Back to resultsEffects of Framing on Medication Beliefs, Intentions to Take Medication, Adherence, and Asthma Control
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Negatively Framed text messages
Positively Framed text messages
Sponsored by
About this trial
This is an interventional supportive care trial for Asthma focused on measuring mHealth, message framing
Eligibility Criteria
Inclusion Criteria: A diagnosis of asthma A prescription for an inhaled corticosteroid Enrolled in college Between 18-29 years of age Owns a mobile phone Exclusion Criteria: Cannot read in english
Sites / Locations
- Auburn University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Positively framed text messages
Negatively frame text messages
Arm Description
Positively framed text messages
Negatively framed text messages
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Changes in Medication Beliefs
Medication Beliefs as measured by the Beliefs about Medicines Questionnaire-Specific (This scale has two sub-scales : necessity (20- points) and concerns (20 points). A difference of necessity and concern scores shows the level of perceived necessity for the medication. Higher scores indicate higher perceived necessity for the medication.
Intentions to take medication as prescribed
Intentions to take inhaled corticosteroids as prescribed as measured by an intentions scale (minimum score = 3, maximum score = 15; higher scores indicate greater intentions; the scale was tested in the study)
Changes in Medication adherence
Adherence to a daily dose of inhaled corticosteroid as measured by the Medication Adherence Report Scale for Asthma (MARS-A) (Minimum score = 10, maximum score = 50, higher scores indicate greater adherence)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06033313
Brief Title
Effects of Framing on Medication Beliefs, Intentions to Take Medication, Adherence, and Asthma Control
Official Title
Examining the Effect of Message Framing on Medication Beliefs, Intentions to Take Medications, Adherence to Medication, and Asthma Control Among College Students
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auburn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
mHealth, message framing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positively framed text messages
Arm Type
Experimental
Arm Description
Positively framed text messages
Arm Title
Negatively frame text messages
Arm Type
Experimental
Arm Description
Negatively framed text messages
Intervention Type
Behavioral
Intervention Name(s)
Negatively Framed text messages
Intervention Description
Negatively Framed text messages delivered to participants three times per week for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Positively Framed text messages
Intervention Description
Positively Framed text messages delivered to participants three times per week for 8 weeks.
Primary Outcome Measure Information:
Title
Changes in Asthma control
Description
Asthma control as measured by the Asthma Control Test (minimum value=5, maximum value= 25) Questionnaire (scores of 20 and above indicate asthma control)
Time Frame
Data collection at baseline, week 4, and week 8
Secondary Outcome Measure Information:
Title
Changes in Medication Beliefs
Description
Medication Beliefs as measured by the Beliefs about Medicines Questionnaire-Specific (This scale has two sub-scales : necessity (20- points) and concerns (20 points). A difference of necessity and concern scores shows the level of perceived necessity for the medication. Higher scores indicate higher perceived necessity for the medication.
Time Frame
Data collection at baseline and week 8
Title
Intentions to take medication as prescribed
Description
Intentions to take inhaled corticosteroids as prescribed as measured by an intentions scale (minimum score = 3, maximum score = 15; higher scores indicate greater intentions; the scale was tested in the study)
Time Frame
Data collection at baseline and week 8
Title
Changes in Medication adherence
Description
Adherence to a daily dose of inhaled corticosteroid as measured by the Medication Adherence Report Scale for Asthma (MARS-A) (Minimum score = 10, maximum score = 50, higher scores indicate greater adherence)
Time Frame
Data collection at baseline, week 4, and week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A diagnosis of asthma
A prescription for an inhaled corticosteroid
Enrolled in college
Between 18-29 years of age
Owns a mobile phone
Exclusion Criteria:
Cannot read in english
Facility Information:
Facility Name
Auburn University
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36849
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data available upon request
IPD Sharing Time Frame
Immediately available upon request for the next 10-20 years
IPD Sharing Access Criteria
This is not applicable
Learn more about this trial
Effects of Framing on Medication Beliefs, Intentions to Take Medication, Adherence, and Asthma Control
We'll reach out to this number within 24 hrs