- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06033313
Effects of Framing on Medication Beliefs, Intentions to Take Medication, Adherence, and Asthma Control
September 8, 2023 updated by: Ruth Jeminiwa, Auburn University
Examining the Effect of Message Framing on Medication Beliefs, Intentions to Take Medications, Adherence to Medication, and Asthma Control Among College Students
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Auburn, Alabama, United States, 36849
- Auburn University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Positively framed text messages
|
Positively Framed text messages delivered to participants three times per week for 8 weeks.
|
|
Experimental: Negatively frame text messages
Negatively framed text messages
|
Negatively Framed text messages delivered to participants three times per week for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Asthma control
Time Frame: Data collection at baseline, week 4, and week 8
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Medication Beliefs
Time Frame: Data collection at baseline and week 8
|
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.
|
Data collection at baseline and week 8
|
|
Intentions to take medication as prescribed
Time Frame: Data collection at baseline and week 8
|
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)
|
Data collection at baseline and week 8
|
|
Changes in Medication adherence
Time Frame: Data collection at baseline, week 4, and week 8
|
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)
|
Data collection at baseline, week 4, and week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
November 30, 2019
Study Completion (Actual)
November 30, 2019
Study Registration Dates
First Submitted
June 14, 2023
First Submitted That Met QC Criteria
September 8, 2023
First Posted (Actual)
September 13, 2023
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 8, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-221
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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