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Application of protection motivation theory to clinical trial enrolment for pediatric chronic conditions.

ABSTRACT: BACKGROUND:Parents of children living with chronic but manageable conditions hope for improved therapies or cures, including Advanced Therapy Medicinal Products (ATMPs). Multiple pediatric clinical trials for ATMPs are underway, but the risk profile of ATMPs for chronic conditions is largely unknown and likely different than for terminal pediatric illnesses. Applying Protection Motivation Theory modified to the context of pediatric ATMP clinical trial enrollment, our study analyses information needs of parents of children living with chronic manageable conditions: Type 1 Diabetes (T1D) or Inherited Retinal Diseases (IRD). METHODS:We conducted semi-structured interviews with 15 parents of children living with T1D and 14 parents of children living with an IRD about: a) family background and the diagnostic experience; b) awareness of gene and stem cell therapy research and clinical trials for T1D and IRD; c) information sources on trials and responses to that information; d) attitudes to trial participation, including internationally; e) understanding of trial purpose and process; and f) any experiences with trial participation. We then discussed a pediatric ATMP clinical trial information sheet, which we developed with experts. We applied directed qualitative content analysis, based on PMT, to examine the information preferences of parents in deciding whether to enrol their children in stem cell or gene therapy clinical trials. RESULTS:Parents balanced trial risks against their child's ability to cope with the chronic condition. The better the child's ability to cope with vision impairment or insulin management, the less likely parents were to assume trial risks. Conversely, if the child struggled with his/her vision loss, parents were more likely to be interested in trial participation, but only if the risks were low and likelihood for potential benefit was high. CONCLUSIONS:Fear of adverse events as part of threat appraisal was the predominant consideration for parents in considering whether to enroll their child living with a manageable, chronic condition in a pediatric clinical trial of an ATMP. This consideration outweighed potential benefits and severity of their child's condition. Parents called for available safety data and fulsome communication processes that would enable them to make informed decisions about clinical trial enrolment on behalf of their children.

SUBMITTER: Brooks SP

PROVIDER: S-EPMC7075002 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Application of protection motivation theory to clinical trial enrolment for pediatric chronic conditions.

Brooks Stephanie P SP Bubela Tania T

BMC pediatrics 20200316 1

<h4>Background</h4>Parents of children living with chronic but manageable conditions hope for improved therapies or cures, including Advanced Therapy Medicinal Products (ATMPs). Multiple pediatric clinical trials for ATMPs are underway, but the risk profile of ATMPs for chronic conditions is largely unknown and likely different than for terminal pediatric illnesses. Applying Protection Motivation Theory modified to the context of pediatric ATMP clinical trial enrollment, our study analyses infor ...[more]

PMID: 32178652

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Project description:Monitoring metabolic adaptation to chronic kidney disease (CKD) early in the time course of the disease is challenging. As a non-invasive technique, analysis of exhaled breath profiles is especially attractive in children. Up to now, no reports on breath profiles in this patient cohort are available. 116 pediatric subjects suffering from mild-to-moderate CKD (n = 48) or having a functional renal transplant KTx (n = 8) and healthy controls (n = 60) matched for age and sex were investigated. Non-invasive quantitative analysis of exhaled breath profiles by means of a highly sensitive online mass spectrometric technique (PTR-ToF) was used. CKD stage, the underlying renal disease (HUS; glomerular diseases; abnormalities of kidney and urinary tract or polycystic kidney disease) and the presence of a functional renal transplant were considered as classifiers. Exhaled volatile organic compound (VOC) patterns differed between CKD/ KTx patients and healthy children. Amounts of ammonia, ethanol, isoprene, pentanal and heptanal were higher in patients compared to healthy controls (556, 146, 70.5, 9.3, and 5.4 ppbV vs. 284, 82.4, 49.6, 5.30, and 2.78 ppbV). Methylamine concentrations were lower in the patient group (6.5 vs 10.1 ppbV). These concentration differences were most pronounced in HUS and kidney transplanted patients. When patients were grouped with respect to degree of renal failure these differences could still be detected. Ammonia accumulated already in CKD stage 1, whereas alterations of isoprene (linked to cholesterol metabolism), pentanal and heptanal (linked to oxidative stress) concentrations were detectable in the breath of patients with CKD stage 2 to 4. Only weak associations between serum creatinine and exhaled VOCs were noted. Non-invasive breath testing may help to understand basic mechanisms and metabolic adaptation accompanying progression of CKD. Our results support the current notion that metabolic adaptation occurs early during the time course of CKD.

Project description:IntroductionExcessive gestational weight gain poses a significant threat to maternal and child health. The healthy behaviour theory has been increasingly applied to weight management during pregnancy, but research is still insufficient. The successful application of the protection motivation theory (PMT) and the information-motivation-behavioural skills (IMB) model in the field of healthy behaviour laid the foundation for this intervention study. The overall aim of this study is to test the effectiveness of interventions based on the behaviour model integrated with the PMT and IMB model (PMT-IMB model) on weight management and provide feasible methods for weight management during pregnancy.Methods and analysisThis prospective, single-centre, randomised controlled trial involves two steps. First, based on the PMT-IMB model, evaluation tools and intervention materials will be developed. Second, more than 800 women in the first trimester of pregnancy will be randomly assigned to two groups and will be followed until 1 week after delivery. The control group will receive standardised antenatal care (ANC), whereas the experimental group will receive both standardised ANC and interventions based on the PMT-IMB model. After three surveys (at enrolment, at 28 weeks of gestation, and on the day of hospitalisation for delivery), primary outcomes (scores of the subscales of the PMT-IMB model, scores of the pregnancy weight management strategy scale, and gestational weight gain) and secondary outcomes (pregnancy outcomes and pregnancy complications) will be obtained. Differences in outcomes between the two groups will be analysed to evaluate the effectiveness of the intervention.Ethics and disseminationThe study protocol has been approved by the ethics committee of Nanjing Medical University. All participants will sign an informed consent form prior to enrolment. The findings of the study will be published in peer-reviewed journals and presented at conferences.Trial registration numberChiCTR2100043231.

Project description:RationaleThe associations between the number of COVID-19 cases/deaths and subsequent uptake of protective behaviors may reflect cognitive and behavioral responses to threat-relevant information.ObjectiveApplying protection motivation theory (PMT), this study explored whether the number of total COVID-19 cases/deaths and general anxiety were associated with cross-situational handwashing adherence and whether these associations were mediated by PMT-specific self-regulatory cognitions (threat appraisal: perceived vulnerability, perceived illness severity; coping appraisal: self-efficacy, response efficacy, response costs).MethodThe study (#NCT04367337) was conducted in March-September 2020 among 1256 adults residing in 14 countries. Self-reports on baseline general anxiety levels, handwashing adherence across 12 situations, and PMT-related constructs were collected using an online survey at two points in time, four weeks apart. Values of COVID-19 cases and deaths were retrieved twice for each country (one week prior to the individual data collection).ResultsAcross countries and time, levels of adherence to handwashing guidelines were high. Path analysis indicated that smaller numbers of COVID-19 cases/deaths (Time 0; T0) were related to stronger self-efficacy (T1), which in turn was associated with higher handwashing adherence (T3). Lower general anxiety (T1) was related to better adherence (T3), with this effect mediated by higher response efficacy (T1, T3) and lower response cost (T3). However, higher general anxiety (T1) was related to better adherence via higher illness severity (T1, T3). General anxiety was unrelated to COVID-19 indicators.ConclusionsWe found a complex pattern of associations between the numbers of COVID-19 cases/deaths, general anxiety, PMT variables, and handwashing adherence at the early stages of the pandemic. Higher general anxiety may enable threat appraisal (perceived illness severity), but it may hinder coping appraisal (response efficacy and response costs). The indicators of the trajectory of the pandemic (i.e., the smaller number of COVID-19 cases) may be indirectly associated with higher handwashing adherence via stronger self-efficacy.

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Application of protection motivation theory to clinical trial enrolment for pediatric chronic conditions.

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Application of protection motivation theory to clinical trial enrolment for pediatric chronic conditions.

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