A Rehabilitation Intervention for Amnestic Mild Cognitive Impairment
NCT ID: NCT01283269
Last Updated: 2014-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2010-10-31
2014-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Memory Support System or Computer
Memory Support System
Training in use of a memory notebook system
Computer Training
Computer brain fitness training
Interventions
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Memory Support System
Training in use of a memory notebook system
Computer Training
Computer brain fitness training
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
National Institute of Nursing Research (NINR)
NIH
Emory University
OTHER
Responsible Party
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Melanie C Greenaway
Associate Professor
Principal Investigators
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Melanie Greenaway, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Dona EC Locke, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States
Emory University
Atlanta, Georgia, United States
Mayo Clinic-Rochester
Rochester, Minnesota, United States
Countries
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Other Identifiers
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IRB00034934
Identifier Type: -
Identifier Source: org_study_id