Patient-Centric Alzheimer’s Disease Trials

Sponsors and study sites face big challenges with recruiting/retaining Alzheimer’s Disease patients in clinical trials and, subsequently, collecting patient data. Of the many challenges, the most notable include study risk/benefit analysis perception by patients, the consenting process, general mistrust in clinical trials, caregiver availability, and trial duration.¹ According to a study that analyzed Alzheimer’s patient retention, only 43.8% completed all study visits.¹ Moreover, many study sites focus their efforts on recruiting AD patients that live at home with their caregivers,¹ however, this model apparently does not work very well. According to the CDC, nursing homes exhibit the highest concentration of patients living with Alzheimer’s and dementia (48.5%).² Considering the caregiver model in nursing homes, the environment appears optimal to recruit and retain Alzheimer’s patients using patient-centric models.

I’ve had the experience of taking care of my grandfather, who had Alzheimer’s Disease. Aside from dealing with different forms of amnesia and corresponding delusional behaviors, it was very difficult for me to drive my grandfather to doctors’ visits because he was afraid of stepping out of his comfort zone at home. Our lives could have been much easier if telehealth and patient centric technologies existed, keeping my grandfather at home during doctor visits.

That was more than a decade ago. Now with the emergence of breakthrough technologies, patient centric trial designs and site operational infrastructures, some of the aforementioned challenges will likely diminish, resulting in better outcomes. This article will demonstrate an innovative structural design on how a New York-based study site is leveraging innovative telehealth technologies and nursing home infrastructures to recruit and retain Alzheimer’s patients.

Patient-Centric Infrastructure Example

Hapworth Psychiatric Medical Center, a New York-based study site that books more than 15,000 patient visits per year, recently enhanced its infrastructure to support telehealth and Alzheimer’s trial recruitment support. The facility is equipped with VOIP video phones, HIPAA compliant servers that support 99.99% runtime, and apps for patients to download on their phones in order to engage their physicians via video conferencing.

What is particularly interesting about this infrastructure is that a VOIP videophone can be integrated in any remote facility (such as a nursing home), and linked directly into the medical center’s servers. This infrastructure results in delivering high-resolution interactions between patients and physicians for patient-centric study visits. The difference between this VOIP infrastructure and consumer-based technologies (i.e., FaceTime, Skype, etc.) include (a) HIPAA compliance, (b) the ability to record conversations for compliance and quality purposes, and (c) high quality video interactions without disruption. Figure 1 illustrates this infrastructure.

Figure 2 demonstrates how this patient-centric infrastructure operates in Alzheimer’s trials. With a VOIP videophone installed in individual nursing homes, the Main Medical Center can recruit, conduct remote study visits, oversee and retain patients from numerous nursing homes, promoting patient-centricity via remote study visits at the nursing home. Naturally, the Sponsor will have to distribute investigational medical product to individual nursing home facilities, monitor drug administration and storage logs, and ensure facility and laboratory compliance (i.e., CLIA/CAP certifications).

How is This Infrastructure Better than Traditional Models?

Enhanced Recruitment and Enrollment Rates: Since nursing homes have the highest concentration of patients living with Alzheimer’s (48.5%) compared to other environments,² sponsors can expect higher enrollment rates through advertising campaigns conducted directly in nursing homes. Additionally, with access to several nursing homes, sponsors can expect higher enrollment rates. It is important to emphasize that these campaigns should be targeted towards the patient’s legally authorized representative, as some Alzheimer’s patients may not be capable of making decisions on their own.

Patient Comfort, Better Retention: Alzheimer’s patients tend to feel out of ease when they’re not in their living environment. This patient-centric model allows patients to conduct study visits remotely with the PI via VOIP videophones, and allows study staff to keep track of patients.

Investigational Product (IP) Adherence: With trained caregivers, and operational infrastructures that support medication administration compliance, there is a much higher chance for Alzheimer’s patients to adhere to IP in a nursing home environment compared to a personal home environment, where relatives/caregivers may not be paying particular attention to administering IP.

Enhanced Patient Safety: Nursing home caregivers are trained to detect adverse drug reactions (ADRs), and will indicate to the Principal Investigator (PI) if they observed an ADR. Additionally, should a serious adverse event (SAE) occur, the caregiver can initiate a VOIP videophone call with the PI, and allow the PI to observe the SAE and suggest an appropriate course of action. If the PI is not in the office, the system will ring the PI’s mobile device to conduct the VOIP video call. If the PI cannot take the call, the nursing home will fall back on emergency protocols for patient care.

Efficient Budgetary Infrastructures, and Better Outcomes: Initiating numerous study sites, expecting them to enroll AD patients, generate quality data, and retain them can be a disconnected and difficult process to manage and oversee. With the nursing home and patient centric infrastructure, sponsors can not only experience better outcomes when it comes to data quality, but the patients and caregivers will also appreciate the convenience of not having to be exposed to the burdens of traveling to the PI’s office for regularly scheduled study visits. The cost of this infrastructure can be higher due to nursing home staffing and training, however, the outcomes of higher recruitment/retention and data quality can be more valuable than a traditional site model; in other words, a site infrastructure with five nursing homes offers more value per site/nursing home than initiating five separate study sites.

Patient-Centric Design: Reducing Study Bias

As mentioned earlier, many patients living with Alzheimer’s are in nursing homes, and designing studies that focus primarily on patients in environments outside of nursing homes introduces bias in study design. Nursing home environments tend to mandate higher compliance in medication adherence, and quality of life can be different in a nursing home environment. These factors can impact study outcomes, and is important to consider during study design.

New Risks: Patient Coercion and Consenting

Alzheimer’s patients are particularly vulnerable to coercion, and study staff should pay careful attention to determining what’s best for their patients. The clinical research infrastructure demonstrated in this article may introduce risks related to coercion, as legally authorized representatives may not be present at all times. The legally authorized representative should be present during the consenting process, and should be required to visit the patient at a specific frequency (i.e., once every two weeks or once a month). Moreover, it is especially important for PIs and study staff to monitor patients more closely via VOIP video conferencing, and occasionally, in-person visits to determine whether nursing home staff are coercing patients. Additionally, it is critical that all staff be trained on detecting coercion, listening to patients’ needs, and risk-based monitoring plans should include monitoring activities to ensure that study staff are compliant with patient management.

Moe Alsumidaie, MBA, MSF is Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.

References

1. Bryna Shatenstein et. al., Issues in Recruitment, Retention, and Data Collection in a Longitudinal Nutrition Study of Community Dwelling Older Adults with Early-Stage Alzheimer’s Dementia, Journal of Applied Gerontology, June 2008, Vol 27

2. http://www.cdc.gov/nchs/data/nsltcp/long_term_care_services_2013.pdf