Caregiver Self-Management Needs Through Skill-Building
Phase: NA
Conditions: Family Caregivers, Stroke
Sponsor: University of Cincinnati

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Caregiver Self-Management Needs Through Skill-Building  
ClinicalTrials.gov Identifier: NCT03635151 
NIH NINR: R21NR016992 
Document Date: 12/04/19 
 
 
 
Study Protocol and Statistical Analysis Plan 
 
 
 
 
 
 

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Study Protocol 
Study Description  
Brief Summary: Caring for a family member after a stroke can be very difficult and worsen the physical and 
mental health of untrained caregivers. The Telephone Assessment and Skill-Building Kit (TASK III) intervention 
is a unique, comprehensive caregiver intervention program that enables caregivers to develop the necessary 
skills to manage care for the survivor, while also taking care of themselves. The long-term goal of this study is 
to offer training and support for family caregivers through an efficacious, cost-effective program. 
 
Detailed Description: Stroke is a leading cause of serious, long-term disability, and has a very sudden onset; 
families are often thrust into providing care without any training from health care providers. Studies have 
shown that caregiving without training can be detrimental to caregiver’s physical and mental health, which can 
impede survivor rehabilitation and lead to institutionalization and higher societal costs. Unlike existing stroke 
caregiver interventions that require costly face to face interactions, and that focus primarily on the survivor’s 
care, the Telephone Assessment and Skill-Building Kit (TASK II) is delivered completely by telephone, and 
empowers caregivers to address both their own and the survivor’s needs using innovative skill-building 
strategies. Aligned with current patient and caregiver guidelines, TASK II has demonstrated evidence of 
content validity, treatment fidelity, caregiver satisfaction, and efficacy for reducing depressive symptoms; 
however, future development of TASK II requires a stronger focus on self-management strategies to improve 
caregiver health, and enhanced use of other telehealth modes of delivery prior to implementation into ongoing 
stroke systems of care. The purpose of this study is to optimize the TASK III intervention through the 
innovative leveraging of technologies and theoretically-based self-management strategies to improve caregiver 
health. Specific Aim 1 consists of focus groups and individual interviews with 40 experts (10 interdisciplinary 
researchers, 10 technology experts, 10 clinicians and clinical leaders, and 10 stroke family caregivers) to 
provide preferences about essential areas of new self-management content, proposed technologies (e.g., 
iBook, eBook, interactive website, FaceTime, Zoom), and future implementation strategies to inform a novel 
TASK III prototype. Specific Aim 2 will determine feasibility of the TASK III intervention with a pilot study of 74 
stroke caregivers randomized to TASK III or an Information, Support, and Referral (ISR) group in preparation 
for a larger randomized controlled clinical trial. Recruitment, retention, treatment fidelity, satisfaction, and 
technology ratings will be obtained for both TASK III and ISR groups who will receive 8 weekly sessions with a 
booster session 4 weeks later. Outcome measures will be explored at baseline, 8 weeks (end of intervention), 
and 12 weeks (after booster). If TASK III is shown to be efficacious in a future randomized controlled clinical 
trial, our next goal will be to translate TASK III into ongoing stroke systems of care; and, someday to adapt it 
for use among caregivers with other debilitating/chronic conditions providing a strong public health impact. 
 
Study Design  
Study Type: Interventional (Clinical Trial) 
Actual Enrollment: 74 Participants 
Allocation – Randomized 
Intervention Model: Parallel Assignment 
Masking – Single (Outcomes Assessor) 
Primary Purpose – Supportive Care 
Enrollment – 74 stroke family caregivers 
 
Arms and Interventions  
Arm 
Intervention/Treatment 
Telephone Assessment and 
Skill-Building Kit (TASK III) 
Group 
The TASK III group will receive a TASK III Resource Guide that we 
developed and 8 weekly calls from a nurse. The nurse will call again a 
month later. The TASK III nurse will help you assess your needs and 
concerns, build your skills as a caregiver, and refer you to community 
resources. 
Information Support and 
Referral (ISR) Group 
The ISR group will receive an American Heart Association brochure and 8 
weekly calls from a nurse. The nurse will call again a month later. The ISR 
nurse will provide information, support, and referral to community 
resources. 

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Randomization 
Caregivers will be randomized 1:1 to the TASK III or ISR group using a permuted block randomization stratified 
by type of relationship (spouse vs adult child/other) and baseline depressive symptoms (non-depressed vs 
depressed PHQ-9 ≥ 5) as in the TASK II trial. Random permutations within each block within each stratum will 
be generated using a random number generator (SAS Proc Plan). Data collectors will be blinded to group 
assignment to mitigate potential bias. The randomization scheme will be accessed by the project manager by 
logging into the REDCap website and entering type of relationship and baseline depressive symptoms for 
group assignment.  
 
Outcome Measures 
Primary Outcome Measure 
Description 
Caregiver satisfaction ratings for 
both TASK III and ISR programs 
measured by the Caregiver 
Satisfaction Scale (CSS). 
[ Time Frame: 12 weeks]  
Caregiver satisfaction ratings (usability, ease of use, acceptability) for both 
TASK III and ISR programs are measured using the Caregiver Satisfaction 
Scale (CSS). The CSS consists of 9 items rated on a response scale ranging 
from 1 = Strongly Disagree to 5 = Strongly Agree. Items are summed for a total 
score with a possible range of 9 to 45. Higher scores indicate greater 
satisfaction. 
Secondary Outcome Measures 
Descriptions 
Depressive symptoms measured by 
the Patient Health Questionnaire 
Depression Scale (PHQ-9). 
[ Time Frame: Baseline to 8 and 12 
weeks ] 
Caregiver depressive symptoms are measured by the Patient Health 
Questionnaire Depression Scale (PHQ-9) consisting of 9 items rated on a 
response scale ranging from 0 = Not at all to 3 = Nearly every day. Items are 
summed for a total score with a possible range of 0 to 27. Higher scores 
indicate higher depressive symptoms. 
Life Changes (i.e., changes in social 
functioning, subjective well-being, 
and physical health as a result of 
providing care) measured by 
the Bakas Caregiving Outcomes 
Scale (BCOS). 
[Time Frame: Baseline to 8 and 12 
weeks] 
Caregiver life changes (i.e., changes in social functioning, subjective well-being, 
and physical health as a result of providing care) are measured by the Bakas 
Caregiving Outcomes Scale (BCOS). The BCOS consists of 15 items rated on 
a response scale ranging from -3 (changed for the worst) to +3 (Changed for 
the best). The items are recoded (-3 = 1) (-2 = 2) (-1 = 3) (0 = 4) (1 = 5) (2 = 6) 
(3 = 7) so that positive numbers can be obtained for analysis. The recoded 
responses to the 15 items are summed for a total score with a possible range of 
15-105. Higher scores indicate more positive life changes as a result of 
providing care. 
Unhealthy Days measured by the 
number of unhealthy days in the past 
30 days. [ Time Frame: Baseline to 8 
and 12 weeks] 
Caregiver unhealthy days are measured using the Unhealthy Days (UD) 
measure consisting of two items: How many days during the past 30 days was 
your physical health not good?; How many days during the past 30 days was 
your mental health not good? These items range from 0 = no unhealthy days to 
30 = 30 unhealthy days. The two items are summed for a total score, with a cap 
of 30 days. Higher scores indicate more unhealthy days in the past 30 days. 
 
Inclusion Criteria 
Exclusion Criteria 
• 
21 years or older 
• 
Primary caregiver (unpaid family member or 
significant other providing care for a stroke 
survivor) 
• 
Must be providing care after discharge to the 
home setting (for Specific Aim 2) 
• 
Fluent in the English language 
• 
Access to telephone or computer 
• 
No difficulties hearing or talking by telephone or 
computer 
• 
(Specific Aim 1) Willing to participate in an online 
or telephone focus group or an online or 
telephone individual interview. Some interviews or 
focus groups may be offered face to face. 
• 
(Specific Aim 2) Willing to participate in 9 calls 
from a nurse and 3 data collection interviews. 
• 
Survivor had not had a stroke 
• 
Survivor did not need help from the caregiver 
• 
Survivor going to reside in a nursing home or 
long-term care facility 
• 
Caregiver scores <16 on the Oberst Caregiving 
Burden Scale Task Difficulty Subscale (for 
Specific Aim 2) 
• 
Caregiver scores <4 on a 6-item cognitive 
impairment screener 
• 
Caregiver or survivor is: 
• 
Prisoner or on house arrest 
• 
Pregnant 
• 
Terminal illness 
• 
History of Alzheimer’s, dementia, or severe 
mental illness 
• 
History of hospitalization for alcohol or drug abuse 

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Statistical Analysis Plan 
 
Statistical Analysis  
 
Data Management. All study data and tracking will be entered into an electronic data system, REDCap 
(www.REDCap.org), a secure research electronic data management system with validated data entry, audit 
trails for tracking data manipulation and export procedures. It is HIPAA complaint satisfying all local, state, and 
federal regulation for the capture and storage of private health information for research purposes.  
 
Sample Size. Sample size is based on satisfaction measures. For evaluating caregiver satisfaction and 
technology ratings, a sample size of 30 in each group will achieve 80% power to detect a mean difference in 
satisfaction of 0.44 between groups, TASK III of 4.4 and ISR of 3.96, with an estimated standard deviation 
(SD) of 0.60 in both groups using a two-sample t-test with a significance level of 0.05. This detectable 
difference is lower than satisfaction scale differences observed in the original TASK study with a total 
satisfaction scale score mean (SD) of 4.41 (0.57) in the TASK group and 3.94 (0.60) in the ISR control group. 
For evaluating outcome trends, group sample sizes of 30 and 30 will produce two-sided 95% CI with a distance 
from the difference in means of ± 0.52 standard deviation of the outcome. 
 
Missing Data. We will make every effort to avoid missing data. We will assess the reasons, patterns, 
and distribution of missing data, allowing us to assess whether an assumption of missing completely at random 
is reasonable or whether missingness is conditional on another variable in the dataset (i.e. missing at random). 
Descriptive statistics will compare characteristics of patients with and without missing data. If missing at 
random, we will incorporate variables that are identified to be related to the missingness in the analysis using 
multiple imputation, if the amount of missing data affects the study results. 
 
Recruitment, attrition rates, and fidelity ratings of data collection and intervention procedures. 
Using procedures similar to the TASK II study, we will monitor screening and recruitment rates, attrition rates, 
and fidelity ratings of all data collection and intervention procedures.  We will compute the numbers screened 
and enrolled per month, proportion of screened eligible who enroll, intervention assignment specific retention 
rates at each follow-up visit, and proportion of outcome measures completed. Fidelity ratings: We will utilize 
an itemized checklist for monitoring adherence to the unique components of the TASK III study. Adherence will 
be scored with dichotomous responses for presence or absence of each item. Frequencies and percentages 
will be calculated for each item by group. Intervention dosage will be calculated for nurse call duration 
(minutes) and time caregivers spend reading study materials (minutes) for each group. Descriptive statistics for 
intervention dosage will be computed by group and between group mean differences will be evaluated using 
two-sample t-tests or non-parametric alternative, if normality assumption is violated. 
 
Caregiver satisfaction and evaluation of technology ratings. Satisfaction ratings from the Caregiver 
Satisfaction Scale (CSS) (usability, ease of use, acceptability) and evaluation of technology ratings will be 
summarized at the item and scale levels by intervention group using descriptive statistics, including mean and 
95% confidence interval (CI). Cronbach alpha will be calculated as a measure of internal consistency. CSS 
scores, total and subscales, will be compared between groups using two-sample t-tests or nonparametric 
alternative, if the normality assumption appears violated. We will explore sex differences by careful description 
of subgroup effects.   
 
Outcome measures by TASK III and ISR groups. Descriptive statistics and graphics will be used to 
evaluate outcomes from baseline to 8 and 12 weeks by intervention group. By intervention group, stick plots 
will be used to show individual caregiver outcomes at baseline, 8 and 12 weeks and we will compute a mean 
and 95% CI for the change from baseline to 8 and 12 weeks for each outcome. In computing the 95% CI, we 
will specify an appropriate distribution, if a Gaussian-based approximation for the interval estimation does not 
appear to be valid. At each follow-up time-point, 8 and 12 weeks, we will compute mean differences and 95% 
CI between groups to evaluate trends in outcomes. We will not test for statistically significant differences 
between groups in outcome measures or estimate effect sizes in this pilot study, because the primary purpose 
is to determine feasibility of our procedures to inform the planning and design of a larger trial. Estimating effect 

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sizes using small pilot samples has been scrutinized in the literature, as such, our effect size estimates for a 
larger efficacy trial will be based on clinically meaningful treatment effect. We will explore sex differences in 
intervention effect by careful description of subgroup effects.   
 
Anticipated Results and Interpretation: This study will enable us to 1) provide the necessary 
preliminary data, recruitment procedures, and training protocols to successfully conduct a large efficacy trial of 
the TASK III; 2) further refine the TASK III intervention via program evaluation data (satisfaction, technology 
ratings); and 3) demonstrate our capacity to measure outcomes and estimate changes from baseline.