Platform-based Mild Cognitive Impairment (MCI) Trial

Platform-Based Mild Cognitive Impairment (MCI) Trial to Address Maladaptive Behaviors

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Planning for the Future; Behavioral: Enhanced Medical Engagement; Behavioral: Confidence Building and Social Engagement; Behavioral: Physical Intervention; Behavioral: Medical Adherence

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Patients with MCI; Participants diagnosed with mild cognitive impairment (MCI) and their study partners

Behavioral: Planning for the Future; This intervention will include attending an advance directives meeting, a living arrangements workshop, and a psychosocial education training workshop.; Behavioral: Enhanced Medical Engagement; This intervention includes creating a health portfolio, health record access training, and a medical engagement workshop; Behavioral: Confidence Building and Social Engagement; This intervention includes mindfulness training, a pre-experience training techniques workshop and a memory strategies class.; Behavioral: Physical Intervention; This intervention includes physical/occupational therapy (PT/OT), a home safety assessment, and an independent exercise program.; Behavioral: Medical Adherence; This intervention includes using automated pillboxes to ensure medication compliance, optimizing appropriate medication use through review, and engaging with memory medications via class.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months
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	9 months
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.	9 months
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.	9 months
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.	9 months
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.	9 months
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.	9 months
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.	9 months
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.	9 months
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.	9 months
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.	9 months
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.	9 months
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.	9 months
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.	9 months
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.	one month
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.	9 months
Crowne-Marlowe Social Desirability (CMSDS)	The CMSDS includes 2-items. Scores range from 0-2, with lower scores indicating higher levels of social desirability.	9 months
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.	9 months
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.	9 months
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.	9 months
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.	9 months
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.	9 months
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.	9 months
Activity	Uniaxial accelerometer (MTI) measured activity counts	9 months
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.	9 months
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.	9 months
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.	9 months
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.	9 months
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.	9 months

Collaborators and Investigators

• Sponsor: Allison Gibson
• Investigators: Principal Investigator: Allison Gibson, PhD, MSW, University of Kentucky

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2019
• Primary Completion (ACTUAL): December 14, 2021
• Study Completion (ACTUAL): December 14, 2021

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (ACTUAL): June 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; behavior; maladaptive
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 44035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No