Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Location status: Recruiting
NCT Number: NCT06817395
Individuals with immune thrombocytopenia (ITP) frequently report difficulties with attention and memory. The main question this study seeks to answer is:
Do patients with ITP have evidence of cognitive impairment as detected by a cognitive function test battery?
To address this issue, participants will take a cognitive function test and complete surveys on quality of life, fatigue, depression, and cognitive symptoms. The primary aim of the study is to evaluate for the presence and extent of cognitive impairment in patients with ITP. The study will also assess whether cognitive impairment in ITP is associated with patient-reported impacts on quality of life, fatigue, mood, and cognitive symptoms as well as clinical characteristics such as ITP disease and treatment history.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Boston, Massachusetts, 02114, United States
Location status: Recruiting
This is a longitudinal observational study that seeks to evaluate for the prevalence and extent of cognitive dysfunction in adults with persistent and chronic ITP. Following enrollment, subjects will complete neurocognitive testing using the NIH Toolbox Cognition Battery (NIHTB-CB). In addition, subjects will complete surveys for patient-reported outcomes of quality of life, fatigue, self-reported cognitive function, and depression. Background characteristics and relevant clinical history will be obtained through an enrollment survey and chart review. The primary aim of the study is to describe the prevalence and extent of cognitive impairment in ITP and explore associated risk factors. This study will also assess the feasibility of longitudinal cognitive testing in patients with ITP and describe any observed changes in cognition over time.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Proportion of subjects with mild (T-score 1 to 2 standard deviations [SDs] below the normative mean) or major (>2 SDs below the normative mean) impairment of the composite measure of fluid cognition, as detected on the NIH Toolbox cognition battery.
Time frame: 2 years
Completion of annual study visit by at least 50% of the enrolled study population over course of 2 years
Contact information is provided by the study sponsor or research team.
Massachusetts General Hospital
Other
Prevalence, Reproducibility, and Feasibility of Longitudinal Assessment of Neurocognitive Dysfunction in Adults with Chronic and Persistent Immune Thrombocytopenia (COGFIT)
Acronym: COGFIT
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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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