Memory Supports for Cognitive Impairment

Recruiting at 2 trial locations

Overseen By Jared Benge, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor University

Disqualifiers: Schizophrenia, Bipolar, Moderate dementia, others

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

Compensation: Varies

Number of Visits: 3

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help individuals with mild cognitive impairment or mild dementia improve their memory for future tasks, such as remembering to take medication, by using either a smartphone app or a paper-based memory aid. Participants will be randomly assigned to use Google Calendar (a digital reminder app) on a smartphone or a pocket-sized notebook to track tasks and reminders. The trial seeks to determine which method is more effective and how long the benefits last, particularly for those who may not frequently use technology. It also examines whether improved memory in patients benefits their study partners, who assist them. Individuals with mild memory issues who can consent to participate, or have someone to consent for them, are suitable candidates for this trial. As an unphased trial, this study offers participants the chance to explore practical memory aids that could enhance daily life and support their caregivers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on memory aids rather than medication changes.

What prior data suggests that these memory support systems are safe for individuals with cognitive impairment?

Research has shown that digital tools like smartphone apps can be safe and helpful for people with mild memory problems or early-stage dementia. One study found that an interactive digital calendar with reminders improved memory for those facing these challenges. Participants reported it was easy to use and useful for organizing daily tasks, with no serious side effects.

Digital health technologies also support patients with memory issues and their caregivers, reducing stress and improving daily life. These findings suggest that using a smartphone reminder app, like Google Calendar, is well-accepted and poses little risk.

Overall, evidence indicates that these digital aids are safe and effective for enhancing memory and daily activities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these methods for supporting cognitive impairment because they harness everyday tools in novel ways. The smartphone-based app leverages Google Calendar, providing a seamless and intuitive way for users to set reminders and manage tasks digitally, making it more accessible and integrated into daily life compared to traditional methods. On the other hand, the paper-based Memory Support System offers a tactile, low-tech option that can be easily carried and used without electronic devices, appealing to those who prefer or require simpler solutions. By comparing these distinct approaches, researchers aim to understand which method is more effective in aiding memory and whether a digital or analog approach better suits different individuals' needs.

What evidence suggests that this trial's treatments could be effective for cognitive impairment?

Research has shown that digital tools, such as the Google Calendar app, can greatly assist people with memory problems. In this trial, participants in the smartphone-based app arm will use Google Calendar to receive reminders for prospective memory tasks. One study found that Google Calendar alerts improved task recall by 90% for someone with severe memory issues. Additionally, digital calendars with phone reminders help people with cognitive difficulties track their tasks. These tools can enhance task performance and ensure timely completion. Using smartphone apps for reminders offers a promising way to support those with mild memory issues or early-stage dementia. ^{3 6 7 8 9}

Who Is on the Research Team?

Michael Scullin, PhD

Principal Investigator

Baylor University

Are You a Good Fit for This Trial?

This trial is for individuals with Alzheimer's Disease, Cognitive Impairment, or Mild Dementia. It aims to include people from digitally-disadvantaged backgrounds as well. Participants should be able to complete memory assessments and willing to use either a smartphone app or paper-based system.

Inclusion Criteria

I understand the study's key points, risks, and benefits, and know I can withdraw anytime.

Adequate sensory and motor abilities to utilize a smartphone with accommodation.

I can take care of my basic needs by myself.

Exclusion Criteria

No study partner.

I am conversational in English.

History of serious mental illness including schizophrenia or bipolar disorder that is judged by the clinician to be the primary cause of cognitive decline.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments before randomization

1 week

Intervention

Participants are randomly assigned to a smartphone reminder app intervention or a paper-based memory support system for a 4-week period

4 weeks

Weekly booster training sessions

Follow-up

Durability of effects assessed at 3-month and 6-month follow-up sessions

6 months

Follow-up sessions at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Digital - Google Calendar
• Paper-Based Memory Support System

Trial Overview The study compares the effectiveness of a smartphone reminder app against a paper-based memory support system in improving prospective memory (remembering future tasks). The trial will involve baseline assessments, a 4-week intervention period with booster sessions, and follow-ups at 3 and 6 months.

How Is the Trial Designed?

Group I: Smartphone-based app Experimental Treatment 1 Intervention

Participants will use Google Calendar, an off-the-shelf app that is free and user-friendly, to provide reminders on their smartphone to perform prospective memory tasks at the appropriate time. In the current study, participants will offload their personal and experimentally assigned tasks into the digital calendar with reminders enabled.

Group II: Paper-based notebook Active Control 1 Intervention

Participants will use a Memory Support System, which is an established paper-based calendar and note taking system that can fit into one's pocket. In the current study they will use the system to offload personal and experimentally assigned tasks and notes into the schedule, to-do list, and journal sections of the notebook.

Who Is Running the Clinical Trial?

Baylor University

Lead Sponsor

Trials

65

Recruited

67,600+

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

Baylor Scott and White Health

Collaborator

Trials

18

Recruited

61,200+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The use of a mobile phone as a reminder tool significantly improved target behaviors in two participants with traumatic brain injury, with increases from 51% to 95% and 58% to 88%, suggesting it can aid in routine learning.

Participants with severe memory impairments and executive functioning difficulties did not benefit from the mobile phone intervention, indicating that this approach may be most effective for individuals with milder impairments who do not require constant care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mobile phone as a memory aid for individuals with traumatic brain injury: a preliminary investigation. Stapleton, S., Adams, M., Atterton, L.[2017]

Smartphone reminders significantly improved task completion rates for individuals with Acquired Brain Injury (ABI), as shown in a study involving six participants and their caregivers.

Participants reported increased independence, confidence, and improved mood due to the reminders, and all continued using the system three months after the study, highlighting its long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone technology: Gentle reminders of everyday tasks for those with prospective memory difficulties post-brain injury. Ferguson, S., Friedland, D., Woodberry, E.[2022]

A study involving 12 participants with acquired brain injury (ABI) found that using Google Calendar as an external memory aid significantly improved prospective memory performance compared to a standard diary.

Google Calendar's active reminders were particularly effective in helping participants remember their intended activities, making it a popular choice and reducing the need for constant monitoring by family members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Google Calendar: a new memory aid to compensate for prospective memory deficits following acquired brain injury. McDonald, A., Haslam, C., Yates, P., et al.[2011]

Using Google Calendar as an external memory aid helped a patient with mild Alzheimer's disease remember more targeted events compared to a baseline phase without cues, indicating its potential effectiveness in improving prospective memory.

The study highlights the practical application of smartphone technology in supporting individuals with cognitive impairments, suggesting that such tools can enhance daily functioning and memory recall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Google Calendar Enhances Prospective Memory in Alzheimer's Disease: A Case Report. El Haj, M., Gallouj, K., Antoine, P.[2018]

In a study of 215 older adults with amnestic mild cognitive impairment (aMCI), better global cognition was found to predict how well individuals learned to use the Memory Support System (MSS) during a two-week training period.

Successful learning of the MSS was linked to higher adherence rates to the system at 6, 12, and 18 months after training, suggesting that early intervention with compensatory strategies could enhance long-term adherence for individuals with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memory Support System training in mild cognitive impairment: Predictors of learning and adherence. De Wit, L., Chandler, M., Amofa, P., et al.[2022]

The study investigates an interactive web-based mobile reminder calendar designed to assist individuals with cognitive impairments due to neurological injuries, aiming to enhance their ability to plan and initiate daily activities.

Preliminary results suggest that this mobile reminder system may improve participants' performance in everyday activities and their perceived quality of life, indicating its potential as a supportive tool for independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Support for Persons with Cognitive Impairment. Andreassen, M., Boman, IL., Danielsson, H., et al.[2018]

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]

Using Google Calendar text alerts as a memory aid significantly reduced forgetting in a 43-year-old man with severe memory problems due to a traumatic brain injury, as shown by a single case experimental design over 12 weeks.

The study highlights the importance of tailoring memory aids to fit an individual's lifestyle and beliefs, which contributed to the participant's initial reluctance and eventual success with the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Google Calendar: A single case experimental design study of a man with severe memory problems. Baldwin, VN., Powell, T.[2021]

Community-dwelling seniors found the RemindMe interactive digital calendar easy to learn and use, but faced challenges in integrating it into their daily routines due to the need to change existing habits.

Active reminders through short text messages helped seniors feel more independent and in control, suggesting that motivation and perceived benefits are crucial for adopting new technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using an interactive digital calendar with mobile phone reminders by senior people - a focus group study. Baric, V., Andreassen, M., Öhman, A., et al.[2020]

Episodic and working memory decline significantly with age, while other types of memory like semantic and procedural memory are less affected, leading older adults to report more memory failures.

The paper presents strategies to combat memory decline through augmentation (enhancing memory processes) and substitution (using tools or techniques), including both low-tech and high-tech memory aids, while also addressing the limitations of high-tech solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memory function and supportive technology. Charness, N., Best, R., Souders, D.[2021]

Citations

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Google Calendar: A single case experimental design study ... The study showed Google Calendar text alerts reduced forgetting in a man with severe memory problems, with a 90% improvement in target events.

2. tandfonline.com tandfonline.com/doi/full/10.1080/11038128.2021.1917654

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Digital Planning-Based Technologies to Support Memory ... A recent study assessing an interactive digital calendar with mobile phone reminders for people with cognitive impairment found that participants increased ...

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Digital technology for addressing cognitive impairment in ... Digital technologies like computer programs, VR, smartphone apps, and online tools can address cognitive impairment in ROP, providing support in daily life.

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Google Calendar: A new memory aid to compensate for ... Thus, using digital reminders in mobile/smartphones can provide cognitive support and may improve performance and task completion rates in ...

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The Effects of the Digital Platform Support Monitoring and ... The platform will provide reminders, information, and memory support in everyday life, with the purpose of giving structure and lowering stress.

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The effectiveness of digital technology interventions for ... This study supported the effectiveness of DTIs in improving cognitive function in older adults aged 60 years old and over.

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Using an interactive digital calendar with mobile phone ... This study focuses on community dwelling seniors' experiences learning and using RemindMe, an interactive digital calendar with active reminders.

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Review Digital Health Technology to Support Health Care ... Digital health technology is a promising way of supporting health care providers and family caregivers as they care for patients with cognitive impairment.