Clinical trial NCT02061280: Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial
Official title: Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Clinical Trial Design
Electronic Data Entry
Mobile Devices
Home Spirometry
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-02-12
Enrollment: 108
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Asthma is an inflammatory disease that imposes a significant burden affecting an estimated 300 million persons and 20% of all children worldwide. It is one of the most common chronic diseases of childhood and is a leading cause of school absenteeism. There continues to be a great need for clinical trials in asthma but traditional clinical trials are expensive and reasons cited by patients for non-participation are extra inconvenience and logistical barriers. Study designs which are patient centered and reduce trial costs are needed. The long-range goal of this application is to transform the paradigm of clinical research into a more efficient and cost-effective enterprise by capitalizing upon current widely used mobile electronic means of communication and information transfer.

This innovative project is a streamlined clinical trial that will run concurrently with a nearly identical traditional clinical trial, "Long-acting Beta Agonist Step Down Study" (LASST) which will allow for direct comparison of processes and outcomes between the streamlined and traditional approach. Children 12 to 17 years old with asthma will be randomized to participate in this project (streamlined trial) or LASST (traditional trial). In this proposal we will: measure comprehension of study information using an original questionnaire, Research Participant Assessment (developed at Nemours), following a parental permission/assent process delivered over the internet in a dynamic interactive multi-media format (Specific Aim 1); measure the efficiency of participant driven data entry from home into a Research Electronic Data Capture (REDCap) online database using the iPad, and quality of spirometry with the EasyOne Plus handheld meter with remote coaching using the iPad (Specific Aim 2); test whether the streamlined approach has a "trial effect" by comparing the differences in Asthma Control Test (ACT) scores following 12 weeks of study drug treatment in children randomized to this project compared to LASST. We will collect effort reporting data to compare personnel costs between the trials. If this streamlined project lacks a "trial effect" and reduces costs compared to LASST, the methodologies would be generalizable to studies which include adults and other diseases.

Detailed description: Introduction Phase III / IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be noninferior and will be less expensive compared to a traditional pediatric asthma trial.

Materials/Methods Parents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi (wireless internet) and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs.

Results Participants have been enrolled in the streamlined and traditional trials and recruitment is ongoing.

Conclusions This project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases.

Eligibility criteria: Main Trial

Inclusion Criteria:

* Age 12-17 years
* Physician diagnosed asthma (without any other co-morbid pulmonary disease) that is well-controlled on medium dose inhaled corticosteroid and long-acting β2-agonist given twice daily \[Advair Diskus (fluticasone propionate/salmeterol) 250/50mcg; Advair HFA (hydrofluoroalkane) (fluticasone propionate/salmeterol hydrofluoroalkane) 115/21mcg; Symbicort (budesonide/formoterol) 160/4.5mcg; Dulera (mometasone/formoterol) 100/4.5mcg\] based on an ACT score \> 20, and the absence of unscheduled visits or use of rescue prednisone for 4 weeks prior to enrollment
* Pre-bronchodilator forced expiratory volume in the first second \> 70% predicted
* \< 10 pack/year history of tobacco use and abstinence for at least 1 year

Exclusion Criteria:

* Chronic oral steroid therapy
* Hospitalization or urgent care visit within 4 weeks of the screening visit
* Near fatal asthma within 2 years of enrollment or high risk of near fatal or fatal asthma 125-127
* Women who are pregnant or lactating

Parallel MICT and Parallel LASST

Inclusion Criteria:

* Age 12-17 years
* Physician diagnosed asthma (without any other co-morbid pulmonary disease) that is well-controlled on medium dose inhaled corticosteroid and long-acting β2-agonist given twice daily \[Advair Diskus (fluticasone propionate/salmeterol) 250/50mcg; Advair HFA (hydrofluoroalkane) (fluticasone propionate/salmeterol hydrofluoroalkane) 115/21mcg; Symbicort (budesonide/formoterol) 160/4.5mcg; Dulera (mometasone/formoterol) 100/4.5mcg\] based on an ACT score \> 20, and the absence of unscheduled visits or use of rescue prednisone for 4 weeks prior to enrollment
* \< 10 pack/year history of tobacco use and abstinence for at least 1 year

Exclusion Criteria:

* Chronic oral steroid therapy
* Hospitalization or urgent care visit within 4 weeks of the screening visit
* Near fatal asthma within 2 years of enrollment or high risk of near fatal or fatal asthma 125-127
* Women who are pregnant or lactating

Primary outcomes:
measure: Adolescent Research Participant Assessment Score at Screening (Visit 1, Week -8)
timeFrame: Screening (Visit 1, week -8)
measure: Caregiver Research Participant Assessment Score at Screening (Visit 1, Week -8)
timeFrame: Screening (Visit 1, week -8)
Secondary outcomes:
measure: Adolescent Research Participant Assessment Score at Study End (Visit 6, Week 12)
timeFrame: Final Visit (Visit 6, Week12)
measure: Caregiver Research Participant Assessment Score at Study End (Visit 6, Week 12)
timeFrame: Final Visit (Visit 6, Week12)
measure: Asthma Control Test Scores at Screening (Visit 1, Week -8)
timeFrame: Screening (Visit 1, week -8)
measure: Asthma Control Test Score at Final Visit (Visit 6, Week12)
timeFrame: Final Visit (Visit 6, Week 12)
measure: Spirometry Quality Control Grade
timeFrame: Visit 3 (week 0)
measure: Number of Errors in Questionnaires Completed by Participants at Visit 1 (Week -8).
timeFrame: Visit 1 (week -8)
measure: Number of Errors in Questionnaires Completed by Participants at Visit 2 (Week -4).
timeFrame: Visit 2 (week -4)
measure: Number of Errors in Questionnaires Completed by Participants at Visit 3 (Week 0).
timeFrame: Visit 3 (week 0)
measure: Number of Errors in Questionnaires Completed by Participants at Visit 4 (Week 3).
timeFrame: Visit 4 (week 3)
measure: Number of Errors in Questionnaires Completed by Participants at Visit 5 (Week 6).
timeFrame: Visit 5 (week 6)
measure: Number of Errors in Questionnaires Completed by Participants at Visit 6 (Week 12).
timeFrame: Visit 6 (week 12)
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Alfred I. duPont Hospital for Children
state: Delaware
city: Jacksonville
country: United States
facility: Nemours Children's Specialty Care
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Hospital
state: Florida
city: Pensacola
country: United States
facility: Nemours Children's Specialty Care
state: Florida
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Nemours Children's Clinic Jacksonville FL
name: Kathryn Blake, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blake K, Holbrook JT, Antal H, Shade D, Bunnell HT, McCahan SM, Wise RA, Pennington C, Garfinkel P, Wysocki T. Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: Study design and rationale. Contemp Clin Trials. 2015 May;42:105-18. doi: 10.1016/j.cct.2015.03.012. Epub 2015 Apr 3.
citation: Antal H, Bunnell HT, McCahan SM, Pennington C, Wysocki T, Blake KV. A cognitive approach for design of a multimedia informed consent video and website in pediatric research. J Biomed Inform. 2017 Feb;66:248-258. doi: 10.1016/j.jbi.2017.01.011. Epub 2017 Jan 19.