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Effect of Delayed-Release and Extended-Release Methylphenidate on Caregiver Strain and Validation of Psychometric Properties of the Caregiver Strain Questionnaire: Results from a Phase 3 Trial in Children with Attention-Deficit/Hyperactivity Disorder.
López, FA, Faraone, SV, Newcorn, JH, Doll, HA, Rhoten, S, Lewis, HB, Khan, TF, DeSousa, NJ, Sallee, FR, Incledon, B
Journal of child and adolescent psychopharmacology. 2021;(3):179-186
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Abstract
Objectives: Inadequately controlled symptoms and associated impaired functioning have a significant negative impact on caregivers of children with attention-deficit/hyperactivity disorder (ADHD). This study aimed to assess the impact of evening-dosed, delayed-release and extended-release methylphenidate (DR/ER-MPH) treatment on caregiver strain, measured by the Caregiver Strain Questionnaire (CGSQ), and present post hoc psychometric analyses assessing the reliability and validity of the CGSQ, its ability to detect change (responsiveness), and to derive responder definitions. Methods: The CGSQ was an exploratory efficacy endpoint in a phase 3, 3-week, randomized, double-blind, multicenter, placebo-controlled, forced-dose titration trial of DR/ER-MPH in children aged 6-12 years with ADHD (NCT02520388). Psychometric properties of the CGSQ evaluated post hoc included internal consistency using Cronbach's alpha; test/retest reliability using intraclass correlation coefficients (ICCs); construct validity (known groups and convergent/divergent validity); responsiveness to changes in assessments of ADHD severity (ADHD Rating Scale-IV [ADHD-RS-IV], Conners' Global Index-Parent [CGI-P], and Clinical Global Impression-Severity [CGI-S]/CGI-Improvement [CGI-I]); and meaningful change threshold (MCT) using receiver operating characteristic curves, which were used to compare response between DR/ER-MPH and placebo groups. Results: Randomized DR/ER-MPH (54.5) and placebo (54.9) groups had similar mean CGSQ scores at screening. Caregivers of children on DR/ER-MPH reported significant reductions in CGSQ scores after 3 weeks of DR/ER-MPH treatment versus placebo (least-squares mean: 41.2 vs. 49.1; p < 0.001). The CGSQ demonstrated strong internal consistency (Cronbach's alpha = 0.93) and good test/retest reliability (ICC = 0.72). Known groups, convergent/divergent validity, and responsiveness were demonstrated from relationships between the CGSQ and the CGI-S, ADHD-RS-IV, and CGI-P. The mean anchor-based MCT for CGSQ total score was estimated as -9.0 (DR/ER-MPH vs. placebo: 53.2% vs. 29.9% p = 0.003). Conclusions: CGSQ scores significantly decreased after 3 weeks of DR/ER-MPH treatment versus placebo, and the CGSQ was found to be a valid and reliable measure of strain in caregivers of children with ADHD. Clinical trial registration identification number: NCT02520388.
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Parental evaluation of a telemonitoring service for children with Type 1 Diabetes.
Losiouk, E, Lanzola, G, Del Favero, S, Boscari, F, Messori, M, Rabbone, I, Bonfanti, R, Sabbion, A, Iafusco, D, Schiaffini, R, et al
Journal of telemedicine and telecare. 2018;(3):230-237
Abstract
Introduction In the past years, we developed a telemonitoring service for young patients affected by Type 1 Diabetes. The service provides data to the clinical staff and offers an important tool to the parents, that are able to oversee in real time their children. The aim of this work was to analyze the parents' perceived usefulness of the service. Methods The service was tested by the parents of 31 children enrolled in a seven-day clinical trial during a summer camp. To study the parents' perception we proposed and analyzed two questionnaires. A baseline questionnaire focused on the daily management and implications of their children's diabetes, while a post-study one measured the perceived benefits of telemonitoring. Questionnaires also included free text comment spaces. Results Analysis of the baseline questionnaires underlined the parents' suffering and fatigue: 51% of total responses showed a negative tendency and the mean value of the perceived quality of life was 64.13 in a 0-100 scale. In the post-study questionnaires about half of the parents believed in a possible improvement adopting telemonitoring. Moreover, the foreseen improvement in quality of life was significant, increasing from 64.13 to 78.39 ( p-value = 0.0001). The analysis of free text comments highlighted an improvement in mood, and parents' commitment was also proved by their willingness to pay for the service (median = 200 euro/year). Discussion A high number of parents appreciated the telemonitoring service and were confident that it could improve communication with physicians as well as the family's own peace of mind.
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Caregiver-Reported Quality of Life in Youth with Down Syndrome.
Xanthopoulos, MS, Walega, R, Xiao, R, Prasad, D, Pipan, MM, Zemel, BS, Berkowitz, RI, Magge, SN, Kelly, A
The Journal of pediatrics. 2017;:98-104.e1
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Abstract
OBJECTIVES To describe caregiver-reported quality of life (QOL) in youth with Down syndrome (DS) and to examine the role of obesity on QOL. STUDY DESIGN Caregivers of youth with and without DS aged 10 through 20 years completed questionnaires examining QOL (Pediatric Quality of Life Questionnaire) and weight-related QOL (Impact of Weight on Quality of Life - Kids). Age- and sex-specific z scores were generated for body mass index. Obesity was defined as a body mass index ≥95th percentile for age and sex. RESULTS Caregiver-reported Total QOL, Physical Health, and Psychosocial Health summary scores were all lower in the DS group compared with the non-DS controls (P < .001). Social and School Functioning were also lower (P < .001), but Emotional Functioning did not differ between DS and non-DS groups (P = .31). Physical Functioning (P = .003) and Total scores (P = .03) differed between youth without DS with and without obesity, but no differences were reported between youth with DS with and without obesity. On the Impact of Weight on Quality of Life - Kids, caregivers of youth with DS reported greater Body Esteem (P = .020) and Social Life scores (P = .03) than caregivers of non-DS youth. Caregivers of youth with obesity, regardless of DS status, reported significantly lower weight-specific QOL scores than caregivers of youth without obesity. CONCLUSION Caregivers reported lower QOL in youth with DS compared with youth without DS with the exception of emotional functioning. Obesity influences most domains of weight-related QOL in youth with and without DS; therefore, providers should address weight concerns in youth with obesity even in the presence of DS. CLINICAL TRIAL REGISTRATION NCT01821300.
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Evaluation of caregiver-friendly workplace policy (CFWPs) interventions on the health of full-time caregiver employees (CEs): implementation and cost-benefit analysis.
Williams, AM, Tompa, E, Lero, DS, Fast, J, Yazdani, A, Zeytinoglu, IU
BMC public health. 2017;(1):728
Abstract
BACKGROUND Current Canadian evidence illustrating the health benefits and cost-effectiveness of caregiver-friendly workplace policies is needed if Canadian employers are to adopt and integrate caregiver-friendly workplace policies into their employment practices. The goal of this three-year, three study research project is to provide such evidence for the auto manufacturing and educational services sectors. The research questions being addressed are: What are the impacts for employers (economic) and workers (health) of caregiver-friendly workplace policy intervention(s) for full-time caregiver-employees? What are the impacts for employers, workers and society of the caregiver-friendly workplace policy intervention(s) in each participating workplace? What contextual factors impact the successful implementation of caregiver-friendly workplace policy intervention(s)? METHODS Using a pre-post-test comparative case study design, Study A will determine the effectiveness of newly implemented caregiver-friendly workplace policy intervention(s) across two workplaces to determine impacts on caregiver-employee health. A quasi-experimental pre-post design will allow the caregiver-friendly workplace policy intervention(s) to be tested with respect to potential impacts on health, and specifically on caregiver employee mental, psychosocial, and physical health. Framed within a comparative case study design, Study B will utilize cost-benefit and cost-effectiveness analysis approaches to evaluate the economic impacts of the caregiver-friendly workplace policy intervention(s) for each of the two participating workplaces. Framed within a comparative case study design, Study C will undertake an implementation analysis of the caregiver-friendly workplace policy intervention(s) in each participating workplace in order to determine: the degree of support for the intervention(s) (reflected in the workplace culture); how sex and gender are implicated; co-workers' responses to the chosen intervention(s), and; other nuances at play. It is hypothesized that the benefits of the caregiver-friendly workplace policy intervention(s) will include improvements in caregiver-employees' mental, psychosocial and physical health, as well as evidence of cost-benefit and cost-effectiveness for the employer. DISCUSSION The expected project results will provide the research evidence for extensive knowledge translation work, to be carried out in collaboration with our knowledge transition partners, to the employer/human resources and occupational health/safety target populations. TRIAL REGISTRATION ISRCTN16187974 Registered August 25, 2016.
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Excellent inter-rater, intra-rater, and telephone-administered reliability of the ALSFRS-R in a multicenter clinical trial.
Kaufmann, P, Levy, G, Montes, J, Buchsbaum, R, Barsdorf, AI, Battista, V, Arbing, R, Gordon, PH, Mitsumoto, H, Levin, B, et al
Amyotrophic lateral sclerosis : official publication of the World Federation of Neurology Research Group on Motor Neuron Diseases. 2007;(1):42-6
Abstract
We wished to determine whether the Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) is reliable when used as primary outcome measure in a multicenter clinical trial. To establish inter-rater reliability, we randomly assigned 19 primary raters and 11 back-up raters to score nine amyotrophic lateral sclerosis (ALS) patients using the ALSFRS-R. To assess intra-rater reliability and reliability of telephone administration, we randomly assigned consecutive participants of the Clinical Trial of High Dose Coenzyme Q10 in ALS (QALS) to have in-person ALSFRS-R interviews at both screening and baseline visits (n=41 patients) or to have the ALSFRS-R interview by telephone at screening and in person at the baseline visit (n=27). An intraclass correlation coefficient (ICC) of reliability was calculated using a one-way random effects analysis of variance model. In the inter-rater reliability assessment, the primary raters performed 54 ratings on nine patients with ICC=0.93 (95% CI 0.84-0.98). For back-up raters, 32 ratings on nine patients resulted in ICC=0.93 (95% CI 0.82-0.98). The intra-rater reliability for in-person interviews was ICC = 0.95 (95% CI 0.92-0.98). The reliability of telephone administration compared to in-person interviews was ICC=0.97 (95% CI 0.93-0.98). We conclude that the ALSFRS-R shows excellent inter- and intra-rater reliability, and reliability of telephone administration when used as primary outcome measure in a multicenter ALS trial.
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Cognition, function, and caregiving time patterns in patients with mild-to-moderate Alzheimer disease: a 12-month analysis.
Feldman, HH, Van Baelen, B, Kavanagh, SM, Torfs, KE
Alzheimer disease and associated disorders. 2005;(1):29-36
Abstract
Placebo data were pooled from two 1-year, randomized, double-blind, placebo-controlled trials of sabeluzole in patients with mild-to-moderate Alzheimer disease (AD). Cognition was assessed using the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and activities of daily living (ADL) with the Disability Assessment in Dementia (DAD). Time spent assisting with ADL was estimated according to the caregiver for each DAD domain in the 2 weeks before assessment. Progressive annual decline was seen on ADAS-cog (5.6 +/- 7.3 [mean +/- SD]) and DAD (-12.4 +/- 17.8), with greater decline in moderate patients (Mini-Mental State Examination [MMSE] < or =18) than mild patients (MMSE >18). An MMSE score of 16 appeared to be a key transition point at which most instrumental ADL were lost and major losses of basic ADL began to occur over the next 12 months. Caregivers spent, on average, 14 hours more assisting with ADL over 2 weeks at the end of 1 year. The proportion of care provided by paid caregivers increased relative to the time spent by informal caregivers. Patients with mild-to-moderate AD experience predictable annual decline in cognition and daily functioning, with measurably increased caregiver time. Small changes in ADAS-cog are nevertheless associated with a substantial measurable effect on the daily lives of both patients and caregivers.
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Acute procoagulant stress response as a dynamic measure of allostatic load in Alzheimer caregivers.
von Känel, R, Dimsdale, JE, Patterson, TL, Grant, I
Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2003;(1):42-8
Abstract
Allostasis designates processes of bodily adaptation to stressful challenges, whereas allostatic load means the costs of wear and tear to the body as a consequence of inefficient allostasis. In distressed dementia caregivers, an acute procoagulant stress response might be one dynamic mediator of allostatic load relevant to cardiovascular endpoints. An interviewer assessed the number of negative life-events independent from caregiving over 4 weeks in 37 spousal Alzheimer caregivers (M age +/- SD = 72 +/- 6 years). Baseline procoagulability scores and procoagulability scores in response to a 15-min speech task included plasma thrombin/antithrombin III complex, D-dimer, von Willebrand factor, tissue-type plasminogen activator, and plasminogen activator inhibitor 1 levels. Allostatic load was defined as the difference in procoagulability scores from baseline to speech, using standardized (z-score) transformations. Speech stress significantly increased heart rate (p =.017), systolic blood pressure (p =.002), and diastolic blood pressure (p <.001). The number of negative life-events (M +/- SD 2.8 +/- 2.0) correlated with allostatic load (r =.367, p =.026). After controlling for age and smoking, which together explained 32% of the variance in the allostatic load (R2 =.324), F(2, 34) = 8.14, p =.001, the number of negative life-events accounted for an additional 13% of that variance (Delta R2=.125), Delta F(1, 33) = 7.49, p =.010. The finding is compatible with the concept of allostasis and allostatic load, suggesting that higher combined caregiving and life distress levels are associated with more dysfunctional hemostatic responses to acute mental stress. The acute procoagulant stress response might constitute a dynamic mediator of allostatic load in Alzheimer caregivers.
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An exercise program for women who are caring for relatives with dementia.
Castro, CM, Wilcox, S, O'Sullivan, P, Baumann, K, King, AC
Psychosomatic medicine. 2002;(3):458-68
Abstract
OBJECTIVE This study describes factors related to retention and adherence to an exercise program for women caregivers. METHODS One hundred sedentary women (average age = 62 years) caring for relatives with dementia were randomly assigned to an exercise program or an attention control (nutrition education) condition. Participants in the exercise condition received 12 months of home-based exercise counseling to achieve at least four exercise sessions per week, for at least 30 minutes per session. Adherence was tracked through monthly exercise logs, validated in a subsample by ambulatory heart rate and motion monitors. Participants also completed a psychosocial questionnaire battery at baseline and 12 months after randomization. RESULTS Participants achieved a 12-month average exercise adherence rate of 74% (ie, three exercise sessions per week) with an average of 35 minutes per session. At 12 months, the exercise condition demonstrated increased knowledge of the benefits of exercise and increased motivational readiness for exercise compared with the nutrition education condition. Both groups significantly improved in perceived stress, burden, and depression from baseline to posttest. Women who were older, less depressed, and more anxious at baseline showed better program retention, and lower baseline depression was associated with better exercise adherence. CONCLUSIONS This study demonstrates the feasibility and success of delivering home-based health promotion counseling for improving physical activity levels in a highly stressed and burdened population. Given the independent risk factors of caregiving and physical inactivity on mortality, programs to improve healthful behaviors are needed to preserve the health of caregivers as they undertake this important familial and societal role.
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A nutritional education program could prevent weight loss and slow cognitive decline in Alzheimer's disease.
Rivière, S, Gillette-Guyonnet, S, Voisin, T, Reynish, E, Andrieu, S, Lauque, S, Salva, A, Frisoni, G, Nourhashemi, F, Micas, M, et al
The journal of nutrition, health & aging. 2001;(4):295-9
Abstract
BACKGROUND Weight loss is a common problem in patients with Alzheimer's Disease (AD). It is a predictive factor of mortality and it decreases patients' and caregivers' quality of life. OBJECTIVE To determine if a nutritional education program can prevent weight loss in AD patients. SUBJECTS 151 AD patients and their caregivers were enrolled to follow the intervention and 74 AD patients and their caregivers constituted a control group. METHOD Caregivers in the intervention group followed 9 nutritional sessions of one hour each, over one year. Caregivers in the control group didn't follow any sessions but were offered advice provided in a normal follow-up. Patients weight, nutritional state, cognitive function, autonomy, mood, behaviour disorders at baseline and at 6- and 12-month follow-up. Caregivers burden, nutritional and AD knowledge at the baseline and at the 12-month follow-up. RESULTS During the year follow-up, the mean weight increased in the intervention group (0.7+/-3.6 kg) whereas it decreased in the control group (-0.7+/-5.4 kg) (p<0.05). The nutritional status (MNA) was maintained in the intervention group (0.3+/-2.6) whereas it decreased significantly in the control group (-1.0+/-3.4) (p<0.005). After adjustment for baseline differences between the two groups (caregiver age, nutritional state, eating behaviour disorders, depression), the weight change between the two groups was not significant (0.6+/-0.4 kg vs. -0.6+/-0. 6 kg respectively in intervention group and control group). However, the percentage of patients with significant weight loss is decreased. The MMSE change became significant between the two groups: -2.3+/-0.3 vs. -3.4+/-0.4 respectively in intervention group and control group (p<0.05). CONCLUSIONS These results suggest that a nutritional educational program intended for caregivers of AD patients could have a positive effect on patients weight and cognitive function.