- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02779426
Texting Atopic Dermatitis Patients to Optimize Learning and EASI Scores (TADPOLES)
Studieöversikt
Detaljerad beskrivning
Atopic dermatitis (AD) is a common, chronic, and debilitating disease that tends to present in children under age 2 and has a waxing and waning course. Poor adherence to treatment is the primary preventable contributor towards adverse outcomes such as infection, hospitalization, permanent disfigurement, and disruptions in normal childhood psychological development. The burden of care for these patients often falls upon parents, who may have difficulty incorporating the necessary daily treatments into the family's lifestyle. Thus, investigating ways of improving adherence could have a significant impact on a patient's long term prognosis and the family's ability to understand and adjust to the demands of AD.Text message reminders with embedded health literacy information have been shown to improve vaccination rates in children and caregivers have reported increased satisfaction with this means of communication.
This study aims to assess whether text message reminders with information about AD are an effective way to improve treatment adherence and provide disease specific information to caregivers of children with AD. The measure of AD severity will be the Eczema Area and Severity Index (EASI) score. Health literacy with regard to AD will be assessed via in-office survey.This study will involve children age 0-6 with newly diagnosed AD and their primary caregivers. The subjects will be randomized to standard care or text message reminder group. All study participants will be asked to complete a survey after their initial evaluation and after their follow up visit on the same day they are in the office. The text message group will receive text messages with information and treatment reminders. All participants will receive the standard of care with regard to AD.
If this study demonstrates that text message reminders can improve EASI scores in AD patients it could lead to a significant change in how these patients are managed. Fewer complications from episodic flares, infections, and other sequelae may lessen the burden of this disease for both patients and their caregivers. Text messaging is an inexpensive, noninvasive, and broadly applicable tool that is worth studying for the purpose of improving treatment adherence and disease literacy.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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New York
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New York, New York, Förenta staterna, 10032
- Columbia University Medical Center, Department of Dermatology
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- New clinical diagnosis of atopic dermatitis
- New patient to Columbia University Medical Center, Department of Dermatology
- Caregiver has mobile that can send/receive text messages
Exclusion Criteria:
- Age over 7 years
- Caregiver is not fluent English speaker
- Those patients in which a definitive diagnosis of atopic dermatitis cannot be made
- Any individual who declines participation
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Text Message Intervention + Standard Care
Enrolled patients and their caregivers who are randomized to this group will receive the usual standard of care for atopic dermatitis patients treated at this institution as well as daily text messages with information about atopic dermatitis and treatment reminders.
1-2 times/week they will receive a message asking if they were able to complete their treatments in the last day.
They will respond with 1=yes, 2=no, 3= I have questions about the treatment.
Those who respond with 3 will be sent the contact information for the office.
No other communications will be sent through text messages.
Caregivers will take two in-office surveys: one upon enrollment, and one follow-up survey at the follow-up visit.
Patient EASI Score will be assessed by the pediatric dermatologist and initial and follow up exam.
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Daily text messages with information about atopic dermatitis and treatment reminders.
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Inget ingripande: Standard Care
Enrolled patients and their caregivers who are randomized to this group will receive the usual standard of care for atopic dermatitis patients treated at this institution.
They will not receive text messages.
Caregivers will take two in-office surveys: one upon enrollment, and one follow-up survey at the follow-up visit.
Patient EASI Score will be assessed by the pediatric dermatologist and initial and follow up exam.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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EASI Score
Tidsram: Up to 6 weeks
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Patient EASI Score (0-72) will be determined at initial and follow up exam.
Mean differences in EASI scores between arms will be assessed using t-tests since EASI scores are used to measure the severity of a patient's atopic dermatitis.
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Up to 6 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Patient Satisfaction
Tidsram: Up to 6 weeks
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The investigators will assess mean difference in reported satisfaction, as indicated on follow up survey, between arms using t-tests.
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Up to 6 weeks
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Christine Lauren, MD, Columbia University
Publikationer och användbara länkar
Allmänna publikationer
- Sokolova A, Smith SD. Factors contributing to poor treatment outcomes in childhood atopic dermatitis. Australas J Dermatol. 2015 Nov;56(4):252-7. doi: 10.1111/ajd.12331. Epub 2015 Mar 29.
- Filanovsky MG, Pootongkam S, Tamburro JE, Smith MC, Ganocy SJ, Nedorost ST. The Financial and Emotional Impact of Atopic Dermatitis on Children and Their Families. J Pediatr. 2016 Feb;169:284-90.e5. doi: 10.1016/j.jpeds.2015.10.077. Epub 2015 Nov 23.
- Bass AM, Anderson KL, Feldman SR. Interventions to Increase Treatment Adherence in Pediatric Atopic Dermatitis: A Systematic Review. J Clin Med. 2015 Jan 27;4(2):231-42. doi: 10.3390/jcm4020231.
- Stockwell MS, Hofstetter AM, DuRivage N, Barrett A, Fernandez N, Vargas CY, Camargo S. Text message reminders for second dose of influenza vaccine: a randomized controlled trial. Pediatrics. 2015 Jan;135(1):e83-91. doi: 10.1542/peds.2014-2475.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AAAQ7858
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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