Improving Asthma Care Together (IMPACT): A Shared Management Pilot Study

NCT04908384 | Completed Results DMC

• 3 other identifiers: STUDY00010461KL2TR0023171R21NR019328
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to iteratively develop, refine and test the Improving Asthma Care Together (IMPACT) Intervention for school-age children (7-11 years) with persistent asthma and their parents.

Conditions

Asthma in Children

Keywords

Self-management; Shared management; mHealth

Outcome Measures

Primary Outcomes (4)

• Asthma Responsibility Questionnaire Change From Baseline to 8 Weeks

  10- items, 5-point scale to report asthma management task responsibility. Total score is the mean of all items calculated. Scores range from 1 to 5, with 1= parent takes responsibility all of the time, 3= parent and child share responsibility about equally, and 5 = child takes responsibility all of the time.

  Baseline and 8 weeks

• Asthma Responsibility Questionnaire Change From 8 to 16 Weeks

  10- items, 5-point scale to report asthma management task responsibility. Total score is the mean of all items calculated. Scores range from 1 to 5, with 1= parent takes responsibility all of the time, 3= parent and child share responsibility about equally, and 5 = child takes responsibility all of the time.

  8 and 16 weeks

• Asthma Management Self-efficacy Change From Baseline to 8 Weeks

  13-items (parent) and 12-items (child), 5-point scale assesses asthma self-efficacy. Scores are averaged with higher scores indicate higher self-efficacy. Possible range of 1-5.

  Baseline and 8 weeks

• Asthma Management Self-efficacy Change From 8 Weeks to 16 Weeks

  13-items (parent) and 12-items (child), 5-point scale assesses asthma self-efficacy. Scores are averaged and higher scores indicate higher self-efficacy. Possible score range of 1-5.

  8 and 16 weeks

Secondary Outcomes (13)

• Spirometry - FEV1/FVC Change From Baseline to 8 Weeks

  Baseline and 8 weeks

• Spirometry - FEV1/FVC Change From 8 Weeks to 16 Weeks

  8 and 16 weeks

• Childhood Asthma Control Test Change From Baseline to 8 Weeks

  Baseline and 8 weeks

• Childhood Asthma Control Test Change From 8 Weeks to 16 Weeks

  8 and 16 weeks

• Childhood Asthma Quality of Life Change From Baseline to 8 Weeks

  Baseline and 8 weeks

Study Arms (2)

IMPACT Intervention

EXPERIMENTAL

IMPACT health application and wearable device

Behavioral: Improving Asthma Care Together (IMPACT)

Usual care control

NO INTERVENTION

Usual care control.

Interventions

Improving Asthma Care Together (IMPACT) BEHAVIORAL

IMPACT is a novel health application and wearable device

IMPACT Intervention

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinician diagnosis of persistent asthma (prescription for daily asthma medication)
• Speak English
• years or older
• Child's primary caregiver
• Able to understand and read English
• Reside with the child 50% or more
• Legal guardian who can consent for child to participate
• Have access to a smart phone and reliable home internet access
• Reported Asthma Responsibility Questionnaire score \< or = 2.5 at screening

You may not qualify if:

• Parent report of developmental delay (language \< 5 year level)
• Co-morbid cancer, diabetes, attention deficit hyperactivity disorder (ADHD)
• Current asthma exacerbation at the time of recruitment

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Nursing Research (NINR): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Washington School of Nursing

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Sonney J, Ward T, Thompson HJ, Kientz JA, Segrin C. Improving Asthma Care Together (IMPACT) mobile health intervention for school-age children with asthma and their parents: a pilot randomised controlled trial study protocol. BMJ Open. 2022 Feb 10;12(2):e059791. doi: 10.1136/bmjopen-2021-059791.

  PMID: 35144958 DERIVED

Results Point of Contact

• Title: Jennifer Sonney
• Organization: University of Washington

jsonney@uw.edu

206-685-2161

Study Officials

• Jennifer T Sonney, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Nursing

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: June 1, 2021
• Study Start: October 1, 2021
• Primary Completion: December 15, 2022
• Study Completion: August 15, 2023
• Last Updated: July 3, 2024
• Results First Posted: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)