How the SuperAgers Family Study Uses Multi-Modal Engagement to eConsent and Engage the Largest Cohort of Centenarians - Vibrent

How the SuperAgers Family Study Uses Multi-Modal Engagement to eConsent and Engage the Largest Cohort of Centenarians

Background 

Researching what leads some individuals to age more slowly than the rest of the population could enable novel strategies for the treatment or prevention of aging-related chronic disease. Some genetic determinants have already been discovered in centenarians, and learning more about these factors could lead to therapies and treatments that improve quality and quantity of life. However, exceptional longevity, generally defined as survival to 85 years or older, is uncommon. Thus, there is the need to improve sample sizes to ensure scientific rigor. The Centenarian Family Research Study and Biorepository to Identify Determinants of Healthy Aging and Exceptional Longevity study formed to use multi-modal engagement to develop the world’s largest centenarian family registry and biorepository for systematic investigation of healthspan and exceptional longevity in humans.

SuperAgers Family Study uses multi-modal engagement

This initiative is spearheaded by the American Federation for Aging Research and the Albert Einstein College of Medicine, and is known as the SuperAgers Family Study.

Scientific Aims 

The overarching goals of this coalition are to amass the world’s largest cohort of centenarians as well as their offspring who possess protective phenotypes related to aging compared to spouse controls. The scientific aims include:

  • Uncovering genetic and biological mechanisms that protect against human aging and age-related diseases.
  • Developing novel protective and therapeutic interventions to target aging and aging-related diseases and conditions in humans.
  • Contributing to a discovery database for multi-morbidities of aging as a composite endpoint for clinical trials.

Cohort

The project is an observational cohort study that includes two phases. In the pilot feasibility phase, the study aims to enroll 250 centenarians and 500 offspring of centenarians and offspring’s spouses. In the scale up phase, 10,000 centenarians, as well as their offspring and offspring spouses if available, will be recruited according to the inclusion criteria:

SuperAgers Family Study by the Numbers

10,000

Centenarians to be recruited

8

Surveys for phenotypic data collection

10X

Larger than any other cohort of centenarians

Approach and Methods for Multi-Modal Data Collection 

The SuperAgers Family Study is a remote study, using a HIPAA compliant direct-to-participant (DTP) using the Vibrent Health Participant Experience Manager and Research Cloud products. These solutions enable eConsent, enrollment, and acquisition of self-reported clinical, lifestyle, social and other data.

The SuperAgers Family Study uses the following methods of data collection: 

Informed eConsent

The study team uses direct-to-participant (DTP) eConsent forms delivered through Participant Experience Manager. In addition to eConsent, individuals who are not able to provide consent using the eConsent application due to limitations in abilities to use technology, can request a hard copy consent form to be mailed to them along with a self-stamped return envelope.

Participants using eConsent can manage their participation in the program through Participant Experience Manager, which includes the ability to download their consent and related information, and withdraw consent at any time.

The study team uses direct-to-participant (DTP) eConsent forms delivered through Participant Experience Manager.

Consent to recontact research participants is also an important element of the research initiative’s eConsent process. The study team contacts participants with periodic updates and opportunities to participate in studies of healthy aging and longevity and drug development activities.

Computer Assisted Telephone Interviews (CATI)

Because of the unique needs of the centenarian population, the SuperAgers Family Study uses CATI features, part of Vibrent’s digital health research platform, to engage participants in contributing data when necessary. This approach helps to increase the eConsent and survey completion volume for such participants.  

CATI is a structured system of data collection by telephone that allows trained program staff to verify participant identity and verbal authorization to proceed, then complete the collection of participant data. Once a CATI session is completed, the participant has access to information submitted within their account.  

Family Relationship Link

With a focus on creating a family registry and biorepository for the centenarian population, the SuperAgers Family Study also collects the family link among offspring and their related centenarian.

The study team uses Data Explorer to visualize links between the centenarians and the offspring through data collected during enrollment in the study.

Electronic Health Records (EHR)

Research participants can eConsent to share their EHR data through HL7 FHIR subject EHR exchange.

Participant-Generated Data & Surveys

Using Participant Experience Manager, the SuperAgers Family Study uses multi-modal engagement (website, SMS, and phone) to collect self-reported clinical, lifestyle, social and other data from optional surveys. The data collection in these surveys includes: 

  • Basic participant information
  • Medical history
  • Daily activity and sleep
  • Lifestyle
  • Mood
  • Social activity
  • The centenarian at age 50
  • Family medical history

Biospecimen Sample Collection

The SuperAgers Family Study aims to perform genome and exome-wide sequencing of samples and to perform association analyses of all genotypes across the genome (genome-wide) with all clinical phenotypes from survey and EHR data (phenome-wide).

Following enrollment and acquisition of phenotypic data, participants submit a biospecimen. Through Participant Experience Manager’s integration with DNA Genotek, participants automatically receive a collection kit so that they can collect the biospecimen at home by doing a simple cheek swab procedure or providing a saliva sample that requires no assistance or presence of outside providers.

This automated process makes the protocol non-invasive and user-friendly for this older population.

Participant Portal

This portal runs on Vibrent Participant Experience Manager, and provides participants access to capabilities that include:

  • Surveys and other data collection
  • Quick polls
  • User account details
  • Appointment scheduling

Multi-Modal Recruitment and Engagement

The study recruits research participants from the Centenarian Family Registry established at the American Federation for Aging Research (AFAR).  The program builds gerontology community awareness about the study using multi-modal engagement methods.

Researchers also use email outreach to invite enrollees in the AFAR Centenarian Family Registry, who agree to receive information about research or other initiatives to participate in the research study.

The study team also targets the offspring of centenarians, which is a population familiar with mobile and computer technologies and motivated to reach out to their centenarian parent and to participate in research themselves.

Email and SMS engagement 

The study team uses Research Cloud to send participants periodic engagement communications via email, mobile phone push notifications or SMS messaging. The participant can choose the method of messaging they prefer through the Participant Portal, which runs on Participant Experience Manager.

The study team sends messages that include:

  • Notifications that a research participant has completed an activity (e,g. consent, specimen collection)
  • Reminders that action is needed
  • Announcements that a new survey is available
  • Messages that an error or problem occurred (e.g. locked out of account, forgot password)

Multi-Modal Appointment Management

The study team uses Research Cloud to manage inbound appointment requests, appointment scheduling, and the fulfillment of the appointments, which include consent and survey assistance, as well as video-based age verification.

Participants can schedule appointments through Participant Experience Manager for video age verification, or call to schedule appointments of the other types over the phone.

Return of Results

As a benefit of participation in the research study, participants can choose whether or not to receive information about their ancestry. Participants can access this data within the Participant Experience Manager portal.

Research Participant Data Access for Researchers

Each researcher and supporting staff have a unique login to Research Cloud and access to participant datasets, adhering to the principle of least privilege.

The Vibrent platform supports multi-modal engagement centrally, where research team members can use push notifications, email, SMS messaging, website content, and computer assisted telephone interviews for data collection.

All study tools that run on the Vibrent platform adhere to the Federal Information Security Management act of 2002 (FISMA), the Federal Risk and Authorization Management Program (FedRAMP), and Defense Information Systems Agency (DISA) guidelines.

Research Impact

The older an individual becomes, the more extreme is the longevity phenotype. Age 85 years is beyond the average life expectancy, but age 90 years is closer to the 90th percentile. Age 100 years is beyond the 99th percentile for contemporary birth cohorts. While not immune to age-related conditions, studying these individuals offers the promise of discovering genetic factors that impact the speed at which humans age.

A deeper understanding of biological and social determinants of healthy aging and exceptional longevity determinants could lead to novel strategies to delay aging and the chronic diseases associated with aging. This would:

  • Improve quality and quantity of life for individuals
  • Enhance healthspan in the population
  • Potentially decrease healthcare costs for society

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