Brief Title
The Effect of Patient Counseling on Adolescent Hemophilia Patient Compliance With Bleeding Logs
Official Title
A Prospective Randomized Pilot Study on the Effect of Patient Counseling on Adolescent Hemophilia Patient Compliance With Bleeding Logs
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 Type
Interventional
Primary Outcome
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
Secondary Outcome
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
Condition
Hemophilia A
Intervention
Counseling
Study Arms / Comparison Groups
1
Description: Patients are contacted every two weeks after initial counseling to discuss completion of bleeding records.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
14
Start Date
May 2005
Completion Date
April 2008
Primary Completion Date
February 2006
Eligibility Criteria
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
Gender
Male
Ages
12 Years - 20 Years
Accepts Healthy Volunteers
No
Contacts
Donna M DiMichele, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00212459
Organization ID
Bleeding Logs
Study Sponsor
New York Presbyterian Hospital
Study Sponsor
Donna M DiMichele, MD, Principal Investigator, Weill Medical College of Cornell University
Verification Date
May 2008