Can the act of completing surveys in a research study help improve symptoms for children with asthma? Yes, according to a new study from University of Rochester Medical Center researchers.
The study, “Considering the Control Group: The Influence of Follow-Up Assessments on Asthma Symptoms,” led by Sean Frey, MD, MPH, an assistant professor in the department of Pediatrics, found that children with uncontrolled asthma who participated in clinical trials as control subjects — and therefore did not receive an active intervention — experienced a decrease in symptoms over the course of the clinical trial that was strongly associated with the number of follow-up surveys completed. This result provides evidence in support of the research participation effect, which refers to changes in patient behavior and outcomes due to simply being assessed in a research study.
Frey’s work, which was published Academic Pediatrics, was based on three different school-based asthma therapy trials led by Dr. Jill Halterman’s research team. As part of those trials, children in the active participation group received their daily controller medications for asthma in school under the supervision of a school nurse or aide. Children in the control group did not receive daily controller medications in school.
Throughout those studies, parents of children in both the active and control groups received calls from researchers, who asked about their children’s illness and their number of “symptom-free” days.
“Looking at the data from those trials, we saw that children in the control group also experienced a decrease in their symptoms,” said Frey. “For our study, we wanted to look at exactly what was driving that improvement.”
Asthma is a disease that fluctuates, so researchers controlled for other factors that could have explained the decrease in symptoms, such as the seasons and the increase in a child’s age over the course of the study. After controlling for those factors, researchers found that the children’s symptoms still improved over the course of the study — and the number of symptom-free days that caregivers reported was significantly associated with the number of follow-up phone calls their parents had received.
“The more follow-up calls parents received, the more symptom-free days their children had,” said Frey.
At the first follow-up call, parents of children in the control group reported 2.4 more symptom-free days in a 14-day period than they did at the start of the study. By the fourth follow-up call, parents reported an additional 3.5 symptom-free days in a 14-day period compared to the start of the study.
Frey’s findings don’t take away from the initial conclusions of those trials, as children who received the school-based interventions still had significantly better asthma outcomes than children in the control group.
More work in the area needs to be done, according to Frey, but the study has a few implications. First, the study suggests that conducting routine telephone-based follow-up could be part of an effective outreach strategy for managing childhood asthma. If proven to be helpful, doctors’ offices could incorporate regular phone calls to parents about their children’s symptoms into routine care practices.
“Parents often perceive asthma as an acute issue, but it’s a chronic illness. It’s possible that asking parents about their children’s asthma on a regular basis helps shift parents’ understanding and could change their behavior — thereby reminding them that their children need to take their medications,” said Frey. “As we think about how to reach families where they are and implement a community-based model of care, this type of outreach could be helpful.”
The findings could also help guide the design of future research projects. Researchers should consider the potential effect of multiple follow-up assessments and how they might impact the results of the study.