NCT05047419

Brief Summary

The long-term goal is to improve the care of patients with asthma. The overarching objective of this pilot grant is to test the feasibility, acceptability and potential clinical utility of deploying a mobile-health intervention to improve asthma surveillance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

September 8, 2021

Last Update Submit

January 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of Number of Peak Flow Measurements Received

    Comparison of number of peak flow measurements received between pregnant and not pregnant groups.

    9 months

Study Arms (2)

Pregnant Participants with Asthma

Participants will be asked to use peak flow meter each day from enrollment to 6 weeks post due date and send peak flow and FEV1 values to the research team via text message. Also, every 3 months participants will be asked to send in a PDF of the values from the peak flow meter app for the previous 7 days via email as a validation of the text message values.

Not Pregnant Participants with Asthma

Participants will be asked to use peak flow meter each day from enrollment to 9 months and send peak flow and FEV1 values to the research team via text message. Also, every 3 months participants will be asked to send in a PDF of the values from the peak flow meter app for the previous 7 days via email as a validation of the text message values.

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant and Not Pregnant participants with an Asthma diagnosis.

You may qualify if:

  • Able to read and write in English or Spanish;
  • Current patient at participating clinic;
  • Diagnosis of asthma;
  • Owns a smartphone capable of supporting Bluetooth-enabled peak flow meter.

You may not qualify if:

  • rd trimester of pregnancy;
  • Current prisoner status;
  • Unable to provide own written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (12)

  • Loftus PA, Wise SK. Epidemiology of asthma. Curr Opin Otolaryngol Head Neck Surg. 2016 Jun;24(3):245-9. doi: 10.1097/MOO.0000000000000262.

    PMID: 26977741BACKGROUND
  • Cloutier MM. Asthma management programs for primary care providers: increasing adherence to asthma guidelines. Curr Opin Allergy Clin Immunol. 2016 Apr;16(2):142-7. doi: 10.1097/ACI.0000000000000242.

    PMID: 26849166BACKGROUND
  • Morton RW, Elphick HE, Craven V, Shields MD, Kennedy L. Aerosol Therapy in Asthma-Why We Are Failing Our Patients and How We Can Do Better. Front Pediatr. 2020 Jun 11;8:305. doi: 10.3389/fped.2020.00305. eCollection 2020.

    PMID: 32656165BACKGROUND
  • Moran C, Doyle F, Sulaiman I, Bennett K, Greene G, Molloy GJ, Reilly RB, Costello RW, Mellon L. The INCATM (Inhaler Compliance AssessmentTM): A comparison with established measures of adherence. Psychol Health. 2017 Oct;32(10):1266-1287. doi: 10.1080/08870446.2017.1290243. Epub 2017 Feb 28.

    PMID: 28276739BACKGROUND
  • Greiwe J, Nyenhuis SM. Wearable Technology and How This Can Be Implemented into Clinical Practice. Curr Allergy Asthma Rep. 2020 Jun 6;20(8):36. doi: 10.1007/s11882-020-00927-3.

    PMID: 32506184BACKGROUND
  • Kouri A, Gupta S, Yadollahi A, Ryan CM, Gershon AS, To T, Tarlo SM, Goldstein RS, Chapman KR, Chow CW. Addressing Reduced Laboratory-Based Pulmonary Function Testing During a Pandemic. Chest. 2020 Dec;158(6):2502-2510. doi: 10.1016/j.chest.2020.06.065. Epub 2020 Jul 8.

    PMID: 32652095BACKGROUND
  • Bousquet J, Arnavielhe S, Bedbrook A, Bewick M, Laune D, Mathieu-Dupas E, Murray R, Onorato GL, Pepin JL, Picard R, Portejoie F, Costa E, Fonseca J, Lourenco O, Morais-Almeida M, Todo-Bom A, Cruz AA, da Silva J, Serpa FS, Illario M, Menditto E, Cecchi L, Monti R, Napoli L, Ventura MT, De Feo G, Larenas-Linnemann D, Fuentes Perez M, Huerta Villabolos YR, Rivero-Yeverino D, Rodriguez-Zagal E, Amat F, Annesi-Maesano I, Bosse I, Demoly P, Devillier P, Fontaine JF, Just J, Kuna TP, Samolinski B, Valiulis A, Emuzyte R, Kvedariene V, Ryan D, Sheikh A, Schmidt-Grendelmeier P, Klimek L, Pfaar O, Bergmann KC, Mosges R, Zuberbier T, Roller-Wirnsberger RE, Tomazic P, Fokkens WJ, Chavannes NH, Reitsma S, Anto JM, Cardona V, Dedeu T, Mullol J, Haahtela T, Salimaki J, Toppila-Salmi S, Valovirta E, Gemicioglu B, Yorgancioglu A, Papadopoulos N, Prokopakis EP, Bosnic-Anticevich S, O'Hehir R, Ivancevich JC, Neffen H, Zernotti E, Kull I, Melen E, Wickman M, Bachert C, Hellings P, Palkonen S, Bindslev-Jensen C, Eller E, Waserman S, Sova M, De Vries G, van Eerd M, Agache I, Casale T, Dykewickz M, Naclerio RN, Okamoto Y, Wallace DV; MASK study group. MASK 2017: ARIA digitally-enabled, integrated, person-centred care for rhinitis and asthma multimorbidity using real-world-evidence. Clin Transl Allergy. 2018 Oct 25;8:45. doi: 10.1186/s13601-018-0227-6. eCollection 2018.

    PMID: 30386555BACKGROUND
  • Huffaker MF, Carchia M, Harris BU, Kethman WC, Murphy TE, Sakarovitch CCD, Qin F, Cornfield DN. Passive Nocturnal Physiologic Monitoring Enables Early Detection of Exacerbations in Children with Asthma. A Proof-of-Concept Study. Am J Respir Crit Care Med. 2018 Aug 1;198(3):320-328. doi: 10.1164/rccm.201712-2606OC.

    PMID: 29688023BACKGROUND
  • McLaughlin K, Foureur M, Jensen ME, Murphy VE. Review and appraisal of guidelines for the management of asthma during pregnancy. Women Birth. 2018 Dec;31(6):e349-e357. doi: 10.1016/j.wombi.2018.01.008. Epub 2018 Feb 21.

    PMID: 29475603BACKGROUND
  • Bonham CA, Patterson KC, Strek ME. Asthma Outcomes and Management During Pregnancy. Chest. 2018 Feb;153(2):515-527. doi: 10.1016/j.chest.2017.08.029. Epub 2017 Sep 1.

    PMID: 28867295BACKGROUND
  • Robijn AL, Murphy VE, Gibson PG. Recent developments in asthma in pregnancy. Curr Opin Pulm Med. 2019 Jan;25(1):11-17. doi: 10.1097/MCP.0000000000000538.

    PMID: 30407268BACKGROUND
  • Labor S, Dalbello Tir AM, Plavec D, Juric I, Roglic M, Pavkov Vukelic J, Labor M. What is safe enough - asthma in pregnancy - a review of current literature and recommendations. Asthma Res Pract. 2018 Dec 27;4:11. doi: 10.1186/s40733-018-0046-5. eCollection 2018.

    PMID: 30607253BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Linnea Polgreen, PHD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 17, 2021

Study Start

August 27, 2021

Primary Completion

January 12, 2023

Study Completion

February 28, 2023

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations