- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02413684
PackHealth: Asthma Engagement Tool
Assessing the Impact of a Patient-Clinician Engagement Tool on Patient Reported Outcomes and Engagement in Asthma
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Patient engagement is a critical part of improving patient care and outcomes. Current patient engagement strategies only focus on the patient-physician interaction and have been shown to be ineffective.
The need for a comprehensive approach to patient engagement is no different among patients with asthma as it is in any other chronic condition. Patients with asthma must make complicated health decisions daily that impact their social and occupational activities, quality of life, and treatment adherence. Obtaining, communicating, processing, and understanding non- biased health information are crucial in making appropriate and informed treatment decisions.
Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care. Each Pack draws on the science of change management and patient activation and contains three categories of materials
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
North Carolina
-
Durham, North Carolina, États-Unis, 27705
- Duke Asthma Allergy and Airway Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients with a physician diagnosis of asthma for at least the previous 12 months.
- Asthma that is not well controlled by NAEPP guidelines.
- Ability and willingness to provide informed consent
Exclusion Criteria:
- Significant alcohol consumption of more than three alcoholic drinks per day or active substance abuse.
- Chronic disease (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system or immunodeficiency that are not well addressed or controlled.
- A diagnosis of cancer with ongoing treatment.
- Any terminal illness or conditions that results in a life expectancy less than one year.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Autre: Asthma Patients
Patient engagement toolkit
|
Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients.
These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Rate of Asthma Exacerbations
Délai: 12 weeks prior to baseline
|
The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations that occurred 12 weeks before baseline.
|
12 weeks prior to baseline
|
Rate of Asthma Exacerbations
Délai: baseline to week 13
|
The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations from baseline to week 13
|
baseline to week 13
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in Asthma Control
Délai: baseline, 13 weeks
|
Measured by the Asthma Control Test (ACT), patient self-administered tool for identifying those with poorly controlled asthma.
The ACT assesses the frequency of dyspnea and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control.
5 items with 4-week recall.
The score range is 5-25 with >19 representing good control and <18 representing poor control.
|
baseline, 13 weeks
|
Change in Asthma Symptoms
Délai: baseline, 13 weeks
|
Measured by asthma symptom utility index (ASUI). The Asthma Symptom utility Index (ASUI) is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of asthma-related symptoms and treatment side effects. Number of items 11 items with 2 week recall. Scores range from 0 (worst possible symptoms) to 1 (no symptoms) Minimal Clinically Important Difference (MCID) > 0.09 |
baseline, 13 weeks
|
Change in Pulmonary Function Tests
Délai: baseline, 13 weeks
|
Measured by spirometry.
We measured forced expiratory volume in one second (FEV1) and forced vital capacity both in liters.
FEV1 is a measure of airflow obstruction.
The change in lung function is the change in these measurements compared to baseline.
|
baseline, 13 weeks
|
Number of Emergency Department and Hospitalization Visits
Délai: Prior Year
|
Number of emergency department and hospitalizations visits will be recorded that occurred within the prior year.
|
Prior Year
|
Number of Emergency Department and Hospitalization Visits
Délai: 13 weeks
|
Number of emergency department and hospitalization visits will be recorded
|
13 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Njira Lugogo, MD, Duke University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
- Pro00057939
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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