Mild Cognitive ImpairmentNCT03987464
Platform-based Mild Cognitive Impairment (MCI) Trial
A study testing Planning for the Future, Enhanced Medical Engagement and Confidence Building and Social Engagement in people with Mild Cognitive Impairment, run by Allison Gibson at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Planning for the Future, Enhanced Medical Engagement and Confidence Building and Social Engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 14 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- history of stroke
- significant neurological or psychiatric conditions
- brain injury
- residence in institutional setting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Planning for the Future, Enhanced Medical Engagement, Confidence Building and Social Engagement, Physical Intervention, Medical Adherence
- Keywords
- Alzheimer's Disease, maladaptive, behavior
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planning for the FutureBehavioural
This intervention will include attending an advance directives meeting, a living arrangements workshop, and a psychosocial education training workshop.
Enhanced Medical EngagementBehavioural
This intervention includes creating a health portfolio, health record access training, and a medical engagement workshop
Confidence Building and Social EngagementBehavioural
This intervention includes mindfulness training, a pre-experience training techniques workshop and a memory strategies class.
Physical InterventionBehavioural
This intervention includes physical/occupational therapy (PT/OT), a home safety assessment, and an independent exercise program.
Medical AdherenceBehavioural
This intervention includes using automated pillboxes to ensure medication compliance, optimizing appropriate medication use through review, and engaging with memory medications via class.
| Study group | Role | What they receive |
|---|---|---|
| Patients with MCI | Experimental | Participants diagnosed with mild cognitive impairment (MCI) and their study partners Receives: Behavioral: Planning for the Future; Behavioral: Enhanced Medical Engagement; Behavioral: Confidence Building and Social Engagement; Behavioral: Physical Intervention; Behavioral: Medical Adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Efficacy; general self-efficacy scale (GSES)
The general self-efficacy scale (GSES) is a ten-item scale. Scores range from 10-40, with higher scores indicating more self-efficacy.
Measured: 9 months
Secondary outcomes (29)
Readiness to complete advance directives (ACPES)
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.
Measured: 9 months
Motivations Around Advance Care Planning (ADS)
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
Measured: 9 months
Long Term Care Planning Behavior Scale (LTCP), planning subscale
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.
Measured: 9 months
Long-Term Supports and Services (LTSS)
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.
Measured: 9 months
World Health Organization Quality-of-Life (WHOQOL), Brief - Psychological and Social Relationship subscale
WHOQOL psychological and social relationships is an 9-item subscale. Scores range from 9-25, with higher scores indicating a higher quality-of-life.
Measured: 9 months
MCI Test of Knowledge (MCI-ToK)
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.
Measured: 9 months
Long Term Care Planning Behavior Scale (LTCP), health subscale
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.
Measured: 9 months
Technophilia Scale, Technology for health subscale (TTfH)
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.
Measured: 9 months
Technophilia Scale, Comfort with technology subscale (TCwT)
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.
Measured: 9 months
Technophilia Scale, Use of technology subscale (TUoT)
The Technophilia Scale-Use of technology is 3-items. Scores range from 3-15, with higher scores indicating more frequent use of technology.
Measured: 9 months
Patient communication pattern scale (PCPS)
The PCPS is a 14-item scale. Scores range from 14-84, with higher scores indicating higher rates of communication with healthcare professionals.
Measured: 9 months
Comfort engaging medical professionals (CEMP)
The CEMP is a 4-item scale. Scores range from 4-20, with higher scores indicating more more comfort with engagement with medical care.
Measured: 9 months
Mindfulness Attention Awareness Scale (MAAS)
The MAAS is a 6-item scale. Scores range from 6-90, with higher scores indicating higher awareness of daily thoughts and tasks.
Measured: 9 months
Mindfulness Adherence Questionnaire (MAQ)
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.
Measured: 9 months
CHAMPS Physical Activity Questionnaire for Older Adults (CHAMPS), Social engagement subscale.
The CHAMPS's social engagement is a 5-item subscale. Scores range from 0-30, with higher scores indicating higher rates of social engagement.
Measured: one month
Social Interaction Anxiety Scale (SIAS)
The SIAS is a 6-item scale. Scores range from 0-12, with higher scores indicating higher levels of social interaction anxiety.
Measured: 9 months
Crowne-Marlowe Social Desirability (CMSDS)
The CMSDS includes 2-items. Scores range from 0-2, with lower scores indicating higher levels of social desirability.
Measured: 9 months
Memory Situation Questionnaire (MSQ; adapted)
The MSQ includes 5-item scale. Scores range from 0-5, with higher scores indicating higher knowledge of memory strategies.
Measured: 9 months
Sickness Impact Profile (SIP) - subscales including body care and movement, mobility, and home management
The SIP subscales include 6-items. Scores range from 0-6, with higher scores indicating higher impact of illness.
Measured: 9 months
CHAMPS Physical Activity Questionnaire for Older Adults (CHAMPS), Physical activity subscale
The CHAMPS's social engagement is a 7-item subscale. Scores range from 0-35, with higher scores indicating higher rates of physical activity.
Measured: 9 months
Long Term Care Planning Behavior Scale (LTCP), home modifications item
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.
Measured: 9 months
Short Falls Efficacy Scale (Short FES-I)
The SIP subscale includes 7-items. Scores range from 0-28, with higher scores indicating higher concern for falls.
Measured: 9 months
36-Item Short Form Survey (SF-36) - physical functioning, pain, energy/fatigue, subscales
These subscales include 16-items. Scores range from 16-61, with lower scores indicating higher limitations to physical functioning.
Measured: 9 months
Activity
Uniaxial accelerometer (MTI) measured activity counts
Measured: 9 months
Medication Adherence (MA-MCI)
The Medication Adherence scale includes 3-items for the MCI subjects. Scores range from 3-15, with lower scores indicating higher medication adherence.
Measured: 9 months
Medication Adherence (MA-SP)
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.
Measured: 9 months
Concerns about Memory Medications (CaMM)
This is 1 item. Scores range from 0-1, with "0" not adhering to medication and "1" is adhering to medication.
Measured: 9 months
Motivations around Memory Medications (MMM)
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.
Measured: 9 months
MCI Medication Test of Knowledge (MCI-MToK)
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start1 Nov 2019
- Primary completion14 Dec 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allison Gibson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Allison Gibson, University of Kentucky
- Investigators
- Allison Gibson, PhD, MSW, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987464
- Sponsor's protocol ID
- 44035
- Status last verified
- Feb 2022
- First submitted
- 12 Jun 2019
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platform-Based Mild Cognitive Impairment (MCI) Trial to Address Maladaptive Behaviors
- ClinicalTrials.gov ID
- NCT03987464
- Acronym / sponsor ID
- 44035
- Conditions
- Mild Cognitive Impairment
- Keywords
- Alzheimer's Disease, maladaptive, behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Allison GibsonUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with MCI | Experimental | Behavioral: Planning for the Future, Behavioral: Enhanced Medical Engagement, Behavioral: Confidence Building and Social Engagement, Behavioral: Physical Intervention, Behavioral: Medical AdherenceParticipants diagnosed with mild cognitive impairment (MCI) and their study partners |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- history of stroke
- significant neurological or psychiatric conditions
- brain injury
- residence in institutional setting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Planning for the FutureThis intervention will include attending an advance directives meeting, a living arrangements workshop, and a psychosocial education training workshop. | Behavioural | Patients with MCI |
| Enhanced Medical EngagementThis intervention includes creating a health portfolio, health record access training, and a medical engagement workshop | Behavioural | Patients with MCI |
| Confidence Building and Social EngagementThis intervention includes mindfulness training, a pre-experience training techniques workshop and a memory strategies class. | Behavioural | Patients with MCI |
| Physical InterventionThis intervention includes physical/occupational therapy (PT/OT), a home safety assessment, and an independent exercise program. | Behavioural | Patients with MCI |
| Medical AdherenceThis intervention includes using automated pillboxes to ensure medication compliance, optimizing appropriate medication use through review, and engaging with memory medications via class. | Behavioural | Patients with MCI |
Primary outcome
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.
29 secondary outcomes
Readiness to complete advance directives (ACPES)
Time frame: 9 months
Motivations Around Advance Care Planning (ADS)
Time frame: 9 months
Long Term Care Planning Behavior Scale (LTCP), planning subscale
Time frame: 9 months
Long-Term Supports and Services (LTSS)
Time frame: 9 months
World Health Organization Quality-of-Life (WHOQOL), Brief - Psychological and Social Relationship subscale
Time frame: 9 months
MCI Test of Knowledge (MCI-ToK)
Time frame: 9 months
Long Term Care Planning Behavior Scale (LTCP), health subscale
Time frame: 9 months
Technophilia Scale, Technology for health subscale (TTfH)
Time frame: 9 months
Technophilia Scale, Comfort with technology subscale (TCwT)
Time frame: 9 months
Technophilia Scale, Use of technology subscale (TUoT)
Time frame: 9 months
Patient communication pattern scale (PCPS)
Time frame: 9 months
Comfort engaging medical professionals (CEMP)
Time frame: 9 months
Mindfulness Attention Awareness Scale (MAAS)
Time frame: 9 months
Mindfulness Adherence Questionnaire (MAQ)
Time frame: 9 months
CHAMPS Physical Activity Questionnaire for Older Adults (CHAMPS), Social engagement subscale.
Time frame: one month
Social Interaction Anxiety Scale (SIAS)
Time frame: 9 months
Crowne-Marlowe Social Desirability (CMSDS)
Time frame: 9 months
Memory Situation Questionnaire (MSQ; adapted)
Time frame: 9 months
Sickness Impact Profile (SIP) - subscales including body care and movement, mobility, and home management
Time frame: 9 months
CHAMPS Physical Activity Questionnaire for Older Adults (CHAMPS), Physical activity subscale
Time frame: 9 months
Long Term Care Planning Behavior Scale (LTCP), home modifications item
Time frame: 9 months
Short Falls Efficacy Scale (Short FES-I)
Time frame: 9 months
36-Item Short Form Survey (SF-36) - physical functioning, pain, energy/fatigue, subscales
Time frame: 9 months
Activity
Time frame: 9 months
Medication Adherence (MA-MCI)
Time frame: 9 months
Medication Adherence (MA-SP)
Time frame: 9 months
Concerns about Memory Medications (CaMM)
Time frame: 9 months
Motivations around Memory Medications (MMM)
Time frame: 9 months
MCI Medication Test of Knowledge (MCI-MToK)
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Gibson, PhD, MSW principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Planning for the Future, Enhanced Medical Engagement and Confidence Building and Social Engagement in people with Mild Cognitive Impairment, run by Allison Gibson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Efficacy; general self-efficacy scale (GSES) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.