Memory Supports for Cognitive Impairment
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Baylor University
Disqualifiers: Schizophrenia, Bipolar, Moderate dementia, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
678910How 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.
134611Eligibility Criteria
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.
+3 more
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.
+3 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Smartphone-based appExperimental Treatment1 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 notebookActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UT Health Austin Comprehensive Memory CenterAustin, TX
Baylor Scott & White HealthcareTemple, TX
Baylor UniversityWaco, TX
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Who Is Running the Clinical Trial?
Baylor UniversityLead Sponsor
University of Texas at AustinCollaborator
Baylor Scott and White HealthCollaborator
National Institute on Aging (NIA)Collaborator
References
Memory function and supportive technology. [2021]Episodic and working memory processes show pronounced age-related decline, with other memory processes such as semantic, procedural, and metamemory less affected. Older adults tend to complain the most about prospective and retrospective memory failures. We introduce a framework for deciding how to mitigate memory decline using augmentation and substitution and discuss techniques that change the user, through mnemonics training, and change the tool or environment, by providing environmental support. We provide examples of low-tech and high-tech memory supports and discuss constraints on the utility of high-tech systems including effectiveness of devices, attitudes toward memory aids, and reliability of systems.
A behavioral rehabilitation intervention for amnestic mild cognitive impairment. [2022]Individuals with amnestic mild cognitive impairment (MCI) currently have few treatment options for combating their memory loss. The Memory Support System (MSS) is a calendar and organization system with accompanying 6-week curriculum designed for individuals with progressive memory impairment. Ability to learn the MSS and its utility were assessed in 20 participants. Participants were significantly more likely to successfully use the calendar system after training. Ninety-five percent were compliant with the MSS at training completion, and 89% continued to be compliant at follow-up. Outcome measures revealed a medium effect size for improvement in functional ability. Subjects further reported improved independence, self-confidence, and mood. This initial examination of the MSS suggests that with appropriate training, individuals with amnestic MCI can and will use a memory notebook system to help compensate for memory loss. These results are encouraging that the MSS may help with the symptoms of memory decline in MCI.
Memory Support System training in mild cognitive impairment: Predictors of learning and adherence. [2022]This study aimed to identify predictors of learning and adherence to a previously validated compensatory calendar and note-taking system (Memory Support System; MSS) in persons with amnestic mild cognitive impairment (aMCI). Age, education, global cognition, depression, and memory-related self-efficacy were studied as predictors of individuals' ability to learn the use of the MSS during the two-week training and of their adherence to the MSS 6, 12, and 18 months after training. How well an individual was able to learn the use of the MSS was itself examined as a predictor of adherence. Two-hundred-and-fifteen older adults with aMCI and their study partners (e.g., spouse, adult child) received MSS training one-hour daily for 10 days. Ordinal logistic regression analyses indicated that (1) global cognition predicted MSS learning at end of training, and (2) MSS learning at end of trainng predicted MSS adherence at 6, 12, and 18 months post-training. The current study suggests that offering compensatory strategies as early as possible for those with MCI might be of most benefit, and might have implications for long-term adherence.
Google Calendar: A single case experimental design study of a man with severe memory problems. [2021]A single case experimental design across behaviours was utilised to explore the effectiveness of Google Calendar text alerts delivered to a mobile phone as a memory aid. The participant was a 43-year-old man (JA) with severe memory problems and executive difficulties caused by a traumatic brain injury (TBI). JA was initially very unwilling to use any memory aid and so a detailed assessment of his beliefs about memory aids, his cognitive difficulties and his social context was performed and a set of specifications for an aid was produced collaboratively. Six weeks of baseline data and six weeks of intervention data were collected for three target memory behaviours and three control memory behaviours. Results were analysed using nonoverlap of all pairs (NAP) analysis which showed a reduction in forgetting in the three target behaviours and no change in two of the three control behaviours. A subjective measure (the revised Everyday Memory Questionnaire) also suggested improvement. This study illustrates that Google Calendar is a highly effective memory aid and emphasises the importance of choosing a memory aid to suit the person's lifestyle and beliefs.
The development of a manual-based digital memory notebook intervention with case study illustrations. [2023]There is currently a need to identify feasible and effective interventions to help older individuals suffering from memory loss maintain functional independence and quality of life. To improve upon paper and pencil memory notebook interventions, the Digital Memory Notebook (DMN) application (app) was developed iteratively with persons with cognitive impairment. In this paper we detail a manual-based intervention for training use of the DMN app. A series of three case studies are described to illustrate the clinical process of the DMN intervention, the key components of the intervention and participants' perceptions of the intervention. The Reliable Change Index was applied to pre/post intervention scores that examined everyday memory lapses, daily functioning, coping self-efficacy, satisfaction with life, and quality of life with standardized measures. Following the intervention, two of three participants self-reported a clinically significant reduction in everyday memory lapses and improved everyday functioning. One participant reported clinically significant change in quality of life. All participants demonstrated clinically significant changes in their ability to cope with problems and build self-efficacy. Furthermore, all participants scored in the normative range post-intervention on the measure of satisfaction with life. Clinical observations and participant feedback were used for refinement of the DMN intervention (ClinicalTrials.gov NCT03453554).
Using an interactive digital calendar with mobile phone reminders by senior people - a focus group study. [2020]New technologies such as mobile/smartphones have the potential to help senior people perform everyday activities. However, senior people may find it difficult using mobile/smartphones, especially the digital calendar and short text message features. Therefore, senior people might need user-friendly, flexible, and interactive digital calendars that provide them with active reminders about their everyday activities. This study focuses on community dwelling seniors' experiences learning and using RemindMe, an interactive digital calendar with active reminders, as part of customizing an intervention appropriate for senior people with cognitive impairments.
Digital Support for Persons with Cognitive Impairment. [2018]Cognitive impairment may cause difficulties in planning and initiating daily activities, as well as remembering to do what is scheduled. This study investigates the effectiveness of an interactive web-based mobile reminder calendar that sends text messages to the users mobile phone as support in everyday life, for persons with cognitive impairment due to neurological injury/diagnoses. The study has a randomised controlled trail design with data collection at baseline and at follow-up sessions after two and four months. Data collection started in August 2016 and continues until December 2017. The interactive web-based mobile reminder calendar may give the needed support to remind the person and thus increase the ability to perform activities and to be independence in everyday life. Preliminary results will be presented regarding what effect the interactive web-based mobile reminder calendar have for the participants performance of everyday life activities as well as perceived quality of life.
Google Calendar Enhances Prospective Memory in Alzheimer's Disease: A Case Report. [2018]We investigated whether an external memory aid (i.e., Google Calendar) would alleviate prospective memory compromise in a patient with mild Alzheimer's disease. The patient was asked in the baseline phase to perform three prospective targeted events (e.g., attending her weekly bridge game at the community club) and three prospective control events (e.g., buying her weekly magazine). The same six prospective events were assessed in the intervention phase but the targeted-events were cued by Google Calendar while the control-events were not. Results showed less omission of the targeted events in the training phase than in the baseline phase, suggesting a positive effect of Google Calendar. This case report offers a unique view into how smartphone calendars may alleviate prospective memory compromise in patients with mild Alzheimer's disease.
Google Calendar: a new memory aid to compensate for prospective memory deficits following acquired brain injury. [2011]Prospective memory impairment is common following acquired brain injury (ABI) and intervention has proved challenging. The current treatment of choice involves using external memory aids as a method of compensation, with those incorporating active reminders proving most successful. In this paper we report findings of an investigation into the effectiveness of a novel external memory aid, Google Calendar. This aid incorporates active reminders and overcomes some of the limitations associated with existing aids. Twelve participants with ABI took part in the study incorporating a randomised control crossover within-subjects design, consisting of a 5-week baseline phase, followed by two 5-week intervention phases where either Google Calendar or a standard diary were used. Participants identified activities to target during the study and a family member monitored their success. Google Calendar was more effective than the diary in enhancing prospective memory performance. It also proved more popular, on account of its active reminders which helped trigger the retrieval of intentions, whilst reducing the need for monitoring. While further research is required to substantiate these initial findings, it is recommended that clinicians familiarise themselves with using Google Calendar, as it appears to offer additional potential in the management of prospective memory deficits following ABI.
A mobile phone as a memory aid for individuals with traumatic brain injury: a preliminary investigation. [2017]To investigate the use of a 'reminders' function on a mobile phone as a compensatory memory aid for five individuals with traumatic brain injury (TBI).
Smartphone technology: Gentle reminders of everyday tasks for those with prospective memory difficulties post-brain injury. [2022]Prospective memory is a common deficit following brain injury that can reduce an individuals' ability to complete everyday tasks. The smartphone is a device that may compensate for these difficulties using the calendar's prompting function. Reminders can be programmed remotely using email to phone synchronization.