The Digital Memory Notebook

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prodromal Alzheimer's Disease, Mild Cognitive Impairment, Subjective Cognitive Complaints

Intervention / Treatment
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* Behavioral: Digital Memory Notebook (DMN) Application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will complete a curriculum involving 2-hour weekly sessions for 6-weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DMN Intervention<br>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<br>* Subjects will be taught to utilize the DMN application through 2-hour weekly sessions for 6-weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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