Essai SMART Contrôle de l'Asthme
Amélioration de l'observance médicamenteuse grâce à une intervention adaptative de santé mobile chez les adolescents asthmatiques.
The primary objective is to examine the efficacy of an mHealth adherence intervention (Asthma Ctrl) on adherence to daily inhaled corticosteroids as measured by electronically monitored adherence in adolescents with asthma. The secondary objective is to compare the effectiveness of three intervention strategies: 1. asthma management app (control); 2. Asthma Ctrl; 3. Asthma Ctrl+ on adherence, lung function, and health care utilization at post-intervention and 1- and 6-month follow-up. The third objective is to explore and contrast different challenges and combinations of challenges to identify which are most impactful in determining response to the three intervention strategies.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Our goal is to evaluate our promising mHealth intervention (Asthma Ctrl) that is easily accessible and tailored based on adherence barriers and to examine predictors of treatment response. In this multi-site R01 with Children's Hospital Colorado, the study investigators will conduct a 2-stage sequential, multiple assignment, randomized trial (SMART) to evaluate the effectiveness of our mHealth intervention strategies for improving adherence to daily inhaled corticosteroids in adolescents with asthma. Following a baseline period, adolescents will be randomized to a mHealth asthma management app (control group) or Asthma Ctrl, a text-messaging intervention providing adherence feedback based on adherence monitoring (treatment) for SMART Stage 1. Participants will be excluded from the study if they have an adherence that is >68%. For SMART Stage 2, adolescents randomized to the treatment group who demonstrate non-adherence (≤68% adherence; non-response) will undergo a second randomization to receive either 1) continued Asthma Ctrl (text messaging) or 2) Asthma Ctrl+ (Asthma Ctrl augmented with a problem-solving intervention delivered via telehealth). Thus, there are three intervention strategies that will be tested in this SMART: #1 control condition, #2 treatment, and #3 adapted treatment after Stage 2 and at follow-up (1 and 6 months). This innovative SMART design will address objectives described in the brief summary.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Rachelle R Ramsey
- Numéro de téléphone: 513-803-8348
- E-mail: rachelle.ramsey@cchmc.org
Lieux d'étude
-
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Colorado
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Aurora, Colorado, États-Unis, 80262
- University of Colorado AMC
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Contact:
- Heather DeKeyser
-
Chercheur principal:
- Heather De Keyser
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Ohio
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Cincinnati, Ohio, États-Unis, 45229
- Cincinnati Children's Hospital Medical Center
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Contact:
- Rachelle R Ramsey
- Numéro de téléphone: 513-803-8348
- E-mail: rachelle.ramsey@cchmc.org
-
Chercheur principal:
- Rachelle R Ramsey
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patient age between 12-18 years
- Patient is diagnosed with severe-persistent or moderate-persistent asthma per NAEPP asthma guidelines
- Patient is prescribed at least one daily inhaled controller medication or a daily combination inhaled corticosteroid and long-acting beta-agonist and a beta-agonist bronchodilator
- English fluency for patient, caregiver, and clinician
Exclusion Criteria:
- Significant cognitive deficits that may interfere with comprehension per medical team or chart review
- Diagnosis of serious mental illness (e.g., schizophrenia)
- Diagnosis of pervasive developmental disorder
- Active chronic disease apart from asthma or allergic disease (e.g. Bronchiectasis, pulmonary hypertension, and moderate or severe tracheomalacia)
- Patient receives school administered daily controller medication at the time of the enrollment visit
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Control
Participants will receive access to an asthma management application providing education and automated reminders |
Asthma management application providing education and automated reminders |
|
Expérimental: Asthma Ctrl
Participants will receive the Asthma Ctrl intervention |
Individualized adherence feedback via text messaging intervention based on real-time adherence monitoring |
|
Expérimental: Asthma Ctrl+
Participants will receive the Asthma Ctrl+ intervention |
Interventions described in Asthma Ctrl with problem-solving skills training via four telehealth sessions to occur every other week. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Electronically Monitored Controller Medication Adherence
Délai: 12 months
|
Monthly adherence rates will be calculated by dividing the number of doses recorded by the electronic monitor by the total number of prescribed doses; the rate is then multiplied by 100 to determine the percentage. For patients prescribed Single Maintenance and Reliever Therapy, per the new asthma guidelines, the study investigators will assume that initial doses taken are for prevention and adherence will be capped at 100%. |
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Composite Asthma Severity Index (CASI)
Délai: Baseline assessment and then once a month for 12 months
|
A weighted score comprised of:
The CASI score, ranging from 0 to 20 points, includes 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. The CASI is designed for children and adults ages 6 and older. A CASI score in the range of 0 to 3 indicates low severity. A CASI score greater than 3 may indicate medium to high asthma severity. |
Baseline assessment and then once a month for 12 months
|
|
Asthma Control: Asthma Control Test (ACT)
Délai: Baseline assessment and then once a month for 12 months
|
Five-item adolescent self-report, 4-week recall of frequency of asthma symptoms, use of rescue medications, effect of asthma on daily functioning, perception of asthma control. Items are rated using a 5-point scale. The total score ranges from 5 to 25. A score of 19 or less indicates that asthma may not be well controlled, signaling the need for a review with a healthcare provide |
Baseline assessment and then once a month for 12 months
|
|
Lung Function
Délai: Baseline and then once a month for 12 months
|
Mobile spirometry to capture Forced Vital Capacity (FVC) |
Baseline and then once a month for 12 months
|
|
Lung Function
Délai: Baseline and then once a month for 12 months.
|
Mobile Spirometry to capture Forced Expiratory Volume in 1 second (FEV1) |
Baseline and then once a month for 12 months.
|
|
Lung Function
Délai: Baseline and then once a month for 12 months
|
Mobile spirometry to capture Ration of Forced Expiratory Volume to Forced Vital Capacity (FEV1/FVC) |
Baseline and then once a month for 12 months
|
|
Lung Function
Délai: Baseline and then once a month for 12 months
|
Mobile Spirometry to capture Forced Expiratory Flow (FEF) |
Baseline and then once a month for 12 months
|
|
Healthcare Utilization
Délai: Baseline assessment and then once a month for 12 months.
|
Patients and caregivers will self-report the occurrence of asthma-related emergency department and urgent care visits, hospital admissions, and ICU admissions in the past month. Study staff will also review the patient's medical chart for the above information as well as asthma-intubation. |
Baseline assessment and then once a month for 12 months.
|
|
Asthma Exacerbations
Délai: Baseline assessment and then once a month for 12 months.
|
Adolescents will provide a two-week recall of their use of oral steroids to treat an exacerbation. Study staff will also review the medical chart for this information. |
Baseline assessment and then once a month for 12 months.
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Demographic Questionnaire
Délai: Baseline
|
Adolescents and caregivers will complete a questionnaire to collect information about demographics. |
Baseline
|
|
Hardship questionnaire
Délai: Baseline assessment and then at 6 months and 12 months
|
Adolescents and caregivers will complete a 19-item validated questionnaire designed to capture current hardships. |
Baseline assessment and then at 6 months and 12 months
|
|
Asthma Knowledge
Délai: Baseline assessment and then at 6 months and 12 months
|
Adolescents will complete a 13-item a questionnaire assessing the extent to which they agree with facts or information about asthma to provide a measure of health beliefs. |
Baseline assessment and then at 6 months and 12 months
|
|
Adolescent Medication Barriers Scale (AMBS)
Délai: Baseline assessment and then at 6 months and 12 months.
|
16 (adolescent) item report assessing perceived barriers to treatment adherence using a 5-point Likert scale from 1 ("strongly disagree") to 5 ("strongly agree"). Higher scores on the AMBS are linked to poorer adherence and increased medical complications. |
Baseline assessment and then at 6 months and 12 months.
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Rachelle R Ramsey, Children's Hospital Medical Center, Cincinnati
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2024-0434
- 1R01HL172827-01A1 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Sufficient data from this project will be preserved to enable sharing via BioLINCC. The study investigators will share summary data (a less detailed data table) with data that is of sufficient quality to validate and replicate research findings described in the Aims.
Informations sur les médicaments et les dispositifs, documents d'étude
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