Skip to main content
OpenTrials
Completed

NCT Number: NCT03987464

Platform-based Mild Cognitive Impairment (MCI) Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Planning for the Future

Behavioral

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

Enhanced Medical Engagement

Behavioral

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

Confidence Building and Social Engagement

Behavioral

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

Physical Intervention

Behavioral

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

Medical Adherence

Behavioral

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

Primary outcomes

  1. Self-Efficacy; general self-efficacy scale (GSES)

    Time frame: 9 months

    The general self-efficacy scale (GSES) is a ten-item scale. Scores range from 10-40, with higher scores indicating more self-efficacy.

Secondary outcomes

  1. Readiness to complete advance directives (ACPES)

    Time frame: 9 months

    The 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.

  2. Motivations Around Advance Care Planning (ADS)

    Time frame: 9 months

    The 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

  3. Long Term Care Planning Behavior Scale (LTCP), planning subscale

    Time frame: 9 months

    The 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.

  4. Long-Term Supports and Services (LTSS)

    Time frame: 9 months

    The 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.

  5. World Health Organization Quality-of-Life (WHOQOL), Brief - Psychological and Social Relationship subscale

    Time frame: 9 months

    WHOQOL psychological and social relationships is an 9-item subscale. Scores range from 9-25, with higher scores indicating a higher quality-of-life.

  6. MCI Test of Knowledge (MCI-ToK)

    Time frame: 9 months

    The 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.

  7. Long Term Care Planning Behavior Scale (LTCP), health subscale

    Time frame: 9 months

    The LTCP health subscale is 3-items. Scores range from 0-12, with higher scores indicate willingness to follow directions about healthcare supports and services.

  8. Technophilia Scale, Technology for health subscale (TTfH)

    Time frame: 9 months

    The 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.

  9. Technophilia Scale, Comfort with technology subscale (TCwT)

    Time frame: 9 months

    The 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.

  10. Technophilia Scale, Use of technology subscale (TUoT)

    Time frame: 9 months

    The Technophilia Scale-Use of technology is 3-items. Scores range from 3-15, with higher scores indicating more frequent use of technology.

  11. Patient communication pattern scale (PCPS)

    Time frame: 9 months

    The PCPS is a 14-item scale. Scores range from 14-84, with higher scores indicating higher rates of communication with healthcare professionals.

  12. Comfort engaging medical professionals (CEMP)

    Time frame: 9 months

    The CEMP is a 4-item scale. Scores range from 4-20, with higher scores indicating more more comfort with engagement with medical care.

  13. Mindfulness Attention Awareness Scale (MAAS)

    Time frame: 9 months

    The MAAS is a 6-item scale. Scores range from 6-90, with higher scores indicating higher awareness of daily thoughts and tasks.

  14. Mindfulness Adherence Questionnaire (MAQ)

    Time frame: 9 months

    The MAAS is a 4-item scale. Scores range from 0-20, with higher scores indicating higher rates of adherence to the practice of mindfulness.

  15. CHAMPS Physical Activity Questionnaire for Older Adults (CHAMPS), Social engagement subscale.

    Time frame: one month

    The CHAMPS's social engagement is a 5-item subscale. Scores range from 0-30, with higher scores indicating higher rates of social engagement.

  16. Social Interaction Anxiety Scale (SIAS)

    Time frame: 9 months

    The SIAS is a 6-item scale. Scores range from 0-12, with higher scores indicating higher levels of social interaction anxiety.

  17. Crowne-Marlowe Social Desirability (CMSDS)

    Time frame: 9 months

    The CMSDS includes 2-items. Scores range from 0-2, with lower scores indicating higher levels of social desirability.

  18. Memory Situation Questionnaire (MSQ; adapted)

    Time frame: 9 months

    The MSQ includes 5-item scale. Scores range from 0-5, with higher scores indicating higher knowledge of memory strategies.

  19. Sickness Impact Profile (SIP) - subscales including body care and movement, mobility, and home management

    Time frame: 9 months

    The SIP subscales include 6-items. Scores range from 0-6, with higher scores indicating higher impact of illness.

  20. CHAMPS Physical Activity Questionnaire for Older Adults (CHAMPS), Physical activity subscale

    Time frame: 9 months

    The CHAMPS's social engagement is a 7-item subscale. Scores range from 0-35, with higher scores indicating higher rates of physical activity.

  21. Long Term Care Planning Behavior Scale (LTCP), home modifications item

    Time frame: 9 months

    This 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.

  22. Short Falls Efficacy Scale (Short FES-I)

    Time frame: 9 months

    The SIP subscale includes 7-items. Scores range from 0-28, with higher scores indicating higher concern for falls.

  23. 36-Item Short Form Survey (SF-36) - physical functioning, pain, energy/fatigue, subscales

    Time frame: 9 months

    These subscales include 16-items. Scores range from 16-61, with lower scores indicating higher limitations to physical functioning.

  24. Activity

    Time frame: 9 months

    Uniaxial accelerometer (MTI) measured activity counts

  25. Medication Adherence (MA-MCI)

    Time frame: 9 months

    The Medication Adherence scale includes 3-items for the MCI subjects. Scores range from 3-15, with lower scores indicating higher medication adherence.

  26. Medication Adherence (MA-SP)

    Time frame: 9 months

    The 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.

  27. Concerns about Memory Medications (CaMM)

    Time frame: 9 months

    This is 1 item. Scores range from 0-1, with "0" not adhering to medication and "1" is adhering to medication.

  28. Motivations around Memory Medications (MMM)

    Time frame: 9 months

    The 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.

  29. MCI Medication Test of Knowledge (MCI-MToK)

    Time frame: 9 months

    The 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.

Sponsors and collaborators

Lead sponsor

Allison Gibson

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 17, 2019
Registry last updated
Feb 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.