The Effect of Patient Counseling on Adolescent Hemophilia Patient Compliance With Bleeding Logs
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||A Prospective Randomized Pilot Study on the Effect of Patient Counseling on Adolescent Hemophilia Patient Compliance With Bleeding Logs|
- 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Clotting factor consumption and the cost of therapy in each group will be compared [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Study Completion Date:||April 2008|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
Patients are contacted every two weeks after initial counseling to discuss completion of bleeding records.
Patients are contacted every two weeks after initial counseling to discuss the completion of bleeding records.
Active Comparator: 2
After the initial counseling with regards to bleeding records, there are no more contacts made with the control patients.
No more contacts are made with control patients after the initial counseling session.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212459
|United States, New York|
|NY Presbyterian Hospital|
|New York, New York, United States, 10021|
|Principal Investigator:||Donna M DiMichele, MD||Weill Medical College of Cornell University|