Co-Enrollment Programs

Background:

One of the goals of the Brain Health Registry is to assist with recruitment, assessment, and longitudinal monitoring of participants for neuroscience studies. We are eager to develop collaborations with other investigators who share the same goal of accelerating the development of improved diagnostic tests, effective treatments and preventative interventions for Alzheimer’s disease and other brain disorders.

One of the ways that the Brain Health Registry can help facilitate clinical research is through a Co-Enrollment Program.

Please read the description and summary of steps below to help you to complete the Co-Enrollment Request Form.

Download the Co-Enrollment Request Form

Description:

Co-enrollment programs allows collaborators to longitudinally track and capture supplemental online study data for their existing, or to-be-developed, cohort of research participants by inviting them to join and “co-enroll” in BHR.

The co-enrollment registration process includes a unique identification code that is provided to participants via email or other recruitment communications, such as a brochure. This code identifies the participant as associated with a specific source or “home study” and allows data linkage between the two studies. This is known as a “co-enrollment code”. After logging in, co-enrolled participants sign a consent form, allowing BHR data to be shared with specifically identified collaborating investigators.

Co-Enrollment Programs, UCSF Brain Health Registry

Recruitment into the BHR co-enrollment program is executed by the collaborator with suggestions from BHR on different recruitment strategies to help the collaborator determine what best fits their co-enrollment program. Suggested methods of recruitment are summarized below:

  • Emails – Email invitations including information about the collaboration, a co-enrollment code and a link to a study specific registration page can be sent to participants by the collaborator.
  • Customized “Sign Up” web page – Participants can be shown a study specific sign-up web page during an in-clinic visit. This page would include information about the collaboration and a sign-up form to provide their name, a co-enrollment code, and email address. BHR would then send an invitation email with a link to the study specific registration page.This method will require a computer to be available during the in-clinic visit.
  • Printed Informational materials – Printed co-enrollment materials such as a brochures or flyers can be mailed to the participant or provided during an in-clinic visit. These materials will include information about the collaboration, a co-enrollment code (CEC), and a URL to a study specific registration page.
  • Phone call – Collaborator study staff can call the participants to inform about BHR and/or invite them to BHR. BHR can then send an invitation email with information about the co-enrollment study, a co-enrollment code (CEC), and a link to the study specific registration page.

These recruitment methods can be done separately or together. For example, a collaborator could choose to provide the participant with a printed brochure AND a customized “Sign Up” web page during an in-clinic visit.

Recruitment materials for any of the above methods including email templates, phone scripts with general BHR talking points and brochure/flyer templates can be downloaded below.

These recruitment methods can be done separately or together. For example, a collaborator could choose to provide the participant with a printed brochure AND a customized “Sign Up” web page during an in-clinic visit.

Recruitment materials for any of the above methods including email templates, phone scripts with general BHR talking points and brochure/flyer templates can be downloaded below.

Download Email Template

Download Sign-Up Template

Download Brochure/Flyer Template

Download Phone Script

Download Additional General BHR Talking Points

Collaborators may opt for a full or modified BHR experience, in which their co-enrolled participants are given a subset of questionnaires and/or cognitive tests to suit their study needs. Participant experience (including task order, grouping and introductions) and study visit frequency may also be customized to the specific needs of the collaborator. Please email investigators@brainhealthregistry.org to receive a copy of the current participant questionnaires.

Download Description of Cognitive Tests

Download Suggested Portal Organization (tiers and introductions example)

All communication content can be co-branded, meaning that the collaboration name, “[Collaborator Name] – Brain Health Registry (BHR)”, and both of the study logos can be used for the following: a) study specific registration page; b) recruitment invitation emails; c) study communication emails (including welcome, reminder to complete tasks, completion, follow-up visit reminder); and d) login page. Templates are provided by BHR. Collaborators are encouraged to provide a study logo.

Download Registration Page Template

Download Study-Specific Welcome Message

Examples of co-branded registration page:

Co-Enrollment Programs, UCSF Brain Health Registry
Co-Enrollment Programs, UCSF Brain Health Registry

BHR will create a demo study in the co-enrollment portal including: a) co-branded login and registration pages; b) customized layout with task order, grouping and introductions; c) schedule of study visits; and d) co-branded invitation emails and study emails.

Collaborator will test the participant experience in the demo environment. Upon Collaborator feedback and approval, the final co-enrollment portal will be generated and launched in production.

Co-enrollment programs function under both UCSF’s IRB and the Collaborator’s IRB. BHR can provide collaborators with the following materials: a) copy of redacted BHR protocol; b) co-enrollment study design details; c) templates for emails and registration pages; d) suggested recruitment materials and e) any other additional documents required by the collaborator’s IRB.

Caregiver and Study Partner Portal (CASPP) Add-on:

Collaborators can chose to include the Caregiver and Study Partner Portal (CASPP) into their co-enrollment study. CASPP allows a study partner (SP) of a BHR participant to separately register, consent, and complete questionnaires. The data linked between the SP and participant includes six questionnaires, each of which takes approximately 3-10 minutes to complete. The questionnaires can be broadly characterized as gathering information about the participant and about the SP him/herself. Questions about the participant include a short health screener, ECog and FAQ adapted for online use, and questions about effective symptoms and disruptive behaviors associated with brain illness. Questions about the SP him/herself include demographics, a short health screener, stress, and SP relationship to participant. SP’s who identify as caregivers also complete the Caregiver Experience questionnaire within the CASPP. Please email investigators@brainhealthregistry.org to receive a copy of the current questionnaires.

Next Steps:

If you are interested in a Co-Enrollment collaboration, please complete the Co-Enrollment Request Form and return the completed form to BHR.

Download the Co-Enrollment Request Form

Summary of Steps:

1

Start-up (Initiation)

a) Download and complete the Co-enrollment Request Form
b) Send the completed form to BHR (investigators@brainhealthregistry.org) for review
2

Program Plan

a) Develop a scope of work including project objectives and timeline
b) Determine budget
3

Contractual Agreement

a) Execute a legal contractual agreement including data use agreement
b) Obtain third party approvals for use of cognitive tests, if applicable
4

Regulatory

a) Obtain institutional IRB approvals
5

Configuration

a) Build study-specific demo environment in Co-Enrollment Portal
b) Test and modify study, as needed
6

Launch

a) Initiate co-enrollment protocol in production environment
b) Send invitation emails
7

Datasets

a) Generate dataset and data dictionary
b) Provide linked data on predetermine schedule
8

Support

a) Identify and report any issues; modifications, as needed

Please note some steps may run concurrently to expedite process.

Personal Motivations

I’ve seen the impact of Alzheimer’s – I’ve had friends who have lost loved ones, and the toll is immense. So I see it as a privilege to help with medical research. I feel like this is a way I can pay it forward to future generations, including my own children.

Jackie BobergSaratoga, CA

There are many reasons why I'm participating in the Brain Health Registry, but here's the number one reason: my father. Ten years ago, he was diagnosed with Parkinson's disease. I want to help find a cure and participating in this project gives me the greatest opportunity to do just that.

Angela DanielsWindsor, CA

It’s been two years since my mom died while suffering from Alzheimer’s. I think about her every day. Participating in the Brain Health Registry is a way for me to honor her. It’s something I can do that’s real and tangible.

John FitzpatrickSan Bruno, CA

My godfather has Parkinson's. He's a priest, and the disease is taking away his ability to preach. I signed up with him in mind. If, in the long run, this can help save and empower voices like his, it will be a great thing. And I'd like to be a part of it.

Theresa WalshSanta Clara, CA

My college roommate was recently diagnosed with Parkinson's. She's working hard - exercising, meditating, doing yoga - to keep her symptoms at bay, and she's holding on to the positive attitude she's always had. I'm hoping this research can lead to a cure and help her stay positive and vital. That’s why I’m here.

Anne de la RosaSan Mateo, CA

PTSD doesn't have to break apart families or end lives, but it often does. Veterans like my dad who go into a war zone and come out with a devastating disorder deserve new and better treatments to help them live normal, happy and fulfilling lives. I am honored to take part in the Brain Health Registry so I might help those who have put themselves at risk in service to the nation.

Roxanna SmithOakland, CA

It’s easy to join!

(You must be 18 years or older)

1. Sign Up

You can join as an individual or with a partner.

2. Tell Us About Yourself

Answer some questions about your medical history, current health, and lifestyle.

3. Do Some Online Brain Tests

These tests exercise your memory, and are like games.