NCT04240665

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

November 11, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

November 10, 2019

Last Update Submit

March 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    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 Outcomes (1)

  • Participant Questionnaire Outcomes

    Week 1, Week 8, and Week 12

Study Arms (1)

DMN Intervention

EXPERIMENTAL

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

Interventions

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

DMN Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to consent
  • Pregnant women
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alzheimer's Disease Center, University of California, Davis

Sacramento, California, 95817, United States

Location

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

desmuslin

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Sarah Farias, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: All participants will complete a curriculum involving 2-hour weekly sessions for 6-weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2019

First Posted

January 27, 2020

Study Start

November 11, 2020

Primary Completion

January 31, 2022

Study Completion

December 31, 2025

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

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

Locations