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Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial

NCT ID: NCT02061280

Last Updated: 2018-12-19

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-02-17

Brief Summary

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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

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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.

Conditions

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Asthma

Keywords

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Asthma Clinical Trial Design Electronic Data Entry Mobile Devices Home Spirometry

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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MICT Trial Design

Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.

Randomized to one of 3 study treatments:

fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily

Group Type EXPERIMENTAL

fluticasone/salmeterol 250/50 Dry Powder Inhaler

Intervention Type DRUG

Participants will receive Advair Diskus 250/50 Dry Powder Inhaler, administered twice daily for 12 weeks after randomization

fluticasone/salmeterol 100/50 Dry Powder Inhaler

Intervention Type DRUG

Participants will receive Advair Diskus 100/50 Dry Powder Inhaler administered twice daily for 12 weeks after randomization

fluticasone 100mcg Dry Powder Inhaler

Intervention Type DRUG

Participants will receive Flovent Diskus 100mcg Dry Powder Inhaler administered twice daily for 12 weeks after randomization

LASST Trial Design

Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.

Randomized to one of 3 study treatments:

fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily.

Group Type ACTIVE_COMPARATOR

fluticasone/salmeterol 250/50 Dry Powder Inhaler

Intervention Type DRUG

Participants will receive Advair Diskus 250/50 Dry Powder Inhaler, administered twice daily for 12 weeks after randomization

fluticasone/salmeterol 100/50 Dry Powder Inhaler

Intervention Type DRUG

Participants will receive Advair Diskus 100/50 Dry Powder Inhaler administered twice daily for 12 weeks after randomization

fluticasone 100mcg Dry Powder Inhaler

Intervention Type DRUG

Participants will receive Flovent Diskus 100mcg Dry Powder Inhaler administered twice daily for 12 weeks after randomization

Interventions

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fluticasone/salmeterol 250/50 Dry Powder Inhaler

Participants will receive Advair Diskus 250/50 Dry Powder Inhaler, administered twice daily for 12 weeks after randomization

Intervention Type DRUG

fluticasone/salmeterol 100/50 Dry Powder Inhaler

Participants will receive Advair Diskus 100/50 Dry Powder Inhaler administered twice daily for 12 weeks after randomization

Intervention Type DRUG

fluticasone 100mcg Dry Powder Inhaler

Participants will receive Flovent Diskus 100mcg Dry Powder Inhaler administered twice daily for 12 weeks after randomization

Intervention Type DRUG

Other Intervention Names

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Advair Diskus Advair Diskus Flovent Diskus

Eligibility Criteria

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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


* 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

Parallel MICT and Parallel LASST


* 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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Nemours Children's Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathryn Blake, PharmD

Role: PRINCIPAL_INVESTIGATOR

Nemours Children's Clinic Jacksonville FL

Locations

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Alfred I. duPont Hospital for Children

Wilmington, Delaware, United States

Site Status

Nemours Children's Specialty Care

Jacksonville, Florida, United States

Site Status

Nemours Children's Hospital

Orlando, Florida, United States

Site Status

Nemours Children's Specialty Care

Pensacola, Florida, United States

Site Status

Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25847579 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28109951 (View on PubMed)

Blake KV, Antal H, Bunnell HT, He J, Henderson R, Holbrook JT, McCahan SM, Pennington C, Rogers L, Shade D, Sugar EA, Taylor A, Wise RA, Wysocki T. Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial. JMIR Pediatr Parent. 2023 Jun 22;6:e44252. doi: 10.2196/44252.

Reference Type DERIVED
PMID: 37347518 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: 12-17 Assent LASST

View Document

Document Type: Informed Consent Form: PPF LASST

View Document

Document Type: Informed Consent Form: 12-17 Assent LASST RPA Ancillary

View Document

Document Type: Informed Consent Form: ICF-PPF LASST RPA Ancillary

View Document

Document Type: Informed Consent Form: 12-17 Assent MICT

View Document

Document Type: Informed Consent Form: ICF-PPF_MICT

View Document

Other Identifiers

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R01HL114899

Identifier Type: NIH

Identifier Source: secondary_id

View Link

332965

Identifier Type: -

Identifier Source: org_study_id