Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04240665 |
| Other study ID # |
1454000 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 11, 2020 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
University of California, Davis |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
