Designing Research Studies for eHealth Programs
Posted on October 22, 2014
Yelena Wu (bio) and Ric Steele (bio) provide tips on planning an eHealth program and discuss some of the challenges of online studies.
Q: What factors should I take into account when designing a study for an eHealth program?
There are many factors to consider when planning an eHealth research project. We will mention a few key ones here. First, it can be helpful to think carefully about the main outcome you want the eHealth program to achieve and to consider what components of the intervention itself are most essential to include. While this is similar to how you would approach any study that involves an intervention, eHealth programs can be expensive to design and test, and thus, having an idea from the beginning of which pieces of the program will be most important can help you allocate resources.
Next, consider what resources are available that will support the design and testing of your eHealth program:
- Do you have access to people who will help with website or software design and do you have resources to pay for their time?
- What other staff will you need for your eHealth program? In addition to personnel who can assist with the technical side, consider whether you will also need personnel to recruit participants, collect and manage data, and deliver the intervention program itself.
On the research side, you will want to consider different study designs and how they would be implemented in an eHealth format. For instance, a waitlist control design in an eHealth study will necessitate technology that lets participants know their status (waitlist or active treatment) and allows participants to begin the active treatment only when they are off the waitlist.
Finally, it's helpful to begin making decisions about how the intervention program's material will be presented (e.g., in what form, in what doses). Depending on the complexity and type of program, it can be useful to collaborate with content area specialists who know the target population of your program well, or other experts in related fields such as in instructional design.
Q: How does an online recruitment process work?
A: Each eHealth study's recruitment process can work differently, depending on the target population and the logistics required for those target populations. Some eHealth studies may involve patients with chronic health conditions who need to be referred by a medical provider first. Other studies might recruit patients directly. In one of our studies, we recruited healthcare providers (i.e., school nurses). Because our study offered continued nursing education credit and provided a service that was needed by many of the school districts, we were able to recruit nurses directly and via a professional organization. An advantage of conducting our study using eHealth was that we were able to e-mail nurses information on the study that directed them to our training and study questionnaires, which were all on a secure website. This allowed us to recruit nurses from around the United States.
Q: Can you describe the consent process that you used in your study?
A: Consent processes will vary depending on the nature of the study, the populations involved in the study (e.g., if children are involved), and local institutional review board regulations. In our study, which included adults as participants, the consent form was on the website. After reading the consent, nurses checked the agree/do not agree box. They were also able to contact the research team by e-mail or phone if they had questions. If they chose not to consent, they received a message letting them know they could not participate in the study.
Q: How did you transfer data from pencil and paper format to the web?
A: Transferring questionnaires and their associated responses from the typical pencil and paper format into an eHealth format can require multiple steps. If the questionnaires have copyrights or other permissions, researchers must first ask for permission to move the paper version into an eHealth version. Sometimes there can be costs for using a pre-established or validated measure in a study, regardless of whether the questionnaire is delivered via an eHealth platform.
Another issue to consider is to what extent moving the questionnaire into an eHealth format changes the questionnaire's validity and reliability. If this information is not already available, researchers can examine the validity and reliability of their measures using the data they collect. Once the researcher is ready to move the questionnaire into the eHealth format, decisions have to be made about how many items will be presented on the webpage, how the items and responses will be formatted, and how missing or skipped responses will be handled.
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