Online Platforms for Alzheimer's Disease Information Delivery

(eSMARTER Trial)

Not currently recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of two methods for delivering Alzheimer's test results. One group will use an online platform, the eHealth Platform, featuring a web portal and chatbot. The other group will have videoconference appointments with healthcare providers, known as the Videoconference Telehealth Platform. The trial aims to determine if the online approach matches the effectiveness of professional consultations. Individuals with internet access who can read and speak English and are comfortable learning about Alzheimer's-related health information may be suitable participants. As an unphased trial, this study allows participants to contribute to innovative approaches in healthcare communication.

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 prior data suggests that these platforms are safe for delivering Alzheimer's-related information?

Research has shown that digital health tools, such as the eHealth platform, are generally safe and helpful for those learning about Alzheimer’s. Studies have found that these platforms simplify access to information and health management without major issues. For instance, digital health technologies assist with screening and diagnosis and allow individuals to access their health information at their own pace.

No specific evidence indicates that using these platforms is unsafe. Instead, they are often praised for enabling flexible learning and discussion about health concerns. This suggests that the eHealth platform is likely well-tolerated, based on the use of similar tools in other settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these platforms for delivering Alzheimer's information because they offer innovative ways to communicate test results and healthcare guidance. The eHealth platform is unique because it combines a self-directed web portal and a chatbot, allowing users to access information flexibly and even schedule virtual appointments, which can enhance patient engagement and autonomy. The videoconference telehealth platform, on the other hand, provides real-time interaction with healthcare providers remotely, making it more convenient for patients who may have mobility issues. Both platforms aim to improve accessibility and personalize care, potentially leading to better patient outcomes compared to traditional, in-person consultations.

What evidence suggests that this trial's methods could be effective for delivering Alzheimer's information?

Research has shown that digital health tools can benefit people with Alzheimer's disease. Studies have found that these tools assist with early detection, diagnosis, and ongoing monitoring. Specifically, online health platforms can enhance mental and social functioning and improve caregiving. They also facilitate communication and information sharing between patients and healthcare providers.

In this trial, participants will be randomized to receive their Alzheimer's-related test results through one of two platforms. The eHealth platform, which includes a self-directed web portal and chatbot, allows participants to switch between these tools or schedule a virtual appointment with a healthcare provider. Alternatively, the videoconference telehealth platform provides remote visits with a healthcare provider for personalized advice and support. Both methods aim to make health information easier to deliver and understand. ^{2 3 4 6 7}

Who Is on the Research Team?

Jessica Langbaum, PhD

Principal Investigator

Banner Alzheimer's Institute

Are You a Good Fit for This Trial?

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 can read, write, and speak English fluently.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8437510/

The Effectiveness of e-Health Solutions for Aging With ... Outcomes included mainly measures of cognition, psychosocial functioning, caregiving processes, caregiver–care receiver relationship, and activities of daily ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10030155/

A digital health home intervention for people within the ... This study tested the efficacy of digital-health home intervention for people within the Alzheimer's disease (AD)-continuum.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2274580724006794

Digital Health Technologies for Alzheimer's Disease and ... Digital health technologies offer valuable advantages to dementia researchers and clinicians as screening tools, diagnostic aids, and monitoring instruments.

4. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.12918

Catalyzing dementia care through the learning health system ... The patient portal facilitates asynchronous communication, transparent information exchange, and awareness of the nature and scope of treatments ...

5. researchprotocols.org researchprotocols.org/2022/11/e41015/

Existing eHealth Solutions for Older Adults Living With ... This paper presents the protocol of an environmental scan to monitor the currently available eHealth solutions targeting dementia and other neurocognitive ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10771641/

Barriers to using eHealth/mHealth platforms and perceived ... The primary uses of such platforms included: 1) gathering information on topics including dementia, caring strategies, as well as caring ...

7. nature.com nature.com/articles/s43587-024-00573-8

Leveraging electronic health records and knowledge ... Leveraging electronic health records and knowledge networks for Alzheimer's disease prediction and sex-specific biological insights.