OMB Control No: 0910-0847 Expiration Date: 02/28/2026
Paperwork Reduction Act Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-0847. The time required to complete this information collection is estimated to average 20 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.
Multimorbidity and Medications: The Unheard Perspective of Older Adults
Introduction
We want to learn how people decide about
joining research studies in which they take a medicine. This
study is being conducted on behalf of the U.S. Food and Drug
Administration (FDA). If
you take part in the study, you will receive a $25 gift card as a
token of appreciation after completion of the survey.
The survey will take about 15 minutes.
Your answers
will be kept secure to the extent permitted by law.
By
continuing, you agree to take part in this survey. Please scroll down
and click the arrow button below to see if you are
eligible!
Derjung
Mimi Tarn, MD, PhD
Department
of Family Medicine
University
of California, Los Angeles
Janice
B. Schwartz, MD
Department
of Medicine
University
of California, San Francisco
End of Block: Introduction
Start of Block: Screening Questions
Below are screening questions to see if
you are eligible for the survey.
What
is your age?
________________________________________________________________
A prescription
medicine is one that you
cannot buy on your own. A doctor needs to prescribe or give it to
you.
How many different prescription
medicines do you take regularly by mouth or as a shot or patch?
(Enter number)
________________________________________________________________
|
Indicate if you have ever been diagnosed with the conditions below. (Mark ALL that apply)
▢ High cholesterol
▢ High blood pressure
▢ Diabetes (not prediabetes)
▢ Arthritis (joint problems)
▢ Osteoporosis
▢ Heart attack, stents or bypass surgery
▢ Stomach ulcers, peptic ulcer disease or chronic heartburn
▢ Heart failure
▢ Atrial fibrillation
▢ Chronic kidney disease
▢ Stroke
▢ Depression
▢ Cancer (other than skin cancers)
▢ Asthma or chronic obstructive pulmonary disease (COPD)
▢ Thyroid problems
▢ Liver disease or cirrhosis
▢ ⊗None of the above
Display This Question:
If Indicate if you have ever been diagnosed with the conditions below. (Mark ALL that apply) = Cancer (other than skin cancers)
|
What type of cancer? (Mark ALL that apply)
▢ Breast
▢ Prostate
▢ Lung
▢ Colon or rectal
▢ Bladder
▢ Lymphoma, leukemia, or other blood cancers
▢ Kidney
▢ Cervical / uterine
▢ Other
▢ ⊗Unsure
Display This Question:
If If Below are screening questions to see if you are eligible for the survey. What is your age? Text Response Is Less Than 65
Or Or A prescription medicine is one that you cannot buy on your own. A doctor needs to prescribe or gi... Text Response Is Less Than 5
Or Indicate if you have ever been diagnosed with the conditions below. (Mark ALL that apply) = None of the above
|
Sorry, you are not eligible for this
survey. Thank you for your willingness to help!
Please
enter your preferred contact information below if you would like us
to contact you for future studies. (Write in ALL
that apply)
Email ________________________
Phone________________________
Mail _________________________
End of Block: Screening Questions
Start of Block: Survey questions
Congratulations! You are eligible for
the survey. Let's get started!
The
following questions are about you.
Which of the following best describes you? (Mark ALL that apply)
▢ American Indian or Alaskan Native
▢ Asian
▢ Black or African American
▢ Native Hawaiian or Other Pacific Islander
▢ White
▢ Please fill in ________________________________________________
▢ Prefer not to answer
Do you consider yourself Hispanic/Latino or not Hispanic/Latino?
Hispanic or Latino
Not Hispanic or Latino
|
What is your current gender?
☐ Female
☐ Male
☐ Prefer not to answer
|
What is the highest degree or level of school you have completed?
High school diploma or less
Some college or associate degree
Bachelor's degree
Master's degree or above
|
What is your zip code?
________________________________________________________________
Page Break |
|
|
Have you ever joined a research study or clinical trial in which you were asked to take a medicine?
No
Yes
Skip To: Q19 If Have you ever joined a research study or clinical trial in which you were asked to take a medicine? = No
Display This Question:
If Have you ever joined a research study or clinical trial in which you were asked to take a medicine? = Yes
|
Why did you join the research study or clinical trial? (Mark ALL that apply)
▢ My doctor recommended it
▢ A family member or friend recommended it
▢ To get a free medicine
▢ To help others
▢ To advance science and/or benefit society
▢ To get paid
▢ To try a different treatment
▢ Other (Write in) ________________________________________________
Display This Question:
If Have you ever joined a research study or clinical trial in which you were asked to take a medicine? = No
|
Have you ever been asked to join a research study in which you were asked to take a medicine?
No
Not sure
Yes
Display This Question:
If Have you ever been asked to join a research study in which you were asked to take a medicine?... = Yes
|
Of the studies you were asked to join, did you consider joining any of them?
No
Yes
Display This Question:
If Of the studies you were asked to join, did you consider joining any of them? = Yes
Did you qualify for any of the studies you considered?
No
Yes
I am not sure
Page Break |
|
The
following questions ask about your opinions.
How important or unimportant is it to test medicines in people
aged 65 and older before doctors prescribe them to patients?
Not important
Moderately important
Very important
|
How likely or unlikely would you be to consider joining a research study that involves taking a medicine if the study was recommended by: (Mark one for each item)
|
Unlikely |
Neither likely nor unlikely |
Likely |
Your doctor |
|
|
|
Your pharmacist |
|
|
|
A trusted friend or family member |
|
|
|
A person in the study (a participant) |
|
|
|
How likely or unlikely would you be to consider joining a research study that involves taking a medicine if you received an invitation from: (Mark one for each item)
|
Unlikely |
Neither likely nor unlikely |
Likely |
A university or healthcare system |
|
|
|
A pharmacy (for example, CVS or Walgreens) |
|
|
|
A drug company |
|
|
|
A lab (for example, Quest or LabCorp) |
|
|
|
A non-profit organization focused on a specific health condition |
|
|
|
I would consider joining a research study that involves taking a medicine for a health problem that: (Mark ALL that apply)
I currently have
I want to prevent (for example, a heart attack, stroke, or diabetes)
Runs in my family
Might help other people
Might advance science and/or benefit society
Other (write in): __________________________________________________
I would not consider joining a research study that involves taking a medicine
I am not sure whether or not I would join
I would consider joining a research study that involves taking a medicine to: (Mark ALL that apply)
Get a free medicine
Try a different treatment
Get paid
None of the above
Display This Question:
If I would consider joining a research study that involves taking a medicine for a health problem th... = I currently have
Would you consider joining a research study for a condition you have if you might be assigned to a group that does not get the medicine being tested?
No
Yes
Display This Question:
If I would consider joining a research study that involves taking a medicine for a health problem th... = I currently have
Would you consider joining a research study for a condition you have if you might be assigned to a group that will not get the medicine being tested right away, but will get it after a delay?
No
Yes
|
Which of the following might make
it hard for you to join a
research study that involves taking a medicine? (Mark ALL
that apply)
▢ Poor hearing
▢ Poor eyesight
▢ Needing to be near a bathroom
▢ Problems with walking or getting around
▢ Forgetting things or problems with memory
▢ Problems with transportation to go to in-person visits
▢ ⊗None of the above
Display This Question:
If Have you ever joined a research study or clinical trial in which you were asked to take a medicine? = No
Which of the items below might make it less likely that you would join a research study that involves taking a medicine? (Mark ALL that apply)
▢ My health conditions keep me from joining
▢ I am afraid of side effects
▢ I already take too many medicines
▢ I do not have time to join
▢ The study does not pay enough
▢ I do not want to be a guinea pig
▢ My friends and family would not want me to join
▢ I take care of somebody whom I cannot leave alone
▢ Other (Write in) ________________________________________________
▢ ⊗None of the above
Page Break |
|
Display This Question:
If Have you ever joined a research study or clinical trial in which you were asked to take a medicine? = Yes
|
Which of the items below would currently prevent you from joining a research study that involves taking a medicine ? (Mark ALL that apply)
▢ My health conditions keep me from joining
▢ I am afraid of side effects
▢ I already take too many medicines
▢ I do not have time to join
▢ The study does not pay enough
▢ I do not want to be a guinea pig
▢ My friends and family would not want me to join
▢ I take care of somebody whom I cannot leave alone
▢ Other (Write in) ________________________________________________
▢ ⊗None of the above
Page Break |
|
|
If you joined a clinical trial, how hard or easy would it be to have in-person visits: (Mark one for each item)
|
Very Hard |
Hard |
Neutral |
Easy |
Very Easy |
In your home |
|
|
|
|
|
At your doctor’s office |
|
|
|
|
|
At a nearby hospital or medical center (the study will pay for parking) |
|
|
|
|
|
At a local place such as a senior center or pharmacy |
|
|
|
|
|
That include an overnight stay at a hospital |
|
|
|
|
|
How hard or easy would it be for you to: (Mark one for each item)
|
Very hard |
Hard |
Neutral |
Easy |
Very Easy |
Travel over 1 hour each way to a research site |
|
|
|
|
|
Connect to a video visit |
|
|
|
|
|
Check your blood pressure at home |
|
|
|
|
|
Wear a device that monitors your physical activity, like a watch or ring |
|
|
|
|
|
Not eat for 8 hours before a morning blood test |
|
|
|
|
|
Have study supplies delivered to your home |
|
|
|
|
|
Page Break |
|
|
If you joined a research study lasting 1 year or more, how often would you be willing to do each of the following? (Mark one for each item)
|
Monthly |
Every 3-4 months |
Twice a year |
Once a year |
Not at all |
Have a physical exam |
|
|
|
|
|
Have blood tests |
|
|
|
|
|
Collect your urine |
|
|
|
|
|
Collect your stool |
|
|
|
|
|
Have x-rays |
|
|
|
|
|
Travel less than 30 minutes one-way for in-person visits |
|
|
|
|
|
Travel 1 hour or more one-way for in-person visits |
|
|
|
|
|
Page Break |
|
If you joined a research study that involves taking a medicine, do you prefer having visits that are: (Mark one)
In-person only
By video only (for example, by telehealth or Zoom)
By telephone only
Both in-person and by video
Both in-person and by telephone
Would you join a research study that involves taking a medicine if visits for the study are held: (Mark one for each item)
|
Yes |
No |
Maybe |
In-person only |
|
|
|
By video only (for example, by telehealth or Zoom) |
|
|
|
By telephone only |
|
|
|
Both in-person and by video |
|
|
|
Both in-person and by telephone |
|
|
|
If you take part in a research study that involves taking a medicine, and a visit will take a half day including travel, should you get paid (parking is free)?
Yes
No
Unsure
|
A few last questions about yourself!
Do
you currently have access to the
internet in your home?
Yes
No
Unsure
|
How confident are you filling out medical forms by yourself?
Extremely
Quite a bit
Somewhat
A little bit
Not at all
|
In general, would you say your health is:
Excellent
Very good
Good
Fair
Poor
|
Did somebody help you fill out this survey?
Yes
No
End of Block: Survey questions
Start of Block: Block 7 - End of Survey
|
Thank you for your participation!
Please choose from the options below.
$25 gift card
I do not wish to receive a gift card.
Display This Question:
If Thank you for your participation! Please choose from the options below = $25 gift card
Please enter your email address to receive your gift card. Gift cards may take 6-8 weeks for delivery.
________________________________________________________________
|
Would you like to be contacted for future studies?
Yes
No
Page Break |
|
End of Block: Block 7 - End of Survey
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | Schwartz, Janice |
File Modified | 0000-00-00 |
File Created | 2023-11-05 |