NCT02498834

Brief Summary

The purpose of this study is to conduct a randomized controlled trial with English and Spanish-speaking adolescents to compare the effectiveness of an adolescent "asthma question prompt list" with a supportive educational video intervention with usual care. The hypothesis of this study is that by showing the parents and adolescents the educational video and then providing the adolescents with the one-page "asthma question prompt lists" to use during their visits will improve: (a) asthma control, (b) adolescent self-efficacy in managing asthma, and (c) adolescent quality-of-life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
359

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable asthma

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 16, 2019

Completed
Last Updated

January 16, 2019

Status Verified

July 1, 2018

Enrollment Period

2.3 years

First QC Date

June 24, 2015

Results QC Date

July 23, 2018

Last Update Submit

July 26, 2018

Conditions

Asthma

Keywords

Communicationprovidercaregiveradolescent

Outcome Measures

Primary Outcomes (3)

  • Number of Participants Achieving Asthma Control

    This will be measured via the 5-item Asthma Control Test, responses are summed to indicate a score ranging from 5 (poor asthma control) to 25 (complete asthma control). A higher score means a better outcome. A score of above 19 is considered "well controlled".

    12 month follow-up

  • Adolescent Asthma Management Self-efficacy Score

    Adolescent asthma management self-efficacy was measured using a 14-item scale that has been shown to have a reliability of 0.87. Prior work in asthma has found asthma management self-efficacy to change in response to an intervention. Scores range from 14 to 70 and a higher score means a better outcome.

    12 month follow-up

  • Asthma Quality-of-life Score

    Adolescent quality-of-life was measured as a continuous variable. The investigators used the standardized version of the Juniper pediatric asthma quality-of-life questionnaire. The questionnaire contains 23 items and has a reliability of 0.84. Scores can range from 1.0 to 7.0, and a higher score means a better outcome.

    12 month follow-up

Study Arms (2)

Educational Video and Question Prompt List

EXPERIMENTAL

Parents and adolescents in this group will watch a short educational video in English or Spanish on an iPad about the importance of encouraging adolescents to ask questions and to be involved during their pediatric asthma visits to improve their self-management skills. Also, the adolescents in this group will be handed a question prompt list to complete, which will be collected after the medical visit.

Behavioral: Educational Video and Question Prompt List

Control group

NO INTERVENTION

Standard of care will be used

Interventions

Educational Video and Question Prompt ListBEHAVIORAL

Educational Video and Question Prompt List

Educational Video and Question Prompt List

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ages 11 to 17 years;
  • speak and read English or Spanish;
  • have persistent asthma;
  • are present for an acute or follow-up asthma visit or a well-child visit;
  • and have previously visited the clinic at least once for asthma.
  • Adolescents' parents will be eligible if they are at least 18 years of age, speak and read English or Spanish, and are the legal guardian of the adolescent.

You may not qualify if:

  • present for gastrointestinal complaints or other non-asthma related acute illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolin at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

AsthmaCommunication

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Betsy Sleath, PhD
Organization
University of North Carolina at Chapel Hill
betsy_sleath@unc.edu
(919) 962-0079

Study Officials

  • Betsy L Sleath, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2015

First Posted

July 15, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

January 16, 2019

Results First Posted

January 16, 2019

Record last verified: 2018-07

Locations

US(1)