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Platform-based Mild Cognitive Impairment (MCI) Trial

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ClinicalTrials.gov Identifier: NCT03987464
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Allison Gibson, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Planning for the Future Behavioral: Enhanced Medical Engagement Behavioral: Confidence Building and Social Engagement Behavioral: Physical Intervention Behavioral: Medical Adherence Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Platform-Based Mild Cognitive Impairment (MCI) Trial to Address Maladaptive Behaviors
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with MCI
Participants diagnosed with mild cognitive impairment (MCI) and their study partners
Behavioral: Planning for the Future
This intervention will include attending an advance directives meeting, a living arrangements workshop, and a psychosocial education training workshop.

Behavioral: Enhanced Medical Engagement
This intervention includes creating a health portfolio, health record access training, and a medical engagement workshop

Behavioral: Confidence Building and Social Engagement
This intervention includes mindfulness training, a pre-experience training techniques workshop and a memory strategies class.

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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. The 8-Item Medication Adherence Scale (MMAS-8) [ Time Frame: 9 months ]
    The MMAS-8 includes 8-items. Scores range from 0-20, with higher scores indicating higher medication adherence.

  28. 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.

  29. 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.

  30. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987464


Contacts
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Contact: Allison Gibson, PhD, MSW (859) 323-7319 Allison.Gibson@uky.edu

Sponsors and Collaborators
Allison Gibson
Investigators
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Principal Investigator: Allison Gibson, PhD, MSW University of Kentucky

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Responsible Party: Allison Gibson, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03987464     History of Changes
Other Study ID Numbers: 44035
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Allison Gibson, University of Kentucky:
Alzheimer's Disease
maladaptive
behavior

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders