- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02436070
Use of Text Messages to Improve Care For Children Following an ED Visit for Asthma
BACKGROUND Asthma is a prevalent and troublesome pediatric condition. In 2013, Emergency Department (ED) providers treated over 3,500 cases of asthma-related complaints at Children's Hospitals and Clinics of Minnesota. Pediatric ED visits for asthma exceeds billions of dollars annually when including direct cost and lost productivity. Many of these visits and resultant costs are avoidable. Patients with well-controlled asthma do not typically exhibit these patterns, while patients with poorly controlled asthma show patterns of increased utilization of healthcare resources and lower quality of life. Evidence suggests that a text message reminder and educational program might positively influence pediatric asthma care practices.
RESEARCH QUESTION Does a targeted ED based text message intervention program improve outpatient follow-up and routine preventive care in pediatric asthma patients?
METHODS Study subjects will be block randomized based on age and insurance group. The experimental group will receive text messages with guidance towards follow-up care with their PCP and the importance of the flu vaccine for children with asthma. The control group will receive a series of educational self-care and health based text messages unrelated to asthma or the flu vaccine. Some self-report of behaviors will be captured via text message response.
ANALYSIS Primary outcomes for the educational versus targeted text message groups will be compared use Chi-square tests. Additional adjustments may be applied for missing data or if, despite randomization, there is substantial imbalance between group in key covariates (eg race/ethnicity, insurance type or asthma severity.)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55404
- Reclutamento
- Children's Hospitals and Clinics of Minnesota - Emergency Department
-
Contatto:
- Anupam B Kharbanda, MD
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Saint Paul, Minnesota, Stati Uniti
- Reclutamento
- Children's Minnesota
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Contatto:
- Anupam Kharbanda, MD
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Caregivers of patients aged 4 - 17 years (inclusive) will be eligible for study participation if they meet the following criteria:
- Presentation to the ED with a chief complaint related to an asthma exacerbation such as shortness of breath, respiratory distress, wheezing, etc…
- Receive an albuterol treatment in the ED
- Previous history of asthma as represented in the medical record or by parental report
- Have a cell phone that is able to receive text messages
- Able to communicate and provide consent in English or Spanish
Exclusion Criteria:
Caregivers of patients will be excluded from this study for the following reasons:
- First episode of wheezing
- Admitted to the hospital
Co-morbid respiratory disease:
- Cystic fibrosis
- Bronchiectasis
- Pulmonary hypertension
- Other chronic lung disease
- Current cancer diagnosis
- Previous cardiovascular surgery
- Inflammatory bowel disease
- Sickle Cell disease
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Control
Subjects receive general, health-related text messages applicable for children with asthma.
|
Subjects received text messages generalized to children with asthma
|
|
Sperimentale: Test group
Subjects receive specific, targeted text messages for post-emergency department discharge asthma care.
|
Subjects received text messages specific to post ED asthma follow-up
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Follow-up care with primary care provider
Lasso di tempo: 1 week after emergency department discharge
|
Assessed via text and follow-up call if no response to text message
|
1 week after emergency department discharge
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Influenza vaccine
Lasso di tempo: 30 days after emergency department discharge
|
Assessed via text and follow-up call if no response to text message
|
30 days after emergency department discharge
|
|
Return visit to the emergency department
Lasso di tempo: 30 days after the inaugural emergency department visit
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Assessed via text and follow-up call if no response to text message; Our health record also checked for return visits
|
30 days after the inaugural emergency department visit
|
Collaboratori e investigatori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1409-082
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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