The Digital Memory Notebook

NCT ID: NCT04240665

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-11
• Study Completion Date: 2025-12-31

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.

Conditions

Prodromal Alzheimer's Disease; Mild Cognitive Impairment; Subjective Cognitive Complaints

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Digital Memory Notebook (DMN) Application

Intervention Type: BEHAVIORAL

Subjects will be taught to utilize the DMN application through 2-hour weekly sessions for 6-weeks.

Interventions

Digital Memory Notebook (DMN) Application

Subjects will be taught to utilize the DMN application through 2-hour weekly sessions for 6-weeks.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Farias, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

Alzheimer's Disease Center, University of California, Davis

Sacramento, California, United States

Countries

United States

Related Links

https://studypages.com/s/the-digital-memory-notebook-training-to-improve-everyday-functioning-in-older-adults-with-mild-cognitive-impairment-518781/

Learn more or sign up for the study here!

Other Identifiers

1454000

Identifier Type: -

Identifier Source: org_study_id