NCT06033313

Brief Summary

The goal of this study is to examine the effects of framed mobile messages on young adults' beliefs about their daily Inhaled Corticosteroids (ICS), intentions to take their ICS, adherence, and asthma control. College students (18-29 years) who owned a mobile phone and had a diagnosis of asthma with a prescription for an ICS will be recruited. Participants will be randomized to receive either gain- or loss-framed mobile messages three times per week for eight weeks. Outcomes including beliefs, intentions, adherence, and asthma control will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Oct 2019

Shorter than P25 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

Study Start

First participant enrolled

October 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

June 14, 2023

Last Update Submit

September 8, 2023

Conditions

Keywords

mHealthmessage framing

Outcome Measures

Primary Outcomes (1)

  • Changes in Asthma control

    Asthma control as measured by the Asthma Control Test (minimum value=5, maximum value= 25) Questionnaire (scores of 20 and above indicate asthma control)

    Data collection at baseline, week 4, and week 8

Secondary Outcomes (3)

  • Changes in Medication Beliefs

    Data collection at baseline and week 8

  • Intentions to take medication as prescribed

    Data collection at baseline and week 8

  • Changes in Medication adherence

    Data collection at baseline, week 4, and week 8

Study Arms (2)

Positively framed text messages

EXPERIMENTAL

Positively framed text messages

Behavioral: Positively Framed text messages

Negatively frame text messages

EXPERIMENTAL

Negatively framed text messages

Behavioral: Negatively Framed text messages

Interventions

Negatively Framed text messages delivered to participants three times per week for 8 weeks.

Negatively frame text messages

Positively Framed text messages delivered to participants three times per week for 8 weeks.

Positively framed text messages

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A diagnosis of asthma
  • A prescription for an inhaled corticosteroid
  • Enrolled in college
  • Between 18-29 years of age
  • Owns a mobile phone

You may not qualify if:

  • Cannot read in english

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 14, 2023

First Posted

September 13, 2023

Study Start

October 1, 2019

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

Data available upon request

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Immediately available upon request for the next 10-20 years
Access Criteria
This is not applicable

Locations