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Completed

NCT Number: NCT00212459

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

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia B Hemorrhagic Disorders

Age range

12 year–20 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

NY Presbyterian Hospital

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling

Behavioral

Patients are contacted every two weeks after initial counseling to discuss the completion of bleeding records.

Control

Behavioral

No more contacts are made with control patients after the initial counseling session.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Clotting factor consumption and the cost of therapy in each group will be compared

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

New York Presbyterian Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2008
First posted
Sep 21, 2005
Registry last updated
Mar 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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