Platform-based Mild Cognitive Impairment (MCI) Trial

NCT ID: NCT03987464

Last Updated: 2022-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-12-14

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with MCI

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

Group Type: EXPERIMENTAL

Planning for the Future

Intervention Type: BEHAVIORAL

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

Enhanced Medical Engagement

Intervention Type: BEHAVIORAL

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

Confidence Building and Social Engagement

Intervention Type: BEHAVIORAL

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

Physical Intervention

Intervention Type: BEHAVIORAL

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

Medical Adherence

Intervention Type: BEHAVIORAL

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

Interventions

Planning for the Future

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

Intervention Type: BEHAVIORAL

Enhanced Medical Engagement

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

Intervention Type: BEHAVIORAL

Confidence Building and Social Engagement

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

Intervention Type: BEHAVIORAL

Physical Intervention

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allison Gibson

OTHER

Sponsor Role: lead

Responsible Party

Allison Gibson

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Allison Gibson, PhD, MSW

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

44035

Identifier Type: -

Identifier Source: org_study_id