search
Back to results

A Rehabilitation Intervention for Amnestic Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Memory Support System
Computer Training
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mild Cognitive Impairment focused on measuring Rehabilitation, Cognitive Intervention, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Enrolled as a research participant in the Alzheimer's Disease Research Center with a consensus diagnosis of amnestic Mild Cognitive Impairment (MCI: single domain or multi-domain).
  • Has a program partner that has at least twice weekly contact with the participant
  • Dementia Rating Scale-2nd Edition (DRS-2) score of 115 or greater
  • Functional Ability Questionnaire (FAQ) score below 6.
  • Program Partner with Mini Mental State Exam (MMSE) of 24 or greater. (If a program partner has an MMSE less than 24, the site PI will recommend that the person seek further evaluation of cognition through their primary care physician. The person with MCI will be encouraged to find an alternate program partner.)
  • Either not taking or stable on nootropic(s) for at least 3 months
  • Has English as primary language

Exclusion Criteria:

  • Diagnosis other than amnestic MCI (single domain or multi-domain)
  • Visual/hearing impairment or history of reading/writing disability sufficient to interfere with training
  • Inclusion in another clinical trial that would exclude participation. Subject will be considered for participation at the end of such a trial or as appropriate.
  • Baseline score on the self-report depression measure suggesting severe depression for either the participant or the program partner (>21 on the Centers for Epidemiological Studies - Depression Scale (CES-D) and need for psychiatric treatment. (If a patient or program partner has a CES-D greater than 21, the site Principal Investigator will rule out suicidal ideation and then recommend that the person seek further evaluation of mood from their primary care physician, psychiatrist, or other mental health practitioner. If they seek treatment and have been stable on that treatment for 3 months, they would then be allowed to be reconsidered for the study.)

Sites / Locations

  • Mayo Clinic - Scottsdale
  • Emory University
  • Mayo Clinic-Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Memory Support System or Computer

Arm Description

Outcomes

Primary Outcome Measures

To assess participant adherence to Memory Support System (MSS) use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment).
To assess participant adherence to (Memory Support System) MSS use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment).
To assess participant adherence to (Memory Support System)MSS use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment).
To assess participant adherence to (Memory Support System) MSS use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment).
To assess participant adherence to (Memory Support System) MSS use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment).

Secondary Outcome Measures

Full Information

First Posted
January 11, 2011
Last Updated
December 3, 2014
Sponsor
Emory University
Collaborators
Mayo Clinic, National Institute of Nursing Research (NINR)
search

1. Study Identification

Unique Protocol Identification Number
NCT01283269
Brief Title
A Rehabilitation Intervention for Amnestic Mild Cognitive Impairment
Official Title
A Multicenter Rehabilitation Intervention for Amnestic Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Mayo Clinic, National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Mild Cognitive Impairment (MCI) is often an early manifestation of Alzheimer's disease (AD). The ability to identify MCI has led to hope that health prevention models might work in AD as they have in cancer and heart disease. Interventions which help sustain functioning in MCI may delay progression to a clinical AD diagnosis. To date, interventions aimed at maintaining functioning in MCI have been pharmacologic in nature. The efficacy of these medications in MCI is controversial, and those with MCI are also often interested in other activities they can do to manage their memory loss. When an individual is noted to have memory difficulties or MCI, a recommendation is often given for the patient to begin taking notes/using a calendar to help with memory or do cognitively stimulating activities. However, there is currently little instruction about how/what specific activities one should do and how effective they may be. The overall goal of this pilot project is to refine delivery of the Memory Support System (MSS)as a formal compensatory program for memory loss in MCI. Enrollment and retention data will be carefully investigated across 6 week and 10 day intervention groups. The investigators will compare participant adherence to the notebook training in the 6 week and 10 day versions of the intervention to the computer activity group. The investigators will also collect data on the clinical efficacy of the notebook and computer training to investigate if these interventions can sustain/improve functional level. Long term goals for this project also include delaying relocation for persons with MCI who may progress to dementia, thus not only improving the lives of these individuals, but also reducing health care expenditures. The investigators will recruit a total of 60 individuals with MCI and their 60 program partners across all three sites for this project. At least 16 of these pairs will be recruited at Emory University (maximum of 20 pairs/40 individuals anticipated). The investigators will randomly assign participants to the 6 week notebook or computer training or 10 day notebook or computer training. All participants will also receive patient education regarding MCI and cognitive health. Subsequent compliance with the MSS will be examined at 3 months, 6 months, and then annually following the intervention. Outcome measures will provide a detailed, multi-modal assessment of participants' functional level, overall cognitive functioning, mood, and self-efficacy, as well as caregiver burden and mood.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Rehabilitation, Cognitive Intervention, Prevention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memory Support System or Computer
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Memory Support System
Other Intervention Name(s)
MSS
Intervention Description
Training in use of a memory notebook system
Intervention Type
Behavioral
Intervention Name(s)
Computer Training
Other Intervention Name(s)
POSIT
Intervention Description
Computer brain fitness training
Primary Outcome Measure Information:
Title
To assess participant adherence to Memory Support System (MSS) use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment).
Time Frame
Baseline
Title
To assess participant adherence to (Memory Support System) MSS use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment).
Time Frame
Intervention End
Title
To assess participant adherence to (Memory Support System)MSS use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment).
Time Frame
3 Month post intervention
Title
To assess participant adherence to (Memory Support System) MSS use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment).
Time Frame
6 Months post intervention
Title
To assess participant adherence to (Memory Support System) MSS use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment).
Time Frame
1 Year post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Enrolled as a research participant in the Alzheimer's Disease Research Center with a consensus diagnosis of amnestic Mild Cognitive Impairment (MCI: single domain or multi-domain). Has a program partner that has at least twice weekly contact with the participant Dementia Rating Scale-2nd Edition (DRS-2) score of 115 or greater Functional Ability Questionnaire (FAQ) score below 6. Program Partner with Mini Mental State Exam (MMSE) of 24 or greater. (If a program partner has an MMSE less than 24, the site PI will recommend that the person seek further evaluation of cognition through their primary care physician. The person with MCI will be encouraged to find an alternate program partner.) Either not taking or stable on nootropic(s) for at least 3 months Has English as primary language Exclusion Criteria: Diagnosis other than amnestic MCI (single domain or multi-domain) Visual/hearing impairment or history of reading/writing disability sufficient to interfere with training Inclusion in another clinical trial that would exclude participation. Subject will be considered for participation at the end of such a trial or as appropriate. Baseline score on the self-report depression measure suggesting severe depression for either the participant or the program partner (>21 on the Centers for Epidemiological Studies - Depression Scale (CES-D) and need for psychiatric treatment. (If a patient or program partner has a CES-D greater than 21, the site Principal Investigator will rule out suicidal ideation and then recommend that the person seek further evaluation of mood from their primary care physician, psychiatrist, or other mental health practitioner. If they seek treatment and have been stable on that treatment for 3 months, they would then be allowed to be reconsidered for the study.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Greenaway, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dona EC Locke, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic - Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Mayo Clinic-Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Rehabilitation Intervention for Amnestic Mild Cognitive Impairment

We'll reach out to this number within 24 hrs