Clinical trial NCT03987464: Platform-based Mild Cognitive Impairment (MCI) Trial
Official title: Platform-Based Mild Cognitive Impairment (MCI) Trial to Address Maladaptive Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Alzheimer's Disease
maladaptive
behavior
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Self-Efficacy; general self-efficacy scale (GSES)
timeFrame: 9 months
Secondary outcomes:
measure: Readiness to complete advance directives (ACPES)
timeFrame: 9 months
measure: Motivations Around Advance Care Planning (ADS)
timeFrame: 9 months
measure: Long Term Care Planning Behavior Scale (LTCP), planning subscale
timeFrame: 9 months
measure: Long-Term Supports and Services (LTSS)
timeFrame: 9 months
measure: World Health Organization Quality-of-Life (WHOQOL), Brief - Psychological and Social Relationship subscale
timeFrame: 9 months
measure: MCI Test of Knowledge (MCI-ToK)
timeFrame: 9 months
measure: Long Term Care Planning Behavior Scale (LTCP), health subscale
timeFrame: 9 months
measure: Technophilia Scale, Technology for health subscale (TTfH)
timeFrame: 9 months
measure: Technophilia Scale, Comfort with technology subscale (TCwT)
timeFrame: 9 months
measure: Technophilia Scale, Use of technology subscale (TUoT)
timeFrame: 9 months
measure: Patient communication pattern scale (PCPS)
timeFrame: 9 months
measure: Comfort engaging medical professionals (CEMP)
timeFrame: 9 months
measure: Mindfulness Attention Awareness Scale (MAAS)
timeFrame: 9 months
measure: Mindfulness Adherence Questionnaire (MAQ)
timeFrame: 9 months
measure: CHAMPS Physical Activity Questionnaire for Older Adults (CHAMPS), Social engagement subscale.
timeFrame: one month
measure: Social Interaction Anxiety Scale (SIAS)
timeFrame: 9 months
measure: Crowne-Marlowe Social Desirability (CMSDS)
timeFrame: 9 months
measure: Memory Situation Questionnaire (MSQ; adapted)
timeFrame: 9 months
measure: Sickness Impact Profile (SIP) - subscales including body care and movement, mobility, and home management
timeFrame: 9 months
measure: CHAMPS Physical Activity Questionnaire for Older Adults (CHAMPS), Physical activity subscale
timeFrame: 9 months
measure: Long Term Care Planning Behavior Scale (LTCP), home modifications item
timeFrame: 9 months
measure: Short Falls Efficacy Scale (Short FES-I)
timeFrame: 9 months
measure: 36-Item Short Form Survey (SF-36) - physical functioning, pain, energy/fatigue, subscales
timeFrame: 9 months
measure: Activity
timeFrame: 9 months
measure: Medication Adherence (MA-MCI)
timeFrame: 9 months
measure: Medication Adherence (MA-SP)
timeFrame: 9 months
measure: Concerns about Memory Medications (CaMM)
timeFrame: 9 months
measure: Motivations around Memory Medications (MMM)
timeFrame: 9 months
measure: MCI Medication Test of Knowledge (MCI-MToK)
timeFrame: 9 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Allison Gibson, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References: