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Telehealth Behavioral Intervention for Chronic Disease Self-Management in Adults With Physical Disabilities (My Health, My Life, My Way): Protocol for Intervention Fidelity and Dashboard Design for a Randomized Controlled Trial.
Evans, E, Zengul, A, Subhash Chilke, T, Knight, A, Willig, A, Cherrington, A, Mehta, T, Thirumalai, M
JMIR research protocols. 2024;:e53410
Abstract
BACKGROUND Individuals with physical disabilities experience higher rates of chronic health conditions than individuals without physical disabilities. Self-management programs that use health coaching are effective at eliciting health behavior change in health outcomes such as goal setting, adherence, and health care use. Additionally, web-based resources such as telehealth-based technologies, including SMSS text messaging, web-based applications, and educational multimedia content, can complement health coaching to improve health-related behaviors and the use of health services. The complexity of studies using these resources requires a fidelity protocol to ensure that health behavior studies are administered properly. OBJECTIVE The My Health, My Life, My Way fidelity protocol provides methods, strategies, and procedures of a multifaceted telehealth program for individuals with permanent physical disabilities and chronic health conditions. This health behavior study is a randomized controlled trial with four study arms: (1) scheduled coaching calls with gamified rewards, (2) no scheduled coaching calls with gamified rewards, (3) scheduled coaching calls with fixed rewards, and (4) no scheduled coaching calls with fixed rewards. To guide the fidelity protocol developed, we used the National Institutes of Health Behavior Change Consortium framework (NIH BCC). METHODS The fidelity intervention protocol was developed by using the 5 primary domains provided by the NIH BCC study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. Following the NIH BCC guidelines and implementing social cognitive theory, this study is designed to ensure that all study arms receive equal treatment across conditions and groups. Health coaches and providers will be trained to deliver consistent health coaching, and thus participants will receive appropriate attention. Educational content will be developed to account for health literacy and comprehension of the material. Multiple fidelity intervention steps such as coaching call logs, regular content review, and participant progress monitoring will translate to participants using the skills learned in their daily lives. Different monitoring steps will be implemented to minimize differences among the 4 treatment groups. RESULTS My Health, My Life, My Way has been approved by the institutional review board and will begin enrollment in January 2024 and end in December 2024, with results reported in early 2025. CONCLUSIONS Intervention fidelity protocols are necessary to ensure that health behavior change studies can be implemented in larger real-world settings. The My Health, My Life, My Way fidelity protocol has used the guidelines by the NIH BCC to administer a telehealth intervention combined with health coaching for individuals with physical disabilities and chronic health conditions. This fidelity protocol can be used as a complementary resource for other researchers who conduct similar research using telehealth technologies and health coaching in real-world settings. TRIAL REGISTRATION ClinicalTrials NCT05481593; https://clinicaltrials.gov/study/NCT05481593. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53410.
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My Health, My Life, My Way-An Inclusive Web-Based Self-management Program for People With Disabilities Living With Chronic Conditions: Protocol for a Multiphase Optimization Strategy Study.
Evans, E, Zengul, A, Knight, A, Willig, A, Cherrington, A, Mehta, T, Thirumalai, M
JMIR research protocols. 2023;:e31694
Abstract
BACKGROUND Individuals with disabilities living with chronic health conditions require self-management programs that are accessible, sustainable, inclusive, and adaptable. Health coaching is an effective approach to promoting behavior change in self-management. Health coaching combined with telehealth technology has the potential to improve the overall quality of, and access to, health services. OBJECTIVE This protocol outlines the study design for implementing the My Health, My Life, My Way intervention. The study will assess the feasibility, acceptability, and preliminary efficacy of the intervention for people with disabilities and optimize it. METHODS The My Health, My Life, My Way study is a 4-arm randomized controlled trial evaluating the delivery of a 6-month intervention involving telecoaching, inclusive educational content, and technology access for 200 individuals with chronic conditions and physical disabilities. This study uses the engineering-inspired multiphase optimization strategy (MOST) framework to evaluate intervention components and assess whether a combination or lack of individual elements influences behavior. Participants will be randomized to 1 of 4 study arms: scheduled coaching calls and gamified rewards, no scheduled coaching calls and gamified rewards, scheduled coaching calls and flat rewards, and no scheduled coaching calls and flat rewards. RESULTS The My Health, My Life, My Way study was approved by the institutional review board of the University of Alabama at Birmingham, and recruitment and enrollment will begin in May 2023. Data analysis is expected to be completed within 6 months of ending data collection. This clinical trial protocol was developed based on the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement. CONCLUSIONS The My Health, My Life, My Way study will help to optimize and improve our understanding of the feasibility and efficacy of a web-based self-management program for people with physical disabilities and chronic conditions. More specifically, My Health, My Life, My Way will determine which combination of interventions (coaching calls and gamification) will result in increased participation in self-management programming. The My Health, My Life, My Way intervention has the potential to become a scalable and novel method to successfully manage chronic conditions in people with disabilities. TRIAL REGISTRATION ClinicalTrials.gov NCT05481593; https://clinicaltrials.gov/ct2/show/NCT05481593. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/31694.
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Phase I trial of intravenous fenretinide (4-HPR) plus safingol in advanced malignancies.
Boulter, AC, Maurer, BJ, Pogue, M, Kang, MH, Cho, H, Knight, A, Reynolds, CP, Quick, D, Awasthi, S, Gerber, DE
Cancer chemotherapy and pharmacology. 2023;(2):97-105
Abstract
PURPOSE Fenretinide (4-HPR) is a synthetic retinoid that induces cytotoxicity through dihydroceramide production. Safingol, a stereochemical-variant dihydroceramide precursor, exhibits synergistic effects when administered with fenretinide in preclinical studies. We conducted a phase 1 dose-escalation clinical trial of this combination. METHODS Fenretinide was administered as a 600 mg/m2 24-h infusion on Day 1 of a 21-day cycle followed by 900 mg/m2/day on Days 2 and 3. Safingol was concurrently administered as a 48-h infusion on Day 1 and 2 using 3 + 3 dose escalation. Primary endpoints were safety and maximum tolerated dose (MTD). Secondary endpoints included pharmacokinetics and efficacy. RESULTS A total of 16 patients were enrolled (mean age 63 years, 50% female, median three prior lines of therapy), including 15 patients with refractory solid tumors and one with non-Hodgkin lymphoma. The median number of treatment cycles received was 2 (range 2-6). The most common adverse event (AE) was hypertriglyceridemia (88%; 38% ≥ Grade 3), attributed to the fenretinide intralipid infusion vehicle. Other treatment-related AEs occurring in ≥ 20% of patients included anemia, hypocalcemia, hypoalbuminemia, and hyponatremia. At safingol dose 420 mg/m2, one patient had a dose-limiting toxicity of grade 3 troponinemia and grade 4 myocarditis. Due to limited safingol supply, enrollment was halted at this dose level. Fenretinide and safingol pharmacokinetic profiles resembled those observed in monotherapy trials. Best radiographic response was stable disease (n = 2). CONCLUSION Combination fenretinide plus safingol commonly causes hypertriglyceridemia and may be associated with cardiac events at higher safingol levels. Minimal activity in refractory solid tumors was observed. TRIAL REGISTRATION NUMBER NCT01553071 (3.13.2012).
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QUality improvement in primary care to prevent hospitalisations and improve Effectiveness and efficiency of care for people Living with coronary heart disease (QUEL): protocol for a 24-month cluster randomised controlled trial in primary care.
Redfern, J, Hafiz, N, Hyun, K, Knight, A, Hespe, C, Chow, CK, Briffa, T, Gallagher, R, Reid, C, Hare, DL, et al
BMC family practice. 2020;(1):36
Abstract
BACKGROUND Cardiovascular disease (CVD), including coronary heart disease (CHD) and stroke, is the leading cause of death and disability globally. A large proportion of mortality occurs in people with prior CHD and effective and scalable strategies are needed to prevent associated deaths and hospitalisations. The aim of this study is to determine if a practice-level collaborative quality improvement program, focused on patients with CHD, reduces the rate of unplanned CVD hospitalisations and major adverse cardiovascular events, and increases the proportion of patients achieving risk factor targets at 24 months. METHODS Cluster randomised controlled trial (cRCT) to evaluate the effectiveness of a primary care quality improvement program in 50 primary care practices (n~ 10,000 patients) with 24-month follow-up. Eligible practices will be randomised (1:1) to participate in either the intervention (collaborative quality improvement program) or control (standard care) regimens. Outcomes will be assessed based on randomised allocation, according to intention-to-treat. The primary outcome is the proportion of patients with unplanned CVD hospitalisations at 2 years. Secondary outcomes are proportion of patients with major adverse cardiovascular events, proportion of patients who received prescriptions for guideline-recommended medicines, proportion of patients achieving national risk factor targets and proportion with a chronic disease management plan or review. Differences in the proportion of patients who are hospitalised (as well as binary secondary outcomes) will be analysed using log-binomial regression or robust Poisson regression, if necessary. DISCUSSION Despite extensive research with surrogate outcomes, to the authors' knowledge, this is the first randomised controlled trial to evaluate the effectiveness of a data-driven collaborative quality improvement intervention on hospitalisations, CVD events and cardiovascular risk amongst patients with CHD in the primary care setting. The use of data linkage for collection of outcomes will enable evaluation of this potentially efficient strategy for improving management of risk and outcomes for people with heart disease. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry (ANZCTR) number ACTRN12619001790134 (dated 20th December 2019).
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The Mediterranean diet and age-related cognitive functioning: A systematic review of study findings and neuropsychological assessment methodology.
Knight, A, Bryan, J, Murphy, K
Nutritional neuroscience. 2017;(8):449-468
Abstract
OBJECTIVES The primary aims of this review were to identify studies investigating the association between the MedDiet pattern and age-related cognitive function, to determine the current status of knowledge, and to ascertain whether a lack of standardization with the operationalization of age-related cognitive function and differences in the chosen neuropsychological assessment methodology impacted on the results and findings. METHODS The systematic review protocol for this paper was carried out following the statement and general principles of PRISMA and the UK Centre for Reviews and Dissemination (CRD). RESULTS A systematic search of electronic databases yielded two cross-sectional studies, two cross-sectional/prospective studies, and 11 prospective studies for inclusion. Among this group of studies, conflicting results and conclusions regarding the efficacy of the MedDiet as a therapeutic approach for age-related cognitive function were found. Of importance, clear differences among studies in relation to neuropsychological assessment methodology were identified. Such disparity appeared to be one plausible factor contributing to the lack of consensus among study findings. DISCUSSION One of the important challenges for future research will be to aim toward some kind of standardized neuropsychological assessment criteria. This type of endeavor will enable the ability to validate with greater confidence, whether or not adherence to a MedDiet does promote benefit for age-related cognitive function.
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The Mediterranean Diet and Cognitive Function among Healthy Older Adults in a 6-Month Randomised Controlled Trial: The MedLey Study.
Knight, A, Bryan, J, Wilson, C, Hodgson, JM, Davis, CR, Murphy, KJ
Nutrients. 2016;(9)
Abstract
Evidence from a limited number of randomised controlled intervention trials (RCTs) have shown that a Mediterranean dietary pattern may reduce the risk of cognitive decline and enhance cognitive function among healthy older adults. However, there are currently no data in non-Mediterranean older adult populations. The present study aimed to address this gap by examining the effect of a Mediterranean dietary pattern (MedDiet) for six months on aspects of cognitive function in a randomised controlled intervention trial (the MedLey study) that extended for a duration of 18 months. In the final analysed cohort, a total of 137 men and women (mean age of 72.1 ± 5.0 years) randomly assigned to either a MedDiet or control diet (HabDiet) (i.e., habitual dietary intake), were assessed on a comprehensive neuropsychological test battery, including 11 individual tests. In multivariable-adjusted models, the MedDiet group did not perform significantly better than the HabDiet control group for executive functioning (adjusted mean differences: +2.53, 95% CI -2.59 to 7.65, p = 0.33); speed of processing (adjusted mean differences: +3.24, 95% CI -1.21 to 7.70, p = 0.15); memory (adjusted mean differences: +2.00, 95% CI -3.88 to 7.88, p = 0.50); visual-spatial ability (adjusted mean differences: +0.21, 95% CI -0.38 to 0.81, 0.48); and overall age-related cognitive performance (adjusted mean differences: +7.99, 95% CI -4.00 to 19.9, p = 0.19). In conclusion, this study did not find evidence of a beneficial effect of a MedDiet intervention on cognitive function among healthy older adults.
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Persistence and Elimination of Human Norovirus in Food and on Food Contact Surfaces: A Critical Review.
Cook, N, Knight, A, Richards, GP
Journal of food protection. 2016;(7):1273-94
Abstract
This critical review addresses the persistence of human norovirus (NoV) in water, shellfish, and processed meats; on berries, herbs, vegetables, fruits, and salads; and on food contact surfaces. The review focuses on studies using NoV; information from studies involving only surrogates is not included. It also addresses NoV elimination or inactivation by various chemical, physical, or processing treatments. In most studies, persistence or elimination was determined by detection and quantification of the viral genome, although improved methods for determining infectivity have been proposed. NoV persisted for 60 to 728 days in water, depending on water source. It also persisted on berries, vegetables, and fruit, often showing <1-log reduction within 1 to 2 weeks. NoV was resilient on carpets, Formica, stainless steel, polyvinyl chloride, and ceramic surfaces; during shellfish depuration; and to repeated freeze-thaw cycles. Copper alloy surfaces may inactivate NoV by damaging viral capsids. Disinfection was achieved for some foods or food contact surfaces using chlorine, calcium or sodium hypochlorite, chlorine dioxide, high hydrostatic pressure, high temperatures, pH values >8.0, freeze-drying, and UV radiation. Ineffective disinfectants included hydrogen peroxide, quaternary ammonium compounds, most ethanol-based disinfectants, and antiseptics at normally used concentrations. Thorough washing of herbs and produce was effective in reducing, but not eliminating, NoV in most products. Washing hands with soap generally reduced NoV by <2 log. Recommendations for future research needs are provided.
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A systematic review of human norovirus survival reveals a greater persistence of human norovirus RT-qPCR signals compared to those of cultivable surrogate viruses.
Knight, A, Haines, J, Stals, A, Li, D, Uyttendaele, M, Knight, A, Jaykus, LA
International journal of food microbiology. 2016;:40-9
Abstract
Human noroviruses (hNoV) are the single largest cause of acute gastroenteritis in the western world. The efficacy of hNoV control measures remains largely unknown, partly owing to the inability to grow the virus in vitro and partly to the large number of surrogate studies of unknown relevance. A systematic review of the persistence and survival of hNoV in foods and the environment was undertaken based upon PRISMA (preferred reporting items for systematic reviews and meta analyses) guidelines to answer the questions: (1) "What are the natural hNoV persistence characteristics in food and the environment?" and (2) "How can these properties be altered by applying physical and/or chemical treatments to foods or food contact surfaces?" Over 10,000 citations were screened using defined inclusion and exclusion criteria. One hundred and twenty-six (126) citations were identified for further evaluation and data were extracted based upon the conditions of study and treatment (e.g., treatment parameters, pH, and temperature, time, infectivity, and RT-qPCR results). Since the only markers for hNoV persistence and survival were RT-qPCR data and human challenge studies, citations for further analysis were restricted to only those that included data on hNoV behavior (using RT-qPCR) as compared directly to surrogate virus behavior (using both RT-qPCR and infectivity) in the same study, and clinical studies. Based on these criteria, a total of 12 independent studies (5 for thermal inactivation and 7 for available chlorine) and 3 human challenge studies were identified. RT-qPCR always underestimated reductions in surrogate virus titre as a function of treatment when compared to infectivity. The corresponding reductions in RT-qPCR signals for hNoV under comparable conditions were nearly always less than those observed for the surrogates. These relationships were statistically significant for heat when comparing persistence of hNoV RT-qPCR signals with surrogate MNV-1 RT-qPCR signals (P equal persistence=<0.07); and for free chlorine when comparing persistence of hNoV RT-qPCR signals to those of FCV F-9 (p=<0.01). Overall the data suggest that hNoV are frequently more resistant to typical food and environmental control measures compared with cultivable surrogate viruses, when basing data on comparative RT-qPCR results.
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Double-blind randomised controlled trial of vitamin D3 supplementation for the prevention of acute respiratory infection in older adults and their carers (ViDiFlu).
Martineau, AR, Hanifa, Y, Witt, KD, Barnes, NC, Hooper, RL, Patel, M, Stevens, N, Enayat, Z, Balayah, Z, Syed, A, et al
Thorax. 2015;(10):953-60
Abstract
RATIONALE Low-dose vitamin D supplementation is already recommended in older adults for prevention of fractures and falls, but clinical trials investigating whether higher doses could provide additional protection against acute respiratory infection (ARI) are lacking. OBJECTIVE To conduct a clinical trial of high-dose versus low-dose vitamin D3 supplementation for ARI prevention in residents of sheltered-accommodation housing blocks ('schemes') and their carers in London, UK. MEASUREMENTS AND METHODS Fifty-four schemes (137 individual participants) were allocated to the active intervention (vitamin D3 2.4 mg once every 2 months +10 μg daily for residents, 3 mg once every 2 months for carers), and 54 schemes with 103 participants were allocated to control (placebo once every 2 months +vitamin D3 10 μg daily for residents, placebo once every 2 months for carers) for 1 year. Primary outcome was time to first ARI; secondary outcomes included time to first upper/lower respiratory infection (URI/LRI, analysed separately), and symptom duration. MAIN RESULTS Inadequate vitamin D status was common at baseline: 220/240 (92%) participants had serum 25(OH)D concentration <75 nmol/L. The active intervention did not influence time to first ARI (adjusted HR (aHR) 1.18, 95% CI 0.80 to 1.74, p=0.42). When URI and LRI were analysed separately, allocation to the active intervention was associated with increased risk of URI (aHR 1.48, 95% CI 1.02 to 2.16, p=0.039) and increased duration of URI symptoms (median 7.0 vs 5.0 days for active vs control, adjusted ratio of geometric means 1.34, 95% CI 1.09 to 1.65, p=0.005), but not with altered risk or duration of LRI. CONCLUSIONS Addition of intermittent bolus-dose vitamin D3 supplementation to a daily low-dose regimen did not influence risk of ARI in older adults and their carers, but was associated with increased risk and duration of URI. TRIAL REGISTRATION NUMBER clinicaltrials.gov NCT01069874.
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Dietary intake in Black British adults; an observational assessment of nutritional composition and the role of traditional foods in UK Caribbean and West African diets.
Goff, LM, Timbers, L, Style, H, Knight, A
Public health nutrition. 2015;(12):2191-201
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Abstract
OBJECTIVE Acculturation to the UK diet may contribute to the increased burden of non-communicable diseases in Black British communities. The present study aimed to assess nutritional composition and the contribution that traditional foods make to dietary intake in a group of UK-residing Caribbean and West African adults and to explore differences according to ethnicity and duration of residence. DESIGN Observational study. Dietary intake was assessed using multiple, standardised triple-pass 24 h recalls and analysed using a nutritional composition database. Associations between sociodemographic variables and duration of residence with dietary intake were assessed using ANCOVA. SETTING London, UK, October 2011-December 2012. SUBJECTS UK adults of Caribbean (n 50) or West African (n 83) ancestry, aged 18-75 years. RESULTS The Caribbean participants were older and more likely to be born in the UK. After adjusting for age, sex and ethnicity, those who had been resident in the UK for the longest duration had significantly higher intakes of energy (P<0·001), fat (P=0·002) and Na (P=0·03). The West African participants sourced significantly more energy (P=0·04), fat (P=0·02), saturated fat (P=0·02) and Na (P=0·001) from traditional cultural foods compared with the Caribbean diet, which was more reliant on 'Westernised' foods such as sugar-sweetened beverages. CONCLUSIONS These results are novel in demonstrating dietary acculturation in UK adults of Caribbean and West African ancestry. We have provided detailed data regarding the role of traditional foods, presenting dietary information that may guide in individualising care for patients from these communities and improve the cultural sensitivity of public health strategies.