The Brain Health Registry Caregiver and Study Partner Portal

Transcription

1 The Brain Health Registry Caregiver and Study Partner Portal Rachel L. Nosheny, PhD. Michael W. Weiner, MD Ronald C. Petersen, MD, PhD UCSF Mayo Clinic

2 Alzheimer s PPRN Goal and Specific Aims Overall goal: To accelerate development of effective treatments for Alzheimer s disease and related dementias Specific Aims Connect patients, caregivers, and researchers focused on developing, conducting, and disseminating patient-centered dementia research Recruit, engage, and educate individuals at risk for or with Alzheimer's Disease and related dementias and caregivers in a patient-centered network Screen, refer, and enroll individuals in Alzheimer s trials and observational studies Increase diversity in Alzheimer s trials through outreach to minority populations, especially African Americans and Latinos 2

3 BrainHealthRegistry.org: Alzheimer s PPRN web portal for recruitment, engagement & longitudinal monitoring 3

4 Brain Health Registry: How It Works Register, consent online 13 questionnaires (health history, family history, medications, memory problems, mood, lifestyle) 3 Online cognitive tests Study Partner can separately register and answer questions about participant and self Participants and study partners return every 6 months to complete follow-up tasks Sign up Tell us about yourself Take some tests Invite a study partner Come back and come back again 4

5 Alzheimer s PPRN Brain Health Registry participants by the numbers 31,466 consented participants enrolled Age 55+ All have opted in to learning about future research opportunities Longitudinal data from 13,410 (48% retention rate) Over 11,000 have been referred to Alzheimer s and Aging clinical research studies (treatment trials and observational) Over 1400 have been enrolled in studies 5

6 The Brain Health Registry Caregiver and Study Partner Portal 6

7 Study Partner Portal: How it works Infrastructure & database within BHR for a study partner (someone who knows the participant well) to separately register and consent online Study partners answer questions. About the participant Recent changes in memory, attention, learning Recent changes in Activities of Daily Living (ADLs) About the study partner him/herself Health Stress Caregiver Experience About the relationship Spouses, friends, etc.? Live together? Years known? 7

8 Why are study partners important in Alzheimer s and other clinical research? Study partners can give unique insight into the functioning of the associated participant Can identify early cognitive and functional changes May sometimes be more accurate than self-report, especially when the participant is cognitively impaired and losing insight about his/her own functioning Can identify change in function using a single data point by asking Have you noticed a recent change in? Study partner engagement is important for advancing patientcentered research Focuses on outcomes that matter to patients & families Can help overcome patient barriers to participation May help recruit participants who are too impaired to join themselves For study partners who are caregivers, can advance our understanding of caregiver burden, experience, and health 8

9 Brain Health Registry study partners A total of 2525 study partner-participant teams have enrolled since August 2016 Age Distribution Gender 9

10 Study partner-participant relationship Spouse % Friend Son/daughter % 7% Sibling 113 5% Parent 40 2% Number of Study Partners 71% live together Have known each other for an average of 34 years 10

11 What are study partners telling us about their associated participants? Number Percent of total 11

12 What are study partners telling us about their associated participants? Number Percent of total and about their own health? Number Percent of total 12

13 Is online study partner information valid? Study partner-reported variables are significantly associated with: Self-reported subjective memory concerns Self-reported recent changes in memory and daily functioning Online memory test scores of the participant Many more studies are planned to validate Study Partner Portal information Online memory test score Study Partner-reported cognitive function 13

14 Can we use study partner information to help identify good candidates for Alzheimer s clinical trials? Total AD-PPRN Brain Health Registry Cohort 31,466 Has Study Partner 2525 Participant gives enough information to determine trial eligibility 1951 Cognitively Normal 1614 Possibly Impaired 186 Likely Alzheimer s 11 14

15 Can we use study partner information to help identify good candidates for Alzheimer s clinical trials? Total AD-PPRN Brain Health Registry Cohort 31,466 Cognitively Normal n=1614 Has Study Partner 2525 Participant gives enough information to determine trial eligibility 1951 Possibly Impaired % 57% 91% Likely Alzheimer s 11 Percentage of study partners who report recent changes or problems 15

16 Capturing Caregiver Experience in the Brain Health Registry In addition to using the Study Partner Portal, we also invite all BHR participants to complete a Caregiver Experience survey. This means we have 2 caregiver populations: Participant + caregiver teams in the Study Partner Portal Participants who self-identify as caregivers in general BHR study, with no associated study partner Caregiver Experience (CareX) module developed in collaboration with Drs. Elissa Epel and Alexandra Crosswell UCSF Psychiatry, UCSF Stress Management Network Based on well-validated instruments In consultation with a number of stress and caregiver experts ~7 minutes to complete 16

17 CareX efficiently captures multiple domains of caregiver experience Relationship to care recipient Spouse? Live together? Caregiving exposure How long? Hours? Care recipient condition? Psychological overload Stress? Affects other relationships? Physical symptoms Sleep? Pain? Physically sick? Sense of captivity/entrapment Feel trapped? Wish you were free? Care recipient symptoms and effect on caregiver Care recipient has trouble? If so, how much has it bothered or upset you? Caregiver satisfaction Enjoyment? Resentment? 17

18 The CareX questionnaire starts with a gateway question to identify caregivers 18

19 Caregivers in the Brain Health Registry Since August 2016, 6421 people have completed CareX, including 1564 study partners (13%) (12%) 19

20 Patient-centered features of the Brain Health Registry Study Partner Portal and CareX Content and user experience was developed and optimized based on feedback from stakeholders >2000 participants, including many caregivers AD-PPRN Advisory councils, led by Meryl Comer Investigators/clinicians/caregiver stress experts Relies on participant- and caregiver-reported outcomes Results will be disseminated to participants through newsletters and website resources Brings the unique and powerful voices of care partners front and center in Alzheimer s research 20

21 Potential Impact of the Caregiver and Study Partner Portal Facilitate recruitment and screening for Alzheimer s clinical trials A new model for screening older adults for cognitive problems and Alzheimer s in many healthcare settings Improved caregiver health Advance the science of caregiver stress Provide meaningful long-term engagement and resources for caregivers Can be adapted for use in other populations beyond Alzheimer s disease such as other PPRNs! 21

22 Future directions: Expanding the capability of the Caregiver and Study Partner Portal Study partner first capability Allows the study partner/caregiver to be the initial point of contact Proxy access Allows the study partner to be the sole point of contact Inclusion of the Caregiver Survivor experience Ways to give more back to study partners/caregivers Feedback about questionnaire answers More educational resources, communication, and opportunities to connect with others 22

23 Alzheimer s PPRN Partners Leadership Principal Investigator: Co-Investigators: Ronald C. Petersen, MD, PhD Mayo Clinic Alex Alexander, MBA, MPA Mayo Clinic Meryl Comer Geoffrey Beene Foundation Glenn Smith, PhD University of Florida Michael W. Weiner, MD UCSF Governance Board: all investigators + Debra Lappin, FaegreBD Consulting Rachel Nosheny, UCSF, Brain Health Registry Sally Sachar, Us Against Alzheimer s George Vradenburg, Global Alzheimer s Platform Foundation 23

24 Team: Michael W. Weiner, MD UCSF Radiology Principal Investigator Diana Truran-Sacrey, Executive Director Derek Flenniken, Technical Director Aaron Ulbricht, Programmer Josh Hwang, Programmer Philip Insel, Statistician Shannon Finley, Regulatory Affairs Monica Camacho, Project Manager Juliet Fockler, Project Manager Kirsten McKenzie, Project Manager Adrienne Kormos, Admin. Support Scott Mackin, PhD UCSF Psychiatry Co-Investigator Rachel Nosheny, PhD UCSF Radiology Co-Investigator Partners & Collaborators: Funding:

25 25