Patient Centered Comprehensive Medication Adherence Management System in Patients With Sickle Cell Disease (SCD Mobile Dot)
3 mars 2021 mis à jour par: Lakshmanan Krishnamurti, Emory University
Patient Centered Comprehensive Medication Adherence Management System to Improve Effectiveness of Disease Modifying Therapy With Hydroxyurea in Patients With Sickle Cell Disease
The purpose of this research study is to learn about ways to help children and adults with sickle cell disease who are taking the medication, hydroxyurea.
Aperçu de l'étude
Description détaillée
Sickle cell disease (SCD) is an inherited chronic multi-organ system disorder that affects approximately 100,000 individuals in the United States, mostly belonging to minority, under-served populations.
SCD is associated with substantial morbidity, premature mortality, individual suffering, health care costs and loss of productivity.
Hydroxyurea (HU) the only disease modifying therapy for SCD is efficacious in reducing complications such as pain crisis and acute chest syndrome and improving survival.
It is however, vastly underutilized and poorly adhered to because of barriers at the health care system, provider, treatment, socioeconomic, and patient levels.
The investigator's overarching hypothesis is that barriers to acceptance and adherence to HU are multi-factorial and that a structured set of interventions can lead to improved adherence to medication and patient centered outcomes.
Type d'étude
Interventionnel
Inscription (Réel)
164
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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District of Columbia
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Washington, District of Columbia, États-Unis, 20010
- Children's National Medical Center
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- Children's Healthcare of Atlanta
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Illinois
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Chicago, Illinois, États-Unis, 60607
- University of Illinois at Chicago
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15224
- Children's Hospital of Pittsburgh
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
2 ans à 65 ans (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- be >2 years of age up to 65 years of age, inclusive
- have a diagnosis of SCD, with either βS/βS, βS/βC, βS/βD, βS/β0, βS/βO-Arab, or βS/β+ genotype
- prescribed Hydroxyurea for at least the 6 months prior to study entry
- have daily access to a smart phone, tablet, personal computer or other device capable of producing and transmitting videos over the internet
- be willing and able to record and transmit videos
Exclusion Criteria:
- patient or caregiver refuses to take Hydroxyurea as treatment for SCD
- diagnosis of significant psychiatric disorder of the subject that could seriously impede the ability to participate in the study
- an assessment by the investigator that the subject will not comply with the study procedures outlined in the study protocol
- patients receiving automatic home delivery of medications since medication possession ratio is reflective of the patient initiation the refill when they have exhausted the home supply of HU
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Adults - Mobile DOT
Subjects with SCD that are older than 21 years old will receive comprehensive medication adherence management (Mobile DOT) after 1 month assessment period.
The subjects will receive the Mobile DOT intervention for 24 months.
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Daily reminders via text or email to send a video of themselves taking their Hydroxyurea, positive feedback, and be encouraged to contact the research coordinator with any questions, concerns, etc.
Autres noms:
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Comparateur actif: Adults - standard of care then Mobile DOT
Subjects with SCD that are older than 21 years old will receive standard of care for the first 12 months.
They will then crossover to the comprehensive medication adherence management plan (Mobile DOT) after 1 month assessment period for the remaining 12 months.
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Daily reminders via text or email to send a video of themselves taking their Hydroxyurea, positive feedback, and be encouraged to contact the research coordinator with any questions, concerns, etc.
Autres noms:
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Expérimental: Children - Mobile DOT
Subjects with SCD that are younger than 21 years old will receive comprehensive medication adherence management (Mobile DOT) after 1 month assessment period.
The subjects will receive the Mobile DOT intervention for 24 months.
|
Daily reminders via text or email to send a video of themselves taking their Hydroxyurea, positive feedback, and be encouraged to contact the research coordinator with any questions, concerns, etc.
Autres noms:
|
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Comparateur actif: Children - standard of care then Mobile DOT
Subjects with SCD that are younger than 21 years old will receive standard of care for the first 12 months.
They will then crossover to the comprehensive medication adherence management plan (Mobile DOT) after 1 month assessment period for the remaining 12 months.
|
Daily reminders via text or email to send a video of themselves taking their Hydroxyurea, positive feedback, and be encouraged to contact the research coordinator with any questions, concerns, etc.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Medication Possession Ratio (MPR)
Délai: 12 months
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Proportion of days the patient is in possession of the medication in the study period
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12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Hemoglobin (Hb) levels
Délai: Baseline, 24 months
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Change in hemoglobin levels from baseline to 24 months will be measured using the HemoCue® rapid test.
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Baseline, 24 months
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Change in mean cell volume (MCV)
Délai: Baseline, 24 months
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Change from baseline in MCV will be calculated as the value at 24 months minus the value at baseline.
MCV is the average size of the red blood cells expressed in femtoliters.
MCV is calculated by dividing the hematocrit (as percent) by the red blood cell (RBC) count in millions per microliter of blood, then multiplying by 10.
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Baseline, 24 months
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Change in fetal hemoglobin (HbF) levels
Délai: Baseline, 24 months
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Change from baseline in HbF will be calculated as the value at 24 months minus the value at baseline.
HbF is expressed as a percentage.
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Baseline, 24 months
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Impact of adherence on clinical outcomes and healthcare utilization
Délai: Baseline, 24 months
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Health care utilization in the emergency department and hospitalization due to sickle cell related complications such as vaso-occlusive crisis (VOC) or acute chest syndrome (ACS).
Retrospective chart review at baseline will be conducted to determine healthcare utilization.
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Baseline, 24 months
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Impact of adherence on patients' lives
Délai: Baseline, 24 months
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Impact of adherence on patients' lives measured using patient reported outcomes (PROMIS), surveys of school attendance, work absenteeism, out-of-pocket costs incurred by patients and their caregivers
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Baseline, 24 months
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Change in adherence with using Mobile-DOT
Délai: Baseline, 24 months
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Retrospective chart review at baseline will be conducted to determine medication possession rate (MPR) and then compared to the MPR at 24 months.
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Baseline, 24 months
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Acceptability of intervention and of Hydroxyurea
Délai: Baseline, 24 months
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Acceptability will be measured by Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) The TSQM is a 14-item subject-assessed evaluation of treatment medication including 4 factors, Effectiveness, Side Effects, Convenience, and Global Satisfaction, and it utilizes the following responses on a 7-point Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied.
Scores range from 0-100, with 0 as extremely dissatisfied and 100 as extremely satisfied.
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Baseline, 24 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Lakshmanan Krishnamurti, MD, Emory University/Children's Healthcare of Atlanta
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2014
Achèvement primaire (Réel)
31 décembre 2018
Achèvement de l'étude (Réel)
31 décembre 2018
Dates d'inscription aux études
Première soumission
19 février 2015
Première soumission répondant aux critères de contrôle qualité
19 février 2015
Première publication (Estimation)
26 février 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 mars 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 mars 2021
Dernière vérification
1 mars 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB00074105
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