A Rehabilitation Intervention for Amnestic Mild Cognitive Impairment
NCT01283269 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128
Last updated 2014-12-04
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.
Conditions
Interventions
- BEHAVIORAL
-
Memory Support System
Training in use of a memory notebook system
- BEHAVIORAL
-
Computer Training
Computer brain fitness training
Sponsors & Collaborators
- collaborator OTHER
-
National Institute of Nursing Research (NINR)
collaborator NIH -
Emory University
lead OTHER
Principal Investigators
-
Melanie Greenaway, PhD · Emory University
-
Dona EC Locke, PhD · Mayo Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-10-31
- Primary Completion
- 2013-08-31
- Completion
- 2014-07-31
Countries
- United States
Study Locations
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