Adaptations to the intervention varied widely: from technology acceptance and consent process concerns to screen/verbiage (in English and Spanish) changes, desire for additional tablet training, and rejection/reselection of educational videos and hours of operation. The sections below describe the general themes and subthemes that emerged from qualitative analyses of 1) the Community Advisory Board and stakeholder committee (patient and provider panel) focus groups, and 2) the focus groups and interviews from the patient pilot test. Additionally, adaptations made to the intervention are discussed.
Community advisory board and stakeholder focus groups
Technology acceptance concerns
During the community needs assessment, a major theme that quickly emerged from clinician stakeholders centered around technology acceptance by the patients. Several clinicians noted that patients would be hesitant to accept the devices into their homes attributable, in large part, to fear that patients and their families could be “watched.” Additionally, clinicians opined that patients in the study population were likely to require help from their extended families to use the technology. These sentiments were echoed in the patient panel, where the importance of having to train patients on using the technology was highlighted.
“But for people that come from a place where the technology didn’t exist, it may be shiny and sparkly, but you have to assume if this is going to be successful that you’re starting from a position where you have to train people from the most basic components of it if we’re going to be successful.”
“The training has to be so basic and so engaging that they don’t feel intimidated by the actual – it’s like when people have a microphone and they never talk. Hey, does this thing work? It’s the same thing.”
Other themes that emerged during the community needs assessment included the importance of access to the nurse, flexibility in scheduling appointments, and using clear policies during recruitment. Furthermore, changes to the intervention tablets included requests for lighter tablets, larger font sizes, a log on or blackout screen for added security, and the need for culturally sensitive components such as language and culturally appropriate videos and food choices.
Tablet interface feedback
During the theater testing of the intervention, three major themes emerged regarding the tablet interface: 1) presentation of the information; 2) language use; and 3) irrelevant information. Patients reported preferences for how the screen should look to best convey the information. Four individuals noted the use of pictures would be more appropriate, given that a significant portion of the study population may be illiterate.
“We could have icons! We have different icons of people doing…”
“Because if we do image and text, I think that would be much more beneficial.”
Additionally, four patients noted that the information displayed was overwhelming and that too much information was being presented per screen.
“I feel like it has too many options.”
“I think we need a clearer dashboard…part of the confusion is that those things, people are not understanding what they are.”
“I think the point is that it’s very busy.”
Finally, participants requested the inclusion of additional examples, particularly regarding what is considered exercise.
“When you’re talking about exercise, I’m thinking about going on a treadmill or maybe I do the garden. And that is considered to be an activity as perfect as to do the treadmill.”
“So, I just think that as long as people know that all of those things [exercise] count, that’s what’s important.”
When reviewing the language used on the tablets, patients noted changes in terminology that should be made to make the instructions more understandable to the study population. It was suggested that language used on the tablets and videos should be at a fourth-grade comprehension level or less and assume a similar level of health literacy.
“A lot of Spanish people they, they use “sugar” [levels] rather than “glucose.””
“So, I don’t know if ‘press’ versus ‘touch’ is the right word….or ‘verify the oxygen level’.
“I’m assuming that’s not a fourth-grade level either for sure.”
Clinicians also identified several instances in which information included on the screens was irrelevant to the current study, thus risking overwhelming the patients. These included requiring patients to measure their temperature daily as well as recording oxygen saturation.
In the final Community Advisory Board focus group, additional changes to the tablet were discussed. Three subthemes were identified: 1) screen or verbiage changes; 2) desire for more training on using the tablet; and 3) video feedback.
Participants noted that translations, despite being adapted once, still needed further refinement. This articulates one of the hallmarks of adaption, the process needs to be iterative and responsive to recommended modifications.
“I understand it but I couldn’t tell you what these translations are.”
Participants also expressed a desire for more training and/or explanation on tablet use. As previously discussed, the study population required substantial assistance from a caregiver to effectively use the technology, thus more information on using the device was requested.
“In other words, or for example, you know, uh, you’re going to hear a sound. I don’t know exactly how it works. But, you know, or you’re going to feel it pressuring, whatever it is that they’re going to be feeling so that they are part of the process.”
New videos developed by KPMG were presented to the Spanish-speaking patient groups, which were considered more acceptable and culturally congruent, both in terms of homophily (the actors “look like me”) and the foods/cultural practices presented. Participants greatly preferred these new videos, while noting additional aspects of the video(s) that were not culturally appropriate or hard to understand for the given population. Participants liked the simplicity of the videos.
“But I think that’s the only thing is culturally going back to is very often, people measure by spoon. They don’t necessarily use measuring cups, which we will try to teach them, but most people don’t. Most people do it by their spoon.”
Video review
HRS videos were presented to the patient panel (in Spanish) and provider panel (in English) during the first and second Community Advisory Board meetings. Video reviews of the Spanish- and English-speaking groups were analyzed to identify common themes and areas needing adaptation. Five themes emerged for the educational videos: 1) repetition of information, 2) presentation of information, 3) language choice, 4) cultural incongruence, and 5) personal connection with actors.
Participants in the English-speaking group expressed the importance of repetition of information presented throughout the educational videos, in reinforcing and understanding the message being delivered.
“I thought it was really important that on two different occasions they talked about exercise and physical activity.”
“I thought the recap at the end really summed it up nicely.”
Both groups noted that certain aspects of the educational videos made it difficult to understand the messaging. These challenges included the narrator speaking too fast and the framing of the information being presented. Specifically, while it is important to communicate the dangers associated with uncontrolled diabetes, it is just as important to outline the steps one should take to avoid the danger and foster better health.
“It’s kind of a downer. Like I get it. I like how they were honest about their feelings. But not until the last sentence of so what do you do about it. They could have spent more time with that.”
“No, it scared me at the very beginning. I mean, imagine we’re already scared when we hear about the diagnosis of diabetes and now you’re telling me all these frickin’ complications at the very beginning. It’s like just shut off light.”
Both groups also expressed concerns regarding the complicated verbiage used throughout the videos. These concerns included suggestions for changing more complex verbiage to simpler words that would be easily understood, including definitions for words, and being provided additional educational information.
“Ophthalmologist and podiatrist, that’s a little bit complex. They should have said eye doctor or foot doctor just to simplify.”
“I had to look up what urinating meant. I didn't know what urinating meant.”
“…the word statistic is probably not even a very familiar word for a lot of people.”
Spanish-speaking participants emphasized the need for the videos to be tailored to be more culturally appropriate. Participants highlighted issues with the translation in the videos being inaccurate as well as the food being presented being representative of a traditional American, rather than a Hispanic, diet.
“It needs to be culturally appropriate for Spanish folks. So, there was nothing about this that made me feel as a Spanish speaker, I should be watching this video versus any other – it seems like it was an English translation into Spanish as opposed to a transcultural…”
“You also – it says Latino population. It didn’t seem to be food from the Caribbean or South America. It looked like an American diet.”
Spanish-speaking participants also noted a need for a personal connection with the video actors for the information to be most effective. Most common among these concerns was an inability to relate to the actors (e.g., “someone like me” i.e., homophily), who were American actors with dubbed over Spanish voice.
“There was no connection and that’s a big problem with my mother…”
“It didn’t have any cultural connection, like for my mom…”
The committees requested that the study team identify alternate, culturally congruent videos that more aligned with the cultural experiences and needs of the target population. The study team searched for educational videos that met the requirements of the committees. New videos that were developed by KPMG were presented at the third Community Advisory Board meeting and found to be acceptable by the committees. Thus, these videos were incorporated into the final intervention (without KPMG’s logo).
Consent process concerns
In the final Community Advisory Board focus group, study procedures were reviewed, and concerns about the consent process emerged. Individuals raised concerns regarding the consent process and how potential study participants were being approached. The process was perceived as overwhelming in terms of the amount of information being presented and the length of the consenting process. These issues were further compounded by the timing in which the recruiter was approaching patients.
“At that point, they have already seen the doctor, they’ve asked their questions and they’re checking out. They’re, they’re -- want to do is make their next appointment that they might not be as interested in hearing from [recruiter].”
Feedback from pilot study participants
Information gathered from a focus group and individual interviews with participants in the pilot study, suggest strong acceptability despite concerns around the consent process and that their private health information would remain confidential using the tablets. Participants expressed positive sentiment regarding the consent process and its ease of completion. Participants also were pleased with the level of information provided regarding the study, although the time required for both the consenting process and survey completion was reported to be onerous.
“Everything was very easy. [The recruiter] explained everything and that made the process even easier.”
“I wanted to hear a verbal explanation of what I was going to do and how it was going to help me. And that is why it took longer.”
Participants expressed a desire to enter the program because it targeted Latino/Hispanic people specifically. Participants also yearned to learn more about diabetes and how to manage the disease, in general.
“Honestly, sometimes as a Hispanic you tend to doubt this type of help…[the recruiter] explained the program to me and I am very interested because I have seen the consequences of diabetes.”
Participants involved their immediate family as caregivers throughout the study.
“I think that the right person, in my opinion, is a relative.”
“My family also got very involved and they were looking out for my weight and the food I ate. All of that is very important.”
Participants considered the Spanish speaking nurse to be integral to the study, and that the trust developed between patient and nurse was crucial. Additionally, the scheduling flexibility afforded to participants for virtual visits was important.
“Yes, the most important thing for me was the language because my doctor speaks English and I was more comfortable speaking to [the nurse] than with my doctor.”
“I got home late and she called me and called me and when I got home, I called her and told her, we should do this tomorrow because it’s too late. And she said, [name], it’s fine. And I was sorry because I explained to her that just like him, I come home from work very late. But she – she worked around my schedule.”
Finally, participants were skeptical of the tablet and felt their privacy may be compromised with the device in their home.
“He felt suspicious because the tablet was there all the time and he felt like he was being watched.”
“It would be good if the personnel could tell us this before they hand us the tablet. Tell us that will not be a problem.”
“They thought they could spy us through the camera.”
Adaptations implemented as a result of stakeholder feedback
A significant number of adaptations were made to the original home telemonitoring program to adapt it to the needs of the underserved Hispanic population with Type 2 Diabetes. As can be seen in Fig. 2, in general, these changes were in two forms: 1) changes to the patient-facing screens on the tablets themselves, and 2) changes to the study design/enrollment procedures.
Changes to the patient-facing tablet screens
When presenting each patient-facing screen and educational video to stakeholders on the Community Advisory Board and its subcommittees, many adaptations were recommended. First, culturally appropriate translations (e.g., using the word “azucar” rather than “glucosa”) system were incorporated into the system. Second, diabetes educational videos that were first presented as part of the HRS system were substituted with the KPMG educational videos, which were considered to be more culturally congruent, and not just “English folks eating American foods dubbed over in Spanish”. Third, patients asked for lighter tablets that were more portable for use at work, with privacy/logon screens. Finally, larger screens and font sizes were requested to accommodate older, diabetic eyes.
Changes to study procedures
In addition to the Community Advisory Board and subcommittee feedback, when conducting focus groups and structured interviews with patients who had participated in a one-month pilot program, several study procedure adaptations were identified. First, a request was made to extend nursing telemonitoring hours to include nights and weekends, as a significant proportion of the patient population was working during the 9–5, Monday-Friday workday. A second recommendation, arising from pilot patient feedback referencing an extremely lengthy consent process, resulted in modifying our protocol, from a traditional RCT to a randomized consent design. This approach is particularly useful in lifestyle interventions, which are often complex and subject to important factors, such as patient preference and non-adherence. A third adaptation, also arising from pilot patient feedback, resulted in a decrease of survey items, which patients considered to be onerous, taking over an hour and ½ to administer. Fourth, patients recommended that a picture of the recruiter be included on recruitment brochures at the clinics, so that patients would recognize the “stranger” that was approaching them for study participation. Finally, there was some fear expressed by patients that: 1) their information could be shared with federal agencies like the INS to identify them, or that the tablets could “listen to” subjects when they were not using them to interact with the nurse. This resulted in the inclusion of an extensive explanation of their privacy protections as part of the enrollment process, including the execution of Certificate of Confidentiality by the National Institutes of Health, which protects the privacy of research subjects by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research.
