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Creation of the Novel Interventions Caution (NIC) Measure to Assess Patient Behavior Towards Unregulated Stem Cell Interventions

创建新型干预警告 (NIC) 措施来评估患者对不受监管的干细胞干预的行为

基本信息

批准号：
10507963
负责人：
Zubin Master
金额：
$ 7.95万
依托单位：
MAYO CLINIC ROCHESTER
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-01 至 2024-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10507963
关键词：
Address Advertisements Age-Years Aging Alzheimer&apos s Disease American Area Attitude Behavior Behavioral Belief Benefits and Risks Cause of Death Cessation of life Chronic Disease Clinic Clinical Trials Communication Tools Consensus Data Databases Degenerative polyarthritis Dementia Dimensions Economics Effectiveness Elderly Emotional Ensure Environment Epidemic Evaluation Factor Analysis Future Generations Goals Health Healthcare Heart Diseases Hypertension Injury Institution International Internet Intervention Knowledge Lead Lung diseases Marketing Measurement Measures Medical Medicine Misinformation Morbidity - disease rate Obesity Outcome Outcome Measure Participant Patient Participation Patient Recruitments Patients Positioning Attribute Procedures Property Psychometrics Regulation Reporting Research Research Support Resistance Risk Safety Science Source Stroke Survey Methodology Translations Trust United States National Institutes of Health Work aging population burden of illness cognitive interview comorbidity cost data format effectiveness evaluation effectiveness testing exhaust health communication innovation interest novel older patient prospective psychosocial randomized trial stem cells theories web site

项目摘要

Project Summary/Abstract There are over 1,200 clinics in the U.S. marketing scientifically unsubstantiated stem cell interventions (SCIs) outside federal regulation and oversight. One major risk to patients from unregulated SCIs is the harm of being misinformed. This has led tens of thousands of patients to take an unregulated SCI resulting in physical, financial, and emotional harm. Our aging population with chronic diseases is the main target of stem cell commercials and are a unique group of health consumers who actively seek information on the internet for unregulated SCIs, for which misinformation is frequently promulgated. Our exploratory, NIH-supported research aims to evaluate patient beliefs and behaviors towards unregulated SCIs and the factors that influence their views on the credibility of information to create pilot health communication interventions. To date, no research has constructed theory-informed and empirically-robust health communication interventions that correct misinformation and enhance autonomy by infusing an appropriate sense of caution toward risky novel health interventions, particularly those given outside of a clinical trial. The overall goal this proposal is to create and validate a new patient-reported Novel Interventions Caution (NIC) measure to assess the psychosocial and behavioral determinants (e.g., perceived risks/benefits, expected outcomes, behavioral intent) of participation toward novel interventions, including SCIs. This crucial measurement step will position us to test the effectiveness of future health communication interventions aimed at correcting (or inoculating against) misinformation about unregulated SCIs. Our two specific aims are (1) to develop the conceptual framework to define the relationship among constructs that influence participation in unregulated SCIs, generate items for the NIC measure, and assess content validity through a Delphi approach using an expert panel and patient cognitive interviews; and (2) to assess the psychometric properties of the NIC measure examining dimensionality, internal consistency reliability, and convergent validity. The measure will be sent to participants using two national databases, including one we have previously characterized and been able to successfully recruit patients. Our work will be the first to delineate the psychosocial and behavioral determinants that influence older, chronic disease patient decisions about unregulated SCIs. This research is particularly innovative because it applies state-of-the-art survey methodology to a new topic area – novel interventions including SCIs. Upon completion of this proposal, we will have the required prerequisite data on outcome measure distributions and necessary pieces for a pilot pre-post evaluation that will culminate in a larger, prospective randomized trial R01 application. Crafting credible, salient messages that effectively counter misinformation about unregulated SCIs and elicit caution towards risky interventions will serve to address the unmet needs of a growing aging, comorbid group of health care consumers.

项目总结/文摘