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?

Alzheimer's disease and related dementias lead to marked declines in daily functioning, independence, and quality of life. One of the earliest cognitive changes in these conditions is impairment in prospective memory, or the ability to remember future intentions such as taking medications at a given time. Prior intervention studies that targeted prospective memory used mnemonic strategies or cognitive training, but these approaches resulted in modest gains in clinical populations. By contrast, a Stage I pilot trial indicated that smartphone-based memory aids (reminder apps) can be accepted and used by persons with mild cognitive impairment and mild dementia to improve both subjective and objective prospective memory performance. The investigators will now test for efficacy, durability, and generalizability of benefits across diverse samples in a Stage II randomized controlled trial. Some 200 participants with mild cognitive impairment or mild dementia will be recruited, half of whom will be from digitally-disadvantaged backgrounds (low socioeconomic status, rural, or historically underrepresented groups). Participants will complete baseline assessments and then be randomly assigned to a smartphone reminder app intervention or an active control condition that uses a paper- based memory support system. Across a 4-week intervention period, participants will complete patient-selected and experimenter-assigned prospective memory assessments and receive booster training sessions to promote self-efficacy with the intervention/control system. Durability of effects will be assessed at 3-month and 6-month follow-up sessions. As a secondary aim, study partners will be simultaneously enrolled to collect informant ratings, track how much study partners assist the participants, and determine whether improving prospective memory in patients improves quality of life in study partners (e.g., by reducing the double to-do list burden of remembering for themselves and for care recipients). As a third aim, the investigators will identify barriers and facilitators to smartphone interventions in digitally-disadvantaged individuals who have historically been underrepresented in technology and dementia research.

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.

Is using digital or paper-based memory aids safe for people with cognitive impairments?

The studies suggest that using digital memory aids like Google Calendar and mobile phone reminders is generally safe for people with cognitive impairments, including those with Alzheimer's disease and brain injuries. These tools help improve memory and daily activity management without reported safety concerns. ^{1 2 3 4 5}

How does the treatment 'Memory Supports for Cognitive Impairment' differ from other treatments for cognitive impairment?

This treatment is unique because it uses both digital tools like Google Calendar and paper-based systems to provide reminders and support for memory, which can be customized to fit individual needs and preferences, unlike traditional treatments that may not offer such flexibility or personalization. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Digital - Google Calendar, Google Calendar, Digital Reminder App, Paper-Based Memory Support System, Paper-Based Memory Support System, Memory Aids, Reminder Systems for cognitive impairment?

Research shows that using Google Calendar as a memory aid can significantly reduce forgetting in people with severe memory problems. Additionally, the Memory Support System (MSS), which includes a calendar and organization system, has been shown to improve functional ability and independence in individuals with mild cognitive impairment. ^{6 7 9 10 11}

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 have been diagnosed with mild cognitive impairment or dementia.

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Memory function and supportive technology. [2021]

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

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

3. England pubmed.ncbi.nlm.nih.gov

Memory Support System training in mild cognitive impairment: Predictors of learning and adherence. [2022]

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

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

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

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

6. England pubmed.ncbi.nlm.nih.gov

Using an interactive digital calendar with mobile phone reminders by senior people - a focus group study. [2020]

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

Digital Support for Persons with Cognitive Impairment. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Google Calendar Enhances Prospective Memory in Alzheimer's Disease: A Case Report. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Google Calendar: a new memory aid to compensate for prospective memory deficits following acquired brain injury. [2011]

10. England pubmed.ncbi.nlm.nih.gov

A mobile phone as a memory aid for individuals with traumatic brain injury: a preliminary investigation. [2017]

11. England pubmed.ncbi.nlm.nih.gov

Smartphone technology: Gentle reminders of everyday tasks for those with prospective memory difficulties post-brain injury. [2022]