Platform-based Mild Cognitive Impairment (MCI) Trial

Purpose

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.

Condition

  • Mild Cognitive Impairment

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

More Details

NCT ID
NCT03987464
Status
Completed
Sponsor
Allison Gibson

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.