AsthmaNCT06033313
Effects of Framing on Medication Beliefs, Intentions to Take Medication, Adherence, and Asthma Control
A study testing Negatively Framed text messages and Positively Framed text messages in people with Asthma, run by Auburn University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Negatively Framed text messages and Positively Framed text messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A diagnosis of asthma
- A prescription for an inhaled corticosteroid
- Enrolled in college
- Between 18-29 years of age
- Owns a mobile phone
Who cannot join
- Cannot read in english
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Asthma
- Being tested
- Negatively Framed text messages, Positively Framed text messages
- Keywords
- mHealth, message framing
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negatively Framed text messagesBehavioural
Negatively Framed text messages delivered to participants three times per week for 8 weeks.
Positively Framed text messagesBehavioural
Positively Framed text messages delivered to participants three times per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Positively framed text messages | Experimental | Positively framed text messages Receives: Behavioral: Positively Framed text messages |
| Negatively frame text messages | Experimental | Negatively framed text messages Receives: Behavioral: Negatively Framed text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Data collection at baseline, week 4, and week 8
Secondary outcomes (3)
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.
Measured: Data collection at baseline and week 8
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)
Measured: Data collection at baseline and week 8
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)
Measured: Data collection at baseline, week 4, and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Oct 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Jeminiwa, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033313
- Sponsor's protocol ID
- 19-221
- Status last verified
- Sep 2023
- First submitted
- 14 Jun 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data available upon request
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Message Framing on Medication Beliefs, Intentions to Take Medications, Adherence to Medication, and Asthma Control Among College Students
- ClinicalTrials.gov ID
- NCT06033313
- Acronym / sponsor ID
- 19-221
- Conditions
- Asthma
- Keywords
- mHealth, message framing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positively framed text messages | Experimental | Behavioral: Positively Framed text messagesPositively framed text messages |
| Negatively frame text messages | Experimental | Behavioral: Negatively Framed text messagesNegatively framed text messages |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A diagnosis of asthma
- A prescription for an inhaled corticosteroid
- Enrolled in college
- Between 18-29 years of age
- Owns a mobile phone
Key exclusion criteria (1 listed)
- Cannot read in english
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negatively Framed text messagesNegatively Framed text messages delivered to participants three times per week for 8 weeks. | Behavioural | Negatively frame text messages |
| Positively Framed text messagesPositively Framed text messages delivered to participants three times per week for 8 weeks. | Behavioural | Positively framed text messages |
Primary outcome
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)
3 secondary outcomes
Changes in Medication Beliefs
Time frame: Data collection at baseline and week 8
Intentions to take medication as prescribed
Time frame: Data collection at baseline and week 8
Changes in Medication adherence
Time frame: Data collection at baseline, week 4, and week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: Yes. Data available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negatively Framed text messages and Positively Framed text messages in people with Asthma, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Asthma control (time frame: Data collection at baseline, week 4, and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.