The Digital Memory Notebook (DMN)
Primary Purpose
Prodromal Alzheimer's Disease, Mild Cognitive Impairment, Subjective Cognitive Complaints
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Memory Notebook (DMN) Application
Sponsored by
About this trial
This is an interventional supportive care trial for Prodromal Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of subjective cognitive complaints (SCC) or Mild Cognitive Impairment (MCI)
- Adults at least 60 years of age (no upper age limit)
- Fluent in English
- Available informant (study partner) to complete surveys
Exclusion Criteria:
- Unable to consent
- Pregnant women
- Prisoners
Sites / Locations
- Alzheimer's Disease Center, University of California, Davis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DMN Intervention
Arm Description
Subjects will attend 2-hour weekly sessions for 6- weeks. Participants will continue to use the DMN application for 4-weeks after the intervention is complete.
Outcomes
Primary Outcome Measures
Real-time data extracted from the DMN Application
data that is automatically collected by DMN (Calendar entries, to-do list entries, alarms set, journal entries)
Secondary Outcome Measures
Participant Questionnaire Outcomes
Questionnaires each consisting of 41 or fewer items on a Likert scale
Full Information
NCT ID
NCT04240665
First Posted
November 10, 2019
Last Updated
May 17, 2023
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT04240665
Brief Title
The Digital Memory Notebook
Acronym
DMN
Official Title
Compensation Training to Improve Everyday Functioning of Older Adults With Mild Cognitive Impairment and Subjective Cognitive Complaints: The Digital Memory Notebook
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Compensatory aids (e.g., alarms, calendars) play an important supporting role when completing everyday tasks (e.g., appointments, medication management), and there is a growing body of scientific work suggesting that compensatory training improves daily functioning. However, traditional paper-based calendars and to-do-lists have limitations related to accumulation of information, difficulty retrieving information, and remembering to complete activities. Such limitations may be overcome using a digital format through organized digital files, search functions, and alarms. This pilot project proposes to train older adults at risk for cognitive decline to use the Digital Memory Notebook (DMN), a tablet-based application (app), to support everyday functioning. The primary goal is to obtain preliminary evidence that a 6-week, individual and group-based DMN training intervention results in demonstrable changes in target behaviors (e.g., goal-directed DMN use to support everyday activities) among older adults with mild cognitive impairment (MCI) and subjective cognitive complaints (SCC). Participants will complete a curriculum involving 2-hour weekly sessions for 6-weeks. Each week will cover a specific function of the DMN and will include standardized goal-setting and weekly homework targets. Following the 6-week intervention, participants will continue to use the DMN app for 4-weeks to evaluate stability. Participants will complete a questionnaire packet 1 week prior to the 6-week intervention, 1 week after the 6-week intervention, and 5 weeks following the 6-week intervention. MCI and SCC participants will complete separate 6-week individual or group interventions spaced two months apart at UCD.
Detailed Description
The manualized curriculum will involve 2-hour weekly sessions for 6-weeks. The study personnel will administer all intervention sessions. Each week will cover a specific function of the Digital Memory Notebook (DMN) and will include standardized goal-setting and weekly homework targets. A research assistant will assess homework adherence using a standardized form and through data extracted from the DMN (e.g., number of alarms set). Mild cognitive impairment (MCI) and subjective cognitive complaints (SCC) participants will complete separate 6-week individual or group interventions. Following the 6-week intervention, participants will continue to use the DMN app for 4-weeks to evaluate stability.
Participants will also be asked to complete questions about their medical background including history of traumatic brain injury or stroke, as well as any current medical conditions and questions regarding demographics including age, ethnicity, and education.
Potential participants will be told that participating in the study will involve completing questionnaires at 3 different time points within 12 weeks (i.e.,week 1, week 8, week 12), identifying a knowledgeable informant who will also complete questionnaires, participating in a 6-week course to learn how to use the DMN and to support everyday functioning, and to continue to use the DMN for one month following the intervention.
Information collected will be in the form of counts (e.g., number of alarms set) and number of minutes spent on the device. Specific content entered into the DMN will not be reviewed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prodromal Alzheimer's Disease, Mild Cognitive Impairment, Subjective Cognitive Complaints
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will complete a curriculum involving 2-hour weekly sessions for 6-weeks.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DMN Intervention
Arm Type
Experimental
Arm Description
Subjects will attend 2-hour weekly sessions for 6- weeks. Participants will continue to use the DMN application for 4-weeks after the intervention is complete.
Intervention Type
Behavioral
Intervention Name(s)
Digital Memory Notebook (DMN) Application
Intervention Description
Subjects will be taught to utilize the DMN application through 2-hour weekly sessions for 6-weeks.
Primary Outcome Measure Information:
Title
Real-time data extracted from the DMN Application
Description
data that is automatically collected by DMN (Calendar entries, to-do list entries, alarms set, journal entries)
Time Frame
Change in number of entries assessed weekly from first weekly session through Week 6 weekly session and for 4 weeks after the completion of the last session
Secondary Outcome Measure Information:
Title
Participant Questionnaire Outcomes
Description
Questionnaires each consisting of 41 or fewer items on a Likert scale
Time Frame
Week 1, Week 8, and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of subjective cognitive complaints (SCC) or Mild Cognitive Impairment (MCI)
Adults at least 60 years of age (no upper age limit)
Fluent in English
Available informant (study partner) to complete surveys
Exclusion Criteria:
Unable to consent
Pregnant women
Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Farias, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alzheimer's Disease Center, University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We are not planning to share individual participant data with other researchers.
Links:
URL
https://studypages.com/s/the-digital-memory-notebook-training-to-improve-everyday-functioning-in-older-adults-with-mild-cognitive-impairment-518781/
Description
Learn more or sign up for the study here!
Learn more about this trial
The Digital Memory Notebook
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