title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Discussion | death, pneumonia, stroke, hypoperfusion, infections, ischemic stroke, Pneumonia, neurological deterioration, artery atherosclerosis, infarct | PNEUMONIA, STROKE, HYPOPERFUSION, INFECTIONS, ISCHEMIC STROKE, SECONDARY, PNEUMONIA, EVENTS, ACUTE STROKE, INFARCT | In this investigator-initiated, randomized, multicenter trial, we investigated the effect of HDP (−20°) on functional outcomes in acute moderate ischemic stroke patients with probable LAA. We found that treatment with HDP for 2 weeks, applied as an adjunct to guideline-based medical management, was safe and did not imp... | PMC10163013 |
Methods | PMC10163013 | |||
Study design | artery atherosclerosis, Stroke | STROKE | HOPES2 (Head-dOwn Position for acutE moderate ischemic Stroke with large artery atherosclerosis) was an investigator-initiated, prospective, randomized, open-label, blinded-endpoint (PROBE), multicenter and phase-2 trial to assess the feasibility, safety and possible efficacy of two weeks of HDP in moderate AIS-LAA pat... | PMC10163013 |
Participants | death, TOAST, Stroke, stroke, Head and neck CTA, ischemic stroke, AIS | STROKE, ACUTE STROKE, STROKE, ISCHEMIC STROKE | Eligible patients were adults aged 18 years or older with acute moderate ischemic stroke (defined as baseline National Institutes of Health Stroke Scale [NIHSS] scores 6 to 16) with probable LAA etiology at the time of randomization who had been functioning independently in the community (modified Rankin Scale [mRS] sc... | PMC10163013 |
Randomization and masking | In this trial, eligible patients were randomly assigned (1:1) using a computer-generated randomization sequence with a block size of four and sealed envelopes, prepared by an independent statistician, into either HDP group receiving Trendelenburg as an adjunct to guideline-based medical management, or a control group o... | PMC10163013 | ||
Procedures | stroke, ischemic stroke | STROKE, ISCHEMIC STROKE | In the HDP group, patients were positioned to −20° Trendelenburg position from 8:00 a.m. to 10:00 p.m. within the first 24 h after randomization. During this period, the patients were continuously monitored by ECG and blood oxygen saturation, and asked to report any discomfort. If the patients could not tolerate this p... | PMC10163013 |
Outcomes | pneumonia, headache, anxiety | PNEUMONIA, ADVERSE EVENTS, INTRACRANIAL HEMORRHAGE, ADVERSE EVENT, EVENTS | In the original design, the primary endpoint was the proportion of excellent functional outcome, defined as an mRS score of 0–1 at 90 days (Supplementary Note Prespecified safety outcomes included any adverse events and serious adverse events during HDP, such as patient fear, headache, anxiety, intracranial hemorrhage,... | PMC10163013 |
Statistical analysis | No formal sample size calculation was performed due to no relevant data available from previous trials. For this exploratory trial, the sample size (50 patients per group) was based on the recommendation of the Steering Committee. Statistical analyses were performed on a modified intention-to-treat (mITT) principle, wh... | PMC10163013 | ||
Reporting summary | Further information on research design is available in the | PMC10163013 | ||
Supplementary information |
Supplementary InformationPeer Review FileReporting Summary | PMC10163013 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41467-023-38313-y. | PMC10163013 | ||
Acknowledgements | We thank the investigators and research staff of the HOPES2 trial (Supplementary Note | PMC10163013 | ||
Author contributions | N.-N.Z. and H.-S.C. wrote the first draft of the manuscript. H.-S.C. designed the study and critically revised the manuscript. N.-N.Z., Y.C., X.-Q.L., C.-S.Z., Y.-T.M., H.Z., C.-H.J., R.-H.L., L.-S.W., Z.J., H.-B.X., Z.L., and T.-G.Y. participated in data collection. N.-N.Z., Y.C., and D.-L.W. analyzed the data. T.N.N.... | PMC10163013 | ||
Peer review | PMC10163013 | |||
Data availability | De-identified data collected for the study, including age, sex, baseline NIHSS score, treatment allocation, and functional outcome, will be shared beginning 3 months and ending 5 years following publication by requesting the corresponding author (Hui-Sheng Chen, email: chszh@aliyun.com) for academic purposes. The corre... | PMC10163013 | ||
Competing interests | The authors declare no competing interests. | PMC10163013 | ||
References | PMC10163013 | |||
Background: | mild-to-moderate coronavirus disease 2019 | CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME | Limited treatment options exist for patients with mild-to-moderate coronavirus disease 2019 (COVID-19), irrespective of vaccination history or risk status. Ensitrelvir is a novel oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 3C-like (3CL) protease inhibitor. While phase 2 studies of ensitrelvir have... | PMC9949372 |
Methods: | sore throat, tiredness, cough | SORE THROAT, SECONDARY, ADVERSE EVENTS | This is a multicenter, randomized, double-blind, placebo-controlled, phase 3 study. Patients with mild-to-moderate COVID-19 within 120 hours from onset will be randomized in a 1:1:1 ratio into 3 treatment arms–ensitrelvir 125 mg (375 mg loading dose on Day 1), ensitrelvir 250 mg (750 mg loading dose on Day 1), and plac... | PMC9949372 |
Discussion: | In a post hoc analysis of the phase 2b study, compared with placebo, ensitrelvir demonstrated a reduced time to resolution of 5 symptoms in patients with mild-to-moderate COVID-19. Through this study, we intend to validate and establish the efficacy and safety of ensitrelvir in patients with mild-to-moderate COVID-19. | PMC9949372 | ||
1. Introduction | SARS-CoV-2 infection, illness, infectious respiratory illness | CORONAVIRUS, CORONAVIRUS DISEASE 2019, SEVERE ACUTE RESPIRATORY SYNDROME, SARS-COV-2 INFECTION | Coronavirus disease 2019 (COVID-19) is an infectious respiratory illness caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)The SARS-CoV-2 Omicron is a variant of concern designated by WHO.As of April 2022, several therapeutic antiviral drugs against SARS-CoV-2 infection are available worldwide.Ensit... | PMC9949372 |
2. Materials and methods | PMC9949372 | |||
2.1. Study design | This is a multicenter, randomized, double-blind, placebo-controlled, phase 3 study to test the efficacy and safety of ensitrelvir in patients with mild-to-moderate COVID-19. The study will be conducted across several sites in Japan, Korea, Singapore, and Vietnam beginning in February 2022 and has been registered in the... | PMC9949372 | ||
2.2. Study ethics | MINOR | This study will be conducted in accordance with the protocol and consensus ethical principles derived from the Declaration of Helsinki, the Council for International Organizations of Medical Sciences international ethical guidelines, the International Council for Harmonisation of Technical Requirements for Pharmaceutic... | PMC9949372 | |
2.3. Randomization and blinding | EVENT, ADVERSE EVENT | Eligible patients will be randomly assigned to the 3 treatment arms in a 1:1:1 ratio using an interactive response technology, and a study intervention allocation table will be created. Randomization will be stratified by the time from the onset of COVID-19 to randomization (<72 hours vs ≥72 hours) and by SARS-CoV-2 va... | PMC9949372 | |
2.4. Eligibility criteria | PMC9949372 | |||
2.4.1. Inclusion criteria. | sore throat, diarrhea, cough, tiredness, headache, nausea,, shivering, chills, aches, shortness of breath | SORE THROAT, TASTE DISORDER, SMELL DISORDER | Patients must be capable of providing signed informed consent/assent and must be ≥12 years and <70 years of age at the time of providing informed consent/assent. All patients must have been diagnosed as SARS-CoV-2–positive within 120 hours before randomization via either a nucleic acid detection test using a nasopharyn... | PMC9949372 |
2.4.2. Exclusion criteria. | gallstones, SARS-CoV-2 infection, kidney disease, liver disease, hepatic or biliary abnormalities, Gilbert syndrome | GALLSTONES, ADVERSE EVENT, SARS-COV-2 INFECTION, KIDNEY DISEASE, LIVER DISEASE, SYSTEMIC INFECTION, GILBERT SYNDROME | Patients will be excluded if they have ≤ 93% (room air) saturation of percutaneous oxygen during wakefulness; require oxygen administration or respirators; are strongly suspected or expected to have worsening of symptoms associated with SARS-CoV-2 infection within 48 hours after randomization in the opinion of the inve... | PMC9949372 |
2.5. Interventions | PMC9949372 | |||
2.5.1. Drug dose and administration. | Based on the results of the phase 2a | PMC9949372 | ||
2.5.2. Criteria for discontinuation. | SARS-COV-2 INFECTION | The study intervention will be discontinued for patients who experience worsening of SARS-CoV-2 infection, experience serious or intolerable AEs, are found to be ineligible for the study by the investigator or subinvestigator, request to discontinue the study interventions, are lost to follow-up, become pregnant, or fo... | PMC9949372 | |
2.5.3. Prohibited concomitant therapy. | APPENDIX | Because ensitrelvir has an inhibitory effect on CYP3A, patients must refrain from consuming any foods and beverages containing grapefruit or Seville oranges and also avoid consuming products containing St. John wort during the study intervention period. Details of prohibited concomitant drugs are provided in the Supple... | PMC9949372 | |
2.6. Outcome measures and endpoints | sore throat, smell or taste disorder, tiredness, cough | SORE THROAT, SECONDARY, RECURRENCE, SARS-COV-2 INFECTION | The primary endpoint for this study will be the time to resolution of the 5 COVID-19 symptoms, defined as the time from the start of the study intervention until the resolution of the 5 symptoms (stuffy or runny nose, sore throat, cough, feeling hot or feverish, and low energy or tiredness) of SARS-CoV-2 infection. Pat... | PMC9949372 |
2.7. Rationale for the primary endpoint | CORONAVIRUS DISEASE 2019, PROLIFERATION, PATHOPHYSIOLOGY, CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME | The phase 2aIn the phase 2a and 2b studies,Patient demographics and clinical characteristics (ITTThis population comprises all patients randomly assigned to the study intervention with SARS-CoV-2 viral titer detected at baseline. The detection of SARS-CoV-2 viral titer was confirmed by viral titer assessment based on n... | PMC9949372 | |
2.8. Patient timelines | The schedule of activities for each patient will include efficacy and safety assessments (Table Schedule of activities. | PMC9949372 | ||
2.9. Statistical analysis | PMC9949372 | |||
2.9.1. Analysis populations. | SARS-CoV-2 infection | SECONDARY, SARS-COV-2 INFECTION | Primary and secondary endpoints and other efficacy endpoints, except for endpoints related to the viral titer, will be assessed in the intention-to-treat (ITT) population, comprising all patients randomized to a study intervention and having SARS-CoV-2 infection confirmed by an RT-PCR test based on the nasopharyngeal s... | PMC9949372 |
2.9.2. Statistical tests. | SECONDARY, RECURRENCE | For discrete variables, summary statistics such as the number and proportion of patients in each group will be calculated. For continuous variables, summary statistics such as the number of patients, arithmetic mean (mean), standard deviation, minimum, median, and maximum values will be calculated for each group. The 9... | PMC9949372 | |
2.9.3. Sample size estimation. | coronavirus disease | Referring to the Kaplan–Meier curve of the time to resolution of the 5 COVID-19 symptoms in a patient group with <72 hours from the onset of COVID-19 to randomization in the phase 2b study, we assumed a Weibull distribution as shown in Figure Weibull distribution (A) and corresponding hazard ratio curve (B) assumed whe... | PMC9949372 | |
2.9.4. Imputation of missing data. | Missing data will not be imputed; all statistical analyses will be based on observed cases, unless otherwise specified. Missing assessments in a patient diary after the initial administration of the study intervention will be imputed: morning times will be imputed as 11:59:59 and evening times will be imputed as 23:59:... | PMC9949372 | ||
2.9.5. Data management and monitoring. | ADVERSE EVENT | No interim analyses will be performed for this phase 3 study. An Independent Data Monitoring Committee will not be established. A Data and Safety Monitoring Board will be established for the purpose of third-party evaluation of safety throughout the study period. All patient data relating to the study will be recorded ... | PMC9949372 | |
3. Discussion | infection, taste disorder, smell disorder, illness | TASTE DISORDER, SARS-COV-2 INFECTION, DISEASE, RECRUITMENT, SEVERE ACUTE RESPIRATORY SYNDROME, INFECTIONS, INFECTION, OF SMELL DISORDERS, CORONAVIRUS, SMELL DISORDER | We described the protocol for a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial to assess the efficacy and safety of ensitrelvir, a novel oral SARS-CoV-2 3CL protease inhibitor, in expediting the resolution of symptoms in patients with mild-to-moderate COVID-19. We aimed to test the hypothesis ... | PMC9949372 |
Acknowledgments | We thank Shintaro Tanaka, Masahiro Kinoshita, Satoshi Kojima, and Manami Yoshida for their contributions toward the development and review of this manuscript. Medical writing and editorial support were provided by Varsha Sreenivasan, PhD, of Cactus Life Sciences (part of Cactus Communications Pvt. Ltd.) and funded by S... | PMC9949372 | ||
Corrections | Table 2 was formatted incorrectly in the original article. This has been updated in the current version of the article. The publication years of references 34 and 35 have been updated from 2017 to 2022. | PMC9949372 | ||
Supplementary Material | PMC9949372 | |||
Abbreviations: | SARS-CoV-2 infection, respiratory syndrome, Sonoyama T | CORONAVIRUS, INFECTIOUS DISEASES, SARS-COV-2 INFECTION | 3C-likeadverse eventconfidence intervalcoronavirus disease 2019cytochrome P450 3Afood and drug administrationelectronic case report formintention-to-treatmodified intention-to-treatribonucleic acidreverse transcription-polymerase chain reactionserious adverse eventsevere acute respiratory syndrome coronavirus 2World He... | PMC9949372 |
References | PMC9949372 | |||
Key Points | PMC10163390 | |||
Question | TBI, traumatic brain injury | Does a home-based intervention that is individually tailored and goal oriented improve health-related quality of life (HRQOL) and participation and ameliorate symptoms in the chronic phase of traumatic brain injury (TBI)? | PMC10163390 | |
Findings | TBI | In this randomized clinical trial including 120 adult participants in the chronic phase of TBI, no significant results were seen in disease-specific HRQOL or social participation. However, generic HRQOL and TBI- and anxiety-related symptom levels improved significantly in the intervention group compared with the contro... | PMC10163390 | |
Meaning | TBI | These findings suggest that an individually tailored and goal-oriented rehabilitation program might be effective in improving generic HRQOL and symptom burden in the chronic phase of TBI. | PMC10163390 | |
Importance | heterogeneous difficulties, TBI, Traumatic brain injury | Traumatic brain injury (TBI) can cause long-lasting and heterogeneous difficulties that require an individually tailored approach to rehabilitation. However, high-quality studies of treatment options in the chronic phase of TBI are lacking. | PMC10163390 | |
Objective | TBI | To evaluate the effect of a home-based, individualized, and goal-oriented rehabilitation intervention in the chronic phase of TBI. | PMC10163390 | |
Design, Setting, and Participants | TBI, TBI-related difficulties | This study was an intention-to-treat parallel-group assessor-blinded randomized clinical trial with 1:1 randomization to an intervention or control group. Participants included adults in southeastern Norway who had sustained a TBI more than 2 years earlier, lived at home, and had ongoing TBI-related difficulties. A pop... | PMC10163390 | |
Interventions | The intervention group received an 8-session individually tailored and goal-oriented rehabilitation program over 4 months. The control group received usual care in their municipality. | PMC10163390 | ||
Main Outcomes and Measures | Anxiety, Preestablished, anxiety, Brain Injury, TBI, psychological distress, depression | DISORDER, SECONDARY, POST CONCUSSION SYMPTOMS | Preestablished primary outcomes were disease-specific health-related quality of life (HRQOL; measured by the Quality of Life After Brain Injury [QOLIBRI] overall scale) and social participation (measured by the Participation Assessment With Recombined Tools–Objective [PART-O] social subscale). Preestablished secondary ... | PMC10163390 |
Results | TBI | Among 120 participants in the chronic phase of TBI, the median (IQR) age was 47.5 (31.0-55.8) years, and the median (IQR) time since injury was 4 (3-6) years; 85 (70.8%) were male. A total of 60 participants were randomized to the intervention group, and 60 were randomized to the control group. Between baseline and 12 ... | PMC10163390 | |
Conclusions and Relevance | TBI, anxiety | SECONDARY | In this study, no significant results were observed for the primary outcomes of disease-specific HRQOL or social participation. However, the intervention group reported improvements in secondary outcomes (generic HRQOL and symptoms of TBI and anxiety) that were maintained at 12-month follow-up. These findings suggest t... | PMC10163390 |
Trial Registration | chronic traumatic brain injury | ClinicalTrials.gov Identifier: This randomized clinical trial assesses the effect of a home-based, individualized, and goal-oriented rehabilitation intervention among adult patients with chronic traumatic brain injury. | PMC10163390 | |
Introduction | chronic disease process, TBI, Traumatic brain injury | Traumatic brain injury (TBI) is a chronic disease process with potential lifelong impact on health and well-being.There are few methodologically rigorous studies that document treatment options in the chronic phase of TBI. The World Health Organization Rehabilitation 2030 InitiativeA challenge when investigating interv... | PMC10163390 | |
Methods | This study followed the Consolidated Standards of Reporting Trials ( | PMC10163390 | ||
Trial Design | This trial was a parallel 2-group RCT with 1:1 randomization to either an intervention or control group. Participants were assessed at baseline before randomization. Outcome assessments were performed at 4 months after inclusion (after the end of intervention, some assessments were performed between 4 and 5 months) and... | PMC10163390 | ||
Participants | TBI | The principal investigator (C.R.) identified potentially eligible participants by screening patients in southeastern Norway who were included in previous studies and outpatient registries, who then were invited by letter. Patients were thereafter contacted by telephone and screened for eligibility. Inclusion criteria i... | PMC10163390 | |
Eligibility Criteria | PMC10163390 | |||
Inclusion Criteria | yLives, TBI | TBI diagnosis (based on Age 18-72 y; age ≥16 y at time of injuryTime since injury ≥2 yLives at homeOngoing TBI-related cognitive, emotional, and/or physical problems and/or reduced physical and mental health and/or difficulties with participation in activities with family, friends, and/or in the communityAble to use co... | PMC10163390 | |
Exclusion Criteria | violent tendencies, death, psychiatric | DISORDER | Unable to provide informed consentSevere progressive neurological condition or severe ongoing psychiatric disorder that may confound outcomesUnable to collaborate in goal-setting processInsufficient command of Norwegian language (cannot communicate with rehabilitation therapists or respond to questionnaires)Active subs... | PMC10163390 |
Intervention Group | The intervention group received an 8-session rehabilitation program over 4 months. In-home and video conference sessions typically lasted 2 hours, while telephone sessions typically lasted 1 hour. Four experienced rehabilitation therapists (psychologist [I.M.H.B.], neuropsychologist [S.L.H.], physician [M.V.F.], and ph... | PMC10163390 | ||
Control Group | epilepsy, TBI, psychiatric disorders | EPILEPSY | All control group participants received feedback on their baseline assessment, and a brief report was sent to their general practitioner. Because an active control group was not feasible, the control group continued to receive any concomitant care (registered at each time point) they were already receiving, with no add... | PMC10163390 |
Outcomes | TBI | Two primary outcomes, disease-specific HRQOL and participation, were defined based on experiences from the feasibility study.Secondary outcomes included target outcomes, generic HRQOL, TBI symptoms, depression- and anxiety-related symptoms, and functional competency. Outcome measures consisted of 1 interview-based asse... | PMC10163390 | |
Sample Size | Sample size calculations were conducted before the trial and were based on between-group differences in the change in primary outcomes. The significance level was Bonferroni corrected for a clinically meaningful between-group mean difference of 12% on the QOLIBRI overall scale (with an estimated SD of 20%) and a betwee... | PMC10163390 | ||
Randomization | Participants were randomized 1:1 by web-based block allocation (variable sizes of 4 and 6) generated in Stata software, version 15 (StataCorp LLC), by an independent statistician, and the randomization list was provided in a fixed sequential order. The allocation sequence could only be accessed by the principal investi... | PMC10163390 | ||
Blinding | Outcome assessors were blinded. Statistical analyses were conducted by an independent statistician. The first author (I.M.H.B.) wrote the Results section of this article while blinded to group allocation. | PMC10163390 | ||
Statistical Analysis | SECONDARY | Linear mixed-effects models were fitted to primary and secondary outcome variables with time and time-by-treatment interaction as categorical fixed effects. The main effect of treatment was removed from the model to adjust for potential baseline differences in the outcome. The models included a random intercept and a r... | PMC10163390 | |
Results | Among 120 participants included in the intention-to-treat analysis, the median (IQR) age was 47.5 (31.0-55.8) years, and the median (IQR) time since injury was 4 (3-6) years; 85 participants (70.8%) were male and 35 (29.2%) were female. A total of 60 participants were randomized to the intervention group (median [IQR] ... | PMC10163390 | ||
Study Flowchart | Baseline demographic and clinical characteristics were generally similar between groups ( | PMC10163390 | ||
Demographic and Clinical Characteristics of the Intervention and Control Groups | death, TBI, Coma, traumatic brain injury | COMA | Abbreviations: GCS, Glasgow Coma Scale; GOS-E, Glasgow Outcome Scale–Extended; NPCS-Gets, Needs and Provisions Complexity Scale–Gets subscale (measuring levels of service provided); TBI, traumatic brain injury.Among 56 patients.Among 57 patients.Severity was measured using the GCS, with scores of 13 to 15 indicating mi... | PMC10163390 |
Linear Mixed-Effects Model Results for Primary and Secondary Outcomes | Anxiety, anxiety, traumatic brain injury, Brain Injury, depression | DISORDER, SECONDARY, POST CONCUSSION SYMPTOMS | Abbreviations: EQ-5D-5L, EuroQol 5-dimension 5-level; GAD-7, Generalized Anxiety Disorder 7-item scale; PART-O, Participation and Recombined Tools–Objective; PCRS, Patient Competency Rating Scale; PHQ-9, Patient Health Questionnaire 9-item scale; NA, not applicable; QOLIBRI, Quality of Life After Brain Injury; RPQ, Riv... | PMC10163390 |
Linear Mixed Model Results for Primary and Secondary Outcomes | Brain Injury, Anxiety | DISORDER, SECONDARY, POST CONCUSSION SYMPTOMS | EQ-5D-5L indicates EuroQol 5-dimension 5-level; GAD-7, Generalized Anxiety Disorder 7-item scale; PART-O, Participation and Recombined Tools–Objective social participation subscale; PCRS, Patient Competency Rating Scale; PHQ-9, Patient Health Questionnaire 9-item scale; QOLIBRI, Quality of Life After Brain Injury; and ... | PMC10163390 |
Discussion | TBI, TBI-related difficulties, anxiety | SECONDARY | This RCT aimed to evaluate the effect of a home-based, individually tailored, and goal-oriented intervention in improving HRQOL and participation, TBI-related difficulties, and symptoms. Although the 2 primary outcomes, disease-specific HRQOL (as measured by QOLIBRI overall scale scores) and social participation (as me... | PMC10163390 |
Limitations | TBI sequelae, intracranial injury, TBI, intracranial damage | This study has several limitations. It is important to emphasize that only participants with a radiologically verified intracranial injury were included. The eligibility criteria only allowed inclusion of patients with the capacity to contribute to goal setting and with self-reported TBI-related symptoms. Hence, result... | PMC10163390 | |
Conclusions | TBI | In this RCT of a home-based, individually tailored, and goal-oriented intervention in the chronic phase of TBI, participants in the intervention group reported significantly improved generic HRQOL and fewer TBI- and anxiety-related symptoms, which were maintained at 12-month follow-up. These findings suggest that rehab... | PMC10163390 | |
Objective | Alzheimer’s disease, AD | Edited by: Hailiang Wang, Hong Kong Polytechnic University, Hong Kong SAR, ChinaReviewed by: Jiaxin Zhang, Southern University of Science and Technology, China; Daniel Young, Hong Kong Baptist University, Hong Kong SAR, ChinaWe aimed to investigate the effect of internet-based and in-person cognitive interventions on c... | PMC10361252 | |
Methods | AD | We recruited 52 patients with probable mild AD, of whom 42 completed the trial. We randomly divided participants into intervention and control groups at a 1:1 ratio and statistically compared the neuropsychological test results of the two groups. In addition, patients in the intervention group were randomly assigned to... | PMC10361252 | |
Results | Compared with the control group, the intervention group (internet-based and in-person) showed significantly improved profile in cognition ( | PMC10361252 | ||
Conclusion | anxiety | This study suggests that both types of cognitive intervention (in-person and internet-based) may be viable supplementary treatments along with approved pharmacological therapy. In terms of anxiety and ADL, the effect of the in-person interventions may be more effective than the-internet based interventions. | PMC10361252 | |
Introduction | Alzheimer’s disease, AD, dementia, coronavirus disease 2019 | CORONAVIRUS DISEASE 2019 | Alzheimer’s disease (AD), a prevalent form of dementia, represent a growing burden in an aging society (The coronavirus disease 2019 (COVID-19) pandemic has challenged the in-person delivery of cognitive interventions to dementia patients ( | PMC10361252 |
Method | PMC10361252 | |||
Participants | Disorders and Stroke-Alzheimer Disease, psychotic or mood disorders, alcoholism, seizure, stroke, metabolic diseases, depressive disorder, schizophrenia, diabetes | FOLIC ACID DEFICIENCY, DISORDERS, CHRONIC RENAL FAILURE, STROKE, HEPATIC FAILURE, METABOLIC DISEASES, HYPERTHYROIDISM, DIABETES | We registered the data of 52 patients at Myongji Hospital in Goyang, Republic of Korea, and Cheongpungho Geriatric Hospital from September to December 2021. All patients underwent a detailed medical history taking, neurological examinations, neuroimaging (brain computed tomography or magnetic resonance imaging), and bl... | PMC10361252 |
Study design | Fifty-two eligible participants were randomized and allocated into the control (only pharmacological treatment, Study design. We randomly divided participants into intervention and control groups at a 1:1 ratio. In addition, patients in the intervention group were randomly assigned to a 4 weeks internet-based or in-per... | PMC10361252 | ||
Randomization | Using covariate-constrained randomization in the cvcrand package, the participants were randomized and allocated to the intervention and control groups. In addition, the participants in the case groups were randomized and allocated to intervention A and intervention B groups. When randomized, age, sex, and baseline CDR... | PMC10361252 | ||
In-person and internet-based cognitive intervention programs | A nonpharmacological treatment program was established, incorporating elements of cognitive, music, and art therapies. This consisted of a 1 hour session (30 min each for 32 sessions), split evenly between cognitive training, and either music therapy or art therapy. Cognitive training was provided twice a week, while m... | PMC10361252 | ||
Neuropsychological tests | The Seoul Neuropsychological Screening Battery ( | PMC10361252 | ||
Assessment of the level of satisfaction | dementia | The level of satisfaction was assessed using the following questions: (1) Was the Centenarian’s Good Memory Program satisfactory? (2) Was the schedule of the Centenarian’s Good Memory Program satisfactory? (3) Were the space and facilities of the Centenarian’s Good Memory Program satisfactory? (4) Was the Centenarian’s... | PMC10361252 | |
Statistical analysis | Demographic characteristics between the control and intervention groups were compared using a two-sample | PMC10361252 | ||
Results | PMC10361252 | |||
Participants’ flow, adherence to interventions, and baseline characteristics | depression, dementia, anxiety | Fifty-six patients were included in this study. Fifty-two participants were randomized and assigned in a 1:1 ratio to the intervention and control groups The intervention group was also divided into two subgroups, intervention A and intervention B, through random allocation: (i) intervention A group underwent an intern... | PMC10361252 | |
Comparison of the score of neuropsychological tests between control and intervention groups | depression, dementia, anxiety | When comparing the effect of non-pharmacological interventions [internet-based intervention (4 weeks) and in-person interventions (4 weeks)] with the control group (pharmacological treatment only for 8 weeks) after controlling for CDR-SOB and education year using ANCOVA, the K-MMSE (Comparison of the neuropsychological... | PMC10361252 | |
Comparison of neuropsychological profiles and the level of satisfaction between the internet-based and in-person intervention periods | depression, dementia, anxiety | For the same participants, we compared the difference in scores during the internet-based and in-person intervention period. The score difference on the internet-based intervention period was not significantly different from that of the in-person intervention period in the MMSE (Comparison of the neuropsychological tes... | PMC10361252 | |
Discussion | depression, AD, anxiety | The present study was a randomized controlled trial (RCT) that investigated the effect of the internet-based and in-person interventions on cognitive function, mood, and ADL of 42 patients with probable AD according to the NINCDS-ADRDA criteria. This study suggests that the multimodal intervention, in conjunction with ... | PMC10361252 | |
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC10361252 |
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