Online Platforms for Alzheimer's Disease Information Delivery

(eSMARTER Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Banner Health

Disqualifiers: Psychiatric illness, Communication difficulties, others

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

Compensation: Varies

Number of Visits: 1

681 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

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

What data supports the effectiveness of the treatment eHealth Platform, Videoconference Telehealth Platform for Alzheimer's Disease?

Research shows that eHealth platforms, like the Digital Alzheimer Center, can improve the quality of dementia care by providing disease information and connecting patients and caregivers with health professionals. Videoconferencing has been found to save time and enhance communication among healthcare providers, which is beneficial for managing complex cases in Alzheimer's care. ^{1 2 3 4 5}

Is it safe to use online platforms for delivering Alzheimer's disease information?

The research does not provide specific safety data for online platforms used for Alzheimer's disease information delivery, but it discusses the use of electronic systems to improve patient safety in general. ^{6 7 8 9 10}

How does the Online Platforms for Alzheimer's Disease Information Delivery treatment differ from other treatments for Alzheimer's?

This treatment is unique because it uses online platforms like eHealth and videoconference telehealth to provide information and support for Alzheimer's patients and their caregivers. Unlike traditional treatments, it focuses on improving knowledge, communication, and care coordination through digital means, which can save time and enhance multidisciplinary exchanges. ^{1 2 3 5 11}

What is the purpose of this trial?

This randomized non-inferiority study will evaluate self-directed scalable electronic health platform (eHealth) methods for communicating Alzheimer's gene and biomarker results compared to videoconference telehealth disclosure with healthcare providers, as well as characterize the impacts of learning this information on the participant.

Research Team

Jessica Langbaum, PhD

Principal Investigator

Banner Alzheimer's Institute

Eligibility Criteria

This trial is for individuals who can follow the study's procedures, are fluent in English, willing to have their blood drawn for future testing, and have internet access with a device. They must understand the consent form content to participate.

Inclusion Criteria

I have access to the internet and a device that can connect to it.

I understand the consent form as proven by correctly answering questions about it.

I can read, write, and speak English fluently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Remote eligibility confirmation

Pre-disclosure Education

Participants use eHealth platforms (ADWebPortal or ADChatbot) for pre-disclosure education

1-2 weeks

Self-directed online sessions

Disclosure

Participants receive Alzheimer's gene and biomarker results via eHealth platform or telehealth videoconference

1 week

1 virtual visit (telehealth or eHealth)

Follow-up

Participants are monitored for psychological and cognitive impacts post-disclosure

6 months

Remote assessments at 0-7 days, 6 weeks, and 6 months

Treatment Details

Interventions

• eHealth Platform
• Videoconference Telehealth Platform

Trial Overview The study compares two methods of communicating Alzheimer's gene and biomarker results: an eHealth platform where participants learn on their own versus a videoconference telehealth session with healthcare providers.

Participant Groups

Group I: eHealth platform Experimental Treatment 1 Intervention

The eHealth platform consists of the self-directed web-portal (ADWebPortal) and chatbot (ADChatbot) to receive their Alzheimer's-related test results. Participants randomized to this arm can switch between the two or schedule a virtual appointment with a healthcare provider.

Group II: Videoconference telehealth Active Control 1 Intervention

The videoconference telehealth platform consists of remote visit(s) with a healthcare provider to receive their Alzheimer's-related test results.

Who Is Running the Clinical Trial?

Banner Health

Lead Sponsor

Trials

26

Recruited

1,006,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Findings from Research

The Digital Alzheimer Center (DAC) was found to be generally useful for patients with dementia and their carers, with 65% of patients and 78% of carers appreciating its information and support features.

Despite its usefulness, only a minority of patients (33%) found the portal easy to learn, highlighting the need for better design and ongoing usability testing to improve user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Digital Alzheimer Center: Testing Usability and Usefulness of an Online Portal for Patients with Dementia and Their Carers. Hattink, B., Droes, RM., Sikkes, S., et al.[2022]

There is a significant need for smartphone-based interventions to support caregivers of the 5.4 million people with Alzheimer's disease, as current apps available for caregivers have limited functions and do not adequately address their complex needs.

Research indicates that there is a lack of tailored caregiving apps for Hispanic populations, highlighting a gap in accessibility and support for diverse caregiver communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-Based Health Technologies for Dementia Care: Opportunities, Challenges, and Current Practices. Brown, EL., Ruggiano, N., Li, J., et al.[2020]

The 'Improvehealth.eu' eHealth service was successfully implemented in a pilot study with 46 patients, showing a significant improvement in medication adherence for those using the intervention (odds ratio = 10.0, P = .03).

Patients using the eHealth service reported feeling more engaged and in control of their treatment, with 81% expressing positive perceptions, suggesting the intervention has potential to enhance treatment outcomes for depressive disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an eHealth service to support collaborative depression care: results of a pilot study. Meglic, M., Furlan, M., Kuzmanic, M., et al.[2021]

A web-based educational intervention for dementia caregivers was feasible, with 55 out of 60 enrolled participants completing the study and averaging 8 hours of learning over 30 days, indicating strong engagement with the platform.

Participants reported high satisfaction (89%) and implemented skills learned from the program, although the intervention showed only small effect sizes in reducing neuropsychiatric symptoms and caregiver distress, suggesting potential benefits that may need further exploration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver Response to an Online Dementia and Caregiver Wellness Education Platform. Rodriguez, K., Fugard, M., Amini, S., et al.[2022]

A new electronic health record (EHR)-based system allowed 26 clinicians to submit 217 adverse drug event (ADE) reports to the FDA in real-time, demonstrating an efficient method for reporting that took an average of just 53 seconds per report.

The system provided detailed clinical information about the ADEs, including comorbid conditions and concurrent medications, which could enhance the quality of data submitted to the FDA and potentially improve drug safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting. Linder, JA., Haas, JS., Iyer, A., et al.[2019]

The study involved 375 patients using an electronic patient portal called MedCheck, which aimed to improve communication about medication-related symptoms, but only 49% of patients responded to the messages.

Despite the potential of the portal to enhance communication, the trial found no significant difference in adverse drug events (ADEs) or health-care utilization between the intervention and control groups, indicating that further development is needed to improve medication safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a patient internet portal to prevent adverse drug events: a randomized, controlled trial. Weingart, SN., Carbo, A., Tess, A., et al.[2018]

In a study analyzing 1,567,659 hospital discharges in Spain from 2005-2007, 96,607 adverse drug events (ADEs) were identified, representing 5.55% of all discharges, with a significant portion (82.86%) deemed not preventable.

The study found that adverse drug reactions (ADRs) were more common in women and led to longer hospital stays, highlighting the importance of monitoring and reporting ADEs for improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse drug events in patients hospitalized in internal medicine]. Zapatero Gaviria, A., Barba, R., Ruiz Giardin, JM., et al.[2013]

In a review of safety data from five 18-month Alzheimer's disease trials, common adverse events included dyspnea (5.3%-5.8%), headache (4.0%-5.5%), and constipation (4.3%-4.7%), indicating a consistent profile of side effects among patients taking placebo.

Larger multinational studies showed higher overall discontinuation rates (24.6%-33.0%) compared to smaller studies (8.2%-21.0%), suggesting that study size and geography may influence patient retention and safety outcomes in Alzheimer's trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of Alzheimer's disease populations in Alzheimer's Disease Neuroimaging Initiative and other 18-month studies. Henley, DB., Sundell, KL., Sethuraman, G., et al.[2021]

The implementation of an electronic Web-based system at a pediatric hospital significantly improved the completion rate of interventions related to adverse drug events (ADEs), increasing from 21% to 44.7% after the system was introduced over a 5-month evaluation period.

The new system also enhanced documentation accuracy, reducing the rate of incomplete interventions from 77% to 43.7%, indicating that a streamlined electronic approach can effectively enhance patient safety in medication management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of medication event interventions through use of an electronic database. Merandi, J., Morvay, S., Lewe, D., et al.[2019]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Evaluation of the Digital Alzheimer Center: Testing Usability and Usefulness of an Online Portal for Patients with Dementia and Their Carers. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[The use of videoconferencing in psychogeriatrics, a pilot experiment]. [2021]

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

Smartphone-Based Health Technologies for Dementia Care: Opportunities, Challenges, and Current Practices. [2020]

4. Canada pubmed.ncbi.nlm.nih.gov

Feasibility of an eHealth service to support collaborative depression care: results of a pilot study. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Caregiver Response to an Online Dementia and Caregiver Wellness Education Platform. [2022]

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

Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting. [2019]

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

Using a patient internet portal to prevent adverse drug events: a randomized, controlled trial. [2018]

8. Spain pubmed.ncbi.nlm.nih.gov

[Adverse drug events in patients hospitalized in internal medicine]. [2013]

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

Safety profile of Alzheimer's disease populations in Alzheimer's Disease Neuroimaging Initiative and other 18-month studies. [2021]

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

Improvement of medication event interventions through use of an electronic database. [2019]

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

The development of an Alzheimer's disease channel for the Michigan Interactive Health Kiosk Project. [2006]