rate module relevance, clarity, accuracy, utility and website acceptability, appropriateness, and feasibility (1 = strongly disagree to 5 = strongly agree). Means and standard deviations (SD) characterized ratings. RESULTS: Qualitative findings were instrumental in designing and refining CG-Well. Ratings were positive for modules (means and SD for relevant [4.9, 0.33], clear [4.6, 0.53], accurate [4.9, 0.33], and useful [5, 0]) and the website (means and SD for acceptable [4.8, 0.36], appropriate [4.8, 0.35], and feasible [4.8, 0.36]). CONCLUSIONS: The iterative design process for CG-Well resulted in a highly acceptable program. An early-stage randomized controlled trial is underway to estimate treatment effects for a future well-powered clinical trial.

The Factors That Influence Chemotherapy Exposure Among Nurses: An Integrative Review.

BACKGROUND: Exposure to chemotherapy is an occupational hazard predisposing nurses to severe health effects. The purpose of this integrative review was to identify the recent literature describing the risk factors for occupational exposure to chemotherapy among nurses. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodology was employed to conduct the review. The databases searched were Scopus, PubMed, and CINAHL using the search terms "chemotherapy," "drugs," "exposure," and "nurses." Included articles were published between January 2010 and February 2022, published in peer-reviewed journals for research conducted in the United States, and written in English language. Excluded articles were studies that did not involve nurses in their samples. Review articles, books, theses, and dissertations were excluded as well. The Johns Hopkins Nursing Evidence-Based Practice Model was used to assess the level of evidence from the reviewed studies. FINDINGS: Fourteen studies were included in this review. Ten studies were rated on Evidence Level III, two on Evidence Level II, one on Evidence Level I, and one on Evidence Level V. The main risk factors for occupational exposure were nurses' knowledge of chemotherapy handling guidelines, nurses' adherence to using the personal protective equipment, nurses' health beliefs regarding chemotherapy exposure, and workplace-related factors such as workload and managerial support. CONCLUSION: Addressing the identified risk factors would protect nurses from chemotherapy exposure. More research on nurses' health beliefs regarding chemotherapy exposure and the cues to adhere to chemotherapy handling guidelines in the work environment is needed.

The Kidney Transplant Self-Management Scale: Instrument Development and Psychometric Testing.

This study reports the development and psychometric testing of the Kidney Transplant Self-Management Scale (KT-SMS). The instrument development phase included the following: (a) conceptual definition, item generation, and framework; (b) face validity assessment; and (c) content validity assessment. The psychometric testing phase included the following: (a) construct validity testing; (b) internal consistency reliability testing; (c) convergent validity testing; and (d) predictive power of the KT-SMS using a cross-sectional sample of kidney transplant recipients (N = 153). Factor analysis results supported the 16-item KT-SMS as multidimensional with five domains (medication adherence, cardiovascular risk reduction, protecting kidney, ownership, and skin cancer prevention). Internal consistency reliability for the total scale and five subscales was adequate. Convergent validity was supported as the intercorrelations of the KT-SMS total score with the five subscales were significant. The KT-SMS total score and five subscales were significantly correlated with self-efficacy for managing chronic disease, patient activation, and health-related quality of life.

A randomized feasibility trial of the Midlife Black Women's Stress and Wellness intervention (B-SWELL); a community participatory intervention to increase adoption of Life's Simple 7 healthy lifestyle behaviors.

BACKGROUND: Black women have a disproportionately higher incidence of cardiovascular disease-related mortality than other groups, yet they are less likely to receive culturally proficient education and competent preventive care. PURPOSE: The purpose of this study was to determine feasibility of the Midlife Black Women's Stress and Wellness intervention (B-SWELL); a culturally adapted, 8-week group intervention leveraging stress reduction and goal setting to increase awareness and adoption of Life's Simple 7 (LS7) healthy lifestyle behaviors. METHODS: A randomized feasibility trial was conducted. Participants (N = 48, mean age = 55 years) were randomized to the B-SWELL or a group wellness (WE) intervention that lacked stress reduction and goal setting instruction. We hypothesized that B-SWELL participants would achieve a lower perceived stress, greater self-efficacy, improved LS7 scores, fewer symptoms (depression and unhealthy days), and greater perceived general health compared to WE participants. Survey data were collected at three timepoints: baseline, 8 weeks, and 12 weeks. RESULTS: Both B-SWELL and WE groups had low attrition and navigated the online platform well. Further, both groups experienced lower perceived stress, improved LS7 scores, reduced depressive symptoms, and greater perceived general health from baseline to 8 weeks. Based on data trends, participants in the B-SWELL had more improvement in perceived stress, self-efficacy, and mental and physical unhealthy days compared to WE participants. CONCLUSION: The B-SWELL is a feasible intervention for midlife Black women. Positive data trends were found for both B-SWELL and WE groups. Based on observations from the feasibility study, a larger outcomes-based study is planned.

Midlife Black women have a greater chance of dying from heart disease compared to other groups. However, Black women are less likely to receive the education and health care needed to affect this difference. The purpose of this study was to compare a new program, the Midlife Black Women's Stress and Wellness intervention (B-SWELL) to a wellness program (WE). The B-SWELL program uses education, stress reduction, and goal setting to improve healthy lifestyle behaviors in midlife Black women. The WE program provided health education in a group setting but did not offer information about stress or goal setting. We enrolled 48 midlife Black women ages 40­64 years old into the study. The women were randomly assigned to either the B-SWELL or WE program. We proposed that women in the B-SWELL program would have lower stress, improved healthy lifestyle scores, less depression, and fewer symptoms compared to women in the WE program. Both groups experienced lower stress, improved healthy lifestyle scores, and less depression. Women in the B-SWELL had greater improvement in stress and symptoms. In conclusion, the B-SWELL program is practical for midlife Black women. A larger study is planned.

The Impact of the COVID-19 Pandemic on the Mental Health of Older Primary Care Patients and Their Family Members.

The COVID-19 pandemic introduced mandatory stay-at-home orders and concerns about contracting a virus that impacted the physical and mental health of much of the world's population. This study compared the rates of depression and anxiety in a sample of older primary care patients (aged ≥65 years old) and their family members recruited for a clinical trial before and during the COVID-19 pandemic. Participants were dyads enrolled in the Caregiver Outcomes of Alzheimer's Disease Screening (COADS) trial, which included 1,809 dyads of older primary care patients and one of their family members. Mean scores on the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder Scale-7 (GAD-7) were measured and compared before and during the pandemic. We found no difference in depression and anxiety among dyads of older primary care patients and their family members recruited before and during COVID-19. Additionally, we found that older primary care patients and family members who reported their income as comfortable had significantly lower depression and anxiety compared to those who reported having not enough to make ends meet. Along with this, older primary care patients with a high school education or less were more likely to have anxiety compared to those with a postgraduate degree. Moreover, our findings support the notion that certain demographics of older primary care patients and family members are at a higher risk for depression and anxiety, indicating who should be targeted for psychological health interventions that can be adapted during COVID-19. Future research should continue monitoring older primary care patients and their family members through the remainder of the COVID-19 pandemic.

Stroke Family Caregiver Life Changes From the COVID-19 Pandemic.

ABSTRACT: BACKGROUND: Stroke family caregivers were already struggling with unmet needs and changes in their own lives from providing care. The COVID-19 pandemic added further stress and disruption to their lives. The purpose of this study was to describe life changes in 17 stroke family caregivers specifically resulting from the COVID-19 pandemic. METHODS: This study was conducted as a secondary data analysis from an ongoing randomized controlled clinical trial testing feasibility of the Telehealth Assessment and Skill-Building Kit (TASK III). Using a multimethod design, both quantitative and qualitative data were analyzed to determine caregiver life changes. Quantitative ratings regarding life changes were obtained using 17 items adapted specifically for COVID-19 from the Bakas Caregiving Outcomes Scale. Rigorous content analysis procedures for the qualitative data were guided by a start list of codes based on the 17 items, with additional themes possible. Representative quotes were selected based on author consensus. RESULTS: Findings revealed both negative and positive life changes from the COVID-19 pandemic. Negative life changes included such things as disrupted daily routines, limited access to healthcare providers and resources (eg, food, masks, hand sanitizers), reduced family and social contact and activities, decreased emotional well-being, and problems with performing caregiving activities for the survivor. Positive life changes were increased use of the Internet and videoconferencing, closer relationships with friends, and learning how to access needed resources in new ways. CONCLUSION: Stroke family caregivers experienced both negative and positive life changes specifically as a result of the COVID-19 pandemic. Responses further indicated that COVID-19 affected most caregivers in different ways and an individualized approach is needed in dealing with caregiver life changes.

The Development and the Content Validation of the Oncology Nurses Health Behaviors Determinants Scale.

OBJECTIVE: Chemotherapy exposure is an occupational hazard affecting oncology nurses. The adherence to chemotherapy-handling guidelines is essential to prevent exposure to these drugs. Oncology nurses' health beliefs and the cues in the environment are factors influencing the adherence to these guidelines. There is a lack of instruments with evidence of reliability and validity in the literature that address these factors. The purpose of this article is to describe the development and the content validation of the Oncology Nurses' Health Behaviors' Determinants Scale relative to adherence to chemotherapy-handling guidelines. DATA SOURCES: This study was conducted in two phases: item development, then, content validation using a quantitative cross-sectional design with an exploratory part. A convenience sample of seven experts reviewed the items for relevance, wording, and comprehensiveness. The initial version of the scale that was sent to experts contained 65 items. CONCLUSION: The Oncology Nurses' Health Behaviors Determinants' Scale has evidence of content validity. Twenty-eight items in the final instrument met the required level of content validity (item content validity index = 0.83). Four additional items were retained due to conceptual significance. Two items were added. The final scale contains 34 items with a total scale content validity index = 0.90. IMPLICATIONS FOR NURSING PRACTICE: This newly developed instrument could be used to assess the factors that influence chemotherapy exposure among oncology nurses in the light of the Health Belief Model. Following that, interventions can be developed and implemented to foster greater adherence to safe chemotherapy handling guidelines.

Development of Written Materials for Participants in an Alzheimer's Disease and Related Dementias Screening Trial.

Given that participants' experiences in clinical trials include a variety of communication touchpoints with clinical trial staff, these communications should be designed in a way that enhances the participant experience by paying attention to the self-determination theoretical concepts of competence, autonomy, and relatedness. In this feature, we argue that clinical trial teams need to consider the importance of how they design their written participant communication materials, and we explain in detail the process our multidisciplinary team took to design written materials for the patient and family caregiver participants in our Alzheimer's disease and related dementias (ADRD) screening trial. This article concludes with suggested guidance and steps for other clinical trial teams.

Systematic Review of the Evidence for Stroke Family Caregiver and Dyad Interventions.

Stroke family caregiver and dyad literature has expanded over the past few years. The purpose of this review was to build upon 2 prior systematic reviews to critique, analyze, and synthesize the evidence pertaining to the impact of family caregiver and dyad interventions on stroke survivor and family caregiver outcomes. CINAHL, PsychINFO, PubMed, and reference lists were searched from December 1, 2016 through March 31, 2021. Using PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyses), articles were identified that tested outcomes from stroke family caregiver or dyad interventions that targeted the health or well-being of family caregivers. Data from the articles were abstracted into tables for analysis, then compared with recommendations from the 2 prior systematic reviews. A total of 18 articles met inclusion criteria (10 caregiver interventions; 8 dyad interventions) representing sample sizes ranging from 7 to 349 caregivers or dyads. Most were randomized controlled trials (n=13); 2 were cluster randomized trials; and 3 were single-group quasi-experimental designs. Of the 18 studies, 8 had <50 caregivers or dyads and 5 were small feasibility studies that reported data trends rather than testing for significance. Only 6 studies reported significant survivor outcomes. Eleven studies reported significant caregiver outcomes, the most common being burden. A number of survivor and caregiver outcomes were not significant, or only significant for certain subgroups. The limited number of studies, small sample sizes, and conflicting results, made it difficult to draw firm conclusions regarding the impact of these interventions on outcomes. Based on the available evidence from these 18 studies, recommendations from the 2 prior reviews were generally supported. Well-designed and well-powered randomized controlled clinical trials are still needed to confirm efficacy of stroke family caregiver and dyad interventions.

Co-Designing a Program to Lower Cardiovascular Disease Risk in Midlife Black Women.

Midlife Black women suffer disproportionately from heart disease and stroke in comparison to White women of similar age and demographic. Risk for cardiovascular disease (CVD) and stroke is largely considered to be modifiable yet CVD prevention and awareness campaigns have been less effective among Black women. Decreased awareness of personal CVD risk is associated with delays in the presentation of women to the emergency room or health care providers for symptoms of myocardial infarction. The Midlife Black Women's Stress and Wellness (B-SWELL) program was designed to increase awareness about CVD risk factors, stress, and healthy lifestyle behaviors among midlife Black women. In partnership with an existing Community Research Advisory Board (C-RAB), materials were developed and culturally adapted for the B-SWELL program. Following successful development of the B-SWELL materials, a trial of the B-SWELL program was conducted with a sample of midlife Black women recruited from the community. The program was co-facilitated by members of the C-RAB. We outline the strategies used to successfully co-create and trial the B-SWELL program materials and reflect on the strengths and challenges associated with the development of a culturally tailored heart disease prevention program using community participatory methods.