The Effect of a 36-week Tablet-based Intervention on Multiple Domains in Older Adults With Mild Cognitive Impairment (Kodro Solution)
The Effect of a 36-week Tablet-based Intervention on Multiple Domains in Older Adults With Mild Cognitive Impairment
Sponsors
Source
Mt. Sinai Medical Center, Miami
Oversight Info
Has Dmc
No
Brief Summary
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.
Detailed Description
Background: Due to increased longevity and aging of the baby boomer, the number of older
persons with cognitive disorders such as Alzheimer's Disease (AD) is increasing rapidly. It
is uncertain whether cognitive and memory training intervention programs can delay the onset
or reduce the risk for the subsequent development of AD, but several studies have shown that
cognitive training in people with Mild Cognitive Impairment (MCI) has a moderate effect on
memory.
A tablet-based platform known as Kodro was developed in 2011 by a French company to improve
multiple domains, including memory and quality of life, among older persons with and without
memory disorders. The goals of the program are to increase physical activity, maintain social
interaction, improve nutrition and exercise cognitive skills. The program requires internet
access to enable connection with the program, family and friends, other Kodro users and
external experts. The version of Kodro in this study, Kodro Solution, was designed for
seniors with mild cognitive impairment or very mild dementia, who are living at home. Kodro
Solution is customized to each user's interests and hobbies. For example, a user with an
interest in cuisine might be presented with a brief video about the top toppings for
hamburgers; this user would then be asked 5 questions to test his/her memory.
Purpose: To determine whether Kodro solution is feasible among older people with MCI. The
secondary aim is to measure the effect of Kodro on cognition, mood, activities of daily
living and quality of life.
Procedures Subjects: Potential subjects will be selected from patients diagnosed with MCI at
the Wien Center who are at least 60 years of age. Subjects will be required to have a
wireless connection to the internet and a study partner. The subject should be capable of
learning to use the tablet and Kodro system with minimal assistance from the study partner
(friend or family member). The role of the study partner is to assist the staff with the
assessment of the subject and to assist the subject with study visits and the use of Kodro.
Baseline Visit and Randomization: After a subject has been consented and deemed eligible for
the study, he/she will be randomized to either a group with Kodro at baseline ("Kodro+") or a
group with Kodro delayed until 12 weeks post-baseline ("Kodro+D"). Study raters will be blind
to subject's randomization.
Intervention: Subjects in the Kodro+ group will be trained on the use of the tablet and Kodro
at the baseline visit, and will continue using Kodro for 36 weeks. Subjects in the Kodro+D
group will be trained on the tablet and Kodro at 12 weeks, and will continue to use Kodro for
24 weeks. Participants will be expected to log in and utilize the program for a minimum of 30
minutes daily. The participants will perform various activities such as reading newspaper
articles, books, listening to audio tapes, watching video clips, and playing games.
Information regarding the participant's usage of the program and how well they perform on the
activities is stored on Kodro's secure server. The program is customized to the user's level
and the information obtained will gauge the level of difficulty as well as appropriateness of
activities that are offered daily to the participant.
Assessments: The subjects' use of Kodro will be collected continuously throughout the study
via a secure server in France. There will not be any identifying information collected such
as name, address, etc. The data collected will include frequency of use, diversity of
activities and scores on activities.
Assessments of cognition, mood, activities of daily living and quality of life will be done
at the baseline visit, 12-week visit and the final 36-week visit.
Statistical Analysis The main outcome measure will be the drop-out rate and use of Kodro. The
secondary outcome measures will be scores on tests of cognition, mood, quality of life and
activities of daily living.
Overall Status
Unknown status
Start Date
2014-03-01
Completion Date
2015-06-01
Primary Completion Date
2015-03-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Compliance with Kodro Solution |
36 weeks |
Secondary Outcome
Measure |
Time Frame |
|
Satisfaction with Kodro Solution |
36-weeks |
Enrollment
50
Condition
Intervention
Intervention Type
Other
Intervention Name
Description
Kodro+ participants will utilize Kodro Solution on a tablet for 30 minutes a day for 36 weeks
Arm Group Label
Kodro+
Intervention Type
Other
Intervention Name
Description
Kodro+D participants will utilize the Kodro Solution program 12-weeks post-baseline for 30 minutes per day for 24-weeks
Arm Group Label
Kodro+D
Eligibility
Criteria
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)
Gender
All
Minimum Age
60 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Ranjan Duara, MD |
Principal Investigator |
Icahn School of Medicine at Mount Sinai |
Overall Contact
Location
Facility |
Status |
Investigator |
|
Mount Sinai Medical Center Miami Beach Florida 33140 United States |
Recruiting |
Last Name: Ranjan Duara, MD Role: Principal Investigator |
Location Countries
Country
United States
Verification Date
2014-03-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Mt. Sinai Medical Center, Miami
Investigator Full Name
Ranjan Duara, MD
Investigator Title
Medical Director, Wien Center
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Kodro+
Arm Group Type
Active Comparator
Description
Will begin Kodro program at baseline
Arm Group Label
Kodro+D
Arm Group Type
Placebo Comparator
Description
Will begin Kodro program 12-weeks post baseline
Firstreceived Results Date
N/A
Acronym
KodroSol
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
March 6, 2014
Study First Submitted Qc
March 13, 2014
Study First Posted
March 14, 2014
Last Update Submitted
March 13, 2014
Last Update Submitted Qc
March 13, 2014
Last Update Posted
March 14, 2014
Last Known Status
Recruiting
ClinicalTrials.gov processed this data on August 27, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.