Platform-based Mild Cognitive Impairment (MCI) Trial
- Conditions
- Mild Cognitive Impairment
- Interventions
- Behavioral: Planning for the FutureBehavioral: Enhanced Medical EngagementBehavioral: Confidence Building and Social EngagementBehavioral: Physical InterventionBehavioral: Medical Adherence
- Registration Number
- NCT03987464
- Lead Sponsor
- Allison Gibson
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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
- history of stroke
- significant neurological or psychiatric conditions
- brain injury
- residence in institutional setting
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with MCI Physical Intervention Participants diagnosed with mild cognitive impairment (MCI) and their study partners Patients with MCI Planning for the Future Participants diagnosed with mild cognitive impairment (MCI) and their study partners Patients with MCI Enhanced Medical Engagement Participants diagnosed with mild cognitive impairment (MCI) and their study partners Patients with MCI Confidence Building and Social Engagement Participants diagnosed with mild cognitive impairment (MCI) and their study partners Patients with MCI Medical Adherence Participants diagnosed with mild cognitive impairment (MCI) and their study partners
- Primary Outcome Measures
Name Time Method Self-Efficacy; general self-efficacy scale (GSES) 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.
- Secondary Outcome Measures
Name Time Method Social Interaction Anxiety Scale (SIAS) 9 months The SIAS is a 6-item scale. Scores range from 0-12, with higher scores indicating higher levels of social interaction anxiety.
Crowne-Marlowe Social Desirability (CMSDS) 9 months The CMSDS includes 2-items. Scores range from 0-2, with lower scores indicating higher levels of social desirability.
Readiness to complete advance directives (ACPES) 9 months The readiness to complete advance directives is a 4-item scale. Scores range from 4-20, with higher scores indicating more readiness to complete advance directives.
Motivations Around Advance Care Planning (ADS) 9 months The motivations around advance care planning is a 9-item scale. Scores range from 9-45, with higher scores indicating motivational influences for advance care planning decisions
Long Term Care Planning Behavior Scale (LTCP), planning subscale 9 months The considered future living arrangement is a 3-item subscale. Scores range from 3-15, with higher scores indicating higher knowledge about future living arrangement options.
Long-Term Supports and Services (LTSS) 9 months The long-term supports and services is an 11-item scale. Scores range from 0-11, with higher scores indicating being more open to long-term support and service options.
World Health Organization Quality-of-Life (WHOQOL), Brief - Psychological and Social Relationship subscale 9 months WHOQOL psychological and social relationships is an 9-item subscale. Scores range from 9-25, with higher scores indicating a higher quality-of-life.
MCI Test of Knowledge (MCI-ToK) 9 months The long-term supports and services is an 5-item scale. Scores range from 0-5, with higher scores indicating a higher level of knowledge about MCI.
Long Term Care Planning Behavior Scale (LTCP), health subscale 9 months The LTCP health subscale is 3-items. Scores range from 0-12, with higher scores indicate willingness to follow directions about healthcare supports and services.
Technophilia Scale, Technology for health subscale (TTfH) 9 months The Technophilia Scale-Technology for health subscale is 2-items. Scores range from 2-10, with higher scores indicate a higher rate of use of technology for one's health.
Technophilia Scale, Comfort with technology subscale (TCwT) 9 months The Technophilia Scale-Comfort with technology is a 4-item scale. Scores range from 4-20, with higher scores indicate a higher rate of perceived comfort with using technology.
Technophilia Scale, Use of technology subscale (TUoT) 9 months The Technophilia Scale-Use of technology is 3-items. Scores range from 3-15, with higher scores indicating more frequent use of technology.
Patient communication pattern scale (PCPS) 9 months The PCPS is a 14-item scale. Scores range from 14-84, with higher scores indicating higher rates of communication with healthcare professionals.
Comfort engaging medical professionals (CEMP) 9 months The CEMP is a 4-item scale. Scores range from 4-20, with higher scores indicating more more comfort with engagement with medical care.
Mindfulness Attention Awareness Scale (MAAS) 9 months The MAAS is a 6-item scale. Scores range from 6-90, with higher scores indicating higher awareness of daily thoughts and tasks.
Mindfulness Adherence Questionnaire (MAQ) 9 months The MAAS is a 4-item scale. Scores range from 0-20, with higher scores indicating higher rates of adherence to the practice of mindfulness.
CHAMPS Physical Activity Questionnaire for Older Adults (CHAMPS), Social engagement subscale. one month The CHAMPS's social engagement is a 5-item subscale. Scores range from 0-30, with higher scores indicating higher rates of social engagement.
Memory Situation Questionnaire (MSQ; adapted) 9 months The MSQ includes 5-item scale. Scores range from 0-5, with higher scores indicating higher knowledge of memory strategies.
Sickness Impact Profile (SIP) - subscales including body care and movement, mobility, and home management 9 months The SIP subscales include 6-items. Scores range from 0-6, with higher scores indicating higher impact of illness.
CHAMPS Physical Activity Questionnaire for Older Adults (CHAMPS), Physical activity subscale 9 months The CHAMPS's social engagement is a 7-item subscale. Scores range from 0-35, with higher scores indicating higher rates of physical activity.
Long Term Care Planning Behavior Scale (LTCP), home modifications item 9 months This is 1 item on home modifications. Scores range from 0-1, with "0" representing no home modifications to prepare for the future and "1" indicating changes home modifications made to prepare for the future.
Short Falls Efficacy Scale (Short FES-I) 9 months The SIP subscale includes 7-items. Scores range from 0-28, with higher scores indicating higher concern for falls.
36-Item Short Form Survey (SF-36) - physical functioning, pain, energy/fatigue, subscales 9 months These subscales include 16-items. Scores range from 16-61, with lower scores indicating higher limitations to physical functioning.
Activity 9 months Uniaxial accelerometer (MTI) measured activity counts
Medication Adherence (MA-MCI) 9 months The Medication Adherence scale includes 3-items for the MCI subjects. Scores range from 3-15, with lower scores indicating higher medication adherence.
Medication Adherence (MA-SP) 9 months The Medication Adherence scale includes 3-items and is for the subjects that are study partners to the participant diagnosed with MCI. Scores range from 3-15, with lower scores indicating higher medication adherence.
Concerns about Memory Medications (CaMM) 9 months This is 1 item. Scores range from 0-1, with "0" not adhering to medication and "1" is adhering to medication.
Motivations around Memory Medications (MMM) 9 months The Motivations around Memory Medications scale includes 4-items. Scores range from 5-20, which measures attitudes around memory medications. Higher score indicates more positive attitudes about taking memory medications.
MCI Medication Test of Knowledge (MCI-MToK) 9 months The MCI Medication Test of Knowledge scale includes 4-items. Scores range from 0-4 where a higher score indicates a higher level of medication knowledge.
Trial Locations
- Locations (1)
University of Kentucky
🇺🇸Lexington, Kentucky, United States