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

Not Applicable

Completed

• Conditions: Hemophilia A; Hemophilia B
• Interventions: Behavioral: Counseling; Behavioral: Control

• Registration Number: NCT00212459
• Lead Sponsor: New York Presbyterian Hospital

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.

Detailed 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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2006-02
• Study Completion: 2008-04
• Status Verified: 2008-05
• Last Update Submitted: 2013-03-26
• Last Update Posted: 2013-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Counseling	Patients are contacted every two weeks after initial counseling to discuss completion of bleeding records.
2	Control	After the initial counseling with regards to bleeding records, there are no more contacts made with the control patients.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

NY Presbyterian Hospital; 🇺🇸 New York, New York, United States