Improving Care Through Improv: Promoting Mastery in the Moment
Phase: NA
Conditions: Caregiver Burden
Sponsor: Georgia State University

 
 
 
 
PROTOCOL 
 
 
 
Improving Care through Improv:  
Promoting Mastery in the Moment 
 
 
NCT Number: 05996718 
 
 
Protocol Date: 02-27-2024 
 
 

Kemp, Candace, L.  Improving Care through Improv                                                                                2 
 
Improving Care through Improv:  
Promoting Mastery in the Moment 
 
PRINCIPAL INVESTIGATOR: 
Candace L. Kemp, PhD. 
Gerontology Institute, Georgia State University, Atlanta, Georgia 
Telephone: 404-413-5216 
Email: ckemp@gsu.edu 
 
Funding Source:   
This work was supported by a developmental grant to CLK from  
the Roybal Center for Dementia Caregiving Mastery at Emory University  
(P30AG064200 – Co-Directors, Hepburn and Perkins) funded by the  
National Institute on Aging at the National Institutes of Health. 
 
 
 

Kemp, Candace, L.  Improving Care through Improv                                                                                3 
 
Background and Rationale 
Nationwide, over 11 million Americans, mostly family members and friends, provide informal 
unpaid care to millions of persons living with dementia.[1] As the population ages, these numbers 
are expected to rise exponentially alongside dementia’s deleterious impact on public health and 
accompanying social and financial costs.[2, 3] Informal care partners play a critical role in the 
quality of life and care of persons living with dementia[1] and influence their ability to age in place 
at home[4] rather than relocating to costlier and less preferred formal long-term care settings 
(e.g., assisted living, nursing homes). Yet, caregiving in the context of dementia frequently 
involves burden, stress, and emotional strain, all of which negatively influence caregivers’ 
overall health, well-being, self-care abilities, and mortality.[1, 5-8] Such outcomes compromise 
caregiving and ultimately negatively affect care recipients, including their ability to remain at 
home.[4] Needed are interventions that bolster informal care partners’ ability to succeed in their 
care roles and minimize negative outcomes. 
 
List of Specific Aims  
 
1. To refine the program, “Improving Care through Improv” for informal dementia 
care partners. 
 
2. To assess the feasibility, acceptability, and preliminary efficacy of “Improving 
Care through Improv” through pilot testing 
 
Brief Description of Project Design 
• Phase 1 involves refining the training program, “Improving Care through Improv” 
(Aim 1).  
 
• Phase 2 involves piloting the training program with 40 adult informal care 
partners of person with moderate dementia to test its effect on self-perceived 
caregiving mastery through a no-control, pre-post design single-group trial with 
three time points: baseline; immediately upon completion, and 3-months post 
baseline (Aim2). The intervention will be delivered to up to 5 groups of 8 to12 
participants each. All groups will be exposed to the same in-person training 
during weekly 2-hour sessions held over a 4-week period. At 3-months post 
baseline, there will be a 90-minute in-person session to allow for completion of 
the assessment and to obtain participant feedback.  
 
Procedures/Human Subjects Involvement 
 
Study participants will be exposed to the same in-person group training delivered by 
study personnel during weekly 2-hour sessions held over a 4-week period. In addition to 
the four in-person training sessions, participants will be invited to attend a final one-and-
a-half hour in-person group meeting, which will involve completion of the 3-month post 
baseline assessment and invite feedback on the overall intervention experience through 

Kemp, Candace, L.  Improving Care through Improv                                                                                4 
 
open-ended questions. Participants will complete a self-administered pen and paper 
survey at all three study time points: baseline; upon training completion; and 3-months 
post baseline. At baseline, we will collect care partners’ demographic details (e.g., age, 
gender, race, ethnicity, employment status, education, urban/suburban/rural status, 
relationship to care recipient), and key information pertaining to their caregiving history, 
experiences, and care recipient. 
 
At all three time points, participants will be asked to complete measures to assess: 
caregiver mastery, self-perceived stress, anxiety, caregiver burden, and perceived 
changes in care recipients’ behavioral expressions and with associated care partner 
distress. We also will ask participants to assess their care recipients’ quality of life. 
Participants will complete these self-administered surveys in person with researchers 
present to answer any questions. The surveys collected at baseline and upon training 
completion will be distributed and completed at the first and fourth training sessions, 
respectively. 
 
Three months post baseline, we will reconvene the group and distribute the final survey 
and invite feedback on the feasibility and accessibility of the intervention. This session 
will be 90 minutes long. Researchers will take detailed fieldnotes to capture the content 
of the group discussion, especially their feedback on their intervention experiences. 
Participants will take part in the training program, “Improving Care through Improv.” The 
training builds care partner skills cumulatively over a series of four classes, each with a 
separate focus: (1) Yes, and…: Actively listening and observing and offering and 
accepting interactions; (2) Being in the moment: Meeting people where they are and 
committing to what is happening; (3) How to collaborate: Give, take, and making your 
partner look good; (4) Giving up control: Accepting failure, pivoting, being flexible, 
leaning into uncertainty, and expecting the unexpected. All classes are highly interactive 
and invite informal caregiver to engage with the instructors and one another. The first 
class (Yes, and…), will begin with introductions, which will allow instructors and 
participants to gain familiarity and comfort with one another and share their care 
situations and experiences. The subsequent three classes (Being in the moment; How 
to collaborate; and Giving up control), will begin by inviting participants to reflect on the 
previous week, including care experiences and any attempts to use improv with their 
care recipients. Each week, an icebreaker exercise will follow opening discussions. 
Next, the instructors will provide an overview of the weekly topic and illustrate relevant 
skills through demonstration. Then, they will introduce and teach relevant improv 
exercises, which will allow participants to model and apply skills, first with the trainers 
and then amongst other caregivers. Feedback and coaching will follow each exercise. 
The final 20 minutes of each 2-hour class will be devoted to review, reflection, and 
group discussion, including how improv skills could be applied to their caregiving 

Kemp, Candace, L.  Improving Care through Improv                                                                                5 
 
situations. The first and fourth training sessions will involve an additional 30 minutes on 
top of the 2-hour training to complete paperwork/surveys. During all training sessions as 
well as the 90-minute three-months post baseline sessions, researchers will 
engage in participant observation. A detailed observation guide will facilitate observation 
during all group sessions. Researchers will observe and document in fieldnotes, what 
transpires, who is involved, what participants do, say, and how they respond to the 
instructors and one another, as well as their reactions to the materials and exercises. 
Researchers also will audio record each group session. These recordings will not be 
transcribed but be available for researcher reference. 
 
Vulnerable Populations 
 
N/A 
 
Number of Participants  
 
Up to 50 participants will be recruited for the pilot test.  
 
Study Timeline 
The overall project has a 12-month timeline.  
 
Participants and Recruitment 
 
This project, located at Georgia State University (GSU), will draw on multiple sources to 
recruit the targeted informal care partners of persons living with moderate dementia into 
the study. We will recruit a sample of informal care partners of community-dwelling 
persons living with moderate dementia (4 or 5 on a 7-point dementia-staging scale) from 
Emory’s Integrative Memory Care Clinic (IMCC). Located in Atlanta, GA, the IMCC 
provides primary care and is a one-stop health-care site for over 600 persons living with 
dementia. A support letter from Dr. Clevenger, the clinic’s Clinical Director, 
accompanies this application and outlines her commitment to assisting with the study, 
including designating an IMCC staff member as a study point person to help promote 
the study. This point person will promote the study to patients’ informal care partners 
and share study information with potential participants. We will advertise the study and 
solicit volunteers through flyers posted and distributed in the clinic, shared in their 
newsletter, and sent via email to patients and their care partners. Informal care partners 
who are interested in potentially participating will be invited to contact GSU 
researchers by phone or email to obtain further details. The flyer contains contact 
information and a QR code. Those who reach out to the study team and remain 
interested after learning about the study will be screened over the phone to ensure they 
meet study criteria. Individuals who meet the criteria and who wish to volunteer will be 

Kemp, Candace, L.  Improving Care through Improv                                                                                6 
 
enrolled on an ongoing basis. Pilot testing will begin with the first group once we have 
recruited at least 8 participants. Research staff will clearly explain the requirements of 
the study prior to enrollment, obtain several contact avenues (phone numbers, email), 
and will work with participants as we schedule training sessions to identify days of the 
week/times of day that might be most convenient. If necessary, we are unable to recruit 
a sample of 40 participants through the IMCC, we will submit an IRB protocol 
amendment to expand our recruitment plan through other organizations and sites. 
At the recommendation of the advisory team (Aim 1) and ongoing recruitment feedback, 
we will expand recruitment to allow the flyers and newsletter information to be shared 
through by advisory team members, researchers, and participants, including snowball 
sampling. In the process of recruiting potential participants are asking if they may share 
the information with their peers. We also realize that flyers are posted and electronic 
communications are sent, they can be shared with others. We wish to include persons 
not directly recruited through the Emory's memory care clinic but who fit study criteria. In 
order to further expand recruitment, we wish to advertise on social media through the 
Gerontology Institute social media accounts with links to a webpage about the project 
hosted on the Gerontology Institute website. The website will include information from 
the recruitment flyer. 
 
Inclusion Criteria  
Eligible participants will be: 1) 18-years or older; 2) actively engaged in the care of 
community-dwelling persons living with moderate dementia (4 or 5 on a 7-point 
dementia-staging scale) who is not likely to be institutionalized within the next 6 months; 
3) able to attend at least 3 of the 4 in-person sessions. Participants also will need to be 
able to read, write, and communicate in English. Screening will take place over the 
phone when potential participants reach out to the study team and express interest in 
the study.  
 
Participant Compensation 
Each participant will be given $75.00 per in-person session to offset any care or travel 
costs and a total of $375.00 per person for those who attend all five in-person sessions. 
 
Benefits & Risks 
Study participants may benefit by having opportunities throughout the training to share 
their experiences and perspectives with others. In past, we have found that research 
participants enjoy the opportunity to talk about their experiences. The group-based 
interactions also will provide a social outlet, which they may find enjoyable. We 
anticipate that the training they receive will give them new skills and techniques to use 
as they perform their care roles. Ideally, these skills, including an ability to “be in the 
moment,” may enhance their self-perceived caregiver mastery and possibly their self-

Kemp, Candace, L.  Improving Care through Improv                                                                                7 
 
reported burden, anxiety, depression, perceptions of care recipients’ behavioral 
expressions and associated care-partner distress and quality of life. We will not state to 
participants that taking part in the training program will be beneficial to them, although 
we believe and are hopeful that it will. We also will acknowledge that study participation 
may eventually contribute to the well-being of other informal care partners. If this 
intervention shows signs of efficacy, we will pursue additional funding to conduct further 
tests and ideally scale up the intervention in size and scope, including for instance, 
training for formal care partners and others. Improv training has the potential to improve 
dementia care experiences for all types of care partners, health care workers, and 
others who engage with persons living with dementia in all types of settings. 
Participating in this study will involve taking part in an in-person group training program 
for informal care partners of persons living with moderate dementia. There is a potential 
risk for discomfort and emotional distress when study participants discuss their 
caregiving experiences. Taking part in the research surveys also may prove 
uncomfortable when reflecting on their experiences and on their own and their care 
recipient’s well-being. Another potential for minimal discomfort and emotional distress 
could arise when participants attempt their homework assignments, which involve apply 
communication strategies from training sessions in the context of caring for their loved 
one with dementia. There also is minimal risk associated with potential breach of privacy 
and confidentiality. Breach of privacy could occur given the group nature of the 
intervention and our inability to control what participants will share outside of the group. 
Meanwhile, although there is virtually no risk to the confidentiality of the research data, it 
is among the potential risks. 
Participant Data 
Upon enrollment, each participant will be assigned a unique numeric participant code, 
which will appear on the self-administered questionnaires. Members of the research 
team will distribute questionnaires to participants during in-person sessions at baseline, 
upon program completion, and 3-months post baseline. These pen & paper self-
administered questionnaires will be filled out by participants in a dedicated meeting 
space within Emory’s Integrated Memory Care clinic (see 8.0). Completed surveys will 
be transported to Georgia State University by a designated member of the research 
team. All hard copies of participant surveys and signed consent forms, as well as any 
other relevant project data and documents, will be kept in a locked cabinet in PI Kemp’s 
locked office, which is located within a locked research suite. All quantitative survey 
data will be entered into GSU’s REDCap data management system. 
Researcher-generated fieldnotes and memos based on their observations of the in-
person sessions will be created in Word files in the project’s secure storage folder and 
stored electronically as described below. 

Kemp, Candace, L.  Improving Care through Improv                                                                                8 
 
These notes will capture what is happening in the training sessions, including what is 
being said and done and by whom. We will use participants’ initials, rather than their 
name, in these notes. Only the PI and designated project staff will have access to 
individually identifiable private information. Participant tracking information will be kept 
on files that do not identify the project or the respondent and these too will be handled 
with the utmost confidentiality. The file linking the ID numbers to subjects’ identities will 
be kept in Dr. Kemp’s password-protected Georgia State University’s Dropbox for 
Business a secure cloud-based server. All electronic study records, including our 
quantitative and qualitative databases, and all digital audio recordings, will be stored on 
a secure, remote, password-protected cloud server, Dropbox for Business. The project 
will be assigned its own folder accessible only to active research team members with 
IRB approval. The folder is maintained and monitored by Georgia State University’s 
Technology Services. This storage solution meets NIH’s requirements for secure 
storage. To protect participant privacy, the document linking participant names and 
study numbers will be destroyed one year after the study ends. We will remove any 
identifying features and use pseudonyms to protect the anonymity if our qualitative data 
are shared outside of the research team or used for dissemination purposes. When we 
present or publish the results of this study, we will not use information that may identify 
participants. If researchers inadvertently collect identifiable data that are not specified in 
our protocol, researchers will de-identify the relevant data immediately upon discovery. 
Data Analysis Plan 
Descriptive statistics will be calculated for all demographics and instrument scores at 
baseline, completion, and three months after baseline. Internal reliability will be 
assessed using Cronbach’s alpha at baseline. Missingness will be assessed and 
corrective measures used as appropriate (multiple imputation). Repeated measures 
analysis of variance will be used with dependent variables across the three time points. 
Error rate adjustments (Bonferroni or Dunn-Sidak tests) will be made due to the 
implementation of multiple comparisons across dependent variables. Effect sizes will 
also be computed and assessed for clinical significance. The percentages of caregivers 
whose scores improve or decline from baseline to completion and post-completion 
assessments will be calculated. IBM SPSS for Windows, version 24.0 will be used to 
perform computations.  
 
 
 
 
Informed Consent 
See Appendix A 
 
 
 

Kemp, Candace, L.  Improving Care through Improv                                                                                9 
 
REFERENCES 
1. 
Association, A.s., 2022 Alzheimer's Disease Facts and Figures. 2022, 
Alzheimer's Association  
2. 
Gaugler, J.E., Unpaid Dementia Caregiving: A Policy and Public Health 
Imperative. Public Policy & Aging Report, 2022. 32(2): p. 51-57. 
3. 
Reinhard, S.C., et al., Valuing the Invaluable: 2019 Update Charting a Path 
Forward. 2019. 
4. 
Villars, H., et al., Predictors of nursing home placement at 2 years in Alzheimer's 
disease: A follow-up survey from the THERAD study. International Journal of 
Geriatric Psychiatry, 2022. 37(6). 
5. 
Trivedi, R., et al., Characteristics and well-being of informal caregivers: Results 
from a nationally-representative US survey. Chronic Illness, 2014. 10(3): p. 167-
179. 
6. 
Lethin, C., et al., Psychological well-being over time among informal caregivers 
caring for persons with dementia living at home. Aging & Mental Health, 2017. 
21(11): p. 1138-1146. 
7. 
Bom, J., et al., The Impact of Informal Caregiving for Older Adults on the Health 
of Various Types of Caregivers: A Systematic Review. The Gerontologist, 2018. 
59(5): p. e629-e642. 
8. 
Bauer, J.M. and A. Sousa-Poza, Impacts of Informal Caregiving on Caregiver 
Employment, Health, and Family. Journal of Population Ageing, 2015. 8(3): p. 
113-145. 
 
 
 

Kemp, Candace, L.  Improving Care through Improv                                                                                10 
 
APPENDIX A 
 
INFORMED CONSENT 

1
Version Date: 11/29/2023
Georgia State University
Gerontology Institute
Informed Consent 
Title: Improving Care through Improv: Promoting Mastery in the Moment
Principal Investigator: Candace L. Kemp, Ph.D.
Co-Investigator: Jennifer Craft Morgan, Ph.D. 
Sponsor: Emory Roybal Center for Caregiving Mastery and the National 
Institute of Aging at the National Institutes of Health. 
Introduction and Key Information
We invite you to take part in a research study. You will decide if you would 
like to take part. The purpose of this study is to develop and test a new 
training program, “Improving Care through Improv.” The program involves 
learning about and using skills from improvisational (improv) theater. The 
program is designed to teach caregivers of people with dementia ways to 
manage unexpected care situations. Your role in the study will last 10.5 
hours over three months. We will ask you to: complete questionnaires, 
participate in four two-hour weekly in-person group training sessions. The 
first and last of these sessions will include 30 minutes to complete surveys. 
You also will be asked to attend a 90-minute in-person focus group session 
to get your feedback on the program. 
If you are part of this study, although unlikely, there is a possibility of 
emotional upset. You may personally benefit from being in the study. The 
training you receive may better equip you to manage challenging care 
situations. Your involvement will help us improve this program and inform 
other caregiver training. If you do not want to take part in this study, you do 
not have to participate.
A description of this clinical trial will be available on 
http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not 
IRB NUMBER: H23627
IRB APPROVAL DATE: 02/27/2024

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include information that can identify you. At most, the website will include a 
summary of the results. You can search this Web site at any time.
Purpose
The purpose of the study is to test training for caregivers of persons living 
with dementia. We are inviting you to take part in this study because you 
are a caregiver of someone who has moderate dementia. Up to 50 people 
such as yourself will be in this pilot study. We expect the study to last 12 
months. 
Procedures 
If you decide to be in this study, you will be put in a group of up to 20 
caregivers. You will be asked to attend five in-person group sessions over 
a three-month period. These sessions will be audio recorded for research 
purposes. Recordings will not be transcribed. You will be asked to fill out 
questionnaires. 
The first month of the study involves two 30-minute registration/survey 
completion period, and four weekly 2-hour sessions. 
Week 1 (150 minutes)

Fill out a questionnaire about yourself, the person you are caring for, 
and your care experiences (30 minutes).

Participate in an in-person group discussion and interactive training 
session. The session will be led by a member of GSU’s research 
team and an improv educator. You will be asked to introduce yourself 
and talk about your caregiving situation (120 minutes). 
Week 2 (120 minutes) and Week 3 (120 minutes)

Participate in an in-person group discussion and interactive training 
session. These sessions will be led by a member of GSU’s research 
team and an improv educator. You will be asked to provide updates 
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on your care experiences and your use of improv skills at home (90 
minutes).
Week 4 (150 minutes)

Participate in an in-person group discussion and interactive training 
session. The session will be led by a member of GSU’s research 
team and an improv educator. You may be asked to provide updates 
on your care experiences and your use of improv skills at home (120 
minutes). 

Fill out a questionnaire about your care experiences (30 minutes).
Three months (plus or minus 7 days) following the Week 1 session, you will 
be asked to attend a 90-minute in-person session. During this session you 
will:  

Fill out a questionnaire about your care experiences and being in the 
study (30 minutes).

Participate in a researcher-led focus-group discussion with your 
group. You will be asked what you think about the training (60 
minutes). 
Sessions will be held at Emory’s Integrative Memory Care Clinic or Dad’s 
Garage Theatre. The clinic address is: 12 Executive Park Dr NE, Atlanta, 
GA 30329. Dad’s Garage is located at 569 Ezzard St SE, Atlanta, GA 
30312. GSU researchers will give you the questionnaires. They will assist, 
observe, and take notes during all group sessions. 
Future Research
We may use your information for future research. We will remove 
information that may identify you. We will not ask for consent from you if we 
do this.
Risks
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You may experience emotional upset from being in this study. If you 
become uncomfortable, you may step away temporarily or stop 
participating at any time. If you experience emotional distress, the 
researcher can refer you to a qualified mental health provider. Georgia 
State University and the research team, however, have not set aside funds 
to pay for this care.
Benefits 
You may benefit from the study by becoming better able to perform your 
caregiving role. The training will teach caregivers of persons with dementia 
ways to manage unexpected and challenging situations. You may have 
more confidence and less distress as a caregiver during and/or after 
participating in the study. You also might enjoy having an opportunity to 
meet and interact with other caregivers. Even if you do not benefit 
personally, the information gained may help others in the future. Your 
participation will help us improve this program and inform future caregiver 
training. 
Alternatives
The alternative to taking part in this study is to not take part in the study.
Compensation
You will receive $75.00 for each of the five sessions you attend. This 
money is meant to offset care and travel costs associated with your 
participation. A researcher will give you this money after each session.
Voluntary Participation and Withdrawal
You do not have to be in this study. If you decide to be in the study and 
change your mind, you can drop out at any time. During group sessions, 
you can choose to step away or leave the room at any point. 
If you do not take part or leave the study early, you will not lose any 
benefits that you are otherwise entitled to. The study will not affect your 
medical care or your family member’s medical care in any way. 
Confidentiality
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We will keep your records private to the extent required by law. The 
following people and groups will have access to the information you 
provide: 

The Principal Investigator and research staff.

GSU Institutional Review Board.

Office for Human Research Protection (OHRP). 

The National Institutes of Health, who funds this research, and people 
or companies they use to carry out the study.
We will use a study number and initials rather than your name on study 
records. We will store hard copies of the information you provide in a 
locked cabinet in Dr. Kemp’s locked office. We will store electronic 
information, including recordings, on a secure password-protected site. 
These data will be accessible only to research staff through encrypted and 
password-protected computers. To protect your privacy, the document 
linking your name and study number will be password protected and stored 
separately from the information you provide. We will destroy this document 
and any audio recordings one year after the study ends. When we present 
or publish the results of this study, we will not use information that may 
identify you. 
We will ask you and your group members to respect others’ confidentiality 
by not sharing identifying details. We ask that you not discuss personal 
details shared by others in the group sessions. However, we cannot stop 
others from talking about the group sessions.
Contact Information 
You can contact Candace L. Kemp at 404-413-5216 and ckemp@gsu.edu

If you have questions about the study or your part in it

If you have questions, concerns, or complaints about the study

If you experience emotional distress and require referral to resources
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The IRB at Georgia State University reviews all research that involves 
human participants. You can contact the IRB if you would like to speak to 
someone who is not involved directly with the study. You can contact the 
IRB for questions, concerns, problems, information, input, or questions 
about your rights as a research participant. Contact the IRB at 404-413-
3500 or irb@gsu.edu.  
A description of this clinical trial will be available on 
http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not 
include information that can identify you. At most, the website will include a 
summary of the results. You can search this Web site at any time.
Consent
We will give you a copy of this Informed Consent Form to keep.
If you are willing to be in this research study, please sign below. 
____________________________________________________________
Printed Participant Name          Signature of Participant
Date
____________________________________________________________
Printed Researcher Name        Researcher Signature
Date
IRB NUMBER: H23627
IRB APPROVAL DATE: 02/27/2024