Testing Preliminary Effectiveness of a Community Health Worker (CHW) Training Program to Support African American and Latino Male Caregivers of Older Adults
Phase: NA
Conditions: Caregiver Burnout
Sponsor: KDH Research & Communication

 
 
 
 
 
 
 
 
 
Cover Page for ClinicTrials.gov 
 
Document: 
IN-HOME Study Protocol and Statistical Analysis Plan 
 
Official Study Title: 
Testing Preliminary Effectiveness of a Community Health Worker (CHW) Training Program to 
Support African American and Latino Male Caregivers of Older Adults 
 
Document Date: 
January 1, 2023 
 

IN-HOME feasibility evaluation 
I. Original proposal narrative 
The Phase 1 feasibility evaluation, a RCT with a two-group pre–post design with 87 CHWs will 
explore the following question: To what extent is IN-HOME exposure (treatment) associated 
with greater CHW knowledge, skills, and perceived self-efficacy to conduct outreach to reduce 
caregiver burden for African American and Latino male informal caregivers of older adults 
compare to CHWs reviewing caregiver information from AARP’s English “Care at Home” 
resource page (control)? What is the relation between demographic characteristics (e.g., age and 
race/ethnicity) and experimental differences in knowledge, skills, and perceived self-efficacy? 
What is the extent of difference in outcomes between treatment and control participants? 
We will enroll 60 CHWs per arm. Eligible participants will (1) be at least 18 years old, (2) self- 
identify as a CHW, (3) live in the United States, (4) conduct outreach, to African American and 
Latino male informal caregivers, (5) have at least six months of field experience and (6) be an 
active CHW within the last six months. 
We will randomly assign participants to the treatment and control conditions. Any stratification 
based on potentially confounding factors will be done by using covariates in the full analyses. 
Treatment participants will complete a pretest before and a posttest after viewing the IN-HOME 
prototype. Control participants will complete a pretest before and a posttest after reviewing 
caregiver information from AARP’s English “Care at Home” resource page. 
IN-HOME is feasible if the treatment group shows statistically significant higher mean scores in 
knowledge, skills, and perceived self-efficacy at posttest compared to the control group. We will 
use covariate-adjusted ANCOVA to control for group differences (e.g., received caregiver 
training before) that may confound outcomes. We will use two-tailed tests to identify potential 
iatrogenic effects. 
 
 
II. IN-HOME study research questions 
 
1. To what extent is IN-HOME exposure (treatment) associated with greater CHW 
knowledge, skills, and perceived self-efficacy to conduct outreach to reduce caregiver 
burden for African American and Latino male informal caregivers of older adults 
compare to CHWs reviewing caregiver information from an online resource (control)? 
• What is the relation between demographic characteristics (e.g., age and 
race/ethnicity) and experimental differences in knowledge, skills, and perceived 
self-efficacy? 
2. What is the extent of difference in outcomes between treatment and control participants? 
• What is the relation between demographic characteristics (e.g., age and 
race/ethnicity) and experimental differences in knowledge, skills, and perceived 
self-efficacy? 

3. To what extent do CHWs exposed to IN-HOME show greater gains in knowledge 
compared to the control group? 
• What is the relation between demographic characteristics (e.g., age and 
race/ethnicity) and experimental differences in knowledge, skills, and perceived 
self-efficacy? 
4. To what extent do CHWs exposed to IN-HOME are more prepared to provide support to 
male caregivers compared to the control group? 
• What is the relation between demographic characteristics (e.g., age and 
race/ethnicity) and experimental differences in knowledge, skills, and perceived 
self-efficacy? 
 
For specific hypotheses, see the research question and hypotheses document, located here: 
S:\Projects\IN-HOME\Feasibility evaluation\Methods and analysis 
 
III. IN-HOME study summary 
 
Study design: Randomized controlled trial with a two-group online pretest/posttest design. 
Study population and sites: The study population will include active CHWs. The study will be 
conducted online and include participants recruited by six CHW organizations in Alabama, 
Georgia, Florida, Virginia, Illinois, and Texas. 
Treatment regimen: Treatment group participants will view the IN-HOME prototype. Control 
group participants will view materials from AARP’s English “Care at Home” resource page. 
Randomization: The research assistant will randomly assign participants to the control or 
treatment group after they consent to the study. 
Institutional Review Board (IRB): KDHRC received approval for pilot testing materials on May 
2, 2023 IRB # 00005850. 
The final approved IRB package can be found at: S:\IRB\Reviews\Reviews - general\2023\2023- 
02-01 - 2023-0213 - In Home\12 - Amended approval packet 
 
 
IV. Pre-launch survey review 
KDHRC conducted a pre-launch review of the survey instrument to ensure its clarity, reliability, 
and validity before full-scale use. Internal staff tested the eligibility, consent, pretest, and posttest 
links to confirm that the surveys were ready to launch. After reviewing the survey questions and 
testing the survey, we submitted an amendment request to the IRB for modifications and 
additions. Staff retested the links. 
 
The amendment request can be found here: S:\IRB\Reviews\Reviews - general\2023\2023-02-01 
- 2023-0213 - In Home\10 - Amendment request 

V. Recruitment 
We contracted with six sites with CHW-related programs. All sites received a brief training 
video to explain IN-HOME and provide an overview of the study requirements, time 
commitment, and consent process. After completing the training call, sites will begin recruitment 
using KDHRC-developed and IRB-approved recruitment materials. Sites shared the recruitment 
materials with their CHWs via email, newsletter, fliers, in-office communications (e.g., Slack) 
and social media posts. The recruitment period began upon receiving IRB approval, and ended 
when we received enough participants for power for analysis. 
 
The recruitment period for IN-HOME lasted from May 15, 2023 to August 16, 2023. 
 
IV. Data collection 
• Recruitment numbers (aimed): 123 CHWs 
• Recruitment numbers (actual): 123 CHWs consented [52 control; 55 treatment] 
• Dates: May 15, 2023 – August 16, 2023 
 
 
V. Data cleaning 
1. Make changes in Alchemer (if required) 
 
2. Download pretest and posttest from Alchemer and save in the “raw data” folder – do not 
make any changes to this data. 
• Location (control group): S:\Projects\IN-HOME\Feasibility evaluation\Raw 
data\Control\Final control group raw data 
• Location (intervention group): S:\Projects\IN-HOME\Feasibility evaluation\Raw 
data\Treatment\Final treatment group raw data 
• File is password protected with standard data protection password. See Dexter for 
password. 
 
3. Copy the raw data file exported from Alchemer into the “Manipulated data folder” 
• Location: S:\Projects\IN-HOME\Feasibility evaluation\Manipulated data 
 
4. Merge the posttest treatment and posttest control surveys together to form a single 
posttest file. 
• Archive separate posttest treatment and posttest control surveys. 
• Save combined posttest survey files as _COMBINED. 
 
5. Merge pretest and posttest data by matching pre- and posttest responses by participant ID. 

• Compare participant ID (last-initials-state) between pre and posttest responses. 
• If the participant matches, merge the pre and posttest variables. 
• Archive pretest and posttest survey files. 
• Save merged survey files as _MERGED. 
 
6. Delete observations, if applicable. 
 
7. Clean data in preparation for data analysis. 
 
 
 
 
VI. Data analysis 
1. Create dichotomous variables for incorrect and correct answers 
a. For the knowledge and skills variables, we will code correct answers as ‘1’ and 
incorrect answers as ‘0’. 
b. The new variable name will use “_correct” (e.g. q1_t1_correct). 
2. Create a dummy variable for treatment. 
a. For all participants in the treatment group, we will code the variable “treatment” 
with a ‘1’ and control group participants with a ‘0’. 
3. Create composite variables for the knowledge, skills, and self-efficacy questions. 
a. Create composite variables for each participant that sums all their answers for 
each outcome and divides them by the total number of questions to create 
composite scores, ranging from 0 to 100 (e.g., a composite knowledge score of 
100 means that a participant correctly answered all knowledge questions on the 
pretest). 
b. The new variable names will be “know_comp_t1,” “know_comp_t2,” 
“att_comp_t1,” “att_comp_t2,” “se_comp_t1,” “se_comp_t2,” “int_comp_t1,” 
and “int_comp_t2.” 
4. Create “gain” or “differences” score for the composite variables. 
a. Subtract the t1 composite variables from the t2 composite variables to get the 
change in composite score from pretest to posttest for each outcome area. 
b. The new variable names will be “know_comp_diff,” “att_comp_diff,” 
“se_comp_diff,” and “int_comp_diff.” 
 
Methods 
• Between groups t-tests on each outcome’s composite score at pretest and posttest. 
• Within group t-tests between each outcome’s pretest and posttest composite scores. 

• Regression analyses using each primary outcome’s posttest composite score as the 
dependent variable and group assignment as the primary independent variable, while 
controlling for participant characteristics at baseline including race, ethnicity, age, sex, 
education, time as CHW, paid/volunteer status, having over 16hrs of training, number of 
usual topics outreach is conducted on, and whether participants had been trained 
previously in older adult care.