Mild Cognitive Impairment Clinical Trial
— KodroSolOfficial title:
The Effect of a 36-week Tablet-based Intervention on Multiple Domains in Older Adults With Mild Cognitive Impairment (Kodro Solution)
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai Medical Center | Miami Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Mt. Sinai Medical Center, Miami | Kodro Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compliance with Kodro Solution | Compliance with the Kodro Solution program will be assessed using: • Frequency of use (average days per week, average hours per day) |
36 weeks | No |
Secondary | Satisfaction with Kodro Solution | Questionnaires given to both the participant and study partner. | 36-weeks | No |
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