scholarly journals Evaluation of the effect of Cooled HaEmodialysis on Cognitive function in patients suffering with end-stage KidnEy Disease (E-CHECKED): feasibility randomised control trial protocol

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Indranil Dasgupta ◽  
Aghogho Odudu ◽  
Jyoti Baharani ◽  
Niall Fergusson ◽  
Helen Griffiths ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cognitive Function ◽  
Cognitive Decline ◽  
Feasibility Trial ◽  
Cognitive Test ◽  
Randomised Control Trial ◽  
Secondary Outcome ◽  
Dialysis Fluid ◽  
Dialysate Temperature

Abstract Background Cognitive impairment is common in haemodialysis (HD) patients and is associated independently with depression and mortality. This association is poorly understood, and no intervention is proven to slow cognitive decline. There is evidence that cooler dialysis fluid (dialysate) may slow white matter changes in the brain, but no study has investigated the effect of cooler dialysate on cognition. This study addresses whether cooler dialysate can prevent the decline in cognition and improve quality of life (QOL) in HD patients. Methods This is a multi-site prospective randomised, double-blinded feasibility trial. Setting: Four HD units in the UK. Participants and interventions: Ninety HD patients randomised (1:1) to standard care (dialysate temperature 36.5 °C) or intervention (dialysate temperature 35 °C) for 12 months. Primary outcome measure: Change in cognition using the Montreal Cognitive Assessment (MoCA). Secondary outcome measures: Recruitment and attrition rates, reasons for non-recruitment, frequency of intradialytic hypotension, depressive symptom scores, patient and carers burden, a detailed computerised cognitive test and QOL assessments. Analysis: mixed method approach, utilising measurement of cognition, questionnaires, physiological measurements and semi-structured interviews. Discussion The results of this feasibility trial will inform the design of a future adequately powered substantive trial investigating the effect of dialysate cooling on prevention and/or slowing in cognitive decline in patients undergoing haemodialysis using a computerised battery of neuro-cognitive tests. The main hypothesis that would be tested in this future trial is that patients treated with regular conventional haemodialysis will have a lesser decline in cognitive function and a better quality of life over 1 year by using cooler dialysis fluid at 35 °C, versus a standard dialysis fluid temperature of 36.5 °C. This also should reflect in improvements in their abilities for activities of daily living and therefore reduce carers’ burden. If successful, the treatment could be universally applied at no extra cost. Trial registration ClinicalTrials.gov NCT03645733. Registered retrospectively on 24 August 2018.

scholarly journals Evaluation of the Effect of Cooled Haemodialysis on cognitive Function in Patients suffering with End-stage Kidney Disease (E-CHECKED): Feasibility Randomised Control Trial Protocol

2020 ◽  
Author(s):  
Indranil Dasgupta ◽  
Aghogho Odudu ◽  
Jyoti Baharani ◽  
Niall Fergusson ◽  
Helen Griffiths ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cognitive Function ◽  
Cognitive Decline ◽  
Feasibility Trial ◽  
Cognitive Test ◽  
Randomised Control Trial ◽  
Secondary Outcome ◽  
Dialysis Fluid ◽  
Dialysate Temperature

Abstract Background: Cognitive impairment is common in haemodialysis (HD) patients and is associated independently with depression and mortality. This association is poorly understood, and no intervention is proven to slow cognitive decline. There is evidence that cooler dialysis fluid (dialysate) may slow white matter changes in the brain, but no study has investigated the effect of cooler dialysate on cognition. This study addresses whether cooler dialysate can prevent the decline in cognition and improve quality of life (QOL) in HD patients.Methods: This is a multi-site prospective randomised, double-blinded feasibility trial. Setting: Four HD units in the United Kingdom.: Participants and interventions Ninety HD patients randomised (1:1) to standard care (dialysate temperature 36.5C) or intervention (dialysate temperature 35°C) for 12 months. Primary outcome measure: Change in cognition using the Montreal Cognitive Assessment (MoCA). Secondary outcome measures: Recruitment and attrition rates, reasons for non-recruitment, frequency of intradialytic hypotension, depressive symptom scores, patient and carers burden, a detailed computerised cognitive test and QOL assessments. Analysis: mixed method approach, utilising measurement of cognition, questionnaires, physiological measurements and semi-structured interviews.Discussion: The results of this feasibility trial will inform the design of a future adequately powered substantive trial investigating the effect of dialysate cooling on prevention and/ or slowing in cognitive decline in patients undergoing haemodialysis using a computerised battery of neuro-cognitive tests. The main hypothesis that would be tested in this future trial is that patients treated with regular conventional haemodialysis will have a lesser decline in cognitive function and a better quality of life over one year by using cooler dialysis fluid at 35°C, versus a standard dialysis fluid temperature of 36.5°C. This also should reflect in improvements in their abilities for activities of daily living and therefore, reduce carers' burden. If successful, the treatment could be universally applied at no extra cost.Trial registration: ClinicalTrials.gov Identifier: NCT03645733. Registered retrospectively on August 24, 2018.

scholarly journals Evaluation of the Effect of Cooled Haemodialysis on cognitive Function in Patients suffering with End-stage Kidney Disease (E-CHECKED): Feasibility Randomised Control Trial Protocol

2020 ◽  
Author(s):  
Indranil Dasgupta ◽  
Aghogo Odudu ◽  
Jyoti Baharani ◽  
Niall Fergusson ◽  
Helen Griffiths ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cognitive Function ◽  
Cognitive Decline ◽  
Feasibility Trial ◽  
Cognitive Test ◽  
Randomised Control Trial ◽  
Secondary Outcome ◽  
Dialysis Fluid ◽  
Dialysate Temperature

Abstract Background: Cognitive impairment is common in haemodialysis (HD) patients and is associated independently with depression and mortality. This association is poorly understood, and no intervention is proven to slow cognitive decline. There is evidence that cooler dialysis fluid (dialysate) may slow white matter changes in the brain, but no study has investigated the effect of cooler dialysate on cognition. This study addresses whether cooler dialysate can prevent the decline in cognition and improve quality of life (QOL) in HD patients.Methods: This is a multi-site prospective randomised, double-blinded feasibility trial. Setting: Four HD units in the United Kingdom.: Participants and interventions Ninety HD patients randomised (1:1) to standard care (dialysate temperature 36.5C) or intervention (dialysate temperature 35°C) for 12 months. Primary outcome measure: Change in cognition using the Montreal Cognitive Assessment (MoCA). Secondary outcome measures: Recruitment and attrition rates, reasons for non-recruitment, frequency of intradialytic hypotension, depressive symptom scores, patient and carers burden, a detailed computerised cognitive test and QOL assessments. Analysis: mixed method approach, utilising measurement of cognition, questionnaires, physiological measurements and semi-structured interviews.Discussion: The results of this feasibility trial will inform the design of a future adequately powered substantive trial investigating the effect of dialysate cooling on prevention and/ or slowing in cognitive decline in patients undergoing haemodialysis using a computerised battery of neuro-cognitive tests. The main hypothesis that would be tested in this future trial is that patients treated with regular conventional haemodialysis will have a lesser decline in cognitive function and a better quality of life over one year by using cooler dialysis fluid at 35°C, versus a standard dialysis fluid temperature of 36.5°C. This also should reflect in improvements in their abilities for activities of daily living and therefore, reduce carers' burden. If successful, the treatment could be universally applied at no extra cost.Trial registration: ClinicalTrials.gov Identifier: NCT03645733. Registered retrospectively on August 24, 2018. URL: https://clinicaltrials.gov/ct2/show/NCT03645733

scholarly journals Does postoperative cognitive decline after coronary bypass affect quality of life?

Open Heart ◽  
2021 ◽  
Vol 8 (1) ◽  
pp. e001569
Author(s):  
Fredrike Blokzijl ◽  
Frederik Keus ◽  
Saskia Houterman ◽  
Willem Dieperink ◽  
Iwan C C van der Horst ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cognitive Function ◽  
Cognitive Dysfunction ◽  
Postoperative Cognitive Dysfunction ◽  
Cognitive Test ◽  
Physical Component Score ◽  
Cognitive Changes ◽  
Component Score ◽  
Postoperative Cognitive Decline

ObjectiveThis study aimed to explore the influence of coronary artery bypass grafting (CABG) on both postoperative cognitive dysfunction and quality of life (QoL) and the association between the two patient-related outcomes.MethodsIn a prospective, observational cohort study, patients with elective, isolated CABG were included. Cognitive function was assessed using the Cogstate computerised cognitive test battery preoperatively, 3 days and 6 months after surgery. QoL was measured preoperatively and at 6 months using the RAND-36 questionnaire including the Physical Component Score (PCS) and the Mental Component Score (MCS). Regression analysis, with adjustment for confounders, was used to evaluate the association between postoperative cognitive dysfunction and QoL.ResultsA total of 142 patients were included in the study. Evidence of persistent cognitive dysfunction was observed in 33% of patients after 6 months. At 6 months, the PCS had improved in 59% and decreased in 21% of patients, and the MCS increased in 49% and decreased in 29%. Postoperative cognitive changes were not associated with QoL scores.ConclusionsPostoperative cognitive dysfunction and decreased QoL are common 6 months after surgery, although cognitive function and QoL were found to have improved in many patients at 6 months of follow-up. Impaired cognitive function is not associated with impaired QoL at 6 months.Trial registration numberNCT03774342.

scholarly journals The Association Between the Changes in General, Family, and Financial Aspects of Quality of Life and Their Effects on Cognitive Function in an Elderly Population: The Korean Longitudinal Study of Aging, 2008–2016

2020 ◽  
Vol 17 (3) ◽  
pp. 1106 ◽  
Author(s):  
Wonjeong Chae ◽  
Eun-Cheol Park ◽  
Sung-In Jang
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Longitudinal Study ◽  
Cognitive Function ◽  
Cognitive Decline ◽  
Elderly Population ◽  
Equation Model ◽  
Cognitive Changes ◽  
Korean Elderly

Background The growing aging population is a global phenomenon and a major public health challenge. Among Organization for Economic Co-operation and Development countries, Korea is the fastest aging country. We aimed to investigate the relationship between changes in quality of life (QOL) and cognitive function in older adults. Method: Data from the Korean Longitudinal Study of Aging collected from 2008 to 2016 were used. In 3453 participants (men: 1943; women: 1541), QOL was measured by three aspects: general, financial, and familial. Changes in QOL status were assessed by four categories: remained poor, worsened, improved, and remained good. The level of cognitive function was measured by the Mini-Mental State Examination score (MMSE, normal range cut-off value: 24 or above). For the statistical analysis, the generalized equation model (GEE) was performed. Results: For all three aspects of QOL measured, participants whose QOL score remained poor were associated with cognitive decline that their odds ratios (OR) were statistically significant (general: OR = 1.33; familial: OR = 1.39; financial: OR = 1.40). For subgroup analysis by gender, the highest OR in men was the financial aspect of QOL (OR = 1.45); in women, the highest OR was the familial aspect of QOL (OR = 1.75). Conclusion: This study showed an association between QOL and cognitive function in a Korean elderly population. Our findings suggest that QOL measurements with a gender-specific approach can be used as a tool to detect cognitive changes in older adults and help prevent or delay cognitive decline.

scholarly journals Early Age of Migraine Onset is Independently Related to Cognitive Decline and Symptoms of Depression Affect Quality of Life

2020 ◽  
Vol 17 (2) ◽  
pp. 177-187
Author(s):  
Jiajia Bao ◽  
Mengmeng Ma ◽  
Shuju Dong ◽  
Lijie Gao ◽  
Changling Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cognitive Function ◽  
Cognitive Decline ◽  
Age Of Onset ◽  
Face To Face ◽  
Symptoms Of Depression ◽  
Significant Disability ◽  
Independent Effects ◽  
Migraine Onset

Background: People with migraine experience cognitive decline more often than healthy controls, resulting in a significant functional impact. Early identifying influencing factors that contribute to cognitive decline in migraineurs is crucial for timely intervention. Although migraine may onset early in childhood and early onset migraine is related to significant disability, there is no research investigating the association between the age of migraine onset and migraineurs’ cognitive decline. Therefore we aim to explore possible factors that correlate to the cognitive function of migraineurs, especially focus on age of migraine onset. Methods: 531 patients with migraine were included. Data on demographics and headache-related characteristics were collected and evaluated using face-to-face interviews and questionnaires. We used the Montreal Cognitive Assessment scale to assess cognitive function. In addition, we analyzed independent correlations between cognitive decline and the age of migraine onset in patients with migraine. And all patients completed the Headache Impact Test-6 to evaluate their quality of life. Results: Migraineurs with cognitive decline showed significant differences from those without in age (OR=1.26, P<0.0001), years of education (OR=0.89, P=0.0182), the intensity of headache (OR=1.03, P=0.0217), age of onset (OR=0.92, P<0.0001) and anxiety scores (OR=1.09, P=0.0235). Furthermore, there was no interaction in the age of onset between subgroups. Multivariate linear regression analyses of HIT-6 scores showed that the intensity of headache (β=0.18, P<.0001) and depression scores (β=0.26, P=0.0009) had independent effects on decreased quality of life. Conclusion: Our findings suggest that younger age of migraine onset is independently related to migraineurs’ cognitive decline, and migraine accompanying anxiety symptoms significantly related to decreased quality of life in migraineurs.

scholarly journals Healing Right Way: study protocol for a stepped wedge cluster randomised controlled trial to enhance rehabilitation services and improve quality of life in Aboriginal Australians after brain injury

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e045898
Author(s):  
Elizabeth Armstrong ◽  
Juli Coffin ◽  
Deborah Hersh ◽  
Judith M Katzenellenbogen ◽  
Sandra Thompson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Brain Injury ◽  
Randomised Control Trial ◽  
Secondary Outcome ◽  
Rehabilitation Services ◽  
Stepped Wedge ◽  
Post Injury ◽  
Aboriginal Australians ◽  
Cluster Randomised

IntroductionDespite higher incidence of brain injury among Aboriginal compared with non-Aboriginal Australians, suboptimal engagement exists between rehabilitation services and Aboriginal brain injury survivors. Aboriginal patients often feel culturally insecure in hospital and navigation of services post discharge is complex. Health professionals report feeling ill-equipped working with Aboriginal patients. This study will test the impact of a research-informed culturally secure intervention model for Aboriginal people with brain injury.Methods and analysisDesign: Stepped wedge cluster randomised control trial design; intervention sequentially introduced at four pairs of healthcare sites across Western Australia at 26-week intervals.Recruitment: Aboriginal participants aged ≥18 years within 4 weeks of an acute stroke or traumatic brain injury.Intervention: (1) Cultural security training for hospital staff and (2) local, trial-specific, Aboriginal Brain Injury Coordinators supporting participants.Primary outcome: Quality-of-life using EuroQOL-5D-3L (European Quality of Life scale, five dimensions, three severity levels) Visual Analogue Scale score at 26 weeks post injury. Recruitment of 312 participants is estimated to detect a difference of 15 points with 80% power at the 5% significance level. A linear mixed model will be used to assess the between-condition difference.Secondary outcome measures: Modified Rankin Scale, Functional Independence Measure, Modified Caregiver Strain Index, Hospital Anxiety and Depression Scale at 12 and 26 weeks post injury, rehabilitation occasions of service received, hospital compliance with minimum care processes by 26 weeks post injury, acceptability of Intervention Package, feasibility of Aboriginal Brain Injury Coordinator role.Evaluations: An economic evaluation will determine the potential cost-effectiveness of the intervention. Process evaluation will document fidelity to study processes and capture changing contexts including barriers to intervention implementation and acceptability/feasibility of the intervention through participant questionnaires at 12 and 26 weeks.Ethics and disseminationThe study has approvals from Aboriginal, university and health services human research ethics committees. Findings will be disseminated through stakeholder reports, participant workshops, peer-reviewed journal articles and conference papers.Trial registration numberACTRN12618000139279.

scholarly journals Individual cognitive stimulation therapy for people with intellectual disability and dementia: protocol of a feasibility randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e022136 ◽  
Author(s):  
Afia Ali ◽  
Emma Brown ◽  
Aimee Spector ◽  
Elisa Aguirre ◽  
Angela Hassiotis
Keyword(s):  
Quality Of Life ◽  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Cognitive Decline ◽  
Controlled Trial ◽  
Cognitive Stimulation ◽  
Secondary Outcome ◽  
Cognitive Stimulation Therapy ◽  
Randomised Controlled

IntroductionCognitive stimulation therapy (CST) is a psychosocial intervention for dementia. Group CST is effective in reducing cognitive decline and improving quality of life in patients with dementia. There is some evidence that individual CST (iCST) may be beneficial in reducing cognitive decline. People with intellectual disability (ID) have an increased risk of dementia. However, there are no published studies of CST in people with ID and dementia. This protocol describes the feasibility and acceptability of a randomised controlled trial of iCST delivered by carers to people with ID and dementia, compared with treatment as usual (TAU). The results of this study will inform the design of a future definitive randomised controlled trial.Methods and analysisThe iCST intervention has been adapted for this trial. Forty dyads (individuals with ID and their carer) will be randomised to either iCST or TAU. The manualised intervention comprises 40 iCST sessions delivered by a carer for 30 min, twice a week, over 20 weeks. The primary outcome will be process measures assessing the feasibility and acceptability of the intervention and trial procedures. The secondary outcome will be changes in the scores of outcome measures (cognition, functional ability and quality of life in individuals with ID, and caregiver burden, competence in managing dementia, and anxiety and depression in carers). Data will be collected at baseline, 11 weeks and at 21 weeks. A process evaluation will examine adherence to iCST and will include qualitative interviews with participants to identify aspects of the intervention that were or were not successful.Ethics and disseminationThe study has received ethical approval. The results of the study will be presented at conferences and submitted to a peer reviewed journal.Trial registration numberISRCTN18312288; Pre-results.

scholarly journals Effects on cognition and quality of life with unilateral magnetic resonance–guided focused ultrasound thalamotomy for essential tremor

2018 ◽  
Vol 44 (2) ◽  
pp. E8 ◽  
Author(s):  
Na Young Jung ◽  
Chang Kyu Park ◽  
Won Seok Chang ◽  
Hyun Ho Jung ◽  
Jin Woo Chang
Keyword(s):  
Quality Of Life ◽  
Cognitive Function ◽  
Cognitive Decline ◽  
Essential Tremor ◽  
Focused Ultrasound ◽  
Rating Scale ◽  
Statistical Significance ◽  
Neurosurgical Procedures ◽  
Neuropsychological Profile

OBJECTIVEAlthough neurosurgical procedures are effective treatments for controlling involuntary tremor in patients with essential tremor (ET), they can cause cognitive decline, which can affect quality of life (QOL). The purpose of this study is to assess the changes in the neuropsychological profile and QOL of patients following MR-guided focused ultrasound (MRgFUS) thalamotomy for ET.METHODSThe authors prospectively analyzed 20 patients with ET who underwent unilateral MRgFUS thalamotomy at their institute in the period from March 2012 to September 2014. Patients were regularly evaluated with the Clinical Rating Scale for Tremor (CRST), neuroimaging, and cognition and QOL measures. The Seoul Neuropsychological Screening Battery was used to assess cognitive function, and the Quality of Life in Essential Tremor Questionnaire (QUEST) was used to evaluate the postoperative change in QOL.RESULTSThe total CRST score improved by 67.3% (from 44.75 ± 9.57 to 14.65 ± 9.19, p < 0.001) at 1 year following MRgFUS thalamotomy. Mean tremor scores improved by 68% in the hand contralateral to the thalamotomy, but there was no significant improvement in the ipsilateral hand. Although minimal cognitive decline was observed without statistical significance, memory function was much improved (p = 0.031). The total QUEST score also showed the same trend of improving (64.16 ± 17.75 vs 27.38 ± 13.96, p < 0.001).CONCLUSIONSThe authors report that MRgFUS thalamotomy had beneficial effects in terms of not only tremor control but also safety for cognitive function and QOL. Acceptable postoperative changes in cognition and much-improved QOL positively support the clinical significance of MRgFUS thalamotomy as a new, favorable surgical treatment in patients with ET.

scholarly journals Intravenous Lidocaine Does Not Improve Neurologic Outcomes after Cardiac Surgery

2019 ◽  
Vol 130 (6) ◽  
pp. 958-970 ◽  
Author(s):  
Rebecca Y. Klinger ◽  
Mary Cooter ◽  
Tiffany Bisanar ◽  
Niccolò Terrando ◽  
Miles Berger ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cardiac Surgery ◽  
Cognitive Function ◽  
Cognitive Decline ◽  
Cognitive Deficit ◽  
Intravenous Lidocaine ◽  
Score Change ◽  
Cognitive Score

Abstract Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New Background Cognitive decline after cardiac surgery occurs frequently and persists in a significant proportion of patients. Preclinical studies and human trials suggest that intravenous lidocaine may confer protection in the setting of neurologic injury. It was hypothesized that lidocaine administration would reduce cognitive decline after cardiac surgery compared to placebo. Methods After institutional review board approval, 478 patients undergoing cardiac surgery were enrolled into this multicenter, prospective, randomized, double-blinded, placebo-controlled, parallel group trial. Subjects were randomized to lidocaine 1 mg/kg bolus after the induction of anesthesia followed by a continuous infusion (48 μg · kg−1 · min−1 for the first hour, 24 μg · kg−1 · min−1 for the second hour, and 10 μg · kg−1 · min−1 for the next 46 h) or saline with identical volume and rate changes to preserve blinding. Cognitive function was assessed preoperatively and at 6 weeks and 1 yr postoperatively using a standard neurocognitive test battery. The primary outcome was change in cognitive function between baseline and 6 weeks postoperatively, adjusting for age, years of education, baseline cognition, race, and procedure type. Results Among the 420 allocated subjects who returned for 6-week follow-up (lidocaine: N = 211; placebo: N = 209), there was no difference in the continuous cognitive score change (adjusted mean difference [95% CI], 0.02 (−0.05, 0.08); P = 0.626). Cognitive deficit (greater than 1 SD decline in at least one cognitive domain) at 6 weeks occurred in 41% (87 of 211) in the lidocaine group versus 40% (83 of 209) in the placebo group (adjusted odds ratio [95% CI], 0.94 [0.63, 1.41]; P = 0.766). There were no differences in any quality of life outcomes between treatment groups. At the 1-yr follow-up, there continued to be no difference in cognitive score change, cognitive deficit, or quality of life. Conclusions Intravenous lidocaine administered during and after cardiac surgery did not reduce postoperative cognitive decline at 6 weeks.

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