Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke
Phase: NA
Conditions: Stroke
Sponsor: Emory University

Version 8.23.20 
CARE-CITE R21 
PI:  Sarah Blanton, PT, DPT 
 
 
 
 
 
 
 
 
Caregiver Collaborative Integrated Therapy in Sub-Acute Stroke 
Protocol-Remote 
 
Protocol date: August 23, 2020 
 
NCT Number: NCT04040751 
 
 

Version 8.23.20 
CARE-CITE R21 
PI:  Sarah Blanton, PT, DPT 
 
 
Caregiver Collaborative Integrated Therapy in Sub-Acute Stroke 
Protocol-Remote 
 
 
Research Design and Methods 
A leading cause of serious, long-term disability in the United States,1 stroke has a particularly pernicious 
impact on individuals and families.  Approximately 4.8 million stroke survivors (SS) require assistance from 
family members who are often untrained and ill prepared for the burdens associated with stroke 
rehabilitation.2, 3 Family care partners (CP) are key contributors to stroke recovery, but their efforts can lead to 
a high level of CP burden and depressive symptoms, reduced quality of life (QOL) and increased stress in the 
context of high levels of family conflict surrounding the recovery process.4, 5 Rehabilitation therapy 
interventions have primarily targeted SS outcomes without specifically addressing the well-being of the CP.6 
Our group has pioneered creative approaches for engaging CPs in rehabilitation activities within the family 
which have great potential to improve physical and psychosocial health for both the CP and SS.  
We have developed a theory-based, family-centered intervention, Carepartner and Collaborative 
Integrated Therapy (CARE-CITE),7 designed to engage CPs during SS upper extremity (UE) functional task 
practice in the home. Residual UE impairments occur in up to 80% of SSs 8 and are a primary factor in loss of 
functional independence.   CARE-CITE guides the CP in collaborative goal setting and providing autonomy 
support (characterized by empathy, choice and reducing use of controlling language) for the SS to promote 
motivation and creative problem solving in UE self-management.  
The goal of this study is to implement CARE-CITE paired with usual and customary UE care sooner 
after stroke when SSs are in outpatient rehabilitation and in the sub-acute stroke (1-3 month) recovery period.  
We will examine CARE-CITE during this early stroke recovery phase and gather evidence to ascertain the 
theorized mechanisms of effect. This new information will inform future intervention development, testing, 
and translation to improve stroke outcomes sooner during the rehabilitation process.  
The scientific premise underpinning this research is that a theory-based, family-centered intervention 
focused on skill building, improved family context, and problem-solving will improve SS physical function and 
quality of life while reducing CP negative outcomes during outpatient rehabilitation. The research design is a 
mixed methods, two-group (2:1) exploratory pilot study comparing intervention (CARE-CITE with usual 
customary care (n=24 dyads) to an attention control with usual customary care (n=12 dyads). 
Aim 1:  To evaluate effects of web-based CARE-CITE at home during subacute stroke 
recovery on both CP and SS health outcomes and QOL.   Hypotheses: 1.1. CPs receiving CARE-CITE 
will have reduced depressive symptoms and improved QOL at 2-month post intervention compared to the 
control group.  1.2. SSs receiving CARE-CITE will have improved upper extremity function and QOL at 2-
month post intervention compared to the control group. 
Aim 2: To examine the effect of web-based CARE-CITE on the family context and 
processes related to stroke rehabilitation.  Hypotheses:   2.1. CPs receiving CARE-CITE will have less 
family conflict and provide greater autonomy support at 2-month post intervention compared to the control 
group.  2.2. SSs receiving CARE-CITE will have improved perceived autonomy support and UE self-efficacy 
at 2-month post intervention compared to control group. 
Exploratory Aim.  Use qualitative methods to complement the interpretation of effects on 
processes and outcomes from Aims 1 and 2.  At 3 months post intervention, we will evaluate CPs’ 
perceptions of the benefits, challenges and experiences with the intervention and explore changes in their 
perceived QOL, family conflict, and autonomy support. 
 
• 
General Overview of Proposed Methods: We propose a mixed methods, convergent design9 with 
a two-group experimental approach with separate quantitative and qualitative analyses followed by 
integration of the findings. We will block randomize (2:1) 36 dyads to treatment or control. All SS will 
be 1-3 months post stroke and living at home to capture family dyads who are still in sub-acute post 
stroke outpatient rehabilitation therapy.  The intervention will last 4 weeks.  Baseline and 3-month 
post-intervention assessments will include questionnaires, measures of recovery, and semi-structured 
interviews (Table 2).  Methodological Modification:  All study interactions with participants 
(including screening, evaluations and interventions) will occur remotely via phone call or HIPPA 
compliant Zoom platform currently being used by Emory Healthcare for telehealth clinic visits.   
Study Participants: All Emory Hospital stroke admissions will be screened based upon study 

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inclusion/exclusion criteria and contacted by the research coordinator, if eligible.  Participant eligibility will be 
confirmed via telephone and virtual screen, and initial virtual evaluation will follow. All self-report written CP 
and SS questionnaires will be delivered to participants’ homes for completion.  Completed questionnaires will 
be returned via self-addressed stamped envelope or study staff will arrange for pick-up from the participant’s 
home.  The evaluator will review questionnaires for completeness and conduct a virtual evaluation to complete 
SS upper extremity assessments and address any missing CP data. All potential dyads will read/sign Emory 
IRB approved consent/HIPAA forms. Evaluations and training sessions will be video-recorded for 
standardization procedures to ensure study rigor and reliability. Video or audio recording is optional and not 
required for participants to participate in the study. Participants will have the option to consent to these 
recordings. A medical screen from participant’s physician will be obtained prior to enrollment.  Patients will 
agree to allow researchers to review their medical records for data collection.  
Inclusion/exclusion criteria:  All SSs will be 1-3 months post ischemic or hemorrhagic event10, discharged 
from inpatient neurologic rehabilitation to their home, have minimal to moderate UE deficits (actively initiate 
20 degrees of wrist and 10 degrees of finger extension), no severe cognitive deficits (Mini-mental test11 >24), no 
physician determined major medical problems that would limit participation in outpatient therapy, and a CP 
living in the home.10, 12  CPs must >21 years old, able to read and write English and have no significant cognitive 
deficits (Mini-mental test >24).  CPs will be defined as those individuals who are a spouse/partner or family 
member dwelling in the same household, the family member most involved in stroke recovery, and self-identify 
as the primary caregiver of the SS.4, 13 CPs must be familiar with using a computer and accessing websites, or be 
familiar with using a tablet (available for loan if no computer available). 
We plan to recruit 12 dyads into the usual care attention control group and 24 dyads into the CARE-CITE 
group. The larger intervention group will contribute precision to the pilot-based estimates of mean changes 
and variability for key outcomes, while also improving the lessons to be learned about feasibility to inform 
future implementation for a larger-scale trial. Given the PI’s extensive and successful recruitment experience 
for other prior stroke studies, a recruitment rate of 2-3 dyads per month is a realistic estimate for the proposed 
time period. An attrition rate of ~8% is projected based on the literature;14-16 thus, we will enroll 40 dyads to 
achieve a complete sample of 36.  
Intervention group: CARE-CITE: While the SS is receiving usual and customary outpatient UE 
rehabilitation, the CARE-CITE intervention will occur over 4 weeks. The primary CARE-CITE components will 
be education via web platform. The research interventionist will conduct a virtual in-home visit via Emory 
Zoom platform at orientation and during week 4, and telephone follow ups. The research interventionist will 
work in tandem with the outpatient rehabilitation treatment team to coordinate care plans and patient goals. 
1) Visit 1:  Virtual Orientation (3 hours).  The research interventionist will meet virtually with CP and SS to 
review collaborative goals setting, evaluate UE movement limitations, and identify functional activity 
preferences. Together, they will begin development of a progressive therapeutic exercise plan for home-based 
functional task practice, determine activities for each goal and measurable milestones to accomplish during the 
treatment period, creating a framework to improve joint responsibilities for self-management skills.    
2) CP completes 6 online CARE-CITE modules (15-30-minute sessions each). During the week following Visit 1, 
the CP will access the website to complete 6 online modules. Modules include demonstration videos and 
instructive content covering following areas:  principles of functional task practice (i.e., activities of daily living 
such as eating, grooming, or leisure/vocational activities), adaptation of tasks, and importance of progression 
of challenging tasks to drive neuroplasticity (i.e., increasing numbers of practice repetitions or weight of objects 
lifted). Examples are provided to address potential SS frustration and improve adherence.  Underpinning the 
content is the concept of autonomy support, with examples of fostering empathy (e.g., the CP using non-
dominant hand during activities), problem solving (guidance for adaptation of functional activities at home to 
increase success or challenge), instruction in the use of non-controlling language with role playing situations 
and the importance of creating choice in activities. For example, in one vignette to demonstrate problem 
solving, a CP interacts with the SS during a meal using non-controlling language to offer choice for task 
modifications for manipulating food with the weaker hand.  The SS becomes frustrated with the challenging 
task, and the CP demonstrates options for dialogue that foster collaborative problem solving.  
3) Weekly teleconference/Zoom check-in.  Each week during the 4-week intervention, the research 
interventionist will complete a structured 10-minute phone call with CP to answer questions and assist with 
problem solving. 
4) Visit 2:  Virtual Home visit (3 hours). At the end of week 4, the same research interventionist will conduct a 
virtual home visit to review progress with milestones and advancement of activity goals. 

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5) “CARE-CITE Booster” session – 4 weeks after the intervention period, the research interventionist will make 
a brief 10-minute telephone booster call to reinforce CARE-CITE content, ask the CPs to identify two 
challenging areas during SS practice activities, and CP opportunities to use principles of autonomy support.  
Attention Control group:  SS and CP will receive customary care outpatient rehabilitation therapy but no 
CARE-CITE intervention.  The CP will receive a CP support brochure with general caregiving information 
including website resources to mimic web interaction of intervention group (e.g., stroke caregiver resource 
site).  The research coordinator will handle all communication. The CP will receive the same number of 
structured weekly phone calls and the “booster call” to answer any questions, assess helpfulness of the 
information and ascertain if there was any use of the web resources or social support groups.  
Procedures: The research coordinator will make a virtual screening appointment at via HIPPA compliant 
Emory Zoom telehealth platform for interested participants. If screening criteria are met, an electronic 
informed consent (via RedCAP data management system) will be obtained from the CP and SS. Following 
baseline data collection obtained via a virtual evaluation by the research evaluator (licensed physical therapist), 
participants will be randomized to groups using a random number generator. The research interventionist 
(licensed physical therapist) will schedule dyads in the intervention group for the orientation virtual home visit 
and the second virtual home visit and complete weekly phone calls. The research coordinator will schedule all 
dyad data collection appointments and complete attention control group dyads phone calls. All dyads complete 
a virtual evaluation for the 3-month post-test visit.  To increase rigor and minimize bias, data collectors will be 
blinded to group assignment/study hypotheses and will be trained in study procedures (e.g. Mini-mental test 
administration) by the PI [Blanton], with regular assessments of competence every 4 months. The PI will train 
the research interventionist in delivering the intervention and provide supervision by reviewing all in home 
visits. To minimize missing data, all participants will be sent email / text / mail reminders for upcoming 
appointment dates. Using the web platform, we will be able to track the frequency and time on each web 
module. All dyads will receive $100 for study participation at the end of the 3-month follow up.  
Instruments:  Variables and measures have all been tested in this population previously.  Each standard tool 
has evidence of established reliability and validity in this patient population as referenced in Table 2.  
Table 2. R21 Measures collected at baseline and 3 months post-intervention 
VARIABLE 
 MEASURES 
Description 
Reliability/Validity 
CP Depression 
CES-D 
20-item, Likert-type scale  
Established validity, internal consistency, reliability 17 
CP Quality of life 
SF-36 
36-item Likert-type scale, mental  health 
domain 
Sensitive indicator CP mental health18, 19  
SS Quality of Life 
Stroke Impact Scale (SIS) 
59-items, 8 domains function 
Test-retest reliability ICC = 0.70 to 0.92;Internal 
consistency alpha coefficient of 0.83-0.90  20 
SS Upper 
Extremity 
Function 
Wolf Motor Function Test 
(WMFT) (dropped from 
remote study) 
Motor Activity Log (MAL) 
15 item speed measures;2 item strength; 
low score/faster speed 
30-item questionnaire, Likert-type scale; 
high score/high quality UE use 
Inter-rater reliability r=.97; valid in the stroke 
population21 
 
CP/SS Autonomy 
Support 
Environment 
Family Care Climate 
Questionnaire  
FCCQ-CP/FCCQ-SS 
14-item, Likert-type scale. Higher 
scores/higher autonomy support 
perception 
Internal consistency >. 70; Construct validity supported- 
higher FCCQ-SS scores related to SS lower perception of 
criticism, higher family emotional involvement-higher 
satisfaction with family support (p ≤ .05)22 
CP Family Conflict 
Family Caregiver Conflict 
Scale (FCCS) about Stroke 
Recovery 
15-item, Likert-type scale; Higher 
scores/higher conflict 
Established content/construct validity in stroke CP; 
reliability Cronbach’s  alpha =.9323 
SS UE Self Efficacy 
Confidence in Hand and 
Movement Scale (CAHM) 
20-item (scale 0-100)UE confidence for 
functional tasks; high scores/high 
confidence  
Reliable and valid with moderate relationship with 
WMFT 3-9 months post stroke10 
 
Additional secondary outcome measures will be collected for CP-Family Assessment Device (FAD) Scale 
(baseline only), CP Caregiver Strain Index (CSI), CP Bakas Caregiving Outcomes Scale (BCOS), SS Fugl-Meyer 
Assessment (FMA) (baseline only), SS Neuro-QoL Short Form v1.1 - Satisfaction with Social Roles and 
Activities, CP BRICS NINR Depression scale (PROMIS Depression- Short Form 6a), SS Neuro-QOL SF v1.0 - 
Upper Extremity Function (Fine Motor, ADL).  
 
Additional clinical data about SS (such as medications, concurrent medical problems, pre-morbid handedness, 
side affected by stroke) and about the CP (co-morbidities and medications) will be collected to fully describe 
the sample and explore relationships using correlation analysis. The CP adherence to the intervention will be 
assessed by monitoring CP review of the CARE-CITE modules through Google Analytics, and completion of 
module feedback questionnaires including specific examples of ways they used the educational information 
(e.g., “provide an example of how you used autonomy support with your loved one”).  Participants will have the 
option to wear bilateral, wrist-worn accelerometers (Actigraph) to assess upper extremity performance in the 
home environment for a period of 1-3 days at time of the baseline and 3-month follow-up evaluations. 

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Data Management and Planned Analysis: All quantitative data storage will be maintained through the 
Emory HIPPA compliant REDCap database. Standard data cleaning, identification of missing data, 
identification of outliers, and internal consistency reliability for standardized scales will be completed.  Initial 
data analysis will include descriptive statistics to describe the sample and summarize major study variables. 
For Aim 1, we hypothesize that for dyads receiving CARE-CITE, CPs will display reduced (improved) CES-D 
depression and improved SF-36 (QOL) scores and SS will have higher scores on the MAL (improved use of arm 
function), SIS (QOL), and reduced scores on the WMFT (faster UE speed of movement) consistent with 
moderate to large effect sizes at 3-months as compared to baseline and more favorable changes in these scores 
after 3-months as compared to the attention control group.  For Aim 2, we hypothesize that for dyads 
receiving CARE-CITE, both members will have higher autonomy support (FCCQ-CP; FCCQ-SS), CP will have 
reduced FCCS (family conflict) and SS will display higher CAHM (UE self-efficacy) as compared to baseline and 
to the control group. The first component of the primary analysis will involve the construction of 95% 
confidence intervals in order to summarize changes from baseline to 3-months within each group. We will also 
report the results of paired t tests or nonparametric Wilcoxon signed rank tests to assess changes from baseline 
to two months post intervention within each group. Similarly, we will compare mean or median changes of the 
outcomes targeted in Aims 1 and 2 across the two groups using two-sample t tests or Wilcoxon rank sum tests, 
respectively. Recognizing the pilot nature of the study, these inferences will be viewed primarily as descriptive 
rather than as definitive hypothesis testing efforts.  To address the multidimensional nature of the data, we will 
examine inter-correlations among the study variables, including variables that may influence response to the 
intervention. As needed, we will use linear regression models to augment the primary analyses in order to 
assess the extent of association between patient characteristics and mean changes and whether observed 
differences in mean changes across groups persist after controlling for such variables. The biological 
variables of CP age, sex, gender and relationship of CP to SS (e.g. spouse, adult child) and other participant 
characteristics such as SS other health problems will be examined and potential relationships explored to gain 
insight into possible confounding factors. Potential limitations:  While CP of any sex/gender will be 
recruited, most CPs are female, which may limit interpretations of any sex/gender differences found.   
 
Exploratory Aim Methods: At the end of 3-month post-intervention evaluation we will invite the 24 CPs in 
the intervention group to participate in focused individual interviews to better understand their perceptions of 
how CARE-CITE impacted health outcomes, QOL, and family conflict and autonomy support.  We will use a 
semi-structured interview guide (developed by the study team and reviewed by content and qualitative experts 
– See Appendices) that addresses both outcomes and process aspects of CARE-CITE. For example, questions 
will focus on: how the dyad incorporated autonomy supportive strategies; benefits/ challenges of using 
autonomy supportive approaches; conflicts in CP and SS working together and how CP perceive the 
intervention impacted SS function.  An open-ended question will be included for CP to share additional 
feedback about CARE-CITE.  Virtual interviews (~45-60 minute each) via HIPPA compliant Emory Zoom 
telehealth platform will be conducted by the PI and a research assistant (RA). Dr. Lutz (qualitative methods 
expert) will provide oversight to the PI and RA for qualitative interviews and analysis. Interviews will be audio-
recorded and transcribed verbatim by a professional transcriptionist for accuracy.   Data Analysis:  Data 
collection and analysis will occur simultaneously. Dr. Lutz, Dr. Blanton and the RA will analyze transcripts 
line-by-line, using thematic analysis, to identify salient themes.24 Transcripts will be reviewed for themes: 
autonomy supportive interactions (e.g. empathy, offering choice, problem solving) or non-autonomy 
supportive interactions (guilt inducing, lack of empathy, controlling language); types and opportunities to work 
together on recovery activities; and perceived effects on outcomes (functional recovery, depression, and QOL). 
As themes are identified in early interviews, they will be verified with new CPs to substantiate their relevance; 
the interview guide will be adapting accordingly. Comparisons of themes will be made within and across 
interviews.24-26 CP responses will be compared for similarities and differences in the challenges and benefits of 
the intervention. Data saturation is expected to occur between 15-24 participants.27 QSR NVivo 11 qualitative 
data management software28 will aid in analyzing the data making comparisons within and across texts, and 
comparisons to the quantitative measures. Using guidelines by Fetters, et. al.,9 triangulating qualitative and 
quantitative data will occur at the study end by merging data, based on methods described by Creswell, et al.,29 
including the use of side-by-side joint displays. Dyad and CP quantitative data (e.g. change in family conflict, 
autonomy support and caregiver depression scores will be compared for concordance or discordance with 
themes identified in the interviews to better understand mechanism of the intervention.  Approaches to ensure 
rigor of the data analysis and interpretation: 1) Team members will keep memos to record findings and track 
analytical interpretations providing an audit trail with supporting documentation from interviews and data 
analysis. 2) The team will meet monthly to discuss the ongoing data analysis and data collection.  3) Provisional 

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findings from early interviews will be discussed with the entire team for feedback on the interpretations and to 
help develop additional interview questions.  
 
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