NCT00212459

Brief Summary

The study will see if counselling adolescents with severe or moderate Hemophilia A or B results in increased compliance in the maintenance of bleeding logs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2005

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

March 27, 2013

Status Verified

May 1, 2008

Enrollment Period

9 months

First QC Date

September 13, 2005

Last Update Submit

March 26, 2013

Conditions

Hemophilia AHemophilia B

Keywords

Bleeding logsFactor Infusions

Outcome Measures

Primary Outcomes (1)

  • Study and control groups will be compared with respect to the % of bleeds reported to the HTC and % of recommended therapy recorded in bleeding logs after a 6 month period

    6 months

Secondary Outcomes (2)

  • Study and control groups will be compared with respect to time between initiation of target joint bleeding and the identification and treatment of such by HTC personnel

    6 months

  • Clotting factor consumption and the cost of therapy in each group will be compared

    6 months

Study Arms (2)

1

EXPERIMENTAL

Patients are contacted every two weeks after initial counseling to discuss completion of bleeding records.

Behavioral: Counseling

2

ACTIVE COMPARATOR

After the initial counseling with regards to bleeding records, there are no more contacts made with the control patients.

Behavioral: Control

Interventions

CounselingBEHAVIORAL

Patients are contacted every two weeks after initial counseling to discuss the completion of bleeding records.

1
ControlBEHAVIORAL

No more contacts are made with control patients after the initial counseling session.

2

Eligibility Criteria

Age12 Years - 20 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages 12 through 20
  • Severe or moderate Hemophilia A or B
  • Self-infusing or transitioning to self infusion in the home setting
  • Already assigned responsibility of monitoring bleeding logs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NY Presbyterian Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Hemophilia AHemophilia B

Interventions

Counseling

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Donna M DiMichele, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

May 1, 2005

Primary Completion

February 1, 2006

Study Completion

April 1, 2008

Last Updated

March 27, 2013

Record last verified: 2008-05

Locations

US(1)