The Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia: Brain Health Support Program Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 354
- 试验地点
- 14
- 主要终点
- Change in Dementia Literacy From Baseline to Month 12
研究概览
简要总结
The Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP, or CTU) is a comprehensive and innovative program aimed to develop, implement and evaluate an interactive and compelling online educational Brain Health Support Program (BHSP) intervention, called Brain Health PRO (BHPro), with potential to positively influence dementia literacy, lifestyle risk factors, and scale-up to reach the broader Canadian public; enroll and retain a community-dwelling Platform Trial Cohort (PTC) of individuals at risk of dementia; and support an open platform trial to test a variety of multidomain interventions that might further benefit individuals at risk of dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion and documentation of the electronic Informed Consent Process (from the participant)
- •Sufficient proficiency in English or French to undergo remote clinical and neuropsychological assessment and participate in an online educational program.
- •Technical ability to participate in an online educational program and remote assessments (i.e. computer and internet access; ability to send and receive emails; ability to complete remote assessments)
- •Sufficient vision and hearing to participate in online educational program and to undergo remote clinical and neuropsychological testing
- •Ability to sit comfortably for a period of about 30 minutes
- •Meets criteria for No Dementia and meet criteria [according to Canadian Consortium on Neurodegeneration in Aging (CCNA) Criteria, Appendix 1] of one of the following:
- •Cognitively Unimpaired (CU)
- •Cognitively Unimpaired plus Subjective Cognitive Impairment (CU + SCI)
- •Mild Cognitive Impairment (MCI)
- •AND Classified as being at increased risk of dementia based on at least one of the following:
- •First-degree family history of dementia
- •Self-Reported or documented current and/or history at midlife (45-60 years) on any of the following lifestyle risk factors:
- •Hypertension (documented Systolic Blood Pressure > 140 mm Hg; OR physician diagnosis of hypertension; OR treatment for hypertension; OR other approaches to treatment (e.g. diet, exercise)) Hypercholesterolemia (documented total cholesterol > 6.5 mmol/L; OR physician diagnosis of hypercholesterolemia; OR treatment for hypercholesterolemia; OR other approaches to treatment (e.g. diet, exercise) Body Mass Index > 30 kg/m2 (derived from NIH Metric BMI Calculator) Physical Inactivity (active is defined as engaging in a minimum of 20- 30 min of physical activity causing sweating and breathlessness, at least 2 times a week)
- •Participant has a family physician or other healthcare provider and agrees to have the provider notified of participation in the study and incidental or other findings that may be clinically significant
排除标准
- •Participants who, in the opinion of the investigator, are not able to complete trial procedures remotely or adhere to the schedule of study assessments will be excluded from study participation.
- •Individuals where English or French is not sufficiently proficient for remote clinical assessment, neuropsychological testing and participation in an online educational program.
- •Participants who do not have sufficient vision and hearing for remote clinical assessment, neuropsychological testing participation in an online educational program
- •Individuals who do not have the technical ability to participate in an online educational program. Technical ability is defined as having computer and internet access; ability to send and receive emails; ability to participate in remote assessments
- •Individuals who have a clinical diagnosis of Dementia
- •Clinical Dementia Rating (CDR; telephone/video-conference administration) Score of >1
- •Total Score on the Montreal Cognitive Assessment (MoCA; video-conference administration) <13
结局指标
主要结局
Change in Dementia Literacy From Baseline to Month 12
时间窗: 12 months
The primary outcome will be change in dementia literacy following participation in the study, as measured by the Alzheimer's Disease Knowledge Scale (ADKS). The ADKS is designed to assess knowledge about Alzheimer's Disease (AD) among laypeople, patients, caregivers, and professionals. This self-report questionnaire contains 30 true/false items. The total score is the sum of the scores from the 30 items, which is quantitative and ranges from 0-30, with a higher score indicating better knowledge about AD. To aide interpretation, change in ADKS scores were converted to standardized change scores by dividing the covariate-adjusted least squares mean change by the baseline standard deviation. The results reported are the standardized change on the scale from baseline to month 12. The converted to standardized score range is -10.81 to +10.81. The greater the positive change in score, the greater the increase in knowledge of dementia.
次要结局
- Change in Self-efficacy From Baseline to Month 12(12 months)
- To Evaluate Usability of BHPro(12 months)
- Number of Chapters Completed on BHPro(12 months)
- To Evaluate User Acceptance of BHPro With the Technology Acceptance Model Questionnaire (TAMQ).(12 months)