Atopic DermatitisNCT01216059
Text Messaging and Atopic Dermatitis
A study testing Text message to cell phone in people with Atopic Dermatitis, run by Northwestern University at 2 sites in United States.
Trial summary
Atopic dermatitis is a common problem faced by patients of all ages and backgrounds. Treatment regimens and specific therapies may be time consuming and multiple studies have documented a parallel decrease in compliance as time after an office visit increases. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Text message to cell phone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Jun 2012
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 10-17 inclusive
- Capable of giving informed consent/assent. Of note, all subjects will sign an assent form and parents will sign a parent consent form.
- Diagnosed with Atopic Dermatitis by a physician (self report)
- IGA score fo 2 or greater
- Currently using at least one prescribed topical therapy for atopic dermatitis
- Have a mobile phone capable of receiving text messages
- Able to retrieve text messages from mobile phone
- Able to adhere to study visit schedule and other protocol requirements.
Who cannot join
- Younger than 10 years of age or 18 years and older at the time of enrollment
- No diagnosis of atopic dermatitis by a physician
- IGA score of 0 or 1
- Currently on no prescribed topical treatment for atopic dermatitis
- UV therapy or climatotherapy is a part of treatment for atopic dermatitis
- Does not have a mobile phone capable of receiving text messages
- Unable to retrieve text message
- Non-English speaking individuals (text messages are in English)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
Children's Memorial Hospital
Chicago, Illinois, 60614
About this study
Official title: The Use of Text Messages to Improve Adherence to Health Maintenance Behaviors in Adolescents With Atopic Dermatitis
Atopic dermatitis is a common problem faced by patients of all ages and backgrounds. Treatment regimens and specific therapies may be time consuming and multiple studies have documented a parallel decrease in compliance as time after an office visit increases. The adolescent population is an extremely challenging sub-group of patients in terms of complying with a treatment regimen. Not only are they striving for independence and thus lacking supervision of a regimen by a parent, but their complex thinking skills are immature, leading to forgetful behavior. By introducing a reminder system for these vulnerable patients that is easily incorporated into their daily lives, the investigators propose that patients will have better compliance at applying their medication and thus improving their atopic dermatitis. Text-messaging via cell phones has become very popular among teenagers and adults and provides a non-obtrusive method of sending a treatment reminder.
Read the detailed description
We propose to conduct a randomized, controlled 6-week trial to evaluate the impact of a text message-based reminder program on adherence to health maintenance behaviors among adolescents diagnosed with Atopic Dermatitis. After obtaining informed consent, subjects will be randomized into either an intervention or control group. Subjects in the intervention group will receive a daily text message with a tailored message regarding atopic dermatitis, while control group subjects will receive a weekly text message with information on local weather, sport or news without any reference to atopic dermatitis. Of note, the decision to send a weekly text message to the control group reflects the expectation that a message will be sent, although the frequency and content of the message will not be revealed.
- Conditions
- Atopic Dermatitis
- Being tested
- Text message to cell phone
- Keywords
- adherence, text message, reminder, adolescents
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message to cell phoneProcedure or surgery
Subjects will receive a daily text message reminder about their treatment for atopic dermatitis during the 6 weeks of the study
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Subjects will receive daily text message reminder about their treatment for atopic dermatitis during the 6 weeks of the study. Receives: Procedure: Text message to cell phone |
| Control Group | No intervention | Subjects will receive a weekly text message reminder about pop-culture, sports or weather. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self reported medication adherence
We will assess the difference in number of missed doses of topical medication in the control group (weekly unrelated text message) and the intervention group (daily eczema-related text message group). All subjects will record missed doses via calendars (diaries). Those in the intervention group will be able to text on a weekly basis the number of days they forgot their medication that week.
Measured: 6 weeks
Change in quality of life
Measured: 6 weeks
Secondary outcomes (2)
Change in AD knowledge score
Measured: 6 weeks
Change in health maintenance behaviors
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Paller, Northwestern University
- Investigators
- Amy Paller, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216059
- Sponsor's protocol ID
- STU29486
- Status last verified
- Nov 2012
- First submitted
- 4 Oct 2010
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Text Messages to Improve Adherence to Health Maintenance Behaviors in Adolescents With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01216059
- Acronym / sponsor ID
- STU29486
- Conditions
- Atopic Dermatitis
- Keywords
- adherence, text message, reminder, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Oct 2010 (estimated)
- 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.
Atopic dermatitis is a common problem faced by patients of all ages and backgrounds. Treatment regimens and specific therapies may be time consuming and multiple studies have documented a parallel decrease in compliance as time after an office visit increases. The adolescent population is an extremely challenging sub-group of patients in terms of complying with a treatment regimen. Not only are they striving for independence and thus lacking supervision of a regimen by a parent, but their complex thinking skills are immature, leading to forgetful behavior. By introducing a reminder system for these vulnerable patients that is easily incorporated into their daily lives, the investigators propose that patients will have better compliance at applying their medication and thus improving their atopic dermatitis. Text-messaging via cell phones has become very popular among teenagers and adults and provides a non-obtrusive method of sending a treatment reminder.
Detailed description
We propose to conduct a randomized, controlled 6-week trial to evaluate the impact of a text message-based reminder program on adherence to health maintenance behaviors among adolescents diagnosed with Atopic Dermatitis. After obtaining informed consent, subjects will be randomized into either an intervention or control group. Subjects in the intervention group will receive a daily text message with a tailored message regarding atopic dermatitis, while control group subjects will receive a weekly text message with information on local weather, sport or news without any reference to atopic dermatitis. Of note, the decision to send a weekly text message to the control group reflects the expectation that a message will be sent, although the frequency and content of the message will not be revealed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Text message to cell phoneSubjects will receive daily text message reminder about their treatment for atopic dermatitis during the 6 weeks of the study. |
| Control Group | No intervention | –Subjects will receive a weekly text message reminder about pop-culture, sports or weather. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age 10-17 inclusive
- Capable of giving informed consent/assent. Of note, all subjects will sign an assent form and parents will sign a parent consent form.
- Diagnosed with Atopic Dermatitis by a physician (self report)
- IGA score fo 2 or greater
- Currently using at least one prescribed topical therapy for atopic dermatitis
Key exclusion criteria (8 listed)
- Younger than 10 years of age or 18 years and older at the time of enrollment
- No diagnosis of atopic dermatitis by a physician
- IGA score of 0 or 1
- Currently on no prescribed topical treatment for atopic dermatitis
- UV therapy or climatotherapy is a part of treatment for atopic dermatitis
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 |
|---|---|---|
| Text message to cell phoneSubjects will receive a daily text message reminder about their treatment for atopic dermatitis during the 6 weeks of the study | Procedure or surgery | Intervention group |
Primary outcome
Change in self reported medication adherence
Time frame: 6 weeks
We will assess the difference in number of missed doses of topical medication in the control group (weekly unrelated text message) and the intervention group (daily eczema-related text message group). All subjects will record missed doses via calendars (diaries). Those in the intervention group will be able to text on a weekly basis the number of days they forgot their medication that week.
Change in quality of life
Time frame: 6 weeks
2 secondary outcomes
Change in AD knowledge score
Time frame: 6 weeks
Change in health maintenance behaviors
Time frame: 6 weeks
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 3 Dec 2012.
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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.
Amy Paller, MD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message to cell phone in people with Atopic Dermatitis, run by Northwestern University at 2 sites 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 8 inclusion and 8 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 3 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in self reported medication adherence (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 3 Dec 2012.