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

NCT02061280 | Completed Phase 4 Results

• 2 other identifiers: 332965R01HL114899
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 5

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.

Conditions

Asthma

Keywords

Asthma; Clinical Trial Design; Electronic Data Entry; Mobile Devices; Home Spirometry

Outcome Measures

Primary Outcomes (2)

• Adolescent Research Participant Assessment Score at Screening (Visit 1, Week -8)

  The Research Participant Assessment Score (RPA Comprehension) was a 17-item questionnaire designed to assess comprehension of study information at screening (Visit 1, week -8) between MICT and LASST trial designs. The same 17-item questionnaire was administered to the adolescent participant and to the caregiver participant. The items were scored as 1=incorrect, 2=partially correct, 3=correct (minimum possible score=17 and maximum possible score=51). Scores were assigned by two trained coders who independently listed to audio recordings of the RPA Comprehension questionnaire administration. Scores from the two coders were averaged for a final score. Higher scores indicate better comprehension. Mean (95% Confidence Interval) are the outcome measure reported.

  Screening (Visit 1, week -8)

• Caregiver Research Participant Assessment Score at Screening (Visit 1, Week -8)

  The Research Participant Assessment Score (RPA Comprehension) was a 17-item questionnaire designed to assess comprehension of study information at screening (Visit 1, week -8) between MICT and LASST trial designs. The same 17-item questionnaire was administered to the adolescent participant and to the caregiver participant. The items were scored as 1=incorrect, 2=partially correct, 3=correct (minimum possible score=17 and maximum possible score=51). Scores were assigned by two trained coders who independently listed to audio recordings of the RPA Comprehension questionnaire administration. Scores from the two coders were averaged for a final score. Higher scores indicate better comprehension. Mean (95% Confidence Interval) are the outcome measure reported.

  Screening (Visit 1, week -8)

Secondary Outcomes (11)

• Adolescent Research Participant Assessment Score at Study End (Visit 6, Week 12)

  Final Visit (Visit 6, Week12)

• Caregiver Research Participant Assessment Score at Study End (Visit 6, Week 12)

  Final Visit (Visit 6, Week12)

• Asthma Control Test Scores at Screening (Visit 1, Week -8)

  Screening (Visit 1, week -8)

• Asthma Control Test Score at Final Visit (Visit 6, Week12)

  Final Visit (Visit 6, Week 12)

• Spirometry Quality Control Grade

  Visit 3 (week 0)

Study Arms (2)

MICT Trial Design

EXPERIMENTAL

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

Drug: fluticasone/salmeterol 250/50 Dry Powder Inhaler; Drug: fluticasone/salmeterol 100/50 Dry Powder Inhaler; Drug: fluticasone 100mcg Dry Powder Inhaler

LASST Trial Design

ACTIVE COMPARATOR

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.

Drug: fluticasone/salmeterol 250/50 Dry Powder Inhaler; Drug: fluticasone/salmeterol 100/50 Dry Powder Inhaler; Drug: fluticasone 100mcg Dry Powder Inhaler

Interventions

fluticasone/salmeterol 250/50 Dry Powder Inhaler DRUG

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

Also known as: Advair Diskus

LASST Trial Design; MICT Trial Design

fluticasone/salmeterol 100/50 Dry Powder Inhaler DRUG

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

Also known as: Advair Diskus

LASST Trial Design; MICT Trial Design

fluticasone 100mcg Dry Powder Inhaler DRUG

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

Also known as: Flovent Diskus

LASST Trial Design; MICT Trial Design

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (5)

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Nemours Children's Specialty Care

Jacksonville, Florida, 32207, United States

Location

Nemours Children's Hospital

Orlando, Florida, 32806, United States

Location

Nemours Children's Specialty Care

Pensacola, Florida, 32504, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

Related Publications (3)

• 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.

  PMID: 25847579 BACKGROUND

• 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.

  PMID: 28109951 BACKGROUND

• 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.

  PMID: 37347518 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Fluticasone-Salmeterol Drug Combination; Dry Powder Inhalers

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Drug Combinations; Pharmaceutical Preparations; Nebulizers and Vaporizers; Equipment and Supplies

Limitations and Caveats

Allocation to trial type was not randomized; enrollment in LASST began 1 year before MICT, and LASST enrollment was competitive across the network. Parents and adolescents likely had varying cognitive abilities and experience with e-learning.

Results Point of Contact

• Title: Kathryn Blake, Pharm.D.
• Organization: Nemours Children's Specialty Care

kathryn.blake@nemours.org

9046865047

Study Officials

• Kathryn Blake, PharmD

  Nemours Children's Clinic Jacksonville FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 12, 2014
• Study Start: October 1, 2013
• Primary Completion: February 17, 2017
• Study Completion: February 17, 2017
• Last Updated: December 19, 2018
• Results First Posted: April 18, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be deposited in BioLINCC after the primary manuscript is published which is expected to be by January 2019.
• Access Criteria: Requests for access to data will be in accordance with any requirements set forth by BioLINCC.

Locations

US (5)