- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02241694
To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives (HERO)
July 9, 2015 updated by: Novo Nordisk A/S
Haemophilia, Experiences, Results and Opportunities (HERO) in Brazil: Assessment of Psychological Effects of Haemophilia on Patients and Caregivers
This survey is conducted in South America.
The purpose is to identify the key psychosocial issues affecting patients with haemophilia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Säo Paulo, Brazil, 05001-400
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Adult males with haemophilia and parents/carers of children with haemophilia.
Description
Inclusion Criteria:
- Men aged 18 years or above with haemophilia A or B (with or without inhibitors) OR Parents/caregivers of children/adolescents younger than 18 years with haemophilia A or B (with or without inhibitors); only one subject per household will be able to participate
- Patients currently receiving one of the following treatments: a. replacement factor VIII therapy, b. replacement factor IX therapy, c. bypassing agents (recombinant factor VIIa or APCC) OR Patients with haemophilia, not receiving any kind of treatment with replacement factor VIII or IX or a bypassing agent (as appropriate), but who have had at least one spontaneous haemorrhage into one or more joints within the last 12 months
- The participants (patients with haemophilia and parents/caregivers for patients under 18 years old) must be able to complete a paper questionnaire in order to participate in the study
- Providing informed consent before the start of any study-related activities
Exclusion Criteria:
- Inability for the patients or parents/caregivers to understand and comply with verbal instructions, unless assisted by a member of the HTC (Haemophilia Treatment Center) or by a relative. (No other conditions were established for patients who cannot read or write to be able to participate in this study in addition to the need of help from a member of HTC or by a relative.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
survey
|
No treatment given.
Participants are to complete a questionnaire in the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Qualitative assessments of perceived impact on daily life
Time Frame: Day 1
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Perceived disease control
Time Frame: Day 1
|
Day 1
|
Carrier status and reactions to haemophilia diagnosis
Time Frame: Day 1
|
Day 1
|
Genetic counselling and testing
Time Frame: Day 1
|
Day 1
|
Impact of haemophilia in siblings
Time Frame: Day 1
|
Day 1
|
Satisfaction with support from partners, family, friends, others
Time Frame: Day 1
|
Day 1
|
Sexual intimacy with partners in long-term relationships
Time Frame: Day 1
|
Day 1
|
Treatment method, compliance and location
Time Frame: Day 1
|
Day 1
|
Modified WHO-5 (World Health Organization-Five Well Being Index)
Time Frame: Day 1
|
Day 1
|
Knowledge and information about haemophilia
Time Frame: Day 1
|
Day 1
|
Improvements in haemophilia care
Time Frame: Day 1
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Global Clinical Registry (GCR, 1452), GZZF, Novo Nordisk A/S
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
September 1, 2014
First Submitted That Met QC Criteria
September 12, 2014
First Posted (Estimate)
September 16, 2014
Study Record Updates
Last Update Posted (Estimate)
July 10, 2015
Last Update Submitted That Met QC Criteria
July 9, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F7HAEM-4146
- U1111-1147-4202 (Other Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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