The Effect of Patient Counseling on Adolescent Hemophilia Patient Compliance With Bleeding Logs

Hemophilia A Clinical Trial

Official title:

A Prospective Randomized Pilot Study on the Effect of Patient Counseling on Adolescent Hemophilia Patient Compliance With Bleeding Logs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212459
• Other study ID #: Bleeding Logs
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: March 26, 2013
• Start date: May 2005
• Est. completion date: April 2008

Study information

• Verified date: May 2008
• Source: New York Presbyterian Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.To do this subjects will be randomized into a control group and a group who will receive consistent counselling by a pharmacist about their bleeding logs.

The aims of the study are:

• To provide a new method of bleeding and treatment documentation in the home setting (logs) to adolescent subjects with Hemophilia A or B

• To counsel these subjects about adherence to their treatment regimen prescribed by physician and the importance of keeping accurate documentation of each bleeding episode and its treatment.

• To improve maintenance of logs, to allow for 1) assessment of bleeding frequency and treatment efficacy and 2) early detection of target joint bleeding and the potential need for prophylactic factor replacement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2008
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years to 20 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Not meeting inclusion criteria

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia B

Intervention

Behavioral:
• Counseling
Patients are contacted every two weeks after initial counseling to discuss the completion of bleeding records.
• Control
No more contacts are made with control patients after the initial counseling session.

Locations

Country	Name	City	State
United States	NY Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Clotting factor consumption and the cost of therapy in each group will be compared		6 months	No