Platform-based Mild Cognitive Impairment (MCI) Trial

Allison Gibson

Status: Completed

Conditions: Mild Cognitive Impairment

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03987464

44035

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Patients with MCI

Experimental group

Description:

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

Treatment:

Behavioral: Planning for the Future

Behavioral: Confidence Building and Social Engagement

Behavioral: Medical Adherence

Behavioral: Physical Intervention

Behavioral: Enhanced Medical Engagement