Platform-based Mild Cognitive Impairment (MCI) Trial

February 23, 2022 updated by: Allison Gibson

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
9 months
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
9 months
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.
9 months
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.
9 months
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.
9 months
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.
9 months
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.
9 months
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 months
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.
9 months
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.
9 months
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.
9 months
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.
9 months
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.
9 months
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.
9 months
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.
one month
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.
9 months
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.
9 months
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.
9 months
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.
9 months
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.
9 months
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.
9 months
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.
9 months
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.
9 months
Activity
Time Frame: 9 months
Uniaxial accelerometer (MTI) measured activity counts
9 months
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.
9 months
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.
9 months
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.
9 months
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.
9 months
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.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allison Gibson

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Allison Gibson, PhD, MSW, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 44035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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