|drug3314||Relation between frailty and clinical outcomes in elderly patients with COVID-19. Wiki||0.35|
|drug4235||Virtual Group Exercise Wiki||0.35|
|drug3623||Simplified Geriatric Evaluation Wiki||0.35|
|drug2638||Nutrition Consult and Protein Supplementation Wiki||0.35|
|drug2454||Museum virtual guided tours Wiki||0.35|
|drug4090||Treatment group: will receive a combination of Nitazoxanide, Ribavirin and Ivermectin for a duration of seven days : Wiki||0.35|
|drug3083||Preventive information Wiki||0.35|
|drug876||Certified cloth face mask plus preventive information Wiki||0.35|
|drug2135||Lifestyle App Wiki||0.35|
|drug2314||Medication Review Wiki||0.35|
|D001835||Body Weight NIH||0.18|
|D051346||Mobility Limitation NIH||0.16|
|D003920||Diabetes Mellitus, NIH||0.06|
There are 8 clinical trials
The ANRS EP66 SEPTAVIH Study aims to screen feasibility of evaluating frailty in people living with HIV aged 70 or older, to estimate its prevalence, to analyse associated risk factors and to evaluate the impact of frailty on pejorative events. SEPTAVIH is a French, multicentre, prospective, observational study which will include 500 HIV-infected participants
Description: Proportion of patients classified as frail according to Fried at BaselineMeasure: Proportion of frail patients Time: 12 months
Coronavirus disease 2019 (COVID-19) is an infectious disease. Physical distancing is one of the most effective ways to reduce the spread of COVID-19, but this key prevention intervention may have adverse consequences on older adults living at home. Screening older adults living at home and at risk for adverse consequences of physical and social distancing is, therefore, a priority in order to prevent their occurrence. ESOGER ("Evaluation Social et GERiatrique") is a clinical tool designed to: 1) screen the risk-levels for adverse consequences related to COVID-19 physical distancing and 2) to continue appropriate preventive interventions in older adults living at home including frail older patients and older community dwellers. Experience cumulated during the past two weeks revealed that ESOGER could be improved, in order to be more effective and efficient for the prevention of adverse consequences related to COVID-19 physical distancing. This improvement is based on two key components: 1) Comments of Montreal ESOGER users and 2) Analysis of data. Because at this time no information is saved and stored, there is a need to save and store ESOGER information and create the ESOGER databank.
Description: presence or not of fever, cough and shortness of breath (binary question)Measure: COVID-19 symptoms Time: 1 day
Description: presence or not of a rupture of access to food, medication and home care (binary question)Measure: issues related to medication and food delivery and access to home care Time: 1 day
Description: Questionnaire Emergency Room Evaluation and Recommandation (ER2), score from 0 = no risk of frailty to 14 = high risk of frailty)Measure: physical frailty Time: 1 day
Description: anxiety Verbal analogic scale, score from 0 = no anxiety to 10 = extremely anxious)Measure: psychological frailty Time: 1 day
Description: Zarit scale, score from 0 = no caregiver burden to 16 = high caregiver burden)Measure: Caregiver burden Time: 1 day
This is a monocentric retro-prospective observational study that wants to evaluate the relation between frailty and clinical outcomes in elderly patients with COVID-19.
Description: The aim of the project is to evaluate whether a tool built to measure frailty in elderly patients admitted to the COVID + hospital wards of San Gerardo hospital is more accurate in predicting clinical states than a clinical evaluation developed on age and comorbidity.Measure: Development of a tool to measure frailty Time: Until patient discharge from the hospital (approximately 1 year).
Description: Assess whether a "proxy" variable of the fragility index can be built on the basis of regional administrative databases only, which is able to predict the clinical outcomes of COVID + patients better than age and comorbidities alone.Measure: A "proxy" variable of the fragility index can be built on the basis of regional administrative databases only. Time: Until patient discharge from the hospital (approximately 1 year).
Description: Relate different levels of chronicity with the susceptibility of the elderly subject to infection to give elements to focus the screening policies for COVID19.Measure: Give elements to focus the screening policies for COVID19. Time: Until patient discharge from the hospital (approximately 1 year).
Description: Relate different levels of chronicity with the susceptibility of the elderly subject to infection to prevent the contagion at the elderly population level.Measure: Give the prevention of contagion at the elderly population level. Time: Until patient discharge from the hospital (approximately 1 year).
Introduction: The World Health Organization has launched the INSPIRE-ICOPE-CARE program towards healthy aging. It includes "intrinsic capacity", defined as "the composite of all the physical and mental capacities of an individual", which has a positive value towards prevention, and is constructed by five domains: cognition, vitality/nutrition, sensory, psychology, and mobility. ICOPE App and ICOPE Monitor are applications for the self-assessment and monitoring of intrinsic capacity. Hypothesis: Intrinsic capacity self-assessed by the ICOPE Apps could be associated with the incidence of frailty and health outcomes. ICOPE Apps might support geriatric and primary care during the COVID-19 pandemic and beyond. Objectives: To assess the association between intrinsic capacity measured by the ICOPE Apps at baseline and the incidence of frailty in community-dwelling older adults during 1-year follow-up. Secondarily, to assess the association of intrinsic capacity and pre-frailty, falls, functional decline, institutionalization, and mortality (COVID-19-related/not related). Methods: Protocol for a cohort study of community-dwelling adults ≥65-year-old, with no other exclusion criteria than the inability to use the Apps or communicate by telephone/video-call for any reason (cognitive or limited access to telephone/video-call). Intrinsic capacity measured by the ICOPE Apps and Rockwood's clinical frailty scale will be assessed at baseline, 4-, 8- and 12-month follow-up by telephone/video-call. Assuming a prevalence of frailty of 10.7%, and incidence of 13% (alpha-risk=0.05), 400 participants at 12-month end-point (relative precision=0.10) and 600 participants at baseline will be required. Associations among the decrease in intrinsic capacity, incidence of frailty, and occurrence of health adverse outcomes during 1-year follow-up are expected. ICOPE Apps might identify individuals at higher risk of frailty and health adverse consequences. The implementation of the ICOPE Apps into clinical practice might help to bring the practitioners closer to their patients, deliver efficient person-centered care-plans, and benefit the healthcare systems during the COVID-19 pandemic and beyond.
Description: Incidence of frailty assessed by Rockwood's clinical frailty scale (CFS) will be assessed at baseline and 12-month follow-up by telephone/video-call. An score <4 will indicate robustness, 4-6 pre-frailty status, and ≥6 frailtyMeasure: Incidence of frailty Time: 1 year
The study team want to see if changes in lifestyle and behaviors and self-monitoring of diet and physical activity in older adults who have type 2 Diabetes (T2D) may help to prevent or reduce frailty. Frailty occurs in older adults and leads people to have falls, become disabled, require nursing home placement, and have increased risk of death. T2D is one of the major risk factors for frailty. T2D is a significant problem in older adults and is known to increase the risk of future frailty.
Description: Change in frailty measured on a scale using a frailty score (0, 1, 2, 3, 4,or 5), with higher scores out of 5 representing greater frailty. Assessments used for scoring include 1) self reported weight loss, 2) self-reported exhaustion 3) low physical activity based on the Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ) 4) Handgrip strength 5) 10 foot walk paceMeasure: Frailty Scale Time: Baseline to 6 months
Description: Change in HbA1c measured over the study periodMeasure: Glycated hemoglobin (HbA1c) Time: Baseline to 6 months
Description: For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.Measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Time: Baseline to 6 months
Description: The study team will administer the Short Physical Performance Battery (SPPB)69 to assess three lower extremity tasks; 1) standing balance (ability to stand with the feet together in side-by-side, semi-and full-tandem positions for 10 seconds each); 2) a 4-meter walk to assess usual gait speed; 3) time to complete 5 repeated chair stand. Each of the 3 performance measures is assigned a score ranging from 0 (inability to perform the task) to 4 (the highest level of performance) and summed to create a score ranging from 0 to 12 (best). The SPPB is sensitive to change over timeMeasure: Short Physical Performance Battery (SPPB) Time: Baseline to 6 months
The coronavirus disease 2019 (COVID-19) pandemic is keeping people apart, which can take a toll on physical and mental health. Many healthcare professionals are concerned vulnerable seniors may become deconditioned, which substantially increases risk of health complications and need for hospitalization. To address the immediate impact of COVID-19 policies (i.e., physical distancing, reduced access to care), the GERAS Frailty Rehabilitation model will be adapted to be delivered remotely in the homes of vulnerable seniors. The investigators' aim is to understand how to best build resilience among vulnerable seniors in the community through at-home rehabilitation services (socialization, exercise, nutrition, and medication support).
Description: Assessed by the 5x Sit-to-Stand (time to complete). Faster times to complete indicate better performance.Measure: Change in Physical Function Time: Baseline and 12 Weeks Post-Intervention
Description: Assessed by the Depression Anxiety Stress Scale (DASS-21). Higher scores indicate greater risk of depression, anxiety and stress [depression, anxiety, stress subscores range 0-21].Measure: Change in Mental Health Time: Baseline and 12 Weeks Post-Intervention
Description: Assessed by the SARC-F - Self-reported strength, assistance with walking, rising from a chair, climbing stairs and falls. Higher scores indicate greater level of sarcopenia [range 0-10].Measure: Change in Sarcopenia Time: Baseline and 12 Weeks Post-Intervention
Description: Assessed by the Fit-Frailty Index. Higher scores indicate greater degree of frailty [range 0-1].Measure: Change in Frailty Time: Baseline and 12 Weeks Post-Intervention
Description: Balance confidence will be assessed using the Activities-specific Balance Confidence Scale (ABCs). Higher scores indicate greater balance confidence [range 0-100].Measure: Change in Self-Efficacy Time: Baseline and 12 Weeks Post-Intervention
Description: Assessed by the interRAI Community Rehab Assessment - Self-ReportMeasure: Self-Reported Change in Function, Health and Well-Being Time: Baseline and 12 Weeks Post-Intervention
Description: Assessed by the interRAI Community Rehab Assessment - Clinician-CompletedMeasure: Clinician-Reported Change in Function, Health and Well-Being Time: Baseline and 12 Weeks Post-Intervention
Description: Assessed by the Borg Rate of Perceived Exertion after exercise. Higher scores indicate greater level of exertion [range 6-20].Measure: Change in Fitness Time: Weekly up to 12 weeks
Description: Assessed using a program questionnaire in accordance with the Kirkpatrick 5-Level Evaluation Model. Scores will be on a 5-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree".Measure: Program Satisfaction Time: 12 Weeks Post-Intervention
Description: Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization.Measure: Change in Emergency Room Visits Time: Baseline and 12 Weeks Post-Intervention
Description: Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization.Measure: Change in Hospitalizations Time: Baseline and 12 Weeks Post-Intervention
Description: Number of calls to 911 will be recorded. Higher number of calls indicates higher healthcare utilization.Measure: Change in Number of Calls to 911 Time: Baseline and 12 Weeks Post-Intervention
Description: Assessed by the number of individuals who participated. Target reach is 70 participants.Measure: Feasibility Outcome #1 - Reach of intervention Time: 12 Weeks Post-Intervention
Description: Assessed by number of referral sites. Target is 5 referral sites.Measure: Feasibility Outcome #2 - Adoption of the Intervention Time: 12 Weeks Post-Intervention
Description: Assessed by the number of individuals who completed the intervention. Higher number of individuals completing the study indicates greater success in implementation.Measure: Feasibility Outcome #3 - Implementation of the Intervention Time: 12 Weeks Post-Intervention
Description: Assessed by the number of referral sites continuing with a second cohort. Greater number of referral sites continuing with a second cohort indicates greater maintenance.Measure: Feasibility Outcome #4 - Maintenance of the Intervention Time: 12 Weeks Post-Intervention
Social isolation is defined as the objective and/or subjective reduction of number and quality of interpersonal contacts leading to a loss of an individual's social role and stigmatization. It is a major problem in Canadian society with a high prevalence in the older population (30% in individuals aged 65 and over, representing 1.5 million individuals). Social isolation is associated with a wide range of mental and physical health problems that leads to an increase in the use of health and social services. This issue increased with the coronavirus disease (COVID-19) pandemic which attacking your society at its core. Social distancing and in particular home confinement exacerbated social isolation of frailer groups like the elderly people. In 2016, the International Federation on Ageing reported that "the main new problem facing seniors in Canada is maintaining their social contacts and activities". This highlights the need for efficient and effective interventions to improve the social inclusion of older adults experiencing social isolation. Research suggests that art-based activities carried out at museums have significant benefits for older adults experiencing social isolation, and may foster social inclusion, well-being, quality of life and mitigate frailty. Yet few studies have examined empirically the effects of museum art-based activities in older adults experiencing social isolation. In 2019, the principal investigator of this research conducted an experimental pilot study based on a pre-post intervention (i.e., 3-month cycle of weekly guided tours carried out at the Montreal Museum of Fine Arts (MMFA)), single arm, prospective and longitudinal follow-up named "Effects of Montreal Museum of Fine Arts visits and older community dwellers with a precarious state: An experimental study", which indicated the potential of museum tours to improve social inclusion, well-being, the quality of life and frailty in older community members experiencing social isolation. However, these studies were performed before the COVID-19 crisis and were in-site activities. The principal investigator hypothesizes that a 3-month cycle of virtual weekly MMFA tours may induce changes in well-being, quality of life and health condition in older community dwellers participating like the 'Beautiful Thursday' cycle, and that this activity can prevent the worsening of vulnerability and social isolation due to social distancing.
Description: using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) self-validated questionnaire composed by 14 positively worded item scale with five response categories. It covers most aspects of positive mental health (positive thoughts and feelings). Scores can range from a minimum of 14 to a maximum of 70 points. Higher scores are associated with higher levels of mental well-beingMeasure: Well-being Time: 3 months
Description: using EuroQol-5D (EQ-5D), a standardized measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal. It is composed of two parts: a questionnaire of five questions with score per question ranged from 1 (i.e., no issue) to 5 (i.e., worse issue), each question ranged from 0 (i.e., no issue) to 25 (i.e., worse issue), and a visual analogic scale of how good or bad participant health was. This scale is numbered from 0 (i.e., worse health participant can imagine) to 100 (i.e., best health participant can imagine).Measure: Quality of life Time: 3 months
Description: using CESAM questionnaire, composed of 20 items providing two complementary information: 1) A global score of frailty ranged from 0 (i.e., best health and functional condition) to 18 (i.e., worse health and functional condition) and 2) Categorized health condition in four levels (vigorous with a score between 0 and 3, mild frailty with a score between 4 and 7, moderate frailty with a score between 8 and 12, and important frailty with a score above 12).Measure: frailty Time: 3 months
Description: using the digital form of the 11-item Dike Social Support Index (DSSI). The index is composed of two subscales: social interaction (i.e., frequency of interactions) and subjective support (i.e., satisfaction with emotional support provided). DSSI score ranges from 11 to 33, increased score indicating higher levels of social insertion. The scores of the 11 items are combined and categorized as low-fair (score ≤26), high (score 27-29) and very high (score 30-33). We will use the mean score of 11-item DSSI and its distribution in three categories.Measure: social isolation Time: 3 months
Description: using ESOGER questionnaire, composed of 17 items exploring the COVID risk, the COVID past history, the social isolation risk due to COVID (access to food, home support and healthcare, contact with external persons, anxiety). Items correspond to a question in closed-ended format (i.e., yes or no, or calling for a specific answer). The ESOGER categorizes state of vulnerability in three levels (Low, Moderate and High vulnerability).Measure: socio-geriatric vulnerability Time: 3 months
Description: recorded at the end of the cycle by asking directly to the participantsMeasure: Incident planned and unplanned visits to physicians, Emergency Department (ED) and hospitalization Time: 3 months
Description: determined by the total number of guided tours performed, on a maximum of 12.Measure: compliance Time: 3 months
Older adults and those with chronic underlying health conditions are the most susceptible to COVID-19 and its complications. Although there has been a rapid response to studying the effects of COVID-19 in the acute stages, little is known about recovery over the longer-term. Older adults who survive the diseases are at risk of developing persistent mobility limitations due to extensive bed rest during hospitalization. For older patients and those with underlying frailty recovering from COVID-19, this could rapidly lead to significant physical deconditioning and rapid declines in mobility. Understanding the trajectory of functional recovery of older hospitalised patients with COVID-19 in the short- and long-term is critical to improving patient outcomes and informing health and rehabilitative interventions for survivors.
Description: The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.Measure: Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Inpatient Version Time: Admission to hospital ward (0-14 days post ward admission) and discharge from hospital (0-14 days post discharge or up to 6 months, whichever comes first)
Description: The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.Measure: Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Outpatient Version Time: Admission to hospital ward (0-14 days post ward admission, to capture pre-morbid function), and at 3,6,9 and 12-months post hospital discharge
Description: The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.Measure: Change in Activity Measure for Post Acute Care (AM-PAC) Applied Cognitive Inpatient Version Time: Admission to hospital ward (0-14 days post ward admission) and discharge from hospital (0-14 days post discharge or up to 6 months, whichever comes first)
Description: The SPPB combines the results of gait speed over 3 meters, the 5-repetition chair-stand, and a progressive balance test to assess lower extremity function.Measure: Change in Short Physical Performance Battery (SPPB) Time: 3,6,9 and 12-months post hospital discharge
Description: The CFS is an interview-based scale wherein the assessor may ask the patient questions about things such as their independence or physical abilities to determine where the patient falls along the 9-point scale, from 1 (Very Fit) to 9 (Terminally Ill).Measure: Change in Clinical Frailty Scale (CFS) for participants over 60 years of age Time: Admission to hospital ward (0-14 days post ward admission, to capture pre-morbid function ), and at 3,6,9 and 12-months post hospital discharge
Description: The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation as measured by spirometry.Measure: Change in Forced Expiratory Volume (FEV1) Time: 3,6,9 and 12-months post hospital discharge
Description: The amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry. FVC is the total amount of air exhaled during the FEV test.Measure: Change in Forced Vital Capacity (FVC) Time: 3,6,9 and 12-months post hospital discharge
Description: The FEV1/FVC Ratio (FEV1%) parameter is calculated by dividing the measured FEV1 value by the measured FVC value.Measure: Change in Forced Expiratory Volume Percentage (FEV1%) Time: 3,6,9 and 12-months post hospital discharge
Description: The BDI rates the severity of dyspnea at a single point in time (baseline) based on a 24-item interviewer administered rating scale.Measure: Baseline Dyspnea Index (BDI) Time: 3 months post hospital discharge
Description: Measures changes in dyspnea severity from the baseline as established by the BDI.Measure: Change in Transition Dyspnea Index (TDI) Time: 6,9 and 12-months post hospital discharge
Description: The PHQ-9 is a self-rating instrument for depression based on nine questions that the patient responds to by indicating how much they have been bothered by these symptoms over the last two weeks.Measure: Change in Patient Health Questionnaire - 9 (PHQ-9) Time: 3,6,9 and 12-months post hospital discharge
Description: The FIM assesses the functional status of a person based on the level of assistance the person requires.Measure: Change in Functional Independence Measure (FIM) Time: 3 and 6 months post hospital discharge
Description: The IES-R is a 22-item self-report measure that asks questions about subjective distress caused by traumatic events. Each item is rated on a 5-point scale, from 0 ("not at all") to 4 ("extremely").Measure: Change in Impact of Event Scale - Revised (IES-R) Time: 3,6,9 and 12-months post hospital discharge
Description: The EQ-5D-5L is a generic and well-established instrument for describing health status or disease-specific outcome measures. It defines health in terms of five dimensions: Mobility, Self- Care, Usual Activities, Pain/Discomfort, and Anxiety/ Depression. The response options are of five levels, from no, slight, moderate, severe, to extreme problemsMeasure: Change in Health status (EQ-5D-5L) Time: 3,6,9 and 12-months post hospital discharge
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports