NCT02868138

Brief Summary

The aim of this single-center observational study was to evaluate quality of life, clinical effectiveness, and satisfaction in pediatric and young adult patients with sickle cell disease receiving hydroxyurea.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

2 months

First QC Date

August 8, 2016

Last Update Submit

August 13, 2016

Conditions

Sickle Cell Disease

Keywords

Sickle cell diseaseHydroxyureaCompliance

Outcome Measures

Primary Outcomes (1)

  • Effectiveness and acceptance of hydroxyurea therapy in patients

    Up to 12 weeks

Secondary Outcomes (6)

  • Demographic characteristics of patients using Demographic Data Collection Form

    Up to 12 weeks

  • Clinical characteristics of patients using Case Report Form

    Up to 12 weeks

  • Health status of pediatric patients using Child Health Questionnaire-Parent Form

    Up to 12 weeks

  • Quality of life of young adult patients using Life Quality Survey Short Form-36

    Up to 12 weeks

  • Effectiveness of hydroxyurea therapy in patients using Case Report Form

    Up to 12 weeks

  • +1 more secondary outcomes

Eligibility Criteria

Age7 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric (7-17 years) and young adult (18-22 years) patients with sickle cell disease who received hydroxyurea

You may qualify if:

  • Patients willing to participate in the study
  • Pediatric and young adult patients
  • Patients diagnosed with HbSS or HbSβ0 sickle cell disease
  • Patients receiving hydroxyurea for at least a year.

You may not qualify if:

  • Patients not willing to participate in the study
  • Patients diagnosed with other types of anemia except HbSS or HbSβ0 sickle cell disease
  • Patients not receiving hydroxyurea for at least a year
  • Patients having other conditions such as physical and/or mental difficulties which may affect their quality of life
  • Patients having any contrindication against hydroxyurea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selma Unal

Mersin, 33169, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anemia, Sickle CellPatient Compliance

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • BAHAR TUNCTAN, Ph.D.

    MERSIN UNIVERSITY FACULTY OF PHARMACY DEPARTMENT OF PHARMACOLOGY

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 16, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 16, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

TU(1)