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

NCT ID: NCT00212459

Last Updated: 2013-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-04-30

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.

Conditions

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Hemophilia A Hemophilia B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

Counseling

Intervention Type BEHAVIORAL

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

2

After the initial counseling with regards to bleeding records, there are no more contacts made with the control patients.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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

Interventions

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Counseling

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

Intervention Type BEHAVIORAL

Control

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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New York Presbyterian Hospital

OTHER

Sponsor Role lead

Responsible Party

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New York Presbyterian Hospital

Principal Investigators

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Donna M DiMichele, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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NY Presbyterian Hospital

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Bleeding Logs

Identifier Type: -

Identifier Source: org_study_id

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