Platform-Based Mild Cognitive Impairment (MCI) Trial to Address Maladaptive Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Self-Efficacy; general self-efficacy scale (GSES)
研究概览
简要总结
The process of receiving a diagnosis of mild cognitive impairment (MCI) is recognized to induce behavioral responses that can be either adaptive or maladaptive. Five specific areas of concern have been identified, including: 1) failure to plan for future decline, decreased compliance and interaction with medical care providers, 3) decreased confidence and reduced social engagement, 4) increased physical limitations and 5) decreased medication compliance. In this pilot study, participants with MCI and their study partners will participate in behavioral interventions (primarily training workshops and classes) targeting each of these five areas of potential maladaptive behaviors.
详细描述
Following the approval of an application reviewed by the University's Institutional Review Board, the researcher will evaluate the intervention using a complimentary mixed methods approach. The study will consist of a single-site platform trial examining the intervention group. There are many benefits to using a platform trial approach. First, using a platform trial allows the 18 participants to explore different arms of the intervention. Second, the platform design will allow us to also determine the effects of the interventions on patient help-seeking and adherence behavior in real-world care is critical to estimates of cost-effectiveness. As one of the specific aims of this study is to determine user feedback about modifying behaviors from various interventions, as opposed to determining which intervention is most effective, a platform trial will accomplish this.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •current subjects of the University of Kentucky Alzheimer's Disease Center (ADC)
- •meet consensus guidelines for mild cognitive impairment (MCI) developed by the Second International Working Group on MCI
- •have been diagnosed within the last year
- •able to provide informed consent
- •have a study partner willing to participate
排除标准
- •history of stroke
- •significant neurological or psychiatric conditions
- •brain injury
- •residence in institutional setting
研究组 & 干预措施
Patients with MCI
Participants diagnosed with mild cognitive impairment (MCI) and their study partners
干预措施: Planning for the Future (Behavioral)
Patients with MCI
Participants diagnosed with mild cognitive impairment (MCI) and their study partners
干预措施: Enhanced Medical Engagement (Behavioral)
Patients with MCI
Participants diagnosed with mild cognitive impairment (MCI) and their study partners
干预措施: Confidence Building and Social Engagement (Behavioral)
Patients with MCI
Participants diagnosed with mild cognitive impairment (MCI) and their study partners
干预措施: Physical Intervention (Behavioral)
Patients with MCI
Participants diagnosed with mild cognitive impairment (MCI) and their study partners
干预措施: Medical Adherence (Behavioral)
结局指标
主要结局
Self-Efficacy; general self-efficacy scale (GSES)
时间窗: 9 months
The general self-efficacy scale (GSES) is a ten-item scale. Scores range from 10-40, with higher scores indicating more self-efficacy.
次要结局
- Readiness to complete advance directives (ACPES)(9 months)
- Motivations Around Advance Care Planning (ADS)(9 months)
- Long Term Care Planning Behavior Scale (LTCP), planning subscale(9 months)
- Long-Term Supports and Services (LTSS)(9 months)
- World Health Organization Quality-of-Life (WHOQOL), Brief - Psychological and Social Relationship subscale(9 months)
- MCI Test of Knowledge (MCI-ToK)(9 months)
- Long Term Care Planning Behavior Scale (LTCP), health subscale(9 months)
- Technophilia Scale, Technology for health subscale (TTfH)(9 months)
- Technophilia Scale, Comfort with technology subscale (TCwT)(9 months)
- Technophilia Scale, Use of technology subscale (TUoT)(9 months)
- Patient communication pattern scale (PCPS)(9 months)
- Comfort engaging medical professionals (CEMP)(9 months)
- Mindfulness Attention Awareness Scale (MAAS)(9 months)
- Mindfulness Adherence Questionnaire (MAQ)(9 months)
- CHAMPS Physical Activity Questionnaire for Older Adults (CHAMPS), Social engagement subscale.(one month)
- Social Interaction Anxiety Scale (SIAS)(9 months)
- Crowne-Marlowe Social Desirability (CMSDS)(9 months)
- Memory Situation Questionnaire (MSQ; adapted)(9 months)
- Sickness Impact Profile (SIP) - subscales including body care and movement, mobility, and home management(9 months)
- CHAMPS Physical Activity Questionnaire for Older Adults (CHAMPS), Physical activity subscale(9 months)
- Long Term Care Planning Behavior Scale (LTCP), home modifications item(9 months)
- Short Falls Efficacy Scale (Short FES-I)(9 months)
- 36-Item Short Form Survey (SF-36) - physical functioning, pain, energy/fatigue, subscales(9 months)
- Activity(9 months)
- Medication Adherence (MA-MCI)(9 months)
- Medication Adherence (MA-SP)(9 months)
- Concerns about Memory Medications (CaMM)(9 months)
- Motivations around Memory Medications (MMM)(9 months)
- MCI Medication Test of Knowledge (MCI-MToK)(9 months)
研究者
Allison Gibson
Assistant Professor
University of Kentucky