Platform-based Mild Cognitive Impairment (MCI) Trial

Mild Cognitive Impairment Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

• NCT number: NCT03987464
• Study type: Interventional
• Source: University of Kentucky
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Completion date: December 14, 2021