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

This study has been completed.
Sponsor:
Information provided by:
New York Presbyterian Hospital
ClinicalTrials.gov Identifier:
NCT00212459
First received: September 13, 2005
Last updated: March 26, 2013
Last verified: May 2008
  Purpose

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.


Condition Intervention
Hemophilia A
Hemophilia B
Behavioral: Counseling
Behavioral: Control

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by New York Presbyterian Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: May 2005
Study Completion Date: April 2008
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients are contacted every two weeks after initial counseling to discuss completion of bleeding records.
Behavioral: Counseling
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.
Behavioral: Control
No more contacts are made with control patients after the initial counseling session.

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.
  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212459

Locations
United States, New York
NY Presbyterian Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
New York Presbyterian Hospital
Investigators
Principal Investigator: Donna M DiMichele, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Donna DiMichele, MD, New York Presbyterian Hospital
ClinicalTrials.gov Identifier: NCT00212459     History of Changes
Other Study ID Numbers: Bleeding Logs
Study First Received: September 13, 2005
Last Updated: March 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York Presbyterian Hospital:
Bleeding logs
Factor Infusions

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on October 02, 2014