Platform-based Mild Cognitive Impairment (MCI) Trial

NCT03987464 | Completed

• 1 other identifier: 44035
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Alzheimer's Disease; maladaptive; behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (29)

• 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

Study Arms (1)

Patients with MCI

EXPERIMENTAL

Participants diagnosed with mild cognitive impairment (MCI) and their study partners

Behavioral: Planning for the Future; Behavioral: Enhanced Medical Engagement; Behavioral: Confidence Building and Social Engagement; Behavioral: Physical Intervention; Behavioral: Medical Adherence

Interventions

Planning for the Future BEHAVIORAL

This intervention will include attending an advance directives meeting, a living arrangements workshop, and a psychosocial education training workshop.

Patients with MCI

Enhanced Medical Engagement BEHAVIORAL

This intervention includes creating a health portfolio, health record access training, and a medical engagement workshop

Patients with MCI

Confidence Building and Social Engagement BEHAVIORAL

This intervention includes mindfulness training, a pre-experience training techniques workshop and a memory strategies class.

Patients with MCI

Physical Intervention BEHAVIORAL

This intervention includes physical/occupational therapy (PT/OT), a home safety assessment, and an independent exercise program.

Patients with MCI

Medical Adherence BEHAVIORAL

This intervention includes using automated pillboxes to ensure medication compliance, optimizing appropriate medication use through review, and engaging with memory medications via class.

Patients with MCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• history of stroke
• significant neurological or psychiatric conditions
• brain injury
• residence in institutional setting

Sponsors & Collaborators

• Allison Gibson: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Behavior

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Allison Gibson, PhD, MSW

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 17, 2019
• Study Start: November 1, 2019
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)