Hemophilia A, Hemophilia B
Conditions
Keywords
Bleeding logs, Factor Infusions
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.
Interventions
BEHAVIORALCounseling
Patients are contacted every two weeks after initial counseling to discuss the completion of bleeding records.
BEHAVIORALControl
No more contacts are made with control patients after the initial counseling session.
Sponsors
New York Presbyterian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
12 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed