Platform-based Mild Cognitive Impairment (MCI) Trial
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Planning for the Future
Enhanced Medical Engagement
Confidence Building and Social Engagement
Physical Intervention
Medical Adherence
Sponsored by

About this trial
This is an interventional other trial for Mild Cognitive Impairment focused on measuring Alzheimer's Disease, maladaptive, behavior
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- history of stroke
- significant neurological or psychiatric conditions
- brain injury
- residence in institutional setting
Sites / Locations
- University of Kentucky
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with MCI
Arm Description
Participants diagnosed with mild cognitive impairment (MCI) and their study partners
Outcomes
Primary Outcome Measures
Self-Efficacy; general self-efficacy scale (GSES)
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
Readiness to complete advance directives (ACPES)
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)
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
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)
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
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)
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
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)
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)
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)
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)
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)
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)
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)
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.
The CHAMPS's social engagement is a 5-item subscale. Scores range from 0-30, with higher scores indicating higher rates of social engagement.
Social Interaction Anxiety Scale (SIAS)
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)
The CMSDS includes 2-items. Scores range from 0-2, with lower scores indicating higher levels of social desirability.
Memory Situation Questionnaire (MSQ; adapted)
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
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
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
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)
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
These subscales include 16-items. Scores range from 16-61, with lower scores indicating higher limitations to physical functioning.
Activity
Uniaxial accelerometer (MTI) measured activity counts
Medication Adherence (MA-MCI)
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)
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)
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)
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03987464
Brief Title
Platform-based Mild Cognitive Impairment (MCI) Trial
Official Title
Platform-Based Mild Cognitive Impairment (MCI) Trial to Address Maladaptive Behaviors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 14, 2021 (Actual)
Study Completion Date
December 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Allison Gibson
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Alzheimer's Disease, maladaptive, behavior
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with MCI
Arm Type
Experimental
Arm Description
Participants diagnosed with mild cognitive impairment (MCI) and their study partners
Intervention Type
Behavioral
Intervention Name(s)
Planning for the Future
Intervention Description
This intervention will include attending an advance directives meeting, a living arrangements workshop, and a psychosocial education training workshop.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Medical Engagement
Intervention Description
This intervention includes creating a health portfolio, health record access training, and a medical engagement workshop
Intervention Type
Behavioral
Intervention Name(s)
Confidence Building and Social Engagement
Intervention Description
This intervention includes mindfulness training, a pre-experience training techniques workshop and a memory strategies class.
Intervention Type
Behavioral
Intervention Name(s)
Physical Intervention
Intervention Description
This intervention includes physical/occupational therapy (PT/OT), a home safety assessment, and an independent exercise program.
Intervention Type
Behavioral
Intervention Name(s)
Medical Adherence
Intervention Description
This intervention includes using automated pillboxes to ensure medication compliance, optimizing appropriate medication use through review, and engaging with memory medications via class.
Primary Outcome Measure Information:
Title
Self-Efficacy; general self-efficacy scale (GSES)
Description
The general self-efficacy scale (GSES) is a ten-item scale. Scores range from 10-40, with higher scores indicating more self-efficacy.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Readiness to complete advance directives (ACPES)
Description
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.
Time Frame
9 months
Title
Motivations Around Advance Care Planning (ADS)
Description
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
Time Frame
9 months
Title
Long Term Care Planning Behavior Scale (LTCP), planning subscale
Description
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.
Time Frame
9 months
Title
Long-Term Supports and Services (LTSS)
Description
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.
Time Frame
9 months
Title
World Health Organization Quality-of-Life (WHOQOL), Brief - Psychological and Social Relationship subscale
Description
WHOQOL psychological and social relationships is an 9-item subscale. Scores range from 9-25, with higher scores indicating a higher quality-of-life.
Time Frame
9 months
Title
MCI Test of Knowledge (MCI-ToK)
Description
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.
Time Frame
9 months
Title
Long Term Care Planning Behavior Scale (LTCP), health subscale
Description
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.
Time Frame
9 months
Title
Technophilia Scale, Technology for health subscale (TTfH)
Description
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.
Time Frame
9 months
Title
Technophilia Scale, Comfort with technology subscale (TCwT)
Description
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.
Time Frame
9 months
Title
Technophilia Scale, Use of technology subscale (TUoT)
Description
The Technophilia Scale-Use of technology is 3-items. Scores range from 3-15, with higher scores indicating more frequent use of technology.
Time Frame
9 months
Title
Patient communication pattern scale (PCPS)
Description
The PCPS is a 14-item scale. Scores range from 14-84, with higher scores indicating higher rates of communication with healthcare professionals.
Time Frame
9 months
Title
Comfort engaging medical professionals (CEMP)
Description
The CEMP is a 4-item scale. Scores range from 4-20, with higher scores indicating more more comfort with engagement with medical care.
Time Frame
9 months
Title
Mindfulness Attention Awareness Scale (MAAS)
Description
The MAAS is a 6-item scale. Scores range from 6-90, with higher scores indicating higher awareness of daily thoughts and tasks.
Time Frame
9 months
Title
Mindfulness Adherence Questionnaire (MAQ)
Description
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.
Time Frame
9 months
Title
CHAMPS Physical Activity Questionnaire for Older Adults (CHAMPS), Social engagement subscale.
Description
The CHAMPS's social engagement is a 5-item subscale. Scores range from 0-30, with higher scores indicating higher rates of social engagement.
Time Frame
one month
Title
Social Interaction Anxiety Scale (SIAS)
Description
The SIAS is a 6-item scale. Scores range from 0-12, with higher scores indicating higher levels of social interaction anxiety.
Time Frame
9 months
Title
Crowne-Marlowe Social Desirability (CMSDS)
Description
The CMSDS includes 2-items. Scores range from 0-2, with lower scores indicating higher levels of social desirability.
Time Frame
9 months
Title
Memory Situation Questionnaire (MSQ; adapted)
Description
The MSQ includes 5-item scale. Scores range from 0-5, with higher scores indicating higher knowledge of memory strategies.
Time Frame
9 months
Title
Sickness Impact Profile (SIP) - subscales including body care and movement, mobility, and home management
Description
The SIP subscales include 6-items. Scores range from 0-6, with higher scores indicating higher impact of illness.
Time Frame
9 months
Title
CHAMPS Physical Activity Questionnaire for Older Adults (CHAMPS), Physical activity subscale
Description
The CHAMPS's social engagement is a 7-item subscale. Scores range from 0-35, with higher scores indicating higher rates of physical activity.
Time Frame
9 months
Title
Long Term Care Planning Behavior Scale (LTCP), home modifications item
Description
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.
Time Frame
9 months
Title
Short Falls Efficacy Scale (Short FES-I)
Description
The SIP subscale includes 7-items. Scores range from 0-28, with higher scores indicating higher concern for falls.
Time Frame
9 months
Title
36-Item Short Form Survey (SF-36) - physical functioning, pain, energy/fatigue, subscales
Description
These subscales include 16-items. Scores range from 16-61, with lower scores indicating higher limitations to physical functioning.
Time Frame
9 months
Title
Activity
Description
Uniaxial accelerometer (MTI) measured activity counts
Time Frame
9 months
Title
Medication Adherence (MA-MCI)
Description
The Medication Adherence scale includes 3-items for the MCI subjects. Scores range from 3-15, with lower scores indicating higher medication adherence.
Time Frame
9 months
Title
Medication Adherence (MA-SP)
Description
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.
Time Frame
9 months
Title
Concerns about Memory Medications (CaMM)
Description
This is 1 item. Scores range from 0-1, with "0" not adhering to medication and "1" is adhering to medication.
Time Frame
9 months
Title
Motivations around Memory Medications (MMM)
Description
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.
Time Frame
9 months
Title
MCI Medication Test of Knowledge (MCI-MToK)
Description
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.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
history of stroke
significant neurological or psychiatric conditions
brain injury
residence in institutional setting
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Gibson, PhD, MSW
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Platform-based Mild Cognitive Impairment (MCI) Trial
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