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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemophilia A, Hemophilia B

Intervention / Treatment
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* Behavioral: Counseling
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients are contacted every two weeks after initial counseling to discuss completion of bleeding records. | Behavioral: Counseling<br>* Patients are contacted every two weeks after initial counseling to discuss the completion of bleeding records.<br>|
| Active Comparator: 2<br>After the initial counseling with regards to bleeding records, there are no more contacts made with the control patients. | Behavioral: Control<br>* No more contacts are made with control patients after the initial counseling session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bleeding logs, Factor Infusions