Phase II trial of web-based tailored asthma management intervention in adolescents at clinics

Abstract

Clinical trials are critical for medical decision-making; however, conduct is costly and labor intensive. Traditionally, clinical trials are conducted in a controlled environment with a restricted patient population. In addition to the use of electronic initiatives (e-initiatives) such as the use of electronic medical records (EMR) for patient identification, recruitment and data collection, pragmatic clinical trials promote patient enrollment in a "real world" setting with fewer exclusion criteria and less need for research infrastructure. The pragmatic trial also uses comparative adaptive methods and approaches to ensure results provide realworld evidence, i.e., evidence that study execution and data analysis are translatable to practice. Puff City, a web-based, asthma management program for urban adolescents with asthma, has been evaluated in Detroit Public High Schools [1] [2], and results of these school-based randomized trials were promising for potential dissemination beyond schools [1] [2]. To demonstrate pragmatic approaches to conduct of a randomized trial, we extended the Puff City program to a clinical setting and conducted a seamless Phase II/III pragmatic trial of the program in a group of urban, primary care clinics.

eHealth Technologies for Monitoring Pediatric Asthma at Home: Scoping Review

“…Four studies showed a positive effect of the intervention on school absence [ 8 , 163 , 290 , 298 ], whereas 8 studies showed no significant effect [ 14 , 194 , 289 , 294 , 296 , 297 , 305 ]. A common factor in successful interventions was active involvement or interaction with HCPs after the digital intervention in terms of personalized feedback [ 290 ], nurse-led management [ 298 ], or proactive contact when issues were identified [ 163 ].…”

Telehealth interventions for transition to self‐management in adolescents with allergic conditions: A systematic review

“…Of these, 18 articles were included, describing 15 telehealth interventions (Figure 1). 45–62 Study designs included RCTs ( n = 7, of which four were pilots), quasi‐experimental ( n = 2), before‐and‐after ( n = 3), single‐arm feasibility ( n = 1), a multi‐method quantitative ( n = 1), quantitative descriptive ( n = 1), longitudinal qualitative ( n = 2) and mixed methods ( n = 1) (Table 1). Interventions were mainly from the USA ( n = 10), with one each from Malaysia, 45,46 the Netherlands, 61,62 Iran, 49 Switzerland 53 and Korea 59 .…”

“…Interventions were mainly from the USA ( n = 10), with one each from Malaysia, 45,46 the Netherlands, 61,62 Iran, 49 Switzerland 53 and Korea 59 . Studies had small sample sizes, with the number of participants ranging from 7 60 to 266 55 . The follow‐up time varied from immediately post‐intervention to 12 months post, with an average of 6.7 months.…”

“…In the ‘NM PicAAP’ intervention, which was intended to be largely pictorial, ‘stickers’ were used to individualize the tool based on the triggers experienced by the teenager and the inhaler medications they were using 60 . ‘In Puff City’, the content of sessions depended on issues reported by the adolescent in a baseline survey 52,55 …”

“…Several studies reported using a theory or theoretical framework to guide intervention development (n = 8), with motivational interviewing, 47,52,55 self-determination theory 48,53 and the health belief model 52,55 the most prominent theories used. Most interventions had an underpinning evidence base (n = 9), with clinical practice guidelines being the most common.…”