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Inadequate recruitment and retention impede clinical trial goals. Emerging decentralized clinical trials (DCTs) leveraging digital health technologies (DHTs) for remote recruitment and data collection aim to address barriers to participation in traditional trials. The ACTIV-6 trial is a DCT using DHTs, but participants’ experiences of such trials remain largely unknown. This study explored participants’ perspectives of the ACTIV-6 DCT that tested outpatient COVID-19 therapeutics.
Methods:
Participants in the ACTIV-6 study were recruited via email to share their day-to-day trial experiences during 1-hour virtual focus groups. Two human factors researchers guided group discussions through a semi-structured script that probed expectations and perceptions of study activities. Qualitative data analysis was conducted using a grounded theory approach with open coding to identify key themes.
Results:
Twenty-eight ACTIV-6 study participants aged 30+ years completed a virtual focus group including 1–4 participants each. Analysis yielded three major themes: perceptions of the DCT experience, study activity engagement, and trust. Participants perceived the use of remote DCT procedures supported by DHTs as an acceptable and efficient method of organizing and tracking study activities, communicating with study personnel, and managing study medications at home. Use of social media was effective in supporting geographically dispersed participant recruitment but also raised issues with trust and study legitimacy.
Conclusions:
While participants in this qualitative study viewed the DCT-with-DHT approach as reasonably efficient and engaging, they also identified challenges to address. Understanding facilitators and barriers to DCT participation and DHT interaction can help improve future research design.
The goals of this investigation were to 1) identify and measure exposures inside homes of individuals with chemical intolerance (CI), 2) provide guidance for reducing these exposures, and 3) determine whether our environmental house calls (EHCs) intervention could reduce both symptoms and measured levels of indoor air contaminants.
Background:
CI is an international public health and clinical concern, but few resources are available to address patients’ often disabling symptoms. Numerous studies show that levels of indoor air pollutants can be two to five (or more) times higher than outdoor levels. Fragranced consumer products, including cleaning supplies, air fresheners, and personal care products, are symptom triggers commonly reported by susceptible individuals.
Methods:
A team of professionals trained and led by a physician/industrial hygienist and a certified indoor air quality specialist conducted a series of 5 structured EHCs in 37 homes of patients reporting CI.
Results:
We report three case studies demonstrating that an appropriately structured home intervention can teach occupants how to reduce indoor air exposures and associated symptoms. Symptom improvement, documented using the Quick Environmental Exposure and Sensitivity Inventory Symptom Star, corresponded with the reduction of indoor air volatile organic compounds, most notably fragrances. These results provide a deeper dive into 3 of the 37 cases described previously in Perales et al. (2022).
Discussion:
We address the long-standing dilemma that worldwide reports of fragrance sensitivity have not previously been confirmed by human or animal challenge studies. Our ancient immune systems’ ‘first responders’, mast cells, which evolved 500 million years ago, can be sensitized by synthetic organic chemicals whose production and use have grown exponentially since World War II. We propose that these chemicals, which include now-ubiquitous fragrances, trigger mast cell degranulation and inflammatory mediator release in the olfactory-limbic tract, thus altering cerebral blood flow and impairing mood, memory, and concentration (often referred to as ‘brain fog’). The time has come to translate these research findings into clinical and public health practice.