Caregiver Participation Research Articles

Financial, Legal, and Functional Challenges of Providing Care for People Living With Dementia and Needs for a Digital Platform: Interview Study Among Family Caregivers.

Alzheimer disease and Alzheimer disease-related dementia represent complex neuropathologies directly challenging individuals, their families, and communities in the United States. To support persons living with dementia, family or informal caregivers often encounter complex financial, psychological, and physical challenges. A widely used solution such as a consolidated web-based assistance or guidance platform is missing, compounding care challenges. In preparation for designing an internet-based artificial intelligence-driven digital resource platform, a qualitative interview study was conducted to characterize the challenges and needs of family caregivers in the United States. A semistructured interview topic guide in English was developed by engaging community partners and research partnerships. Family caregiver participants were purposefully recruited via various means, such as word of mouth, local dementia community service providers, digital recruitment emails, flyers, and social media. Interested individuals were first invited to complete an eligibility screening survey, and eligible individuals were then contacted to arrange a web-based in-depth interview via Zoom (Zoom Video Communications) from January 1, 2022, to May 31, 2022. A follow-up survey was administered in May 2022 to provide an overview of the participants' demographics, socioeconomic characteristics, and caregiving information. Thematic analysis in a framework approach was used to identify and organize themes and the study findings. Following the prescreening of 150 eligible respondents, 20% (30/150) individuals completed both the interviews and follow-up survey, allowing for an in-depth look into the challenges, experiences, and expectations of primary caregivers of people living with dementia. Most participants (20/30, 67%) were primary caregivers of persons with dementia, and 93% (28/30) had provided care for at least a year. Most participants were aged >50 years (25/30, 83%), female (23/30, 77%), White (25/30, 83%), and non-Hispanic (27/30, 90%) and held a bachelor's or graduate degree (22/30, 73%). Collectively, all participants acknowledged challenges in caring for people living with dementia. Thematic analyses elicited the challenges of caregiving related to functional care needs and financial and legal challenges. In addition, participants identified the need for an integrative digital platform where information could be supplied to foster education, share resources, and provide community support, enabling family caregivers to improve the quality of care and reducing caregiver burden. This study emphasized the difficulties associated with the family caregiver role and the expectations and potential for a supportive web-based platform to mitigate current challenges within the caregiving role.

Opinions of Turkish Physicians About the Participation of Patients and/or Patient Caregivers in Multidisciplinary Tumor Boards; A Survey Study From Tertiary Center in Konya

Abstract Objective: Multidiscplinary management is very important component of treatment of cancer. Multidisciplinary tumor boards (MB) provide the chance for shared-decision making in this complex type of disease. The participation of patients or caregivers in MB is a contentious issue and is not common in Turkey. In this study we aimed to determine what Turkish physicians participating MTBs in Selcuk University Faculty of Medicine think about the participation of patients and caregivers in MTBs. Method: The study was conducted in Selcuk University Faculty of Medicine in August 2022. The physicians that accepted to participate completed a 9-item questionnaire. The relationships between the participants’ sociodemographic characteristics and their questionnaire responses concerning MTBs were analyzed using Pearson’s chi-square test or the Fisher-Freeman-Halton test. Results: No statistically significant correlation was found between the socio-demographic characteristics of the participants and the opinions of cancer patients or their relatives about their participation in multidisciplinary tumor boards. 50 % of the participants do not approve participation of patient or caregivers in MTBs. 35 % of participants approve the participation of both in the MB. 4.4 % of participants approve only the participation of caregivers whereas only the 8.9 % of medical oncologist approve only the participation of patients in tumor board. Conclusion: Among 45 Turkish physicians in a tertiary care center, half of the participants do not approve of the participation of patients or caregivers in MTBs. The major reason for this lack of approval is fear that patients and caregivers will not understand medical terminology which may lead to misunderstanding by patients or caregivers.

Association Between Online Health Information-Seeking Behaviors by Caregivers and Delays in Pediatric Cancer: Mixed Methods Study in China.

Pediatric cancer patients in China often present at an advanced stage of disease resulting in lower survival and poorer health outcomes. One factor hypothesized to contribute to delays in pediatric cancer has been the online health information-seeking (OHIS) behaviors by caregivers. This study aims to examine the association between OHIS behaviors by caregivers and delays for Chinese pediatric cancer patients using a mixed methods approach. This study used a mixed methods approach, specifically a sequential explanatory design. OHIS behavior by the caregiver was defined as the way caregivers access information relevant to their children's health via the Internet. Delays in pediatric cancer were defined as any one of the following 3 types of delay: patient delay, diagnosis delay, or treatment delay. The quantitative analysis methods included descriptive analyses, Student t tests, Pearson chi-square test, and binary logistic regression analysis, all performed using Stata. The qualitative analysis methods included conceptual content analysis and the Colaizzi method. A total of 303 pediatric cancer patient-caregiver dyads was included in the quantitative survey, and 29 caregivers completed the qualitative interview. Quantitative analysis results revealed that nearly one-half (151/303, 49.8%) of patients experienced delays in pediatric cancer, and the primary type of delay was diagnosis delay (113/303, 37.3%), followed by patient delay (50/303, 16.5%) and treatment delay (24/303, 7.9%). In this study, 232 of the 303 (76.6%) caregiver participants demonstrated OHIS behaviors. When those engaged in OHIS behaviors were compared with their counterparts, the likelihood of patient delay more than doubled (odds ratio=2.21; 95% CI 1.03-4.75). Qualitative analysis results showed that caregivers' OHIS behaviors impacted the cancer care pathway by influencing caregivers' symptom appraisal before the first medical contact and caregivers' acceptance of health care providers' diagnostic and treatment decisions. Our findings suggest that OHIS among Chinese pediatric caregivers may be a risk factor for increasing the likelihood of patient delay. Our government and society should make a concerted effort to regulate online health information and improve its quality. Specialized freemium consultations provided by health care providers via online health informatic platforms are needed to shorten the time for caregivers' cancer symptom appraisal before the first medical contact.

Underserved head-and-neck and lung cancer patient characteristics are associated with caregiver participation in a clinical trial

BackgroundPatient-caregiver relationships affect cancer outcomes, yet factors related to joint enrollment in cancer research trials are unclear. This work examined associations between cancer patients' sociodemographic and health factors and their caregivers’ trial participation. MethodsBaseline data were drawn from a parent trial testing psychosocial interventions delivered to medically underserved head-and-neck cancer (HNC) and lung cancer (LC) patients (N = 274) and caregivers (N = 210). Logistic regression evaluated whether patient characteristics were associated with participating alone versus with a caregiver(s) and type of caregiver. ResultsMany patients (65.0%) had a caregiver in the study, which was more common for married (OR = 2.05, p < .01) and retired patients (OR = 1.95, p < .05). Patients who indicated Hispanic (OR = 2.31, p < .05), Medicaid insurance (OR = 4.12, p < .001), monthly income <$4000 (OR = 3.04, p < .01), and smoked (OR = 2.87, p < .01) were more likely to enroll with a non-spouse/partner caregiver versus a spouse/partner. Participation was unrelated to distress. ConclusionsPatient characteristics highlight caregiver relationships, informing trial design and recruitment for medically underserved cancer populations. Psychosocial interventions targeting underserved patients and their informal caregivers, those most in need of intervention support, should consider the inclusion of non-spousal cancer caregivers. Understanding how patient factors may be associated with caregiver involvement informs recruitment strategies and increases the utility of psychosocial interventions.

Pain Management Education for Rural Hospice Family Caregivers: A Pilot Study With Embedded Implementation Evaluation.

Assessing and managing hospice patients' pain is a common source of anxiety among hospice family caregivers (HFCGs), especially caregivers in rural communities who face special challenges including distance, limited access, and concerns about opioid misuse. To pilot test Ready2Care, a pain management education intervention for rural HFCGs. We sought to determine whether there was a signal of benefit for clinically-relevant outcomes and to identify contextual factors pertinent to conducting a future randomized clinical trial of Ready2Care. We conducted a multi-method, single-arm study, enabling completion of paired t-tests comparing pre- and post-intervention measures of caregiver anxiety, pain management self-efficacy, barriers to pain management, and reports of patient pain intensity and corresponding patient and caregiver distress. We concurrently conducted an embedded implementation evaluation via calculation of descriptive statistics (recruitment and retention data) and directed content analysis of brief caregiver interviews. Twenty-seven (n = 27) HFCGs participated; 15 completed the study. Among completers, significant improvement was observed in patient pain intensity (average 1.4 points decrease on 0-10 scale) and in overall pain experience. No statistically significant changes were detected in caregiver anxiety, barriers to pain management, or pain management self-efficacy. Facilitators to successful conduct of a future clinical trial included high acceptability of Ready2Care, driven by its perceived clarity and relevance to caregivers' concerns. Barriers included lower-than-anticipated accrual and an attrition rate of nearly 44%. A multisite clinical trial of Ready2Care is warranted; however, its success may require more effective recruitment and retention strategies for rural caregiver participants.

Language modeling using an augmentative and alternative communication device during virtual schooling: A single case study

Aided augmentative and alternative communication (AAC) modeling is an important approach to facilitating language learning for individuals with complex communication repertoires. This study examines the implementation of this approach during COVID-19 virtual schooling. Key implementation challenges are identified, along with implications for educational practice to facilitate language learning. We conducted a qualitative case study of a 5-year-old child with Rett syndrome, a rare neurological disorder, who used an eye-tracking AAC device. We collected and triangulated data using participant observation of three one-on-one story reading sessions involving the child, her caregiver, and her teacher during virtual schooling as well as a semi-structured interview with the teacher. The study identified key steps for successful language modeling during virtual sessions. These included: ensuring access to the device, promoting attention through gestural and verbal prompts, providing modeling of AAC symbols, confirming responses, providing feedback, using visual supports, a collaborative approach, and positive reinforcement. Our findings suggest these strategies can help facilitate effective language development for children using AAC devices in online schooling contexts. The virtual context presented significant barriers to the practice of aided AAC modeling. Active participation of caregivers and teacher–caregiver collaboration is essential for effective implementation of aided AAC modeling during such schooling.

Glycemic Control and Associated Factors Among Children and Adolescents with Type 1 Diabetes Mellitus, Southwest Ethiopia.

Type 1 diabetes mellitus is the most common endocrine disorder among children and adolescents worldwide. Glycemic control is the ultimate goal of management of diabetes. Poor glycemic control is shown to be associated with complications of diabetes. Only a few studies have addressed the problem in Ethiopia, and this study aimed to determine the level of glycemic control and factors associated among children and adolescents with type 1 diabetes mellitus on follow up. Institution based cross sectional study design was conducted on a total of 158 children and adolescents with type 1 diabetes on follow up at Jimma Medical Center from July to October 2022. Data were collected using structured questionnaire and entered into Epi Data 3.1 then exported to SPSS for analysis. Glycemic control was assessed based on glycosylated hemoglobin (HbA1c) level. Descriptive and inferential statistics were employed, and a p-value <0.05 was considered to declare statistical significance. The mean glycosylated hemoglobin of the participants was 9.67 ± 2.28%. Of the total study participants, 121 (76.6%) had poor glycemic control. In multivariable logistic regression, guardian or father as a primary caregiver [guardian (AOR=4.45, 95%, p=0.045), father (AOR=6.02, 95%, p=0.023)], minimal involvement of caregiver in insulin injection (AOR=5.39, 95%, p=0.002), poor blood glucose monitoring adherence (AOR=4.42, 95%, p=0.026), faced problems at health facility (AOR=4.42, 95%, p=0.018) and being admitted to hospital in the past 6 months (AOR=7.94, 95%, p=0.004) were the variables significantly associated with poor glycemic control. Majority of children and adolescents with diabetes had poor glycemic control. Whereas, primary caregiver other than mother, minimal involvement of caregiver in insulin injection, and poor adherence to glucose monitoring were among the contributing factors for poor glycemic control. Therefore, adherence counseling and the participation of caregivers in diabetes management is recommended.

EXPERTS II - How are patient and caregiver participation in health and social care shaped by experienced burden of treatment and social inequalities? Protocol for a qualitative synthesis.

The workload health and social care service users and caregivers take on, and their capacity to do this work is important. It may play a key part in shaping the implementation of innovations in health service delivery and organisation; the utilisation and satisfaction with services; and the outcomes of care. Previous research has often focused on experiences of a narrow range of long-term conditions, and on factors that shape adherence to self-care regimes. With the aim of deriving policy and practice implications for service redesign, this evidence synthesis will extend our understanding of service user and caregiver workload and capacity by comparing how they are revealed in qualitative studies of lived experience of three kinds of illness trajectories: long-term conditions associated with significant disability (Parkinson's disease, schizophrenia); serious relapsing remitting disease (Inflammatory Bowel Disease, bipolar disorder); and rapidly progressing acute disease (brain cancer, early onset dementia). We will review and synthesise qualitative studies of lived experience of participation in health and social care that are shaped by interactions between experienced treatment burdens, social inequalities and illness trajectories. The review will involve:1.Construction of a theory-informed coding manual; systematic search of bibliographic databases to identify, screen and quality assess full-text papers.2.Analysis of papers using manual coding techniques, and text mining software; construction of taxonomies of service user and caregiver work and capacity.3.Designing a model of core components and identifying common factors across conditions, trajectories, and contexts.4.Work with practitioners, and a Patient and Public Involvement (PPI) group, to explore the validity of the models produced; to develop workload reduction strategies; and to consider person-centred service design. We will promote workload reduction models to support service users and caregivers and produce policy briefs and peer-reviewed publications for practitioners, policy-makers, and researchers.

Challenges and Experiences Faced by Physiotherapists in Stroke Rehabilitation: A Qualitative Study

ABSTRACT Introduction: Stroke is one of the leading causes of death and disability in India and rehabilitation therapy is underdeveloped. Neurorehabilitation is a program that caters to people who have disabilities to help them attain and maintain optimal performance. The majority of people with disabilities are economically underprivileged and have trouble getting access to basic health care (including rehabilitation). Physiotherapists also face limitations in providing services to stroke survivors and this study is to identify those challenges. Objective: The objective of this study is to identify the limitations faced by physiotherapists during stroke rehabilitation. Material and Method: In November 2022, a focus group discussion was held with a sample size of 12 physiotherapy residents from neurorehabilitation and community rehabilitation working in a tertiary hospital. After consent was taken, audiovideography was recorded, transcripted, and documented. Data were thoroughly transcribed, and thematic analysis and characteristics were established. Results: After extraction of codes and themes, the following results were found. General categories of themes are lack of awareness on stroke and physiotherapy, infrastructure, financial constraints, family dynamic, social health, amotivation and mental health, collaboration limitations, problems in-home services, and the impact of COVID-19 pandemic on rehabilitation. Recommendations given by the participants were creating a stroke community, availability of more insurance companies to support and provide relief for financial stress, early education and awareness on stroke from school level, active participation of caregivers and family members to assist the patient in home-based therapy, and availability of NGOs that cater specifically to physiotherapy. Conclusion: It was concluded that neurorehabilitation in India needs to attend to the given categories. Policymakers must be aware of the financial and social issues that stroke survivors experience and enact legislation that will decrease mental and financial stress.

Stroop for electronic touchscreen self‐administration (eStroop) as used in the remote iPACES neuro‐exergaming trial for Mild Cognitive Impairment (MCI): An initial validation report

AbstractBackgroundIn collaboration with the Mobile Monitoring of Cognitive Change (M2C2; 1‐U2C‐AG060408‐01) Project, our team developed a tablet‐based electronic Stroop (eStroop) task. Initial development explored direct translation of the paper‐Stroop (pStroop) often used in clinical settings, and found that this resulted in ceiling effects. Herein we report on initial validation of the eStroop task from the iPACES v3 clinical trial.MethodInitial validation examined eStroop data (n = 59 sessions) serially collected from ten MCI and caregiver participants in the iPACES v3 clinical trial (mean age = 70.2, mean years of education = 16.9). Included in analyses were eStroop data for both traditional metrics (i.e., overall accuracy by block condition), response time, as well as typically constructed difference/ratio scores (i.e., AC ratio). After a baseline tele‐neuropsychological evaluation in which paper Stroop was administered, at predetermined study intervals (typically weekly), participants were automatically prompted to complete the eStroop on their iPACES Android tablet. In the eStroop, participants were presented with four blocks of 40 trials: (1) color words in black font, (2) congruent word and font color; (3) incongruent words with font color; (4) mixed congruent and incongruent trials.ResultThe paper Stroop AC Ratio (total seconds to complete paper A, divided by time to complete paper C), was moderately negatively correlated (r = ‐0.52, p &lt; .001) with average response time on block three of eStroop (incongruent words with font color). The pStroop AC Ratio was also significantly negatively correlated with number of errors on block one (r = ‐0.42, p &lt; .001), two (r = ‐0.26, p = 0.04), three (r = ‐0.39, p = 0.002), and four (r = ‐0.26, p = .049). A weak, significant positive correlation (r = 0.44, p &lt; .001) was observed between the AC ratio from pStroop and eStroop. Very weak non‐significant correlations between paper Stroop AC Ratio and average response time on blocks one, two, and four of eStroop were observed.ConclusionThese pilot data provide preliminary evidence that the eStroop can serve as a remotely and self‐administered digital test for serial assessment of executive function and will be further evaluated in our current iPACES study.

Trail Making for electronic touchscreen self‐administration (eTrails) as used in the remote iPACES neuro‐exergaming trial for Mild Cognitive Impairment (MCI): An initial validation report

AbstractBackgroundTo enable brief and integrated serial assessment across a national sample, we developed an electronic version of the Trail Making test (eTrails) for remote self‐administration on digital devices. eTrails, a digital, web‐based assessment, mimicking the traditional paper version of Trails B (see demo: https://bit.ly/33DCPGP), in which participants draw a line from a number to a letter in alternating, ascending order, was integrated into the iPACES app. Herein we report on initial validation of eTrails, as compared with the paper Trail Making Test.MethodThis initial validation report examined digital trail making data (n = 34 sessions) serially collected from ten MCI and caregiver participants in the iPACES v3 clinical trial (mean age = 70.2, mean years of education = 16.9). Included in analyses were eTrails data for traditional metrics (i.e., overall completion time) and novel digital biomarkers extracted from event‐level data (e.g., # of lifts and pause time). After a baseline tele‐neuropsychological evaluation in which paper Trail Making was administered (Forms A&amp;B), at predetermined study intervals (typically weekly), participants were automatically prompted to complete the eTrails on their iPACES tablet. In the eTrails, participants were presented with one of four randomly selected alternate forms of trail making stimuli (i.e., different spatial configurations of Form B).ResultOverall completion time from eTrails was moderately correlated with both forms of paper‐based trail making completed at baseline (correlation with Paper Trails A: r = .37, p = .030; correlation with Paper Trails B: r = .41, p = .017). Novel digital biomarkers (i.e., # lifts, pause time) were moderately correlated (r’s = 0.59‐0.6, p’s &lt; .001) with the traditional scoring of the eTrails (i.e., assessment completion time in seconds), and though non‐significant, weakly correlated with completion time of paper Trails A (r = 0.20, p = 0.25).ConclusionThese preliminary data provide initial evidence of validity, that eTrails as a serial assessment of subtle cognitive decline can serve as a remote self‐administered digital test for serial assessment of executive function and will be further evaluated in our ongoing iPACES study. Future research may explore the sensitivity of novel digital biomarkers extractable from event‐level data.

A question prompt list for sudden unexpected death in epilepsy

A question prompt list for sudden unexpected death in epilepsy

Caregiver Engagement in Outpatient Treatment for Adolescents in Community Settings: Construct and Predictive Validity of Family Therapy Techniques.

Caregiver engagement and participation in community-based outpatient treatment services for adolescents is generally poor, which is problematic given the integral role of caregivers prescribed by evidence-based treatments across orientations. The current study explores the psychometric and predictive properties of a set of caregiver engagement techniques distilled from family therapy, used by community clinicians in routine care. It highlights relational engagement interventions and adds to growing work distilling core elements of family therapy. The study examined caregiver engagement techniques observed in 320 recorded sessions and outcome data from 152 cases treated by 45 therapists participating in one of three randomized trials investigating delivery of family therapy for adolescent behavior problems in community settings. Construct and predictive validity of caregiver engagement coding items were analyzed to understand the degree to which they cohered as a single factor and predicted outcomes in predictable ways. Results demonstrated item reliability and construct validity of a Caregiver Engagement Techniques factor. Greater use of these techniques was associated with decreased adolescent substance use. Unexpected results suggested greater use of techniques was associated with worsening internalizing symptoms and family cohesion per youth-report only. Post-hoc analyses revealed additional complexities in the association between engagement techniques and outcomes. Caregiver engagement practices tested in the current study represent a unified treatment factor that may contribute to positive therapeutic outcomes for adolescents in some clinical domains. Further research is needed to understand predictive effects.

The use of music therapy to address psychosocial needs of informal caregivers: An integrative review

In 2020 there were estimated to be 117 million Americans who needed care assistance, which continues to rise as the aging population increases. The complexities of caregiving duties, the balance of employment, and how long caregiving duties last contribute to caregiver physiological and psychological health needs. Music therapy, an interdisciplinary health profession incorporating patient-and-family centered care, is an effective nonpharmacological approach for psychosocial health needs, including those effecting informal caregivers. The purpose of this investigation was to systematically review and analyze the existent music therapy literature addressing psychosocial needs of informal caregivers. Studies were obtained through a computer-assisted search using OneSearch platform, ProQuest Databases, and a manual search of pertinent journals based on the established criteria. The search produced (N = 50) studies, which were appraised for quality utilizing Cuenca & Crawford’s (2011) Evidence Leveling System (ELS). Three categories were developed to sort and synthesize the literature including articles with interventions targeting joint informal caregiver (ICG) and care receiver (CR) participation (n = 30), ICG specific participation (n = 12), and CR specific participation (n = 8). Most studies utilized an experimental design (n = 15) and incorporated a variety of active music therapy techniques in a group format (n = 10) or songwriting (n = 13).

Concept analysis: Community-based postnatal care.

Community-based postnatal care is a valuable resource in the provision of maternal and neonatal care, specifically outside the hospital environment. However, its application in maternal and neonatal care is not clearly documented in relation to the rendering of services by primary caregivers. This study clarifies the concept of 'community-based postnatal care' by using the concept analysis method. To analyse the concept, relevant literatures were reviewed and analysed using the Walker and Avant method, namely, selecting a concept, determining the purpose of analysis, identifying all uses of the concept, defining attributes, identifying a model case, identifying borderline, related and contrary cases, identifying antecedents and consequences and identifying the empirical referents. Characteristics that repeatedly appeared throughout the literature were noted and categorised. It was established from the concept analysis that 'community-based postnatal care' was complex and experienced ethnically. The analysis included that primary caregiver participation was based on home-levelled-skilled care, community participation and mobilisation, linkages of health services and community stakeholders. The attributes were influenced by antecedents and consequences. The empirical referents of community based can be integrated within the midwifery guidelines to measure the concept. When concepts are understood, self-care on early detection, early management and referral during early postnatal care will be enhanced.Contribution:The results of this study will foster independence, confidence and a respectful relationship between primary caregivers and the health care facility staff. The results are expected to guide future research and enhance community-based postnatal care in midwifery practice.

Examining the Feasibility of Telehealth Trauma-Focused Cognitive Behavioural Therapy (TF-CBT) with Young People in Foster Care.

Purpose: Despite the high rate of trauma exposure among young people with child welfare involvement, various systematic and patient barriers exist that inhibit utilization of evidence-based trauma treatments. One strategy for alleviating barriers to such treatments is using telehealth. A few studies have found that the clinical outcomes of telehealth TF-CBT are comparable to those found from clinic-based, in-person treatment administration. Studies have yet to examine the feasibility of telehealth TF-CBT with young people in care. The current study sought to address this gap by examining outcomes for patients who received telehealth TF-CBT, along with factors that may have impacted successful completion, at an integrated primary care clinic exclusively serving young people in care. Methods: Patient data were collected retrospectively from the electronic health records of 46 patients who received telehealth TF-CBT between March 2020 and April 2021, and feedback was sought via focus group from 7 of the clinic's mental health providers. A paired-sample t-test was conducted to evaluate the impact of the intervention for the 14 patients who completed treatment. Results: Responses from the Child and Adolescent Trauma Screen showed a significant decrease in posttraumatic stress symptoms when comparing pre-treatment scores (M = 25.64, SD = 7.85) to post-treatment scores (13.57, SD = 5.30), t(13) = 7.50, p < .001. The mean decrease in scores was 12.07 with a 95% confidence interval ranging from 8.60 to 15.55. Themes emerging from the focus group centered on home environment, caregiver participation, and systemic topics. Conclusions: Findings suggest that telehealth TF-CBT with young people in care is feasible but relatively low completion rates suggest that barriers to treatment completion remain.

Experiences of and recommendations on clinical trial design in Alzheimer’s disease from the participant’s point of view: a mixed-methods study in two clinical trial centers in the Netherlands

IntroductionIn the context of the development of pharmaceutical interventions, expectations and experiences of participants are essential. Their insights may be particularly helpful to address the challenges of recruiting and retaining participants for Alzheimer’s disease (AD) clinical trials. We examined clinical trial participants’ experiences to optimize trial design in Alzheimer’s disease (AD).MethodIn this mixed-methods study, we included adults who participated in sponsor-initiated AD trials at Brain Research Center, a clinical trial organization in the Netherlands. Participants (N = 71, age 69 ± 6.5, 54%F, 19 cognitively normal (CN), 19 mild cognitive impairment (MCI), and 33 AD dementia) first completed an online survey. Diagnostic group differences were investigated using chi-square tests or one-way ANOVAs. Next, a subsample (N = 12; 8 = CN, 4 = MCI) participated in focus groups to gain in-depth insight into their opinions on optimizing trial design from a participants’ point of view. Audio recordings from focus group interviews were transcribed verbatim and analyzed by thematic content analysis by two independent researchers.ResultsMost reported motives for enrolment included “to benefit future generations” (89%), followed by “for science” (66%) and “better monitoring” (42%). Frequent suggestions for increasing willingness to participate included a smaller chance to receive placebo (n = 38, 54%), shorter travel times (n = 27, 38%), and sharing individual results of different assessments (n = 57, 80%), as well as receiving trial results (n = 52, 73). Highest visual analogue burden scores (0–100) were found for the lumbar puncture (M = 47.2, SD = 38.2) and cognitive assessments (M = 27.2, SD = 25.7). Results did not differ between diagnostic groups, nor between patient and caregiver participants (all p-values>.05). Two additional themes emerged from the focus groups: “trial design,” such as follow-up visit(s) after participating, and “trial center,” including the relevance of a professional and empathic staff.ConclusionRelevant factors include expectation management and careful planning of high-burden assessments, provision of individual feedback, and prioritizing professionalism and empathy throughout conduct of the trial. Our findings provide insight into participants’ priorities to increase willingness to participate and can be used to optimize trial success.

Effectiveness of Pictorial Education Handout on Tracheostomy Care Self-efficacy in Patients With Head and Neck Cancer and Family Caregivers: A Pilot Quasi-Experimental Study.

Learning and performing tracheostomy care are challenging for laypersons. Effective pictorial patient education handouts are needed for nonprofessional individuals to learn health management skills. The study aims to (1) evaluate the preliminary efficacy of the pictorial education handout on patients' and family members' self-efficacy in tracheostomy care and (2) identify demographic, psychological, and education-related factors associated with lower self-efficacy on tracheostomy care. This was a preliminary pilot study with a pretest-posttest design. We recruited a total of 39 participants, including 22 patients with head and neck cancer-related tracheostomy and 17 family caregivers in 2021. All participants received A3-size (297 × 420 mm) pictorial patient education handouts on how to suction and how to clean their tracheostomy at home. Pictorial education handouts showed a medium to large effect size on self-efficacy in the patient (Cohen D = 0.46) and caregiver participants (Cohen D = 0.78). Participants with higher anxiety were associated with a greater gain in self-efficacy with the pictorial patient education handouts ( r = 0.35, P = .027). Pictorial patient education handouts were effective tools for improving patients' and family caregivers' confidence in tracheostomy care, and it is particularly helpful for individuals with high anxiety with tracheostomy. Clinical nurses should use the pictorial education handouts not only to assist patients and family members on learning and practicing tracheostomy care but also to relieve anxiety associated with tracheostomy care at home.

Assessing the Comprehensive Training Needs of Informal Caregivers of Cancer Patients: A Qualitative Study.

The increasing demand for cancer services is projected to overwhelm the cancer care system, leading to a potential shortfall in human resource capacity. Informal caregivers (unpaid family/friend caregivers of cancer patients) provide a significant amount of care to patients and the cancer care system could not cope without them. The aim of this study was to analyze the needs of informal caregivers (CGs) through interviews with cancer patients and CGs, and to assess the content and utility of a comprehensive caregiver training course. Cancer patients and CGs were recruited from an academic cancer centre to elicit their thoughts and perceptions of cancer CG education needs through a qualitative, phenomenological design using semi-structured interviews and a curriculum review activity. Six patients and seven CGs were interviewed. Patients averaged 53.8 years of age and CGs averaged 53.1 years. Caregiver participants reported that they were unprepared for their caregiving role. Depending on the severity of the disease, CGs reported significant emotional strain. Most participants wanted more practical information, and all expressed the desire for greater social support for CGs. While there were differences in terms of desired modality (e.g., online, in-person), support for greater CG education was strong. CGs experience a significant learning curve and receive little to no direct training or education to help them acquire the knowledge and skills they need to support a cancer patient. This is especially challenging for new CGs, for whom emotional and informational needs are particularly acute. Participants shared a great deal of endorsement for a comprehensive training course for new CGs. Given the multiple demands on their time, some participants suggested that consideration be made to establish synchronous classes. Participants held that having the course take place (online or in-person) at a specific time, on a specific date could help CGs prioritize their learning. Participants also endorsed the idea of "required" learning because even though CGs may recognize that a course could be beneficial, some may lack the motivation to participate unless it was "prescribed" to them by a healthcare provider.

Clinical characteristics of 80 subjects with KCNQ2-related encephalopathy: Results from a family-driven survey

Variants of KCNQ2 are associated with a wide spectrum of disorders, ranging from Self-limiting Neonatal Epilepsy (SelNE) to Early Onset Developmental and Epileptic Encephalopathy (KCNQ2-DEE). Comorbidities associated with this end of the spectrum have been seldomly described and their impact on the life of patients and their families is yet to be investigated.Collaborating with caregivers from different European family associations, we have developed a questionnaire aimed at investigating the onset and frequency of epileptic seizures, anti-seizure medications (ASM), hospitalizations, stages of development, and comorbidities.Responses from 80 patients, 40 males, from 14 countries have been collected. Median age 7.6 years (4 months – 43.6 years). Of 76 epileptic patients (93.6%), 55.3% were seizure-free with a mean age at last seizure of 26.7 months. Among patients with active epilepsy, those older have a lower frequency of seizures (p > 0.05). We were able to identify three different clusters of varying severity (Mild, Severe, Profound), based on neurodevelopmental features and symptoms, excluding epilepsy. Patients in a higher severity cluster had a higher mean number of comorbidities, which had a higher impact on families. Notably, patients in different clusters presented different epilepsy onset and courses.This study constitutes the most extensive data collection of patients with KCNQ2-DEE, with a focus on comorbidities in a wide age group. The participation of caregivers helps to define the impact of the disease on the lives of patients and families and can help identify new primary and secondary outcomes beyond seizures in future studies.