Digital Memory Notebook for Cognitive Impairment

(DMN Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Unable to consent, pregnant, prisoners

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Digital Memory Notebook treatment for cognitive impairment?

Research shows that the Digital Memory Notebook (DMN) app is user-friendly and helps people with cognitive impairment complete tasks faster and with high satisfaction. In case studies, participants reported fewer memory lapses and improved daily functioning after using the DMN, indicating it may help maintain independence and quality of life. ^{1 2 3 4 5}

How is the Digital Memory Notebook treatment unique for cognitive impairment?

The Digital Memory Notebook (DMN) is unique because it is a digital application designed to serve as an 'all-in-one' memory aid and organizational tool, improving everyday functioning for individuals with cognitive impairment. Unlike traditional paper-and-pencil memory aids, the DMN offers features like a today page, to-do list, calendar, notes, journaling, and alarms, all of which are designed to support memory and enhance quality of life. ^{1 2 5 6 7}

What is the purpose of this trial?

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.

Research Team

Sarah Farias, PhD

Principal Investigator

University of California, Davis

Eligibility Criteria

This trial is for English-speaking adults aged 60 or older with mild cognitive impairment (MCI) or subjective cognitive complaints (SCC). They must have someone to help with surveys. Pregnant women, those unable to consent, and prisoners are excluded.

Inclusion Criteria

Fluent in English

You have been diagnosed with memory problems or mild forgetfulness.

You must be at least 60 years old to participate, with no upper age limit.

Exclusion Criteria

Unable to consent

Pregnant women

Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

DMN Training Intervention

Participants attend 2-hour weekly sessions for 6 weeks to learn how to use the Digital Memory Notebook (DMN) to support everyday functioning

6 weeks

6 visits (in-person)

Stability Evaluation

Participants continue to use the DMN app for 4 weeks to evaluate stability

4 weeks

No additional visits required

Follow-up

Participants are monitored for changes in target behaviors and complete questionnaires at specified intervals

5 weeks

Questionnaires at week 8 and week 12

Treatment Details

Interventions

• Digital Memory Notebook (DMN) Application

Trial Overview The study tests a Digital Memory Notebook app designed to aid daily tasks for people with memory issues. It involves a 6-week training on using the app followed by a 4-week period of regular use, with assessments before and after the intervention.

Participant Groups

Group I: DMN Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Findings from Research

The Digital Memory Notebook (DMN) app was developed to assist older individuals with memory loss, and a manual-based intervention showed promising results in improving everyday memory and functioning among participants.

In a series of three case studies, two participants reported significant reductions in memory lapses and improved daily functioning, while all participants demonstrated enhanced coping skills and satisfaction with life after using the DMN app.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of a manual-based digital memory notebook intervention with case study illustrations. Chudoba, LA., Church, AS., Dahmen, JB., et al.[2023]

The Memory Support System (MSS) was successfully learned and utilized by 20 participants with amnestic mild cognitive impairment (MCI), with 95% compliance at the end of training and 89% at follow-up.

Participants showed a medium effect size in improved functional ability, along with reported benefits in independence, self-confidence, and mood, indicating that the MSS may effectively help manage memory loss symptoms in MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A behavioral rehabilitation intervention for amnestic mild cognitive impairment. Greenaway, MC., Hanna, SM., Lepore, SW., et al.[2022]

The Memory Support System (MSS) training significantly improved adherence and functional ability in individuals with amnestic mild cognitive impairment (MCI), with benefits lasting up to 8 weeks after the intervention.

Care partners of individuals who received MSS training reported improved mood and reduced caregiver burden, while those in the control group experienced worsening burden, highlighting the broader positive impact of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The memory support system for mild cognitive impairment: randomized trial of a cognitive rehabilitation intervention. Greenaway, MC., Duncan, NL., Smith, GE.[2022]

The MindMate application significantly improved memory performance in two out of three participants with Alzheimer's disease, as shown by a Tau-U analysis indicating a strong effect (Tau-U = 1, p < .01).

Despite its effectiveness, one participant withdrew due to usability issues, highlighting the importance of user-friendly design in memory aids for individuals with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MindMate: A single case experimental design study of a reminder system for people with dementia. McGoldrick, C., Crawford, S., Evans, JJ.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Creating a digital memory notebook application for individuals with mild cognitive impairment to support everyday functioning. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The development of a manual-based digital memory notebook intervention with case study illustrations. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A behavioral rehabilitation intervention for amnestic mild cognitive impairment. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The memory support system for mild cognitive impairment: randomized trial of a cognitive rehabilitation intervention. [2022]

5. England pubmed.ncbi.nlm.nih.gov

MindMate: A single case experimental design study of a reminder system for people with dementia. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Supporting conversations between individuals with dementia and their family members. [2014]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Development and evaluation of a memory clinic information system. [2022]