Phase 4
Completed N=108
Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial
Source: ClinicalTrials.gov NCT02061280 ↗Enrolled (actual)
108
Serious AEs
3.9%
Results posted
Apr 2018
Primary outcomePrimary: Adolescent Research Participant Assessment Score at Screening (Visit 1, Week -8) — 41.08; 42.26 Scores on a scale
◆ Published Evidence
Established
67citations · ~7 / year
A cognitive approach for design of a multimedia informed consent video and website in pediatric research.
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.
Linked Publications (3)
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A cognitive approach for design of a multimedia informed consent video and website in pediatric research.
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Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: Study design and rationale.
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Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adolescent Research Participant Assessment Score at Screening (Visit 1, Week -8) |
41.08; 42.26 | — |
| PRIMARY Caregiver Research Participant Assessment Score at Screening (Visit 1, Week -8) |
43.2; 42.9 | — |
| SECONDARY Adolescent Research Participant Assessment Score at Study End (Visit 6, Week 12) |
41.22; 41.27 | — |
| SECONDARY Caregiver Research Participant Assessment Score at Study End (Visit 6, Week 12) |
43.28; 41.08 | — |
| SECONDARY Asthma Control Test Scores at Screening (Visit 1, Week -8) |
22; 22 | — |
| SECONDARY Asthma Control Test Score at Final Visit (Visit 6, Week12) |
24; 23 | — |
| SECONDARY Spirometry Quality Control Grade |
3.75; 4.00 | — |
| SECONDARY Number of Errors in Questionnaires Completed by Participants at Visit 1 (Week -8). |
— | — |
| SECONDARY Number of Errors in Questionnaires Completed by Participants at Visit 2 (Week -4). |
— | — |
| SECONDARY Number of Errors in Questionnaires Completed by Participants at Visit 3 (Week 0). |
— | — |
| SECONDARY Number of Errors in Questionnaires Completed by Participants at Visit 4 (Week 3). |
— | — |
| SECONDARY Number of Errors in Questionnaires Completed by Participants at Visit 5 (Week 6). |
— | — |
| SECONDARY Number of Errors in Questionnaires Completed by Participants at Visit 6 (Week 12). |
— | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT02061280) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.