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Platform-based Mild Cognitive Impairment (MCI) Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03987464
Enrollment
38
Registered
2019-06-17
Start date
2019-11-01
Completion date
2021-12-14
Last updated
2022-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

Alzheimer's Disease, maladaptive, behavior

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.

Interventions

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

BEHAVIORALEnhanced Medical Engagement

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

BEHAVIORALConfidence Building and Social Engagement

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

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

BEHAVIORALMedical Adherence

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

Sponsors

Allison Gibson
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Self-Efficacy; general self-efficacy scale (GSES)9 monthsThe general self-efficacy scale (GSES) is a ten-item scale. Scores range from 10-40, with higher scores indicating more self-efficacy.

Secondary

MeasureTime frameDescription
Motivations Around Advance Care Planning (ADS)9 monthsThe motivations around advance care planning is a 9-item scale. Scores range from 9-45, with higher scores indicating motivational influences for advance care planning decisions
Long Term Care Planning Behavior Scale (LTCP), planning subscale9 monthsThe considered future living arrangement is a 3-item subscale. Scores range from 3-15, with higher scores indicating higher knowledge about future living arrangement options.
Long-Term Supports and Services (LTSS)9 monthsThe long-term supports and services is an 11-item scale. Scores range from 0-11, with higher scores indicating being more open to long-term support and service options.
World Health Organization Quality-of-Life (WHOQOL), Brief - Psychological and Social Relationship subscale9 monthsWHOQOL psychological and social relationships is an 9-item subscale. Scores range from 9-25, with higher scores indicating a higher quality-of-life.
MCI Test of Knowledge (MCI-ToK)9 monthsThe long-term supports and services is an 5-item scale. Scores range from 0-5, with higher scores indicating a higher level of knowledge about MCI.
Long Term Care Planning Behavior Scale (LTCP), health subscale9 monthsThe LTCP health subscale is 3-items. Scores range from 0-12, with higher scores indicate willingness to follow directions about healthcare supports and services.
Technophilia Scale, Technology for health subscale (TTfH)9 monthsThe Technophilia Scale-Technology for health subscale is 2-items. Scores range from 2-10, with higher scores indicate a higher rate of use of technology for one's health.
Technophilia Scale, Comfort with technology subscale (TCwT)9 monthsThe Technophilia Scale-Comfort with technology is a 4-item scale. Scores range from 4-20, with higher scores indicate a higher rate of perceived comfort with using technology.
Technophilia Scale, Use of technology subscale (TUoT)9 monthsThe Technophilia Scale-Use of technology is 3-items. Scores range from 3-15, with higher scores indicating more frequent use of technology.
Patient communication pattern scale (PCPS)9 monthsThe PCPS is a 14-item scale. Scores range from 14-84, with higher scores indicating higher rates of communication with healthcare professionals.
Comfort engaging medical professionals (CEMP)9 monthsThe CEMP is a 4-item scale. Scores range from 4-20, with higher scores indicating more more comfort with engagement with medical care.
Mindfulness Attention Awareness Scale (MAAS)9 monthsThe MAAS is a 6-item scale. Scores range from 6-90, with higher scores indicating higher awareness of daily thoughts and tasks.
Mindfulness Adherence Questionnaire (MAQ)9 monthsThe MAAS is a 4-item scale. Scores range from 0-20, with higher scores indicating higher rates of adherence to the practice of mindfulness.
CHAMPS Physical Activity Questionnaire for Older Adults (CHAMPS), Social engagement subscale.one monthThe CHAMPS's social engagement is a 5-item subscale. Scores range from 0-30, with higher scores indicating higher rates of social engagement.
Readiness to complete advance directives (ACPES)9 monthsThe readiness to complete advance directives is a 4-item scale. Scores range from 4-20, with higher scores indicating more readiness to complete advance directives.
Crowne-Marlowe Social Desirability (CMSDS)9 monthsThe CMSDS includes 2-items. Scores range from 0-2, with lower scores indicating higher levels of social desirability.
Memory Situation Questionnaire (MSQ; adapted)9 monthsThe MSQ includes 5-item scale. Scores range from 0-5, with higher scores indicating higher knowledge of memory strategies.
Sickness Impact Profile (SIP) - subscales including body care and movement, mobility, and home management9 monthsThe SIP subscales include 6-items. Scores range from 0-6, with higher scores indicating higher impact of illness.
CHAMPS Physical Activity Questionnaire for Older Adults (CHAMPS), Physical activity subscale9 monthsThe CHAMPS's social engagement is a 7-item subscale. Scores range from 0-35, with higher scores indicating higher rates of physical activity.
Long Term Care Planning Behavior Scale (LTCP), home modifications item9 monthsThis is 1 item on home modifications. Scores range from 0-1, with 0 representing no home modifications to prepare for the future and 1 indicating changes home modifications made to prepare for the future.
Short Falls Efficacy Scale (Short FES-I)9 monthsThe SIP subscale includes 7-items. Scores range from 0-28, with higher scores indicating higher concern for falls.
36-Item Short Form Survey (SF-36) - physical functioning, pain, energy/fatigue, subscales9 monthsThese subscales include 16-items. Scores range from 16-61, with lower scores indicating higher limitations to physical functioning.
Activity9 monthsUniaxial accelerometer (MTI) measured activity counts
Medication Adherence (MA-MCI)9 monthsThe Medication Adherence scale includes 3-items for the MCI subjects. Scores range from 3-15, with lower scores indicating higher medication adherence.
Medication Adherence (MA-SP)9 monthsThe Medication Adherence scale includes 3-items and is for the subjects that are study partners to the participant diagnosed with MCI. Scores range from 3-15, with lower scores indicating higher medication adherence.
Concerns about Memory Medications (CaMM)9 monthsThis is 1 item. Scores range from 0-1, with 0 not adhering to medication and 1 is adhering to medication.
Motivations around Memory Medications (MMM)9 monthsThe Motivations around Memory Medications scale includes 4-items. Scores range from 5-20, which measures attitudes around memory medications. Higher score indicates more positive attitudes about taking memory medications.
MCI Medication Test of Knowledge (MCI-MToK)9 monthsThe MCI Medication Test of Knowledge scale includes 4-items. Scores range from 0-4 where a higher score indicates a higher level of medication knowledge.
Social Interaction Anxiety Scale (SIAS)9 monthsThe SIAS is a 6-item scale. Scores range from 0-12, with higher scores indicating higher levels of social interaction anxiety.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026