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Seeking your ideas for ways to enhance recruitment and retention of Alzheimer’s disease study participants

Vicky Cahan
Vicky CAHAN,
Branch Chief,
Office of Communications & Public Liaison (OCPL)
.
Eliezer Masliah
Eliezer MASLIAH,
Director,
Division of Neuroscience (DN)
.

It’s hard to recruit people for clinical research these days. And that is doubly true if the topic is Alzheimer’s disease and its related dementias. Recruiting volunteer participants is a primary, persistent bottleneck that poses unique challenges to clinical trials researchers. Among these challenges are strict eligibility requirements for participation of study partners, sometimes invasive and time-consuming procedures, and barriers for underrepresented communities. A newer aspect is the engagement of pre-symptomatic or healthy volunteers as we try to intervene as early as possible in the disease process.

Developing a national strategy

To address increasing concerns about difficulties in reaching study recruitment goals, the NIA, with co-facilitation from the Alzheimer’s Association and other organizations, is asking a wide range of stakeholders, particularly those underrepresented in research, to help develop a comprehensive National Strategy for Alzheimer’s Disease Clinical Research Recruitment and Participation. We very much want to hear ideas and views from the academic and pharma research communities, patients and families, clinicians and other health care providers, businesses and employers, advocates, government and community leaders, communications experts, research funders, and more. In short, we need you—to help formulate that Strategy and join in its implementation.

Join the conversation!

We are currently seeking public comment for feedback on the ideas generated by the working groups. We’re also soliciting new ideas, aiming to fill gaps. For this outreach, we are trying something new to NIA, but which has been used across NIH and HHS recently for just this sort of conversation—a crowdsourcing platform called IdeaScale. Different than a traditional Request for Information, this online platform will allow us to hear from and engage with diverse stakeholders, creating a dialogue among participants.

How does this crowdsourcing thing work?

To comment, please visit and join our IdeaScale community, to browse ideas that have already been submitted, comment, cast a non-binding vote for your favorites, and submit your own ideas. It is vital that participation and comment reflect a diverse array of perspectives and priorities. So, please, invite others—colleagues, relatives, or friends who might have a good idea about what works and what doesn’t in encouraging study participation—to be part of the discussion as well. We’re seeking ideas in key topic areas such as:

  • Optimizing recruitment by building trusting relationships in local communities,
  • Raising national awareness about participation in studies,
  • Enhancing the capacity of study sites,
  • Tracking our progress, and
  • Cultivating a science of recruitment.

The public comment period is planned to run through April 15.

What’s happened so far to develop a strategy?

Over the past year, an initial group of dedicated volunteer experts has worked to draft initial recommendations. To name just a few, we want to thank our co-facilitators at the Alzheimer’s Association, members of a Strategy steering committee, and tireless working groups led by:

  • Dr. Jason Karlawish, Outreach, Recruitment, and Education core leader, University of Pennsylvania School of Medicine Alzheimer’s Disease Research Center, who chaired the working group focusing on national approaches
  • Dr. Pierre Tariot, director, Banner Alzheimer's Institute and co-director, Alzheimer's Prevention Initiative, who chaired the working group on capacity building
  • Dr. Laura Baker, associate director, Wake Forest Alzheimer’s Disease Core Center, who chaired the working group focusing on local and diverse efforts.

They looked at recruitment and retention from the national and local perspectives, and what actions are needed to enhance messaging, partnering, building study site capacity and more. Their dedication, diligence, and thoughtfulness are the foundation for the wider discussion we invite today.

What happens next?

After receiving your ideas, we’ll be analyzing and organizing them, with the working groups and others, to view and evaluate the input we’ve received. We’ll finalize the national recruitment strategy document over the next few months.

But that is only the beginning. The Strategy can only succeed when we all take part in real action to move forward. We’re eager to continue the conversation and with your help, to implement the components of the Strategy to optimize participation in Alzheimer’s and related dementias research.

Alzheimer's Disease Clinical Research

Comments

Submitted by Dr. Trinidad A… on March 07, 2018

My humble opinion is to make the Recruitment and Retention plan an intrinsic part of the study's methodology. It is important to perhaps run focus groups prior to developing this phase both with the potential participants, and also with their service providers.

We need to take into account not only a participant's race, ethnicity, SES, culture in general, but also historical factors, and their ideas and stigmas about the disease itself. In addition, we need to study the the mechanisms that the specific group might be more receptive to in terms of the marketing of the research project (example-using social marketing).

When I have done recruitment in the past, for example, we learned that some Latino groups might respond best to ethnic radio or media, others to fotonovelas. There is so much to take into account that recruitment and retention should be prioritized at all stages of the research project, and most of all it should be initially conceptualized including all of the stakeholders involved (patients, caregivers, care providers, the community in which they reside, the researcher, and the funding agency).

Thank you.
Dr. Trinidad Argüelles

Thanks to everyone who commented on this blog post. There are so many good and interesting ideas! We'd really appreciate it if you would go to the IdeaScale site and share your ideas with the community. That way, others can see and comment on your idea. And, you can comment on ideas from others, as well. Thanks again!

Submitted by Jeff Borghoff on March 07, 2018

Recruit Existing Clinical Trial Participants to Campaign for more Participation
I am 53 and have younger onset Alzheimer's. I have been a participant in the Biogen Aducanumab clinical trial for 20 months. During that time I have had many conversations with my community of friends also living with younger onset Alzheimer's. There is tremendous value hearing a clinical trial story from people living with the disease and who are actively and joyfully participating in a clinical trial. I'm able to appeal to their sense greater good, to their sense of generations and legacy.
There is tremendous value hearing a clinical trial story from people living with the disease and who are actively participating in a clinical trial. I'm able to appeal to their sense greater good.
It will help solve the enrollment and participation problem by putting a human face to clinical trials and lifting the stigma, stereotypes and myths.

Submitted by Kumar Sambamurti on March 07, 2018

I used to be the co-director of the Carroll Campbell Jr neuropathology lab, which is now being run to the Pathology department chair, Dr. Steven Carroll at MUSC, and worked to recruit next of kin to donate the brain tissues of their dead relatives. One important observation from this experience is that most AD families are eager to provide the brain in exchange for a good quality neuropathology report to give them information on the cause of dementia and give them closure in the process. The major problem was obtaining unaffected controls, where the families had no compelling reason to participate.

While recruiting recruiting live patients for clinical work, there appears to be an issue of logistics, transport and awareness. I believe there is a major need of support for caregivers of handicapped elderly subjects, including those dementias and special needs. Developing small institutes that can provide affordable daytime space with community care and simultaneously providing an environment with behavioral research and physical therapy will be a valuable win-win for for recruitment and service and will also expand research infrastructure.

Submitted by Shirley Crow on March 07, 2018

This is a timely topic. I received your call for ideas through my work email at Johns Hopkins, but in fact I have an ex spouse who has young onset Alzheimer's and he used to be a Professor here at Hopkins as well. It is extremely difficult for us to find clinical trials that are within commuting distance and for which he is eligible. Many trials require participants to be over 65 years of age, which he is not. Still others have strict requirements regarding MME scores. Recently we tried to engage in a trial that required an MME of 15 -- he scored 14 so was ineligible. I realize that strict criteria are important for controls, but in a disease that is so badly in need of some research advancement, perhaps the participant requirements as far as mental ability is concerned could be more lax. If someone has been diagnosed with Alzheimer's type dementia through in-depth testing, surely they should be eligible for almost any studies that are not preventative? Provided of course that they do not have an interfering co-morbidities. More trials closer to home, reimbursement for subjects and caregivers, other incentives, loser criteria once disease has been diagnosed -- these are just a few suggestions. Interestingly, the Alzheimer's Association, of which we are members (we go to their early onset support group), complains about the shortage of reliable and current information about the availability of clinical trials because these trials seem to be somewhat "secret." The Alzheimer's Association's Trial Match tool can be inaccurate and inadequate.

Submitted by Jennifer Lloyd on March 07, 2018

I have a few ideas. Reaching out to Home Care Agencies, Assisted Livings, Adult Day Cares, along with Skilled and Long Term Care Facilities to coordinate a plan. This maybe easier than having random Seniors entered in a Case Study. Also, offering incentives, such as gift cards after completion of the Study.

Submitted by Linda McCone on March 07, 2018

So many of the studies I have inquired about require subjects who are very early stage. Most folks are not diagnosed at that stage. I think the focus for recruitment needs to start with the family physician and providing education on what to look for or ask about.

Submitted by Mary Postma on March 07, 2018

I have put my name in to several organizations blog sites looking for a research study. I have never received any answer to any of my inquiries. So the header used on this blog interested me.

Submitted by Terri Hastings on March 07, 2018

I am a local Parkwood volunteer clinical trials research participant.

I was motivated, as a healthy volunteer, to sign up for the Alzheimer's Registry. So far I have participated as a healthy volunteer in one Alzheimer's research program. This consisted of giving two samples and completing a short questionnaire.

Truly, my motivation for completing this registration and research was because I was the pedestrian in a severe, high velocity car/pedestrian collision on February 3, 2014, and had a severe traumatic brain injury with a subarachnoid hemorrhage and ventricular bleed. It makes sense that all aspects of a healthy brain are interesting.

My previous experience with brain research includes a might fine study "Effects of Translocator Protein on Areas of Inflammation in the Brain." For this clinical research trial I had several mini consents. Meeting separately with two of the Human Research Subject Protection people was calming to me. They were very focused and I liked that. I found it reassuring.

Then there is reliable transportation to Baltimore. It could be something approaching saleship.

My individual experience includes my personal brain research. I appreciate those people who do donate brains; however, I have misgivings about it. Every second of your life counts. This seems clear doesn't it.

Keep up the good work.

Terri Hastings

Submitted by Brian Chen on March 07, 2018

Make data gathering passive and automated, including tracking participant health records after they move. Team with other government agencies (e.g., SSA) to track individuals and their health records.

Submitted by Kathy on March 07, 2018

I have and am currently participating. It's nice to get financial reimbursement as I am working full time and need to take time off. While the funds are nice I honestly think getting more information about my health would probably encourage me to participate more. Not getting anything of value for my wellbeing is a bit tough to take. Money is not everything.

Submitted by Monica Lauren … on March 08, 2018

True committment to engaging, recruiting and retaining members of minority or underrepresented populations in Alzheimer's research, could be demonstrated by ensuring that clinical investigators,"steering committees"and research teams are consistently representative. Strategies that have proven successful, though perhaps more labor and cost intensive, should be promoted.
Building enduring relationships in minority communities requires time and consistent effort. Community relationship development should be an ongoing, functional activity and not created just for obtaining a letter of support for a project proposal. Diverse communities have their own formal and well established community service/health/ social networks with both local and national affiliations that we can work with. Initiatives at the MAYO Clinic led by Drs. Sharonne Hayes and Michele Halyard at Rochester and Arizona, do this successfully. Here in Atlanta, we are using these networks with much improved interest and participation.
Bottlenecks occur and participation lags when our research personnel are NOT responsive. All research coordinators and research center's are NOT comfortable with "diversity". Are we really interested in recruiting Latin Americans with limited English proficiency if there are no Spanish speaking coordinators or assistants available who can use the Spanish language documents? Discomfort with diversity manifests itself in different ways. Can we objectively address these aspects of recruitment and retention without getting defensive?

Monica W. Parker, MD

Thanks to everyone who commented on this blog post. There are so many good and interesting ideas! We'd really appreciate it if you would go to the IdeaScale site and share your ideas with the community. That way, others can see and comment on your idea. And, you can comment on ideas from others, as well. Thanks again!

Submitted by Martha Escandon on March 25, 2018

The registry that I signed up on asked me to take cognitive tests, which is fine; however, the tests had to be taken on a PC platform. Every computer I own is an Apple. At first I borrowed time on a friend’s PC to take the tests. Now that I have been asked to take part in a test, the repeated use of someone eles’s computer is a real inconvience. If they want more people to take part, they should at least offer an Apple platform to take the tests.

Submitted by Kathryn on March 25, 2018

I've signed up for several studies and have found it off-putting that each time, I'm asked to fill out the same ream of paperwork—probably five or more double-sided sheets. When I explain that they already have all this information on me, they just say, "Sorry, each study requires its own forms." I point out that they could keep a basic set on file and give a copy to each study, which could then ask for any extra particulars, but the receptionists don't care and only repeat their statement. The last time I was called about a study, I declined, as I'd just gone through the paperwork ordeal twice that week for a new dentist and a podiatrist and couldn't face another round.
A different stumbling block is that many studies require you to have someone who observes you daily come with you to every appointment to report on your status. If you don't have someone who can do this, you can't take part in the study. This could be one reason for the shortage of healthy volunteers who live independently.

Submitted by Allan Irvine on March 25, 2018

I filled out a request for a test. I sent the results back but I have never heard anything about the test. You asked for participation. I did now what?

Submitted by Shirley Jones on March 25, 2018

I submitted my saliva and do NOT like the idea that we do not get the results of your findings. Also, I started the series of tests that you can do on your computer. I found them way too long and NEVER finished all of them and I lost interest. My feelings are why am I taking the time for this when I will NOT receive any results....especially when I am worried of early onset Alzheimer's...since my Mom and both her parents had it. Change that and give us ALL results and make us WANT to be a part of helping the cause!

Submitted by Joanne Gibbs on March 26, 2018

I agree with some of the suggestions already made. The only way I "hear" of studies is if I go looking for them. There should be a way for you to inform medical offices of your studies so they can inform the kind of patient you are looking for. There are lots of internal medicine practitioners and those who specialize in geriatric patients where I live in York, PA where you could focus your attention. Place an announcement in AARP - a national organization that starts recruiting members at 50 yrs!
I'm 59 and my mother died 2 yrs ago of dementia - probably of the Alzheimer's type. I say "probably" because she never had a PET scan or other studies to prove that what she had was Alzheimer's and not one of the other dementias. She also had stage 4 breast cancer, but I'm sure it was the Alzheimer's that ended her life. She was just a "shell" of a woman when she died. I lost my husband, prematurely, 4 yrs ago, and now live alone. Like many others, I don't have family I can depend upon for help.
I do not want to get this disease as it would mean I could not live in my home and take care of myself. This disease would be a death sentence for me. I saw first hand how nursing homes take care of patients - those who have control of their cognitive abilities and those who don't, and even the best ones are not very good. I want no part of a (classic) nursing home where one is basically ignored except for mealtime, yet they get paid a good deal for that privilege! People need to be recruited into studies where they could find out whether or not there's a probability they could get Alzheimer's or one of the dementias before it gets beyond the point of no return. We need more researchers studying the process whereby the process of tau formation can, first, be detected via a blood or CSF sample and, if present, be aborted before significant damage is done. I would like to see this miracle performed during my lifetime.

Submitted by Bruce Bogart on March 26, 2018

I registered for all studies that match my qualifications. Those that replied said say they have all the volunteers they need.

Which studies are having trouble recruiting and retaining volunteers?

Thanks to everyone who commented on this blog post. There are so many good and interesting ideas! We'd really appreciate it if you would go to the IdeaScale site and share your ideas with the community. That way, others can see and comment on your idea. And, you can comment on ideas from others, as well. Thanks again!

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