The Effect of a 36-week Tablet-based Intervention on Multiple Domains in Older Adults With Mild Cognitive Impairment
Status unconfirmed · Not applicable
Conditions studied: Mild Cognitive Impairment
In brief
This is a pilot study to examine the feasibility of a formal 30-minute daily program on a tablet computer (simply a "tablet") in subjects with mild cognitive impairment (MCI). The purpose of the program, known as Kodro Solution, is to increase physical activity, maintain social interaction, improve nutrition and exercise cognitive skills using a tablet. In addition to feasibility, outcome measures will include: (a) health-related quality of life, (b) self-esteem, (c) activities of daily living, (d) socialization, (e) mood, and (f) cognition. Study participants must have a study partner who can assist them with training on use of the tablet and the Kodro Solution program. Fifty (50) study subjects and their study partners will be recruited at the Wien Center. A delayed start design will be utilized. Study subjects will be randomly assigned to either active treatment (Kodro+) or delayed treatment (Kodro+D). Active treatment with Kodro Solution will be initiated at the baseline visit for Kodro+ subjects and 12 weeks after baseline for Kodro+D subjects. The 12-week period without tablets will serve as a control. Active treatment with Kodro Solution will continue for 36 weeks for the Kodro+ subjects and 24 weeks for the Kodro+D subjects. For both groups, the outcome measures will be assessed at baseline, week 12 and week 36. The lagged design will facilitate enrollment and enable the assessment of a dose effect.
Key facts
- Study ID
- NCT02087618
- Run by
- Mt. Sinai Medical Center, Miami
- People needed
- 50
- Starts
- 2014-03-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2014-03-14
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of Mild Cognitive Impairment as defined below:
- Clinical Dementia Rating (CDR) global score = 0.5 (Morris 1993)
- MMSE > 20
- Diagnostic and Statistical Manual of Mental Disorders, Version 4, Text Revised (DSM-IV-TR) criteria of dementia not fulfilled (Appendix II)
- 60 years and older
- Subjective memory complaints
- Able to use Kodro by him/her self or with minimal assistance from the study partner
- Understands English at an 8th grade proficiency level
- Wifi access in the subject's home
- Willing and able to connect to Kodro for a minimum of 30 minutes daily
- Study partner able to fill in the self-report questionnaires during visits and supervise the subject as needed
You may not qualify if…
- MMSE < 20
- Motor or sensory disorders limiting the manipulation of an tablet
- Any involvement with brain-based programs during the study (e.g., Posit Science, Luminosity)
Where it is running
- Mount Sinai Medical Center — Miami Beach, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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