The Digital Memory Notebook (DMN)

May 17, 2023 updated by: University of California, Davis

Compensation Training to Improve Everyday Functioning of Older Adults With Mild Cognitive Impairment and Subjective Cognitive Complaints: The Digital Memory Notebook

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Alzheimer's Disease Center, University of California, Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DMN Intervention
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.
Behavioral: Digital Memory Notebook (DMN) Application
Subjects will be taught to utilize the DMN application through 2-hour weekly sessions for 6-weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-time data extracted from the DMN Application
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
data that is automatically collected by DMN (Calendar entries, to-do list entries, alarms set, journal entries)
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 Measures

Outcome Measure
Measure Description
Time Frame
Participant Questionnaire Outcomes
Time Frame: Week 1, Week 8, and Week 12
Questionnaires each consisting of 41 or fewer items on a Likert scale
Week 1, Week 8, and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Sarah Farias, PhD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2020

Primary Completion (Actual)

January 31, 2022

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

November 10, 2019

First Submitted That Met QC Criteria

January 23, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1454000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are not planning to share individual participant data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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