Comparison of recruitment methodologies for clinical trials: Results from the time for living and caring (TLC) intervention study.

BACKGROUND: Recruiting participants for research studies is a critical yet challenging task. Community-engaged recruitment strategies have gained prominence as effective means to engage diverse populations and ensure the representativeness of study samples. This case study aims to investigate the cost and effectiveness of various recruitment methods in enhancing research participation. METHODS: A comparative approach was employed to assess the outcomes of five different recruitment strategies used in the Time for Living & Caring (TLC) research study. Data on recruitment success, participant demographics, and retention rates were collected and analyzed using descriptive statistics, including ANOVA and Chi-squares, to statistically compare the outcomes associated with 5 different recruitment methodologies. The recruitment methodologies included two community-engaged strategies (community partner referral and community-based recruiters), a clinical database, social media, and word-of-mouth referral. CONCLUSION: The meta-data used to build this methodological case study describe different recruitment methodologies that may be used for clinical trials. This data-driven evaluation provides examples and considerations for researchers when developing budgets and proposals for future clinical trials. The primary finding is that there are tradeoffs in terms of cost, time, labor, and ultimately the representativeness of the sample, based on the type of recruitment methodology chosen.

Using Digital Inequality Framework to Evaluate a Technology-Delivered Intervention for Caregivers: Age, Education, and Computer Proficiency.

Objectives: Using "digital inequality" as a conceptual framework, this study evaluates the feasibility and usability of a technology-delivered intervention (an "app") for Alzheimer's and related dementia family caregivers. Time for Living and Caring (TLC) is an on-line intervention that provides virtual coaching and self-administered education and resources. Methods: A sample of family caregivers (n = 163) used the tool for 16 weeks, which included completing the Computer Proficiency Questionnaire (CPQ-12) at baseline. Analyses investigate the relationship between age, CPQ scores, intervention use, appraisal, and caregiver outcomes. Results: Age was inversely associated with CPQ; however, CPQ scores did not have a significant relationship with participant's self-perceived benefits or intervention appraisal. Computer Proficiency Questionnaire scores provided insight regarding research feasibility, with lower scores associated with greater odds of discontinuing engagement. Discussion: CPQ-12 scores can be used as a screening tool to identify those who may need additional support to engage with and benefit from technology-delivered interventions.

Family caregiver experiences and needs across health conditions, relationships, and the lifespan: a Qualitative analysis.

PURPOSE: The purpose of this study was to understand the lived experiences of family caregivers who provide care to individuals across a broad range of ages, caregiving relationships, and health conditions and/or disabilities. Family caregiver research is typically siloed by health condition or by caregiving relationship, leaving gaps in understanding similarities and differences among caregivers. METHODS: We hosted three virtual focus groups with diverse family caregivers (n = 26) caring for an individual with a long-term disability and/or health condition(s). We conducted a qualitative thematic analysis using an iterative, inductive process. RESULTS: Participants primarily expressed shared experiences, despite having unique caregiving situations. We identified themes among a) caregiver experiences: Trying to Do It All, Balancing Complex Emotions, Managing Expectations, and Adjusting to Changes Over Time and b) caregiver needs: Longing for Breaks and Self-Care; Lacking Help, Support and Resources; and Desiring Understanding and Recognition. CONCLUSIONS: These findings emphasize that many elements of the caregiving experience transcend care recipient age, condition, and relationship and are applicable to clinicians, researchers, and policy makers. The evidence of shared caregiver experiences can guide efficiencies in policy and practice (e.g., pooling of existing resources, expansion of interventions) to meet the needs of a broader population of caregivers.

Promoting Resilience After Stroke in Dyads (ReStoreD): A Supplemental Analysis.

OBJECTIVE: To examine preliminary effects of ReStoreD (Resilience after Stroke in Dyads) on resilience in couples coping with stroke-related challenges. DESIGN: Supplemental analysis of prospective pilot trial with pre-/post-assessments and 3-month follow-up. SETTING: Community. PARTICIPANTS: Thirty-four cohabitating stroke-care partner dyads (N=34); at least 3 months post-stroke. INTERVENTIONS: 8-week self-administered dyadic intervention (ReStoreD) consisting of activities completed individually and as a couple. MAIN OUTCOME MEASURES: 10-item Connor-Davidson Resilience Scale. RESULTS: Care partner baseline resilience scores were significantly higher than persons with stroke scores. Repeated-measures analysis of variance suggest significant pre-post improvement in resilience for persons with stroke (mean difference [I - J]=-2.42, SE=.91, P=.04, 95% CI [-4.75, -0.08]) with a large effect size (η2=.34), which was maintained at 3-month follow-up. Care partners showed no significant change over time. CONCLUSIONS: This study provides preliminary evidence that ReStoreD improves resilience in persons with stroke. More research is needed to address resilience in care partners. These findings represent a promising first step to address the mental health needs in this population.

Online interventions to support family caregivers: The value of community-engaged research practices.

Family members provide significant amounts of unpaid care to aging, chronically ill, and disabled persons in their homes. They often do this with little education or support and commonly report feeling overwhelmed and stressed. Providing education and support to family caregivers has demonstrated benefit on the health and well-being of the caregiver and care-receiver. However, because "caregiver" is not a reimbursable category in health care, caregiver interventions need to be delivered in a cost-efficient way. Technology-delivered and self-administered intervention models are increasingly being recommended as a pragmatic way to support aging families in our communities. This paper outlines the redevelopment of two behavioral interventions to an exclusively online delivery. This case-study analysis presents a model for community-engaged intervention research practices, which have the potential to create interventions that are more sustainable and more likely to be implemented than those designed and tested with more traditional research methodology.

Learning to flourish in a new reality: a thematic analysis of couples' experience of participation in a positive psychology intervention post-stroke.

PURPOSE: Explore the experiences of couples engaging in a positive psychology intervention post-stroke (ReStoreD: Promoting Resilience after Stroke in Dyads). MATERIALS AND METHODS: This is a secondary analysis of qualitative data collected following an 8-week self-administered dyadic positive psychology intervention (Clinical Trial number: NCT03335358). Participants included dyads consisting of one partner who had a stroke at least three months prior and their cohabiting partner. Couples had to be community-dwelling and one or both had to report depressive symptoms. A thematic analysis was conducted on semi-structured feedback interviews from 26 dyads (n = 77 interviews). RESULTS: Two primary themes with multiple secondary themes were identified, depicting the experiences of couples post-stroke while engaging in the ReStoreD intervention. Primary and secondary themes included: changes in self (learning about the self, building new coping strategies, and acting with intention) and changes in the relationship (awareness of spouse, spending more positive time together, being more intentional in the relationship, and increased/improved communication). CONCLUSIONS: Individuals and couples post-stroke often experience negative mood changes, poor health outcomes, and decreased participation. Implementation of ReStoreD activities in the clinical setting can be a valuable and impactful way to encourage and foster positive experiences and re-engagement post-stroke.Implications for RehabilitationThrough dyadic positive psychology intervention activities, rehabilitation professionals can build upon existing strengths and resources to encourage couples to increase their awareness and development of positive coping strategies as individuals and couples.Positive psychology intervention activities can be implemented by rehabilitation professionals at inpatient and outpatient settings through self-directed, low-cost, and time-efficient strategies to increase engagement in positive activities at home.

Positive Psychology Approaches to Interventions for Cancer Dyads: A Scoping Review.

OBJECTIVE: Positive psychology approaches (PPAs) to interventions focus on developing positive cognitions, emotions, and behavior. Benefits of these interventions may be compounded when delivered to interdependent dyads. However, dyadic interventions involving PPAs are relatively new in the cancer context. This scoping review aimed to provide an overview of the available research evidence for use of dyadic PPA-based interventions in cancer and identify gaps in this literature. METHODS: Following PRISMA guidelines, we conducted a scoping review of intervention studies that included PPAs delivered to both members of an adult dyad including a cancer patient and support person (e.g., family caregiver, intimate partner). RESULTS: Forty-eight studies, including 39 primary analyses and 28 unique interventions, were included. Most often (53.8%), the support person in the dyad was broadly defined as a "caregiver"; the most frequent specifically-defined role was spouse (41.0%). PPAs (e.g., meaning making) were often paired with other intervention components (e.g., education). Outcomes were mostly individual well-being or dyadic coping/adjustment. CONCLUSIONS: Wide variability exists in PPA type/function and their targeted outcomes. More work is needed to refine the definition/terminology and understand specific mechanisms of positive psychology approaches.

Piloting GETCare: A Goal-Based Education and Skills Training Program for Caregivers.

PURPOSE: Many individuals with stroke require informal caregiver support. These caregivers are often unprepared and overwhelmed. This study assesses the feasibility and acceptability of GETCare, a remote Goal-based Education and skills Training program for Caregivers caring for an individual poststroke. DESIGN: Single-arm mixed-methods pilot trial was performed. METHODS: The GETCare program is a 5-week remote, individually administered program for informal stroke caregivers that includes education, skills training, guided goal setting, and resource recommendations. Quantitative data were analyzed using descriptive statistics and qualitative data via a deductive approach. RESULTS: Twenty-eight caregivers were recruited with 18 caregivers completing the program. These 18 caregivers reported high satisfaction, and over 75% reported program content was at least quite helpful. Caregivers suggested that the length of the program was appropriate, indicated that weekly check-ins were helpful, and supported this program for informal caregivers across the time trajectory poststroke. Eight of 10 caregivers who dropped out of the program were caring for someone 0-4 months poststroke. CONCLUSIONS: Caregivers positively received the GETCare program, which was uniquely structured to provide resources and skills for this high-need population. This pilot study provides valuable insight for future remote interventions poststroke. CLINICAL RELEVANCE TO PRACTICE OF NURSING: Results provide foundational knowledge in how to better support caregivers through guided goal setting and individualized education.

Overvaluation of Shape and Weight (Not BMI) Associated with Depressive Symptoms and Binge Eating Symptoms Pre- and Post-bariatric Surgery.

PURPOSE: Overvaluation of shape and weight (OSW) involves defining self-worth by body shape/weight. Among persons seeking bariatric surgery, cross-sectional studies have found associations between OSW, depressive symptoms, and disordered eating. MATERIALS AND METHODS: Relationships among OSW, depressive symptoms, binge eating symptoms, and BMI were analyzed both cross-sectionally and over time among 145 adults who had bariatric surgery. Participants completed the following measures pre-surgery and 1.5 to 3 years post-surgery: Eating Disorder Examination Questionnaire (EDE-Q), Binge Eating Scale, Patient Health Questionnaire, and body weight and height. OSW was measured by averaging two items on the EDE-Q which ask participants to rate how much their weight/shape influences how they judge themselves as a person. Analyses included Wilcoxon signed-ranks, bootstrapped Pearson correlations, and bootstrapped hierarchical linear regressions. RESULTS: OSW was significantly associated with depressive symptoms and binge eating symptoms both pre- and post-surgery, but was not associated with BMI at either timepoint. Improvements in OSW were associated with concurrent changes in depression and binge eating; reductions in BMI were not significantly associated with changes in any of these variables. CONCLUSIONS: Findings suggest that self-evaluation is more important in regard to changes in depressive and binge eating symptoms than is BMI (and vice versa), and support the importance of assessing and treating psychological considerations among persons seeking bariatric surgery.

Perceptions of function and recovery among persons with stroke and care partners.

PURPOSE/OBJECTIVE: Perceptions of function can differ between persons with stroke and care partners. The current study described the frequency of discrepancy in ratings of poststroke functioning across romantic partners and examined associations between perceptions of function, depressive symptoms, and caregiver strain. RESEARCH METHOD/DESIGN: A secondary analysis was conducted using data from the baseline visit of an intervention pilot study. Twenty-nine dyads completed measures of perceived current functioning of the person with stroke (Stroke Impact Scale 3.0: overall percent recovery, ADL, and cognition), self-reported ratings of depressive symptoms for both partners (PROMIS Depression Short Form v8b), and self-reported caregiver strain for the care partners only (Caregiver Strain Index). RESULTS: A discrepancy of over 10 points on the SIS 3.0 variables was seen in over 50% of dyads for all subscales, with care partners rating worse recovery on average. Actor partner interdependence models showed that more depressive symptoms were associated with perceptions of worse overall recovery and ADL function in persons with stroke, whereas more depressive symptoms were associated with perceptions of worse cognitive and ADL function in care partners. Discrepancy in perception of ADL function was associated with more caregiver strain though this was inextricable from the overall level of impairment in ADL function perceived by the care partner. CONCLUSIONS/IMPLICATIONS: These findings suggest that discrepancy in perceptions of stroke recovery among romantic partners is common. This underscores the importance of perception when considering risk for depression and caregiver strain as well as how to best promote psychological resilience following stroke. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Constraint-Induced Movement Therapy for Infants With or at Risk for Cerebral Palsy: A Scoping Review.

IMPORTANCE: Although research shows that older children with hemiplegic cerebral palsy (CP) benefit from constraint-induced movement therapy (CIMT), the efficacy of CIMT among the infant population is unknown. OBJECTIVE: To explore the existing evidence on CIMT for infants age 24 mo and younger with CP or at risk for CP. DATA SOURCES: PubMed, CINAHL, Cochrane, and ProQuest were searched. Study Selection and Data Collection: Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and American Occupational Therapy Association guidelines were used for abstracting data and assessing data quality. Two frameworks guided this scoping review. Studies met the following criteria: infants with hemiplegic CP, published in English between 2000 and 2020, peer reviewed, and addressed changes in upper limb function of the hemiplegic upper limb. FINDINGS: Eight articles met the inclusion criteria: 2 randomized controlled trials, 1 retrospective cohort design, 1 pretest-posttest study, 2 single-subject studies, and 2 case studies. In this scoping review, we examined CIMT protocols for an overview of dosage, constraint, administration, parent training and education, and objective outcome measures. CONCLUSIONS AND RELEVANCE: Existing literature supports CIMT protocols for infants with CP. However, much variability exists in protocol design and appropriate outcome measures among studies. Higher level research is needed to support the efficacy of CIMT among infants with CP. What This Article Adds: This scoping review summarizes the existing literature on CIMT for infants with hemiplegic CP. This information can help guide therapists to implement CIMT protocols in the clinical setting and to identify additional research to establish practice standards.

Intimate Relationships and Stroke: Piloting a Dyadic Intervention to Improve Depression.

Stroke affects not only the survivor but also their romantic partner. Post-stroke depression is common in both partners and can have significant negative consequences, yet few effective interventions are available. The purpose of this study was to pilot test a novel 8-week remotely administered dyadic intervention (ReStoreD) designed to help couples better cope with stroke-related changes and reduce depressive symptoms. Thirty-four cohabitating survivor-partner dyads at least 3 months post-stroke and reporting some changes in mood were enrolled. Depressive symptoms were assessed pre- and post-intervention and at 3-month follow-up. Repeated measures analysis of variance was used to assess the effects of ReStoreD over time on depressive symptoms in stroke survivors and their partners. Twenty-six dyads completed the study. Although statistical significance was not reached, there was a large effect size for improvements in depressive symptoms for stroke survivors. There was no significant improvement for partners, and the effect size was minimal. Those with more significant depressive symptoms at baseline were more likely to benefit from the intervention. This pilot study established proof-of-concept by demonstrating that depressive symptoms can be lessened in stroke survivors and partners with more severe depressive symptoms. Future research will establish the efficacy of the intervention in a fully powered study.

The Role of Resilience in Psychological Health Among Bariatric Surgery Patients.

OBJECTIVE: Many individuals who undergo bariatric surgery have experienced repeated unsuccessful diet attempts and negative messages from healthcare providers, family, and others about their weight. Research pre- and post-operatively has taken a pathological or risk-based approach, investigating psychiatric problems and disordered eating. In contrast, the current study explores resilience in this population. METHODS: Participants were 148 bariatric surgery patients. Participants completed measures pre-operatively and 1.5-3 years post-operatively, including the Binge Eating Scale, Eating Disorder Examination Questionnaire, Patient Health Questionnaire, Generalized Anxiety Questionnaire, Impact of Weight on Quality of Life, Coping Responses Inventory, and Duke Social Support and Stress Scales. The Connor-Davidson Resilience Scale was measured post-operatively. RESULTS: Correlations demonstrated a significant association between post-operative resilience and lower symptoms of binge eating, disordered eating, depression, anxiety, and impact of weight on quality of life. Resilience was also associated with greater social support and less social stress, and greater use of approach coping strategies. Resilience was significantly associated with improvements in symptoms of binge eating, disordered eating, depression, anxiety, and impact of weight on quality of life from pre- to post-operative assessments. In regression models, associations remained significant after controlling for psychosocial variables at baseline (e.g., binge eating symptoms pre-operatively) and demographic covariates. CONCLUSIONS: Psychological resilience has been under-studied in the literature on obesity and bariatric surgery, with a primary focus on risk factors for poor outcomes. This study was among the first to investigate associations between resilience and post-operative psychological outcomes. Results suggest the field would benefit from consideration of patient resilience in psychological assessments and interventions.

Applying the RISE Model of Resilience in Partners Post-Stroke: A Qualitative Analysis.

BACKGROUND: Resilience is dynamic and influenced by internal and external factors. In persons with chronic illness and/or disability, resilience is viewed as the ability to adapt to new life circumstances. Existing models of resilience typically focus on the absence of deficit and pathology in the individual, overlooking resources, well-being, and broader social impacts. Our proposed novel Relational, Intrapersonal, Social and Environmental (RISE) Model of resilience incorporates and describes the interconnection and influence of constructs that impact resilience and affect the quality of life. PURPOSE: The purpose of this study is to examine the fit of the RISE Model against original interview data obtained from persons with stroke and their partners. METHODS: This study is a secondary analysis of qualitative data collected from post-intervention interviews that were part of an intervention pilot study designed to promote resilience in couples coping with stroke. Interviews were coded to examine relationships between RISE Model constructs. RESULTS: The study included 36 interviews from 18 cohabitating couples; mean participant age was 53.33 years (SD ±14.70). Examples of each construct within the RISE Model appeared in transcribed interviews and common patterns of co-occurring constructs were identified. CONCLUSION: The constructs within the RISE Model were supported by the interviews. The impact of disability does not remain confined to a single individual and instead branches out into the broader social context, including close interpersonal relationships. A deeper understanding of resilience and its relationship with intrapersonal, interpersonal and socio-ecological constructs would add value to our understanding and fostering of resilience in persons with disabilities and/or chronic illness. CLINICAL TRIAL INFORMATION: NCT03335358.

"You Feel Very Isolated": Effects of COVID-19 Pandemic on Caregiver Social Connections.

One in five individuals in the United States provides care and support to ill, disabled, and aging family members in the home, leading to feelings of burden, stress, and poor health and well-being. Social support represents an important buffer for family caregivers that allows them to feel less isolated and more positive about their caregiving role. This sequential mixed-methods study aimed to examine the effect of the COVID-19 pandemic on family caregivers' social connections. Eighty-two caregivers completed a web-based survey which comprised of fixed-choice and open-ended questions. Survey data showed that the majority of caregivers (83%) reported an increase in stress and feeling lonely (77%) during the pandemic. Qualitative interviews with a subsample of caregivers (n=27) further explored social connections during the pandemic. Three themes echoed the quantitative findings and centered around defining boundaries, intentionality in social interactions, and loss of social resources. Although caregivers were often strained by new or increased caregiving demands, many experienced positive changes such as feeling a deeper connection with the care-recipient. Findings from this study highlight the need for further consideration of the impact of social isolation on the well-being of caregivers.

Occupational Therapy Practitioners' Knowledge, Comfort, and Competence Regarding Youth Suicide.

Suicide rates for young people are climbing in the United States and worldwide. Increasing rates of youth suicide are of concern to occupational therapy (OT) practitioners in pediatric settings, yet the profession's role in this area is poorly defined. To understand OT practitioners' awareness and needs related to youth suicide, we administered a survey including objective (e.g., knowledge of suicide-related facts) and subjective items (open- and close-ended questions) related to youth suicide to 134 OT practitioners working in pediatric settings. Only 5.2% of respondents correctly answered four items about youth suicide facts and only 32% reported they had received suicide-focused education. Just under half (45%) of respondents were able to identify all best practice responses to clinical scenarios related to youth suicide; older practitioner age was the only significant predictor of best practices. OT practitioners in pediatric settings would benefit from youth-focused suicide education and training.

Development of a resilience item bank and short forms.

PURPOSE: The purpose of this study was to develop a publicly available, psychometrically sound item bank and short forms for measuring resilience in any population, but especially resilience in individuals with chronic medical conditions or long-term disability. RESEARCH METHODS: A panel of 9 experts including disability researchers, clinical psychologists, and health outcomes researchers developed a definition of resilience that guided item development. The rigorous methodology used focus groups, cognitive interviews, and modern psychometric theory quantitative methods, including item response theory (IRT). Items were administered to a sample of people with chronic medical conditions commonly associated with disability (N = 1,457) and to a general population sample (N = 300) representative of the Unites States general population with respect to age, gender, race, and ethnicity. RESULTS: The final item bank includes 28 items calibrated to IRT with the scores on a T-metric. A mean of 50 represents the mean resilience in the general population sample. Four and eight item short forms are available, and their scores are highly correlated with the item bank score (r ≥ .94). Reliability is excellent across most of the resilience continuum. Initial analyses provide strong support for validity of the score. CONCLUSIONS: The findings support reliability and validity of the University of Washington Resilience Scale (UWRS) for assessing resilience in any population, including individuals with chronic health conditions or disabilities. It can be administered using computerized adaptive testing or by short forms. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Association of mindfulness to resilience, anxiety, and depressive symptoms after spinal cord injury-a correlational study.

STUDY DESIGN: Online survey of individuals with spinal cord injuries (SCI). OBJECTIVE: This pilot study examined associations between mindfulness factors, resilience, and levels of depression and anxiety after SCI. SETTING: Community-based; United States. METHODS: A survey was posted online and shared with individuals with recent SCI (≤5 years). RESULTS: Thirty-four individuals responded to the survey. The Five Facet Mindfulness Questionnaire (FFMQ) measures mindfulness with the following subscales: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity of inner experience. Nonjudgment of inner experience was significantly associated with depression (ß = -0.74, p = 0.007) and anxiety (ß = -0.60, p = 0.01). Nonreactivity to inner experience was significantly associated with anxiety (ß = -0.57, p = 0.007) and resilience (ß = 0.55, p = 0.004); and there was a trend with depression (ß = -0.45, p = 0.07). Higher resilience was significantly associated with less anxiety (r = -0.62, p = 0.04) and less depression (r = -0.75, p < 0.001). Depression and anxiety were significantly correlated (r = 0.84, p < 0.001). When comparing those who are employed to those who are not, they differed significantly in terms of anxiety (t(32) = 2.53, p = 0.02). CONCLUSIONS: These findings suggest that factors of mindfulness, specifically the practice of acting nonjudgmentally and nonreactively to one's inner experience, may act as protective factors against depression and anxiety following SCI. These preliminary data support the literature that individuals with lower resilience are more susceptible to depression following SCI. Interventions aimed at maximizing mental well-being following SCI may benefit from incorporating these factors of mindfulness practice.