Hemophilia ANCT00212459
The Effect of Patient Counseling on Adolescent Hemophilia Patient Compliance With Bleeding Logs
A study testing Counseling in people with Hemophilia A and Hemophilia B, run by New York Presbyterian Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 20 years, men only
- Conditions the study is for
- Hemophilia A, Hemophilia B
- What is being tested?
- Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Pilot Study on 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.
Read the 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.
- Conditions
- Hemophilia A, Hemophilia B
- Being tested
- Counseling, Control
- Keywords
- Bleeding logs, Factor Infusions
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
Patients are contacted every two weeks after initial counseling to discuss the completion of bleeding records.
ControlBehavioural
No more contacts are made with control patients after the initial counseling session.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients are contacted every two weeks after initial counseling to discuss completion of bleeding records. Receives: Behavioral: Counseling |
| 2 | Active comparator | After the initial counseling with regards to bleeding records, there are no more contacts made with the control patients. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (2)
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
Measured: 6 months
Clotting factor consumption and the cost of therapy in each group will be compared
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionFeb 2006
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Donna M DiMichele, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212459
- Sponsor's protocol ID
- Bleeding Logs
- Status last verified
- May 2008
- First submitted
- 13 Sep 2005
- Last updated
- 27 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Pilot Study on the Effect of Patient Counseling on Adolescent Hemophilia Patient Compliance With Bleeding Logs
- ClinicalTrials.gov ID
- NCT00212459
- Acronym / sponsor ID
- Bleeding Logs
- Conditions
- Hemophilia A, Hemophilia B
- Keywords
- Bleeding logs, Factor Infusions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- New York Presbyterian HospitalUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: CounselingPatients are contacted every two weeks after initial counseling to discuss completion of bleeding records. |
| 2 | Active comparator | Behavioral: ControlAfter the initial counseling with regards to bleeding records, there are no more contacts made with the control patients. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounselingPatients are contacted every two weeks after initial counseling to discuss the completion of bleeding records. | Behavioural | 1 |
| ControlNo more contacts are made with control patients after the initial counseling session. | Behavioural | 2 |
Primary outcome
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
2 secondary outcomes
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
Clotting factor consumption and the cost of therapy in each group will be compared
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna M DiMichele, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling in people with Hemophilia A and Hemophilia B, run by New York Presbyterian Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2013.