Cognitive Stimulation in Older Adults With Alzheimer's Disease
NCT07041008
Alzheimer Disease, Anxiety Disorders
Leiria, Leria, Portugal
View Trial DetailsNCT Number: NCT04773015
This is a study to determine the effectiveness of the VIZAMYL™ reader training programme in clinical practice in Europe
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Notify Me18 year and older
All sexes
Observational
Kepler Universittsklinikum Neuromed Campus, Linz, Wagner-Jauregg-Weg, Austria
This study is a combination of Prospective and Retrospective models.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to 1093 days
Accuracy was estimated as 100 percent (%) *(number of true positives [TP] + number of true negatives [TN]) / (number of TP + number of TN + number of false positives [FP] + number of false negatives [FN]). The data presented are the point estimates representing percentage of accuracy, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Time frame: Up to 1093 days
Sensitivity was defined as 100%*number of TP / (number of TP + number of FN). The data presented are the point estimates representing percentage sensitivity, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Time frame: Up to 1093 days
Specificity was defined as 100%*number of TN / (number of TN + number of FP). The data presented are the point estimates representing the percentage specificity, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Time frame: Up to 1093 days
The PPV was defined as 100%*number of TP / (number of TP + number of FP). The data presented are the point estimates representing percentage PPV, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Time frame: Up to 1093 days
The NPV was defined as 100%*number of TN/ (number of TN + number of FN). The data presented are the point estimates representing percentage NPV, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Time frame: Up to 1093 days
Correlation coefficient was used to assess the correlation between clinical reader age and accuracy. A scatterplot of clinical reader accuracy vs. reader age was plotted to check correlation (coefficient) between accuracy and age.
Time frame: Up to 1093 days
Number of participants with accuracy < 0.9333 or >= 0.9333 in terms of sex of clinical readers were reported.
Time frame: Up to 1093 days
Number of participants with association of electronic training (with or without In-person training) with clinical reader accuracy were reported.
Time frame: Up to 1093 days
Number of participants with association of In-person training (with or without electronic training) with clinical reader accuracy were reported.
Time frame: Up to 1093 days
Number of participants with association of training type with clinical reader accuracy (excluding readers who took both types) were reported.
Time frame: Retrospective data covering up to 8.1 years
Time from last training was reported. Number of readers remaining at timepoint was number of readers with accuracy greater than or equal to 0.9333. All readers met this criterion at time 0 hence, data for all clinical reader is reported. All 18 readers were trained in interpretation of Vizamyl images & as part of their training, had their interpretation accuracy tested using 15 test images. To pass test, a reader had to interpret atleast 14 of 15 images correctly. 14 represents 0.9333 of 15, so each reader had to have an accuracy of atleast 0.9333 in order to pass test. Date on which a reader took his/her test is considered to be Time 0. Each reader's accuracy at a later time was assessed in study.
GE Healthcare
Industry
A Post-Authorisation Safety Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training in Europe
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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