To Reduce the Burden of Caregiving on Health Outcomes of Midlife Women: Asian American Family Caregivers of Persons Living With Alzheimer's Disease
Phase: NA
Conditions: Alzheimer Disease
Sponsor: University of Texas at Austin

 
FORM: IRB Proposal - Standard Submission 
NUMBER 
VERSION DATE 
HRP-UT901 
10/23/2024 
 
 
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GENERAL STUDY INFORMATION 
 
Study Title  
 
Include the study title below.  
 
To reduce the burden of caregiving on health outcomes of women: Asian American family 
caregivers of persons living with Alzheimer's Disease 
 
 
 
1 
Review Type (Choose one) 
 
Please choose which level of review best fits your research. This is an investigator’s assessment of review and 
does not preclude the IRB from alternate determinations. In cases where the investigator and the IRB’s 
determination of review conflict, the IRB’s determination will be considered the official determination.  
 
Note: Expedited review does not refer to the timeliness of the review of your protocol, but specific categories of 
research defined by OHRP. If you would like help determining which type of review best fits your research study, 
please contact the IRB staff in the Office of Research Support & Compliance: 
https://research.utexas.edu/ors/human-subjects/get-help/  
 
a ☐ 
 
 Full Board Review – Greater than Minimal Risk Research 
b ☒ 
 
 Expedited Review – Minimal Risk Research  
 
2 
Research Hypotheses 
Please describe the research aims and hypotheses in the box below. To input text, click in the box below and 
start typing.  
Note: Procedures will be explained in a separate section below. 
 
 
 
The purpose of the proposed study is to preliminarily evaluate a technology-based information and 
coaching/support program, TACAD (Technology-based Information and Coaching/Support Program for Asian 
American women who are family caregivers of persons living with Alzheimer’s Disease), in improving health 
outcomes of Asian American women who are family caregivers of persons living with Alzheimer’s disease (AACA) 
and their care recipients. The specific aims of the study are to: 
 
Aim 1. Qualitatively evaluate TACAD through an expert review and a usability test. 
 
Aim 2. Quantitatively evaluate the preliminary efficacy of TACAD in improving health outcomes of AACA and their 
care recipients. 
- Hypothesis 1. After controlling for background and health/disease factors, the intervention group (AACA who 
use TACAD and the Alzheimer’s Association [AA] website) will show significantly greater improvements than the 

 
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active control group (AACA who use only the AA website) in their health outcomes (stress, physical and 
psychological symptoms, and quality of life) and their care recipients’ health outcomes (activities of daily living, 
behavioral and psychological symptoms, mood status, and quality of life) from baseline (pre-test) to Time Points 
1 (post 1 month) and 2 (post 3 months). 
- Hypothesis 2. After controlling for background and health/disease factors, the intervention group will show 
significantly greater improvements than the control group in caregiving experience (caregiving activity, coping, 
caregiving competence, and caregiving skills) from baseline to Time Points 1 and 2. 
- Hypothesis 3. After controlling for background and health/disease factors, the intervention group will show 
significantly greater improvements than the control group in theory-based variables (attitudes, self-efficacy, 
perceived barriers, and social influences related to caregiving of PLAD) from baseline to Time Points 1 and 2. 
 
 
 
3 
Study Background 
Provide the rationale and the scientific or scholarly background for the proposed activity, based on existing 
literature (or clinical knowledge). Describe the gaps in current knowledge that the project is intended to address. 
 
 
  PLAD spend most of the course of their illness in the community and receive most of their care from informal 
(usually family) caregivers.5 Currently, about 15 million adults, mainly women, annually provide 17.9 billion hours 
of family care for community-dwelling persons living with Alzheimer’s and other illnesses.1, 2  The situation is 
worse for AACA. Under-detection of cognitive impairment among Asian Americans remains prevalent,1–3 and their 
cultural stigma produces suboptimal dementia management, placing them at a greater risk than Whites.1–3 
Although Asian Americans include highly diverse sub-groups, all Asian Americans across the sub-groups share 
many common characteristics, one of which is “filial piety,” the belief that family members are in charge of 
caregiving roles.3–6 Mainly due to this cultural belief, 42 percent of Asian Americans reportedly provide care to an 
older adult while 22 percent of the general population provides care to an older adult.7  
The negative influences of caregiving on health outcomes of family caregivers are well documented.8–10 The 
chronic stress of their role places them at greater risk for morbidity and mortality than non-caregiving peers.8–10 
The adverse effects on their psychological and physical well-being are extensive.10–14 Furthermore, racial/ethnic 
minority women are more likely to suffer from caregiving burden compared with their counterparts, mainly due 
to their cultural attitudes related to AD and caregiving.15–17 Furthermore, they rarely complain about their 
caregiving burden, delay seeking help, and seldom get support due to their cultural values, beliefs, and language 
barriers.4–6,17 Subsequently, they have lower quality of life and fewer sources of information and support than 
Whites.4–6,17 To reduce the burden of caregiving on health outcomes among family caregivers of PLAD and 
subsequently improve health outcomes of care recipients, many psychoeducation interventions were developed 
and used to provide information and support/coaching.18 Indeed, a number of psychoeducation programs for 
caregivers have been developed and tested in relieving distress, increasing self-efficacy, managing caregiving 
challenges, and enabling caregivers to sustain care over longer periods of time.19–22   
As mentioned above, however, existing psychoeducational interventions have rarely succeeded in achieving 
their goals among racial/ethnic minorities including Asian Americans because of several reasons.18,23–25  Again, one 
major reason is the lack of consideration on caregivers’ cultural attitudes related to AD and caregiving.18,23–25 For 
instance, due to cultural hesitance to discuss dementia,3,26–28 Asian Americans tend not to share their caregiving 
experience (e.g., heavy burden of caring, psychological and physical symptoms) until they get severe/serious 
problems that cannot be tolerated anymore. These women consequently shoulder the heavy burden of caregiving 
without adequate support although there exist some information and/or coaching/support available to them.3,26–
28  However, there is virtually no program that considers these women’s cultural attitudes. Also, another major 
reason is: many caregivers cannot take part in existing programs because most require them to arrange care for 
the care recipients while they attend the programs.29–35  

 
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  Technology-based programs could help overcome these two major drawbacks of existing programs by 
incorporating cultural tailoring and providing 24-hour access through the Internet without physical 
transportation. Also, in a meta-analysis of randomized clinical trials, Davies et al. found that technology-based 
programs were effective in producing changes in health outcomes.36 Researchers also supported the effectiveness 
of technology-based interventions in approaching marginalized people with stigmatized conditions (e.g., 
racial/ethnic minorities).37–40 These marginalized groups report greater interest in e-health than their more 
affluent counterparts.41–46 Moreover, Internet use by Asians is greater than that of any other racial/ethnic groups; 
about 97% of Asian Americans have access to the Internet.47, In PSs, Asians preferred a technology-based program 
that would not require travel to a location outside of their home.48–51  About 94% of Asian-American households 
own a cell phone (compared with 86% of total population).52,53, 54 Both the literature55, 56, 57 and PSs48–51 support 
that older Asian American women preferred technology-based programs to traditional programs, and nationally 
recruiting/retaining Asian American women for a technology-based intervention is feasible.  
Despite the reported strengths, few technology-based interventions are actually available for MWPLAD.58 A 
meta-analysis of 12 interventions using information and communication technologies among informal caregivers 
of persons living with dementia58 identified only two computer-based studies.59,60 These two studies reported 
significant positive effects of the computer-based interventions that included educational modules and videos, 
decision support, and communication features.59,60 Kajiyama59 reported a significant positive effect on caregivers’ 
stress (p=.017), and Brennan60 indicated significant improvement in caregivers’ decision-making confidence 
(p<.01). However, none of these programs specifically targets or offers features most appealing to AACA.  
TACAD that will be tested in the proposed study offers several unique features that were rarely used in existing 
programs. First, none incorporated racial/ethnic minorities’ cultural attitudes in the design, and none used 
cultural tailoring. Yet, cultural tailoring is essential in providing effective information and coaching/support for 
Asian American caregivers. For example, Confucian cultural heritages prescribe Chinese women to live in 
harmonious social relations, subsequently inhibiting them from expressing potentially disruptive and distressing 
emotions and/or symptoms.2,4–7  Thus, technology-based programs that do not consider this cultural attitude 
would not best serve this group. It is also well known that the programs culturally tailored to meet the specific 
needs of a subgroup would be much more effective than generic programs because tailored programs address 
only those factors known to be important to specific recipients.61–64 TACAD has multiple components that are 
culturally tailored to AACA based on the findings from PSs and the criteria for rigor in cross-cultural research65 
(see Intervention). Second, the self-adaptation functionality included in TACAD allows further personalization of 
the intervention components using a machine-learning method (Genetic Algorithm; see the section on TACAD), 
which was never used in existing programs. Through this functionality, TACAD can deliver the most relevant and 
effective information and coaching/support to each participant while considering diversities among AACA. 
Because there exist diversities even among the two sub-ethnic groups of Asian Americans,66 this personalization 
is necessary for AACA. Furthermore, this is consistent with the NIH’s direction related to precision/personalized 
medicine/health.67–69 Third, none of the programs incorporated both group and individual (real-time and 
personalized) coaching/support by culturally matched bilingual healthcare providers. There exist added benefits 
to protocols that include both group and individual coaching/support. Group coaching/support through non-face-
to-face interactions work well for Asian Americans because of their collectivist culture.70–72 Also, individual (real-
time and personalized) coaching/support through non-face-to-face interactions would work well for those whose 
cultures still stigmatize dementia.73–76 Furthermore, culturally matched bilingual interventionists can ensure 
efficacy in coaching/support, limit the potential for harmful communications, provide reliable and objective 
information/resources, and nurture a positive group culture in culturally appropriate and sensitive ways.77–79 
Fourth, peer-based social media services that allow individuals to generate public profiles, develop a list of users 
with whom to share connections, and interact with the users through Internet interactions and instant messaging 
are rarely used in existing programs.80 Social media sites such as Facebook effectively communicate and 
encourage user participation around health topics.81 While social media as a health tool is understudied, findings 
indicate its effectiveness in providing information and coaching/support to racial/ethnic minorities.81–83 Finally, 
few existing programs incorporate VR technology in the intervention.84–86 VR can be a more accessible, scalable, 
and appealing delivery method for this specific population since they would not need to travel. VR can be used to 

 
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create highly ecologically controlled simulations resembling the daily life contexts in which patients' daily 
instrumental activities usually take place. The immersive and engaging virtual environment promotes caregivers’ 
actual understanding of PLAD’ daily experience and provides a sense of control and multiple dimensions of 
empathy.84–86 Actually, VR has been widely used to help family members learn more about the challenges their 
loved ones with dementia face, and to build empathy among family caregivers of PLAD.87–90  Its effectiveness in 
increasing empathy has been reported in the literature,87–90 and VR was reported to be an effective intervention 
to train caregivers of persons with dementia.84–86  Originally, TACAD includes a VR component based on “A Walk 
Though Dementia”(a free Android & iOS Virtual Reality app giving an insight into life with dementia), which will 
be used to change AACA’s attitudes related to AD and caregiving by increasing their empathy. However, the 
original VR that we planned to use was discontinued by the developer and only a 360 degree video clipping of the 
VR component is currently available. Thus, the VR component was replaced with the 360 degree video clipping of 
the VR.  In summary, if TACAD, by incorporating all these components, proves to be effective, it can fill the gap in 
these programs and ultimately reduce health disparities in racial/ethnic minority caregivers of PLAD. This study 
will also accelerate the translation of the technology-based programs into various settings and populations and 
will be an important contribution to health and quality of life among racial/ethnic minority caregivers of PLAD.  
 
 
4 
Design and Methodology 
 
Provide a brief description of the study design or data collection methodologies. Details regarding protocol 
specific research procedures will be discussed in a later section. 
 
 
The study includes two phases: (a) a usability test and an expert review (Phase 1) and (b) a pilot randomized 
clinical trial (Phase 2). Phase 1 has been completed at Emory, and only Phase 2 will be conducted at Univ. of 
Texas at Austin (UT Austin).  For Phase 2, the data will be collected at three points: (a) pre-test; (b) post 1 
month; and (c) post 3 months. The collected data will be analyzed after the data collection of all the participants 
is completed.  
 
 
 
5 
Data Analysis 
Describe the data analysis plan, including any statistical procedures or power analysis. 
 
 
The data will be randomly assigned with serial ID numbers. All tests will be assumed two-sided and an alpha level 
of .05 will be used. SAS 9.4 will be used for data processing and all statistical analyses. Missing data will be handled 
by multiple imputations of dependent values.101–103 Analyses just of complete data will be conducted and 
comparisons of groups with and without missing data will be made. In addition, sensitivity analyses of complete 
data will be conducted and compared imputed data analysis. An intent-to-treat analysis will be 
employed. For Hypotheses 1 to 3, differences in continuous outcome measures over time will be examined 
using linear mixed-effects modeling.104 In particular, we will fit mixed effects models to each continuous outcome 
measure.105,106  We will use random intercepts as well as explore random slopes to represent subject level 
variability. Fixed-effects corresponding to group, time and group x time interaction will be included in the model. 
A significant group x time interaction will indicate substantial differences in the groups over time. Restricted 
maximum likelihood method will be used for estimation, and the most appropriate covariance structure will be 
examined. 
 Since Data and Safety Monitoring Boards (DSMBs) are required only for phase III clinical trials (NOT-OD-00-
038.html), we do not include a DSMB for this intervention study. For the proposed intervention study, we have 

 
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the following data safety monitoring plan (DSMP). First, to manage and protect the data collected, only summary 
data will be openly accessible to funding agency or will appear in publications. Research participants will be 
informed that they are free to decline to answer any questions they do not wish to answer or to stop participating 
in the project at any time. When a participant withdraws from participation, the data that they have provided will 
be immediately removed. Also, the data will have no identifying information to link a subject to the data. 
  The participants' records will be handled as confidentially as possible. Only the research team will have access 
to the study records. As mentioned above, only a serial ID number assigned by the researcher will be attached to 
the data, and the data will be stored in a locked file cabinet in a research office. No identity information, including 
IP addresses, will be attached to any of the individual or group data. Therefore, research participants will not be 
identifiable directly or through the identifying information linked to subjects. No individual identities will be used 
in any reports or publications that will result from this study. Additionally, as explained above, the Web site will 
be developed and maintained such that it conforms to the HIPAA standards. Finally, data in the servers will be 
daily monitored by Dr. Chee to ensure its safety and security. 
 
STUDY ELEMENT IDENTIFICATION 
6 
Study Elements 
 
Check each research procedure included in your study. 
A full description of all study procedures should be provided in the Procedures (Details) section below.  
Procedures denoted with “*” below have supplemental forms. Navigate to the UTRMS-IRB Library, Templates 
tab to download the applicable supplemental form. 
 
 
 
☐ 
 
Bio-specimens* 
 
☐ 
 
Biometrics 
 
☐ 
 
Registry or Repository* 
 
 
☐ 
 
Focus Group 
 
☐ 
 
Genetic Analysis 
 
☐ 
 
Genomic Data Sharing 
 
 
☐ 
 
International 
Research* 
☒ 
 
Interview/Survey 
 
☐ 
 
MRI 
 
 
☐ 
 
Protected Health 
Information* 
☐ 
 
Observation 
 
☐ 
 
Radioactive Material/PET/Nuc. 
Med 
 
☐ 
 
Record Review 
 
☐ 
 
Sensors  
(Externally Placed) 
☐ 
 
Sensors  
(Inserted) 
 
☐ Audio (only) 
Recording 
☐ Video Recording 
 
☐ 
X-Ray/CT/DEXA 
 
 
 
7 
Study Intervention 
 
Click on the check box (or double click and type an “X” if using Google Docs) if you will implement any of the 
following interventions. 
A full description of all study interventions should be provided in the Procedures (Details) section below.  

 
Page 6 of 37 
 
* Interventions denoted with “*” below have supplemental forms. Navigate to the UTRMS-IRB Library, 
Templates tab to download the applicable supplemental form. 
 
 
☒ Behavioral 
 
☐ Device* 
 
☐ 
Drug/Biologic* 
 
 
 
8 
Clinical Trial  
 
Click on the following check box (or double click and type an “X” if using Google Docs) if the research meets the 
below definition of a clinical trial.  
 
 
 
☒ This study meets the definition of a clinical trial according to clinical trials.gov in 
that it involves one or more human subjects who are prospectively assigned to 
one or more interventions (which may include placebo or other control) to 
evaluate the effects of those interventions on health-related biomedical or 
behavioral outcomes. 
 
 
9 
Additional Oversight  
 
Check the box(es) below if you are implementing research procedures that require oversight from additional UT 
committees. 
 
 
 
☐ Energy introduced 
to the subject 
(electrical, 
magnetic, light) 
 
 
☐ Human embryonic, 
human induced 
pluripotent, or human 
totipotent stem cells; 
or human gametes or 
embryos 
☐ Radiation exposure without 
direct clinical benefit 
 
 
 
 
 
 
 
 
 
 
 
 
☐ 
Biological Samples, Biohazards, Recombinant DNA, or Gene Transfer  
 
 
If biological samples are used and stored on UT campus UT IBC approval is needed. 
 
a 
☐ 
UT IBC has (or will have) oversight.  
 
 
 
Provide UT IBC Number:  
 
 
 
      
 
 
 
 
 
 
b 
☐ 
Biological samples collected will not be stored at UT Austin and another 
agency has responsibility for biospecimen safety. 
 

 
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10 Alternatives to Participation in This Study 
Provide a description of alternatives to participation in this study, as applicable.  
 
   Since this is not a treatment study, the alternative is not to participate. 
    
 
 
 
 
 
STUDY PROCEDURE DESCRIPTION  
1
1 
Procedure Description 
 
Describe all study procedures, including a step-by-step outline of what participants will be asked to do or how data 
will be used. Be sure to describe all of the following in detail, as applicable:  
• 
Description of all research procedures being performed and when they are performed, in sequential order.  
• 
Describe/list all research measures/tests that will be used [NOTE: upload copies of all measures, surveys, 
scripts, data collection forms, etc., in “Other Attachments” in UTRMS-IRB].  
• 
Secondary data or specimens that will be obtained, how they are collected, how are they used.  
• 
Where research activities will take place and duration (include expected time commitment of participants).  
• 
Study elements checked in #6 above should be described here.  
Note: if this is a multi-site or collaborative study include the following:  
• 
This is a “Multi-site Study that involves more than one site performing ALL aspects of the research 
procedures as outlined above.” OR “This is a collaborative study that involves UT Austin researchers 
working with external researchers who are engaged in performing the following study activities (list 
activities).”  
• 
For assistance with multi-site/collaborative research, download HRP-UT932 Request to Rely Assessment 
Form from the UTRMS-IRB Library and email irbreliance@austin.utexas.edu. 
 
 
The study includes two phases: (a) Phase 1 including an expert review and a usability test and (b) Phase 2 (a 
randomized control trial among 60 AACA). Only Phase 2 will be conducted at the Univ. of Texas at Austin. 
 
Phase 1 (Aim 1) 
For the expert review, the Cognitive Walkthrough method,95 will be used with several topics related to the logistics 
and content of TACAD (including the adequacy of cultural tailoring and specific unique needs of Asian Americans). 
Please see the below for the details on TACAD. First, 5 self-identified experts in family caregivers of PLAD who 
never participated in any previous studies of PIs will be recruited through announcing the study at and outside 
Emory University, and asked to provide their evaluation on the TACAD within 2 weeks. Five experts are an 
adequate number for an expert review.95 For a usability test, the first 10 AACA who agree to evaluate an early 
version of the TACAD, will be involved in a 1-month-long online forum. On the forum site, 1-2 topics related to 
specific areas for which the users’ evaluation is needed will be posted each week. The topics include: (a) the overall 
structure, (b) preferences for color, designs, and menus, (c) preferences for content, (d) technical support and 
difficulties, (e) areas for additional content, (f) preferences for Internet resources, and (g) other issues (the 
adequacy of cultural tailoring and specific unique needs of Asian Americans). The messages will be analyzed using 

 
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a content analysis.96 About 80-90% of usability problems could be identified by about 5-10 participants.97  The 
findings from Phase 1 was incorporated into the refinement of TACAD. 
 
Phase 1 was completed at Emory and TACAD was defined based on the findings. Thus, the data from the first 
phase will not be shared with UT research team.  
 
Phase 2 (Aim 2) 
All research activities in Phase 2 will be done virtually. The study website will be developed first. The study website 
is the Web-App of the intervention program. The website at Emory was originally developed and refined by the 
other PI, Dr. Wonshik Chee, and it is owned by Dr. Chee.  As soon as the grant transfer is completed, the website 
will be housed at The Univ. of Texas at Austin. To access/use the program through the website, the participants 
will be provided with an account with ID and passwords, which they could change at their convenience. The data 
collected through the website will be just the data on the participants’ activities in the website (e.g., how many 
times per week they log in and out, what components they used in the website, how many messages that they 
are posting) that will be used to determine the dose-response effect of the program later.  The current website at 
Emory is:  https://tacad.nursing.emory.edu  Again, the website will be moved to UT- Austin once the grant transfer 
is completed, which requires this IRB approval. 
 
When potential participants visit the website, they will review the “informed consent” and click “I agree to 
participate” if they agree. After checking them against the inclusion criteria, only those who meet the criteria will 
be automatically randomized into two groups within each sub-ethnic group using an automated random number 
generator through the website. The randomization will be done within each sub-ethnic group to have an adequate 
number of participants in each sub-ethnic group. The intervention group (Group 1) will use both TACAD and 
Alzheimer’s Association (AA) website while the control group (Group 2) will use only AA website. 
The women will be asked to fill out the baseline questionnaire. Then, they will be provided with IDs and passwords 
to log on the website. Both groups will have an electronic instruction sheet on when they need to come back and 
fill out questionnaires (see the below for the instruments) and/or use TACAD (see the below for more information 
on TACAD). Also, both groups will use the AA website (see the below for more information on the website) for 3 
months. Only the intervention group will use TACAD for 3 months. Basically, they need to use TACAD and/or the 
AA website whenever they want to use; no requirement for reimbursement. They are recommended to visit the 
project website at least once a week and the intervention group is recommended to have weekly 
coaching/support sessions with the interventionists through chatting. At first time of use, the participants will 
have an informational session on the proper use of AA website and TACAD (with instructions on headsets) by 
phone and/or a webcam. During the intervention, the participants will provide their feedback on the research 
process as well as TACAD. Two weeks before the end of the 1st and the 3rd months, both groups will fill out the 
next set of the instruments; it usually takes about 30 minutes to complete each questionnaire. The questionnaires 
will be provided via Qualtrics. In addition, during the intervention period, the participants will be screened using 
the PHQ-9 only if the research team identifies severe depressive symptoms or suicidal ideation at any time point. 
We will make immediate recommendations for psychiatric referral for those with scores more than 10 on the 
PHQ-9 (the cut-point of moderate depressive symptoms; range=0~27) as the literature suggests107–110In such 
cases, participants will also be dismissed from the study. 
 
TACAD. TACAD has four components in three languages (English, Mandarin Chinese, and Korean): (a) 2 sub-ethnic 
specific social media sites; (b) interactive online educational modules; (c) online resources; and (d) a 360 degree 
video clipping (a replacement of the VR component that was originally planned). The original VR that we planned 
to use was discontinued by the developer and only a 360 degree video clipping of the VR component is currently 
available. Thus, the VR component was replaced with the 360 degree video clipping of the VR.  Two languages 
other than English were adopted because they are the primary languages of Chinese Americans or Korean 
Americans. The comparability of different language versions has been ensured through the standard-back 

 
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translation process. The social media sites will be assisted, coached/moderated, and monitored by culturally 
matched bilingual RNs under the supervision by PIs. Coaching/support through social mediate sites (with chat 
functions) will focus on: (a) changing attitudes toward and beliefs about AD and caregiving, (b) building self-
efficacy for caregiving, (c) minimizing information needs and uncertainty, and (d) enhancing social support through 
multiple ways. Within the project website, a social media site (like Facebook) is included. The site is developed by 
Dr. Wonshik Chee and owned by him. The participants’ activities are daily monitored by the interventionists and 
Dr. Chee to prevent any possible harmful effects. The RNs will be trained by the PI. Her/his first 10 messages 
through social media sites and chat functions will be monitored/evaluated by the research team, and the team’s 
feedback will be incorporated into her/his subsequent interactions.  The social media site will be very similar to 
Facebook.  All participants can post their messages (e.g., sharing their experience) and pictures and they can see 
others’ postings. The participants will use their pseudonyms that they choose when they join the study, but their 
profile pictures will not be posted. All postings will be visible only at the project website. No identifiers will be used 
except pseudonyms. We also developed online educational modules while considering the women’s cultural 
attitudes found in the literature: TACAD aims to correct misinformation on AD and caregiving by providing state-
of-science evidence-based educational content and to provide examples of culturally appropriate caregiving 
strategies that can be easily adopted. Culturally relevant content (e.g., filial piety, respect for elderly, mind-body 
interactions, etc.) and culturally tailored educational materials and online resources from Asian scientific 
authorities are also incorporated. Again,  360 degree video clipping components based on “A Walk Through 
Dementia (WTD)” will be used to help caregivers learn more about the challenges their loved ones with dementia 
face, and to build empathy among the caregivers (subsequently changing their attitudes). WTD uses VR technology 
to give an idea of the challenges faced by people with dementia. Using 3 everyday scenarios (at the supermarket, 
on the road and at home), users are given insight into some of the symptoms that people with different forms of 
dementia including AD may experience. The original VR that we planned to use was discontinued by the developer 
and only 360 degree video clippings of the VR component is currently available.  Thus, the VR component was 
replaced with the 360 degree video clippings of the VR. The 360 degree video clippings basically have the same 
content of the VR component without the 3-dimentionality, which could be just viewed through Youtube site 
without any device. They are: 
A Walk Through Dementia - walking home (3 minutes 20 seconds) 
https://www.youtube.com/watch?v=R-Rcbj_qR4g&ab_channel=AlzheimersResearchUK). 
 
A Walk Through Dementia - at the supermarket (4 minutes 52 seconds) 
https://www.youtube.com/watch?v=TaeNgo8bR2k&ab_channel=AlzheimersResearchUK 
  
A Walk Through Dementia - at home (2 minutes 34 seconds) 
https://www.youtube.com/watch?v=2EO7Dh3fM7Y&ab_channel=AlzheimersResearchUK 
 
TACAD also has self-adaptation functionality based on Genetic Algorithm such that the program can deliver the 
most relevant and effective educational modules and online resources to each participant by using a machine 
learning method. Cultural tailoring was theoretically guided by the criteria for rigor in cross-cultural research.65 
Based on the criteria, TACAD incorporated specific components to: (a) respect cultural uniqueness; (b) understand 
cultural contexts; (c) use cultural examples; (d) have flexibility; (e) adopt multiple languages; (f) have culturally 
matched bilingual research team members; and (f) engage community consultants and research participants. 
Presentation styles were tailored to Asian culture. Through the process, both surface and in-depth cultural 
tailoring was done. TACAD used a free-form matrix information architecture91 and included menus based on the 
four components. Graphic User Interface controls,92 the Ruby on Rails (ROR)93 framework, and the Xen hypervisor94 
were used. Due to the use of ROR, different language versions could be easily added to the program, and cultural 

 
Page 10 of 37 
 
tailoring methods used in this program could been easily adopted to different sub-ethnic groups. All the usages of 
different components will be automatically recorded in the server, which will allow the evaluation of different 
components. For instance, the usages of individual educational modules will be recorded on the server, so the 
association of the usages of specific modules to outcome variables could be easily determined later. To assess 
contamination, we will gauge crosstalk by open-ended questions about it at T1&2. We will estimate its effects 
statistically by testing if intervention effects are weaker among those who crosstalk.  
 
Alzheimer’s Association (AA) Website. The AA website has information in various areas related to AD and 
caregiving 
(https://act.alz.org/site/Donation2?df_id=51079&51079.donation=form1&mfc_pref=T&utm_source=google&ut
m_medium=paidsearch&utm_campaign=giving_google&s_subsrc=giving_google&gad=1&gclid=CjwKCAjw8symB
hAqEiwAaTA__CfaR61oNeY9mrdwZRbCKeviZPR7UdFVXpPJaAoSv8GavnyaFx0nxhoCH6EQAvD_BwE).  
For instance, the webpage on caregiving includes information on caregiving, care option, financial/legal planning, 
caregiver health, daily care, stages and behaviors, and safety. The content will be available in the three languages 
at the project website. The usages of the AA website and additional information searches (the participants will 
use them only through the project website) will be automatically recorded through the project server and later 
used for data analyses. Both groups will be asked to maintain their usual care. The interventionists will weekly 
remind the control group to use the AA website.  
 
Instruments. The instruments to measure caregivers’ health outcomes (primary outcomes; Hypothesis 1) include: 
(a) Multidimensional Caregiver Strain Index,2 Perceived Stress Scale,3 Acculturation Stress Scale (ASS),148 and Social 
Readjustment Rating Scale (SRRS) 149 (to measure stress); (b) the Women’s Symptom Index150 (to measure physical 
and psychological symptoms); and (c) EQ-5D-5L151–154(to measure the quality of life). The instruments to measure 
care recipients’ health outcomes (primary outcomes; Hypothesis 1) will include: (a) Informant Questionnaire on 
Cognitive Decline in the Elderly (IQCODE)155,156(to measure the cognitive status of care recipients); (b) Lawton 
ADL/IADL Scale157 (to measure PLAD’s activities of daily life); (c) Revised Memory and Behavior Problem Checklist158 
(to measure behavioral and psychological symptoms of care recipients); (d) Neuropsychological Inventory 
Questionnaire159 (to measure care recipients’ mood status); and (e) Quality of Life Scale in Alzheimer’s Disease160 (to 
measure care recipients’ quality of life). The instruments to measure caregiving experience (secondary outcomes; 
Hypothesis 2) will include: (a) Caregiver Activity Survey1 (to measure caregiving activity); (b) Ways of Coping Scale161 
(to measure  coping); (b) Pearlin Mastery, Loss, and Competence Scale162 (to measure caregivers’ mastery of 
caregiving competence); and (c) Caregiver Assessment of Behavioral Skill Scale (to measure caregiving skills).163 The 
theory-based variables (attitudes, self-efficacy, perceived barriers, & social influences; Hypothesis 3) will be 
measured using the modified Questions on Attitudes, Subjective Norm, Perceived Behavioral Control, and 
Behavioral Intention (QASPB).164 Covariates that will be considered in determining the effect of TACAD on outcome 
variables include caregivers’ sociodemographic characteristics and caregiving history (e.g., socioeconomic status, 
PLAD information, length of caregiving, co-residence with recipient). The reliability and validity of all the instruments 
have been established among Asian Americans. Cronbach’s alpha of the instruments ranged from .70 to .96 among 
Asian Americans. Because no existing instruments have culture-specific measures, we will add open ended questions 
to all the measures to explore culture specific aspects that are missing in the specific measures. The same 
questionnaire will be used at the three time points except the questions on sociodemographic characteristics and 
caregiving history (e.g., socioeconomic status, PLAD information, length of caregiving, co-residence with recipient). 
The questions on sociodemographic characteristics and caregiving history (e.g., socioeconomic status, PLAD 
information, length of caregiving, co-residence with recipient) will be asked only at the pre-test. This has been 
clarified on p. 10. 
 
The final versions of all materials will be uploaded via Modification for IRB review prior to any implementation. All 
communication/reminder templates will be uploaded via Modification prior to administration. 
 

 
Page 11 of 37 
 
 
 
 
 
 
SUBJECT POPULATION 
 
12 
Protected Subject Populations 
Click on the check box (or double click and type an “X” if using Google Docs) each population, if they are 
specifically studied for this research. 
 
 
☐ 
 
Active Military 
Personnel 
☐ 
 
Children/Minors 
 
☐ 
 
Decisionally Impaired Adults 
 
 
☐ 
 
Emancipated Minors 
 
☐ 
 
Fetuses 
 
☐ 
 
Individuals with Limited 
English Proficiency 
 
☐ 
 
Neonates (Uncertain 
Viability) 
☐ 
 
Neonates (Non-
Viable) 
☐ 
 
Prisoners 
 
 
☐ 
 
Pregnant Women 
 
☐ 
 
UT Staff/Employees 
 
 
☐ 
 
UT Students 
 
 
13 Research Participant Information 
Describe the general characteristics of the subject populations or groups including gender, health status, and 
any other relevant characteristics. If you have multiple research populations (e.g., teachers and students), 
clearly outline characteristics for each group. 
 
 
Asian American women who are family caregivers of persons living with Alzheimer’s Disease 
 
 
 
b Minimum Age 
Include the minimum age range for target population. If you have multiple research populations (e.g., teachers 
and students), clearly state the minimum age for each group.  
  
 18 years old 
 
  
c Maximum Age 

 
Page 12 of 37 
 
 
 
Include the maximum age range for target population. If you have multiple research populations (e.g., teachers 
and students), clearly state maximum age for each group. 
  
  
  
d Inclusion Criteria 
Describe the specific criteria that will be used to decide who will be INCLUDED in the research from interested or 
potential subjects. Define technical terms in lay language, as applicable. 
  
 Participants will be included if, by self-report, they are Asian American women who identify as Chinese or 
Korean; are caregivers of PLAD; can read and write English, Mandarin Chinese or Korean; and have access to 
the Internet through computers or mobile devices. Participants must be providing assistance for the PLAD in 
the early-middle stage of illness (Clinical Dementia Rating of ³ 1) for whom there is no plan for 
institutionalization in six months. Caregivers may or may not reside with their care recipient.  
 
  
e Exclusion Criteria 
Describe the specific criteria that will be used to decide who will be EXCLUDED from the research. Define 
technical terms in lay language, as applicable.  
  
 Those who used the AA website previously and/or participated in other studies related to AD will be excluded.  
Men are excluded because the intervention was designed for Asian American women who are family caregivers 
of persons living with Alzheimer’s Disease.   
 
  
14 Total Sample Size 
Enter the total target sample size below.  
 
 
60 
 
15 
Sample size rationale 
Describe your sample size rational below.  
 
 
 
To test Hypotheses 1 to 3 (Aim 2), with 80% power and a type I error rate equal to 0.00625 to account for 9 
outcome measures modeled within two hypotheses, group sample sizes of 105 each will have enough power to 
detect a difference of 0.5 between group means overall in the follow-up period. However, considering the 
proposed study period, limited budget, and the inherent explorative nature of the study, we will include only 60 
(30 per group) women; 30 will be adequate for a pilot intervention study.100  

 
Page 13 of 37 
 
SCREENING AND RECRUITMENT 
 
17 
Identification and/or Screening Procedures 
Describe the identification and/or screening procedures below. 
 
 
When potential participants visit the project website after seeing the study announcements posted on online 
and offline communities/groups, they will be provided with the information sheet (consent form) and asked to 
give their consent by clicking the “I agree to participate” button. Then, when they agree, they will be verified 
against the inclusion and exclusion criteria (see the above) by server-side programs. When they meet the criteria, 
they will be asked about their sub-ethnicity. Then, the potential participants will be divided into Chinese and 
Korean, and randomized into two groups using an automated random number generator via the project website.   
 
 
19 
Describe the recruitment process, including where recruitment will take 
place. 
Describe recruitment procedures in the box below. Describe all elements checked above to provide a complete 
understanding of the recruitment strategies/methods.  
NOTE: Upload copies of all recruitment materials to UTRMS-IRB in the “Recruitment Materials” section.      
 
16 
Identification and Screening 
 
Check the box below if this study involves a screening process prior to the informed consent process.   
 
 
☐ This study involves obtaining information or biospecimens for the purpose of 
screening, recruiting or determining eligibility of prospective subjects prior to 
informed consent by either: 
1. Oral or written communication with the prospective subject or LAR 
2. By accessing records containing identifiable private information or stored 
identifiable biospecimens. 
18 
Recruitment Overview 
 
Check box indicating all recruitment methods utilized for this research. 
 
 
☒ 
E-mail 
☒ Flyer 
 
☒ 
In-Person 
☐ Letter 
 
☒ 
Social Media 
☐ Research Pool 
 
☐ 
Telephone/Text 
☒ Snowball Sampling 
 
☒ 
Web-post 
☒ Word of Mouth 

 
Page 14 of 37 
 
 
The settings will be online and offline communities/groups for Asian Americans. About 97% of Asian Americans 
have access to the Internet and regularly use it.47, Thus, a technology-based intervention will likely have larger 
public health effect for this group than others. Both the literature55, 56, 57 and PSs also support that nationally 
recruiting and retaining AACA through the Internet is feasible and highly effective. In a Google search, over 48 
million online groups for Asian Americans were retrieved (with up to over 1,000 members). Yet, Asians are also 
well known about their hesitance to participate in a research study.72 Thus, offline communities/groups for Asian 
Americans (e.g., clinics, churches) will also be targeted, which allows to recruit those who do not use online 
groups. Racial/ethnic minorities are more successfully recruited in churches and support/social groups with 
culturally specific memberships.99 When offline communities/groups for Asian Americans were searched with 
Google, over 4 million sites were retrieved (with up to 30,298 members). Thus, we do not expect any difficulties 
in recruiting 60 participants through these settings (see Recruitment & Retention plan). The study will be 
announced through their sites, listservs, instant messaging, flyers, snowball sampling, and word of mouth after 
obtaining the permission to post the study announcements through online and offline communities/groups.  In 
addition, Facebook groups related to Alzheimer’s Disease will also be contacted for study announcements. We 
will also recruit from the Collaborative Approach for Asian Americans & Pacific Islanders Research & Education 
(CARE) Registry (UCSF IRB No.23-39121). The final recruitment materials will be updated and provided via 
Modification prior to administration. 
 
In addition, the announcements for recruitment will be posted on the feed on the @utnursing_research 
Instagram.  Please note that the research team will not post anything regarding the study on their personal 
account. 
 
OBTAINING INFORMED CONSENT 
 
20 
Consent Overview 
 
Check the box(es) for consenting procedures that will be used.  
 
 
☐ 
Obtaining Written Informed 
Consent/Parental Permission 
 
☒ Requesting a Waiver of Documentation of 
Informed Consent 
 
 
☐ 
Requesting a Waiver of 
Informed Consent 
 
☐ Requesting an Alteration of the Required 
Elements of Informed Consent 
 
 
☐ 
Obtaining Child Assent 
 
☐ Obtain Consent Using a Short Form with a 
Witness 
21 
Consent and Assent Processes 
 
Provide a detailed description of consent/assent procedures in the box below. Include: who will obtain consent, 
where will consent be obtained, how is consent obtained, how consent/assent is documented, and when the 

 
Page 15 of 37 
 
 
consent process will occur in such a manner that participants will have sufficient time for adequate 
consideration.   
NOTE: Upload copies of all consent/assent/permission forms/scripts to UTRMS-IRB in the “Consent Forms” 
section. This is required for UTRMS-IRB to appropriately stamp consent forms for approval.  
 
 
When potential participants visit the project Web site, they will be asked to review the informed consent form 
that provides general information on the proposed project, including: (a) the purpose of the study, (b) staff on 
the study, (c) the data collection period, (d) potential physical and psychological risks involving inconvenience, 
confidentiality, and invasion of privacy, (e) their rights to withdraw, (f) how to maintain complete 
confidentiality (using IDs and passwords), (g) what they are being asked to contribute to the study, and (h) how 
their participation will be reimbursed. They will be asked to give their consent to participate by clicking I agree 
to participate. When the button is clicked, participants’ profiles will be checked against the inclusion and 
exclusion criteria. Internet protocol addresses of the participants will also be monitored to detect multiple 
submissions by the same person. After getting the consent, the participants will be linked to the Qualtrics 
system to go through the screening process and fill out the pre-test questionnaire. 
 
When participants give their consent to participate in the study, they will be informed that the data collected 
during the study will remain confidential unless a participant appears at risk for harming herself or others. The 
informed consent form will include checkboxes next to each risk statement in red font that participants must 
check to indicate that they have read it. Also, the informed consent form on the Web site will include e-mail 
addresses for the PI and research staff under the question “Do you have any questions?” Thus, participants will 
be able to send an e-mail directly to the PI and/or research staff with their questions. E-mail will be answered 
within 24 hours on weekdays and 48 hours on weekends. In addition, participants will be able to call the 
research office using the phone number provided on the informed consent form (next to the risk statements), 
which will also be responded to within 24 hours on weekdays and 48 hours on weekends. The risks involved in 
the proposed study will not be more than those usually faced in daily life. 
 
The reason for obtaining online consent (waiving the signed written consent) is multiple. First, we believe that 
it is unnecessary to meet with participants or to mail hard copies of the informed consent form for the sole 
purpose of obtaining signed written consent. Second, obtaining signed written consent from the participants 
across the nation raises a feasibility issue related to mailing and possible follow-up phone calls. Third, previous 
studies indicated that Asian Americans did not wish to sign a written consent for a historical reason: for 
instance, in Korea, data from surveys were once used to identify tax fraud, and some people’s honest answers 
on the survey were used to assess an additional tax.72 This Internet-based consent process has been used in all 
preliminary studies without any issues or concerns from participants or research staff members. The 
preliminary studies that compared the pen-and-pencil survey with the Internet survey questionnaire showed 
that the Internet-based consent process was similar to that of the pen-and-pencil survey in terms of its ability 
to explain the study and respond to questions from participants.112 Interestingly, some participants in 
preliminary studies indicated that they preferred Internet communications to ask questions about the study 
because Internet communications are asynchronous (they could ask questions at any time) and e-mail is a 
written form of communication. 
 
22 
Electronic Consent  
 
Check the box below if this study involves obtaining consent with an electronic signature. Be sure the section 
above is consistent.  
NOTE: This box should NOT be checked participants are responding “yes” or clicking “I Agree” on a consent 
form. This section should only be completed if an electronic signature is being obtained.  
 

 
Page 16 of 37 
 
 
 
 
☐ 
This study involves documenting informed consent/parental permission using 
an electronic signature.  
 
 
 
If true, specify method for obtaining e-consent below (e.g., DocuSign): 
 
 
 
      
 
23 
Consent and Translation 
Check the box below to indicate that consent documents/scripts will be translated to a language other than 
English.  
 
 
 
☒ 
The study population will likely include participants whose limited English 
speaking status requires translation of the consent form. 
 
 
 
Translation Process 
If above is checked, complete the below information describing the translation process. Either A or B 
must be checked. 
 
 
A 
☐ 
The consent documents will be translated by a certified translator. 
 
 
B 
☒ 
A non-certified translator will translate the consent documents. 
If selected, complete the next two items below. Section describing qualifications must be 
completed and backtranslation (ii) must be true.  
 
 
 
i 
Describe the translator’s qualifications 
To input text, click in the light grey area below. 
 
 
 
 
Bilingual graduate students at School of Public Health, Emory University, have already 
translated and got certified at Emory Univ. For each language, at least two bilingual 
graduate students were involved in the standard-back translation process. 
 
 
 
 
 
 
 
ii 
☒ 
Another individual will confirm that the translation is accurate and 
appropriate  
 
26 
Waiver of Documentation of Informed Consent  
 
Only complete this section if a waiver of documentation of consent is requested (checked above in #21). To 
approve a waiver of documentation of consent, one of the following options must be appropriate and justified 
by the researcher.  

 
Page 17 of 37 
 
Please choose one waiver option and provide additional information as prompted.  Waiver option 2 is most 
common.  
 
 
A Waiver Option 1 
 
 
Check the box below for each item (all required – #1-4) and provide protocol-specific information as to 
how the criteria below are met.    
NOTE: This is the only applicable waiver of documentation option for greater than minimal risk 
research. If your study is greater than minimal risk and does not meet Option 1 criteria, you will need 
to obtain written consent.   
 
1 ☐ 
 
The only record linking the subject and the research would be the consent 
document. 
 
 
i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
  
 
 
  
 
2 ☐ 
 
The principal risk would be potential harm resulting from a breach of 
confidentiality. 
 
 
i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
       
 
 
 
 
 
3 ☐ 
 
Each subject will be asked whether the subject wants documentation 
linking the subject with the research, and the subject’s wishes will govern. 
 
 
 
i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
       
 
 
 
 
 
4 ☐ Describe the mechanism for documenting that informed consent was 
obtained 
 
  
Briefly explain how the researcher will document that consent was obtained from participants.  
 
  
      
 
 
 
 

 
Page 18 of 37 
 
 
B Waiver Option 2 
 
Check the box below for each item (all required – 1-3) and provide protocol-specific information as to 
how the criteria below are met.    
 
1 ☒ 
 
The study is minimal risk. 
 
 
i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
 
This is an online educational and behavioral change intervention study with minimal risk. The 
participants will participate in the study only through the project website using pseudonym and 
passwords.  
 
 
 
  
 
2 ☒ 
 
Written consent would not be required outside the research context. 
 
 
i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
 
The participants will participate in the study only through the project website using pseudonym 
and passwords.  They will just need to click “I agree to participate” through the project website. 
 
 
 
 
  
 
3 ☒ Describe the mechanism for documenting that informed consent was 
obtained 
 
  
Briefly explain how the researcher will document that consent was obtained from participants. To 
input text, click in the light grey area below. 
 
 
i 
The participants will participate in the study only through the project website using pseudonym 
and passwords.  They will just need to click “I agree to participate” through the project website. 
 
 
 
  
 
 
C Waiver Option 3 
 
Check the box below for each item (all required – 1-4) and provide protocol-specific information as to 
how the criteria below are met.    
 
1 ☐ 
 
The subjects or legally authorized representatives are members of a distinct 
cultural group or community in which signing forms is not the norm 
 
 
i 
Describe the cultural group or community. 

 
Page 19 of 37 
 
 
 
 
 
      
 
 
 
 
2 ☐ 
 
The research presents no more than minimal risk of harm to subjects. 
 
 
i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
       
 
 
 
  
 
3 ☐ 
 
There is an appropriate alternative mechanism for documenting that 
informed consent was obtained. 
 
 
 
i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
       
 
 
 
  
 
4 Describe mechanism for documenting that informed consent was obtained 
To input text, click in the light grey area below 
 
       
 
27 
Waiver or Alteration of Informed Consent  
 
Only complete this section if a waiver or alteration of consent is requested. To approve a waiver or alteration 
of consent, all of the following criteria must be appropriate and justified by the researcher. All boxes must be 
checked.  
SKIP THIS SECTION IF NOT REQUESTING A WAIVER/ALTERATION OF CONSENT 
 
 
A 
☐ 
 
The research involves no more than minimal risk to the subjects.  
 
 
i 
Provide protocol specific information as to how this criterion is met.  
 
 
 
To input text, click in the light grey area below 
 
 
 
      
 

 
Page 20 of 37 
 
 
 
 
 
 
 
B 
☐ 
 
The waiver or alteration will not adversely affect the rights and welfare of 
the subjects.  
 
 
 
i 
Provide protocol specific information as to how this criterion is met.  
 
 
 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
 
C 
☐ 
 
The research could not practicably be carried out without the waiver or 
alteration (it is impracticable to perform the research if obtaining consent 
is required and not just impracticable to obtain consent).  
 
 
 
i 
Provide protocol specific information as to how this criterion is met.  
 
 
 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
 
D 
☐ 
 
If the research involves using identifiable private information or 
identifiable biospecimens, the research could not practicably be carried 
out without using such information or biospecimens in an identifiable 
format.  
 
 
 
i 
Provide protocol specific information as to how this criterion is met.  
 
 
 
To input text, click in the light grey area below. 
 
 
 
      
 
28 Deception/Incomplete Disclosure and Debriefing 
Only complete the sections below if requesting an alteration of informed consent for research that involves 
deception/incomplete disclosure.  
Deception (as applies to research) means intentionally giving research subjects false information in order to 
establish false beliefs during the course of a research study. 
Incomplete disclosure means that the principal investigator withholds some information about the real purpose of 
the study or the nature of the research procedures. 
See IRB Policies and Procedures Section 15 for a description of deception. 
If this study does not involve deception/incomplete disclosure, skip this section. 
 

 
Page 21 of 37 
 
BENEFITS 
29 
Benefits to Society 
Describe the scientific and societal benefit(s) below. 
 
 
The information that the participants provide will assist health care providers in developing and refining 
technology-based information and coaching/support programs for racial/ethnic minorities, which will ultimately 
benefit the society. 
 
30 
Potential Direct Benefits to Participants 
Click on the applicable check box. A or B must be checked.  
 
 
A 
☒ 
There is no anticipated direct benefit to participants. 
 
 
B 
☐ 
There are anticipated benefits to participants. 
 
 
 
i 
If applicable, describe the potential direct benefits to participants. 
 
A 
☐ It is appropriate to provide additional pertinent information to the subject 
after research activities are complete (e.g., the researcher needed to deceive 
the subject to the nature of the study). 
 
 
B 
☐ Research participants will have the opportunity to withdrawal their data 
during the debriefing. 
 
 
C 
Describe the nature of deception/incomplete disclosure and why it is necessary 
to conduct the research. 
To input text, click in the light grey area below. 
 
 
      
 
 
 
 
 
D 
Describe debriefing procedures. 
To input text, click in the light grey area below. NOTE: Upload the debriefing form to UTRMS-IRB in the 
“Consent Forms” section.  
 
 
      
 

 
Page 22 of 37 
 
 
 
 
Describe potential direct benefits to participants below.  
 
RISKS 
31 
Describe the risks associated with each activity in this research 
To input text, click in the light grey area below. Note: Risks should also be outlined in the consent form(s).  
 
 
 This study poses minimal risks to participants, and the probability and magnitude of harm or discomfort 
anticipated in the proposed study are no greater, in and of themselves, than those ordinarily encountered in 
daily life. As in other traditional survey studies, participation in this study may be an inconvenience, and some 
of the questions may make research participants uncomfortable or upset. In addition, because internet 
communications are not 100% safe, and despite our efforts to ensure safe and secure internet communications, 
participation in online data collection may pose an added risk of the invasion of privacy and possible violations 
of confidentiality. Even with the most sophisticated technologies, there is always a possibility of hacking by 
outsiders. 
 
 
 
32 
Describe how each risk is mitigated/minimized. 
To input text, click in the light grey area below. Note: Risks mitigation should be outlined in the consent form(s), 
as applicable.  
 
 
Data collected through email and the Internet will remain confidential unless a participant appears at risk of 
harm. All the activities will be automatically recorded on the servers. All the online interactions will be daily 
monitored by the engineering PI, Dr. Chee, and by RN interventionists with consultation of a MD (Dr. Mao). 
During implementation, all research team members will meet weekly to monitor the research process, monitor 
the daily online records of the program usages and data collection progress, monitor participant adherence, and 
address any issues that arise, and consult as necessary with consultants.  
   All e-mail communication between participants and the research team will be kept confidential by saving e-
mails on a firewall-protected computer that will be accessible only to research team members using passwords 
and will be kept in a locked research lab. Also, at the completion of the study, the saved e-mails will be 
permanently destroyed to ensure confidentiality. In addition, as described below, e-mail addresses will be used 
only for reminders and participation reimbursement, and will be kept separate from other participant data. 
Furthermore, their email addresses will be accessed only by the research team, and the participants can 
communicate with other participants only through the social media sites (no email address will be disclosed to 
other participants). 
   We have multiple strategies to check and monitor any potential health risks including depressive symptoms 
or suicidal ideation. First, when the participants select “yes” to the question on other diagnosed diseases at pre-
test, they will be asked to specify the diseases on the questionnaire. Although the proposed study mainly 
depends on self-reports and we do not include clinicians’ evaluation of each participant, the detailed screening 
questions will definitely check for specific symptoms that may indicate any medical conditions that may place 
participants at risk. Then, before participating in the study, participants will be asked if they have a regular source 
 
 
 
      
 

 
Page 23 of 37 
 
of healthcare so that the research team can refer them if an adverse event is identified during the data collection 
process. If participants do not have a regular source of healthcare, then the researcher will provide a list of 
nearby clinics or healthcare centers so they can go to for emergency healthcare, if needed.  During the data 
collection process, online records of the intervention process will be monitored daily by the engineering PI, Dr. 
Chee, to ensure data safety and security. Also, the records will be monitored daily by the interventionists who 
are RNs in consultation with a MD (Dr. Mao) and a NP (Dr. Brewster), and any potential and actual medical risks 
and adverse reactions (e.g., severe depressive symptoms or suicidal ideation, etc.) will be identified. For effective 
communication during emergency situations, the research team will establish emergency communication 
channels before starting the study. In addition, during the intervention period, the participants will be screened 
using the PHQ-9 only if the research team identifies severe depressive symptoms or suicidal ideation. We will 
make immediate recommendations for psychiatric referral for those with scores more than 10 on the PHQ-9 (the 
cut-point of moderate depressive symptoms; range=0~27) as the literature suggests107–110In such cases, 
participants will also be dismissed from the study. Participants in both intervention and control groups will be 
encouraged to seek mental health help if and when necessary. Also, we will provide the participants with local 
mental health referrals and contact information for the National Suicide Prevention Lifeline (NSPI; 1-800-273-
8255) or the crisis text line. If a participant is in imminent danger to self or others (at any time during the study), 
a proper authority (local police or dial 911) will be notified to ensure the individual’s safety. Also, a participant’s 
family may be notified with the participant's permission. Family members will be offered the fact sheet 
developed by the National Institute of Mental Health (NIMH),111 and RN interventionists will help them learn 
about the signs and symptoms, risk factors, and warning signs of suicide.  
 
All communication/reminder templates will be uploaded via Modification prior to administration. 
 
 
 
 
 
33 
Data Safety Monitoring 
For additional information regarding data safety monitoring boards and data safety monitoring plans, please 
see Section 21 of our Policies and Procedures. 
One of the following must be checked (A, B, or C).  
 
 
A 
☐ 
 
In the investigator’s opinion, this study is minimal risk and does not 
require a Data Safety Monitoring Plan (DSMP) or a Data Safety 
Monitoring Board (DMSB). 
PLEASE NOTE: The IRB may determine minimal risk studies do require data safety monitoring 
under certain circumstances (e.g., if there is a known risk with an expected frequency).  
 
 
B 
☒ 
 
This study does not have a Data Safety Monitoring Board, but 
researchers have an internal plan to monitor for safety (Data Safety 
Monitoring Plan (DSMP)). 
Complete Data Safety Monitoring Details  
 
 
C 
☐ 
 
This study has a Data Safety Monitoring Board (DSMB). 
Complete Data Safety Monitoring Details section below or upload this study’s Data Safety 
Monitoring Board’s charter that contains the information below.  
 

 
Page 24 of 37 
 
 
34 
Data Safety Monitoring (Details) 
Complete this section if the study has a Data Safety Monitoring Plan. SKIP this section there is not a 
DSMP/DSMB. 
If the study has a DSMB, ensure all items below are addressed in the charter (and charted uploaded to UTRMS-
IRB) or provide additional information below, as needed.  
 
 
A 
How is safety information collected? 
To input text, click in the light grey area below. 
 
 
 
All the activities for the intervention and for the retention strategies will be automatically recorded in 
the servers. All the online interactions will be monitored daily by the engineering PI, Dr. Chee and by 
RN interventionists with consultation from a medical doctor (Dr. Mao). During the intervention process, 
the research team will meet weekly to monitor the research process, the daily online record of program 
uses, data collection progress, and participant adherence; to address any issues that arise; and to 
consult as necessary with consultants.  
 
 
 
 
 
B 
When will safety data collection start (for each participant or for the whole 
study, as applicable)? 
To input text, click in the light grey area below. 
 
 
 
From the point that each participant is enrolled with the project website. 
 
 
 
 
 
C 
How frequently will safety data be collected? 
To input text, click in the light grey area below. 
 
 
 
All the activities for the intervention and for the retention strategies will be automatically recorded in 
the servers (24 hours for 7 days per week). 
 
 
 
 
 
D 
Who will review the data for safety? 
To input text, click in the light grey area below. 
 
 
 
All the online interactions will be monitored daily by the engineering PI, Dr. Chee and by RN 
interventionists with consultation from a medical doctor and a nurse practitioner. Dr. Jun Mao 
(medical doctor) and Dr. Glenna Brewster (nurse practitioner) are consultants of the study. Only the 
interventionists will interact with the participants, and they will get consultation and advice from 
these two doctors. 
 
 
 
 
 
E 
How frequently will data be monitored for safety concerns? 
To input text, click in the light grey area below. 

 
Page 25 of 37 
 
 
 
 
All the online interactions will be monitored daily by the engineering PI, Dr. Chee and by RN 
interventionists with consultation from a medical doctor.  
 
 
 
 
F 
What data will be reviewed? 
To input text, click in the light grey area below. 
 
 
 
The research process, the daily online record of program uses, data collection progress, and 
participant adherence.       
 
 
 
 
 
G 
State the frequency or periodicity of the review of cumulative data. 
To input text, click in the light grey area below. 
 
 
 
Through weekly research team meetings. 
 
 
 
 
 
H 
State any conditions that would trigger an immediate suspension of the 
research. 
To input text, click in the light grey area below. 
 
 
 
Nonspecific for this study. The study will follow the NIH policies and regulations. 
 
35 
Early Withdrawal 
Only complete this section if there are planned conditions under which a participant will be withdrawn from 
the study. If not applicable, skip to next section. Include this information in your consent form. 
 
 
A 
List the criteria for withdrawing individual participants from the study (e.g., 
safety or toxicity concerns, emotional distress, inability to comply with the 
protocol, or requirements from study sponsor). 
To input text, click in the light grey area below. 
 
 
 
While the participants fill out the questionnaire, several random questions that they have already 
answered will be repeated to check consistency for the purpose of identity and authenticity 
verification. When inconsistency is detected, the participant will not be allowed to continue her 
participation in the study. This mechanism has been used in the former studies of the PIs without a 
problem. 
 
The participants have the right to leave a study at any time without penalty.  If they want to withdraw, 
they need to send an email notification or a text message indicating their withdrawal to the research 
team. Participation is voluntary, refusal to participate will involve no penalty or 
loss of benefits to which the subject is otherwise entitled, and the subject may discontinue 
participation at any time without penalty or loss of benefits to which the subject is otherwise 

 
Page 26 of 37 
 
entitled. New findings developed during the course of the research that may affect the subject's 
willingness to continue to participate will be provided to the subject. 
 
 
 
 
 
B 
Describe any necessary procedures for ensuring the safety of a participant 
who has withdrawn early. 
To input text, click in the light grey area below. 
 
 
 
Those who withdraw will be encouraged to seek mental health help if and when necessary, but no 
further actions from the research team after they withdraw. 
 
 
 
36 
Describe any pre-specified criteria for stopping or changing the study protocol due 
to safety concerns. 
To input text, click in the light grey area below. 
 
 
None specific for this study. The study will follow the NIH policies and regulations. 
 
REQUIRED DISCLOSURES 
37 
Required Consent Disclosures  
 
Identify each element below that may require additional information to be disclosed in the consent form. 
Click on the check box (or double click and type an “X” if using Google Docs).  
 
 
A 
☐ It is reasonable that researchers could discover or suspect child or elder abuse. 
Add appropriate disclosure in consent form(s). 
 
 
B 
☐ It is reasonable that researchers could learn of an incident that could require 
reporting under Title IX. 
Add appropriate disclosure in consent form(s). See Title IX and Research Guidance for information and 
download the Title IX Reporting Form on the Special Topics page.  
 
 
C 
☐ It is reasonable that researchers could discover incidental findings or other 
information of medical interest about a participant's previously unknown 
condition. 
Add appropriate language to consent form(s).  
 
 
 
i 
Articulate methods for addressing and reporting incidental findings, if 
applicable. 
Ensure appropriate information is in consent form(s), as applicable.  

 
Page 27 of 37 
 
 
PRIVACY AND CONFIDENTIALITY 
 
 
 
 
      
 
38 
Privacy 
Describe how you will protect the identity and privacy of study participants during each phase of research. 
Privacy focuses on the individual participants rather than data. In this section, researchers should focus on 
issues such as where research activities take place and how participant involvement is protected from non-
participants. Describe methods to ensure participants’ privacy during identification, recruitment, screening, the 
consent process, the conduct of the study, and dissemination of data. 
To input text, click in the light grey area below. 
 
 
All the procedures will happen at the project server and website.  The participants will use pseudonym during 
their participation in the intervention components through the project website; research staff members or 
other participants will not be able to identify them. Also, the participants will join the study independently 
through the project website, so non-participants will not know that they join the study. 
 
To manage and protect the data collected, only summary data will be openly accessible to funding agencies or 
will appear in publications. Research participants will be informed that they are free to decline to answer any 
questions they do not wish to answer or to stop participating in the project at any time. When a participant 
withdraws, the data that they have provided will be removed immediately. Also, the data will have no 
identifying information to link a subject to it. The collected data will be recorded in a database using 
postgreSQL. The database backup will be performed daily and will be encrypted. Again, data in the servers will 
be daily monitored by the engineering PI, Dr. Chee, to ensure its safety and security. 
 
39 
Confidentiality and Data Security Plan 
 
Provide general information below regarding confidentiality and data security plan. Provide additional details 
regarding how you will protect the confidentiality of data or address confidentiality concerns.  
Include the following, as applicable:  
• 
If identifiers will be coded to protect confidentiality describe how and where identifiers are stored.  
• 
Describe where and how data is stored and maintained. 
• 
Include details regarding storage of consent forms, if applicable. 
To input text, click in the light grey area below. 
 
 
For safe and secure data collection via the Internet, the project Web site will conform to the HIPAA standards.  
The servers for the project website will be hosted on a HIPAA certified resource provided by UT Austin.  Data 
are backed up according to UT Austin Information Systems Security protocols and procedures and conform to 
NIH research data retention guidelines. A detailed disaster recovery plan is in place and regularly reviewed by 
the University of Texas IT office. 
  The participants' records will be handled as confidentially as possible. Only the research team will have access 
to the study records. The data will be de-identified.  Only a serial ID number assigned by the research team will 

 
Page 28 of 37 
 
 
be attached to the data. Therefore, research participants will not be identifiable directly or through the 
identifying information linked to subjects.  No individual identities will be used in any reports or publications 
that will result from this study.  
  All e-mail communication between participants and the research team will be kept confidential. Email 
addresses will be separately stored from the deidentified data. At the completion of the study, the saved e-
mails will be permanently destroyed to ensure confidentiality. E-mail addresses will be used only for reminders 
and participation reimbursement and will be kept separate from other participant data. 
 
 
 
40 
Research Data/Records Destruction Details  
 
Confirm general research data/information (including consent forms, as applicable) destruction timeline. One of 
the following must be checked.  
 
 
☐ 
Research Data/Records will be retained for 3 years after study completion per 
UT record retention policy.  
 
 
☒ 
Research Data/Records will be retained for longer than 3 years and retention 
information is provided below.  
Describe data retention timeline below. To input text, click in the light grey area below. 
 
 
 
Deidentified data will be retained at the UT Qualtrics system for secondary analyses of the data and for 
data sharing requirements by NIH for 10 years after the completion of the study.  All the data will be 
stored at the UT Qualtrics system. The data with the identifiers will be eliminated when the study is 
completed. 
 
 
 
 
 
41 
Confirm identifiable data destruction details 
One of the following must be checked.  
 
 
☒ 
Identifiable data will be destroyed.  
If checked, ensure the below section describes identifiable data destruction plan and timeline.   
 
 
 
The only identifiable data will be the participants’ email addresses, which will be destroyed after the 
completion of the study (will be kept only for the participant reimbursement and accounting purposes, 
which will not be linked to the data).  The electronic consent will be stored on the project server that will 
be linked only to a serial number attached to the data (no link to ID information). 
 
 
 
 
 
☐ 
Identifiable data will not be destroyed.  
If checked, explain below the rationale for retaining identifiable data indefinitely.  
 
 
 
      
 

 
Page 29 of 37 
 
42 Data Access 
 
Click on the check box (or double click and type an “X” if using Google Docs) for each group of individuals that 
will have access to study data. 
If you plan on creating a repository, complete the repository form as well (download from Library in UTRMS-
IRB). 
 
 
☒ Study Team 
Members 
☒ External Collaborators 
 
☐ Data coordinating center 
 
 
☒ Sponsor 
 
☒ Future Sharing with 
other researchers 
 
 
☐ Others 
Describe below. To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
43 
Describe data sharing plan for each group checked above and state whether 
researchers plan on sharing identifiable, coded, or de-identified data. 
To input text, click in the light grey area below. Ensure that data sharing and future use is addressed in the 
consent form(s).  
 
 
The final data that will be available through the proposed study will be de-identified and the associated 
codebook that defines the data will be available for sharing with other researchers. The data will be available 
for secondary analyses especially by those who wish to investigate the efficacy of the technology-based 
program in various variables other than our major outcome variables. The availability of the data will be 
announced on the project website of the proposed study. Any researcher who wishes to use the data must 
request permission to conduct secondary analyses of the data from the PIs of the proposed study by e-mail or 
regular mail and provide the PIs with a 1-page long abstract (single-spaced) of the proposed analysis and 
her/his CV. The decision on data sharing will be made by the research team, including the PIs, co-investigators, 
and consultants, after they review the abstract and CV. When the research team decides to share the data with 
the researcher, the data in SPSS format, abstract, and original findings of the proposed study will be provided 
to the researcher. The researcher will be requested to: (a) agree that she/he will provide the findings from 
her/his analyses to the PIs at the completion of the analyses, (b) acknowledge the original study and the NIH 
in her/his future publications, and (c) not use the findings from the data for any commercial purposes. This 
agreement will be made in a written form. The data will have no identifying information to link a subject to 
her/his data. The data will be provided to the researcher as a password-protected zipped file that needs to be 
downloaded from a HIPAA certified cloud resource provided by UT Austin.  
 
44 
Certificate of Confidentiality  
Click on the check box (or double click and type an “X” if using Google Docs) to identify each element below that 
may require additional information to be disclosed in the consent form. 
If a Certificate of Confidentiality is not applicable for this study, skip this section.  
 

 
Page 30 of 37 
 
COMPENSATION AND COSTS 
 
 
A 
☒ 
 
NIH has issued a Certificate of Confidentiality for this study. 
 
Ensure CoC language is included in the consent form(s).  
 
 
B 
☐ 
 
A Certificate of Confidentiality has not been obtained, but there are plans to 
apply for one. 
Ensure appropriate CoC language is included in consent form(s). Apply for a CoC for non-NIH funded 
research here: NIH Certificate of Confidentiality System. Once CoC is granted by NIH, you must update 
the consent form language and ensure a copy of the CoC approval (only for non-NIH funded research) 
is uploaded to UTRMS-IRB.  
45 
Compensation  
Click on the check box (or double click and type an “X” if using Google Docs). A or B must be checked.  
 
 
A 
☒ 
 
Subjects receive compensation. 
 
 
 
 
 
 
i ☒ Confirm: Amount of compensation and its form is reasonable for this 
population for the activities requested of them. 
 
 
 
 
 
 
 
ii Total Amount of Compensation  
Include the total amount of compensation below.  
 
 
 
Each participant will receive $50 gift certificates upon completion of pre-test (T0), T1 (post 1 
month), and T2 (post 3-months). The amount was determined based on Preliminary Studies while 
considering the internet and smartphone fees that may occur due to the participation.  
 
 
  
 
 
iii Type of Compensation  
 
 
 
☐ 
 
Cash  
☐ 
 
Check  
☒ 
 
Gift Card 
 
 
 
☐ Course Credit 
☐ ClinCard 
☐ Tango Card 
 
 
 
☐ Other 
 
 
 
 
 
Describe other form of compensation below.  
 
 
 
 
      

 
Page 31 of 37 
 
 
 
References 
 
 
 
 
 
 
 
 
iv Proration Schedule  
Describe the proration schedule for multi-visit/session studies. Skip if not applicable.  
 
 
 
The participants will be paid for the questionnaires completed each time point.  But, they will 
NOT be paid by their participation in the intervention. For instance, if they withdraw after 
completing the pre-test, they will get a gift certificate of $50. If they withdraw after 
completing the post 1-month test, then they will get two gift certificate of $50 (one for pre-
test and the other for post 3-month test).  
 
 
 
 
 
 
B 
☐ 
 
Subjects will not receive compensation. 
 
46 
Costs 
A or B must be checked.  
 
 
 
A 
☒ 
Participants will have no costs associated with this study 
 
 
B 
☐ 
Participants will have the following costs associated with this study.  
 
 
 
 
☐ Standard of care procedures 
contributing to study data 
 
☐ Research procedures not 
associated with standard of 
care 
 
 
 
☐ Administration of drugs / devices  
☐ Study drugs or devices 
 
 
 
 
☐ Transportation and parking  
 
 
 
i 
Describe all costs below. 
To input text, click in the light grey area below. 
 
 
 
 
 
 
 
      
 

 
Page 32 of 37 
 
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