Patient Centered Comprehensive Medication Adherence Management System in Patients With Sickle Cell Disease (SCD Mobile Dot)
3 maart 2021 bijgewerkt door: 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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
164
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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District of Columbia
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Washington, District of Columbia, Verenigde Staten, 20010
- Children's National Medical Center
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Children's Healthcare of Atlanta
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Illinois
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Chicago, Illinois, Verenigde Staten, 60607
- University of Illinois at Chicago
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15224
- Children's Hospital of Pittsburgh
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
2 jaar tot 65 jaar (Kind, Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
Andere namen:
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Actieve vergelijker: 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.
Andere namen:
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Experimenteel: 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.
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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.
Andere namen:
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Actieve vergelijker: 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.
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Medication Possession Ratio (MPR)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Hemoglobin (Hb) levels
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Lakshmanan Krishnamurti, MD, Emory University/Children's Healthcare of Atlanta
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juni 2014
Primaire voltooiing (Werkelijk)
31 december 2018
Studie voltooiing (Werkelijk)
31 december 2018
Studieregistratiedata
Eerst ingediend
19 februari 2015
Eerst ingediend dat voldeed aan de QC-criteria
19 februari 2015
Eerst geplaatst (Schatting)
26 februari 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
5 maart 2021
Laatste update ingediend die voldeed aan QC-criteria
3 maart 2021
Laatst geverifieerd
1 maart 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB00074105
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