HaemophiliaNCT02870114
National Survey of People With Haemophilia in Portugal
An observational study of Haemophilia, run by University of Minho at 1 site in Portugal.
Trial summary
The purpose of this study is to implement a national survey to collect information regarding Portuguese people with haemophilia (PWH) on socio-demographic, clinical and psychosocial factors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Haemophilia
- How many people
- 146 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2016to 22 May 2017
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with Haemophilia A or B, of any age and gender, registered in the Portuguese Haemophilia Association
Who may be able to join
- Haemophilia A or B
- Portuguese nationality
Who cannot join
- Acquired Haemophilia
- Psychiatric or neurological deficit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sociodemographic, Clinic and Psychosocial Aspects of People With Haemophilia in Portugal: a National Survey
The purpose of this study is to implement a national survey to collect information regarding Portuguese people with haemophilia (PWH) on socio-demographic, clinical and psychosocial factors.
Read the detailed description
This is a cross-sectional design investigation focused on the socio-demographic, clinical and psychosocial characterization of Portuguese people with haemophilia (PWH). All PWH, registered in the Portuguese Hemophilia Association (APH) will be identified in APH registries and contacted through mail, in order to be invited to participate in the first Portuguese survey on haemophilia. In case of acceptance, patients must sign the Informed Consent, fill in the questionnaires and send both back to the investigation team through a pre-paid envelope in the national mail system.
PWH of all ages are invited to participate in this survey. Adults (aged 18 and over) and children/youth from 10 to 17 will answer the questionnaires by self report. Parents of small children (0 to 9) will fill in the proxy versions. All questionnaires are adapted for the specific age groups.
This study will comply with ethic guidelines and was approved by the Life Sciences and Health Ethics Subcommittee (University of Minho) and is registered on the Portuguese authority for data collection (CNPD).
- Conditions
- Haemophilia
- Keywords
- Haemophilia, Quality of Life, Distress, Hemarthrosis, Pain
- Medical subject headings
- Hemophilia A, Hemarthrosis, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life in Adults as assessed by A36Hemofilia-Qol
Measured: 1 year
Health Related Quality of Life in Children as assessed by Canadian Haemophilia Outcomes-Kids Life Assessment Tool
Health Related Quality of Life in Children
Measured: 1 year
Pain Intensity
Pain Questionnaire developed specifically for this investigation to assess PWH (based on Wallny's Pain Questionnaire for PWH and Brief Pain Inventory).
Measured: 1 year
Pain Location
Pain Questionnaire developed specifically for this investigation to assess PWH (based on Wallny's Pain Questionnaire for PWH and Brief Pain Inventory).
Measured: 1 year
Pain Duration
Pain Questionnaire developed specifically for this investigation to assess PWH (based on Wallny's Pain Questionnaire for PWH and Brief Pain Inventory).
Measured: 1 year
Secondary outcomes (9)
Total score of Haemophilia-related functional limitations as assessed by Haemophilia Activities List (HAL) and Pediatric HAL
Measured: 1 year
Anxiety score as assessed by PROMIS-Anxiety Short Form v1.0
Assessmet of Anxiety
Measured: 1 week
Depression score as assessed by PROMIS-Depression Short Form v1.0
Measured: 1 week
Illness Perception as assessed by IPQ-R
Measured: 1 year
Pain Catastrophizing as assessed by CSQ - Catastrophizing Subscale
Measured: 1 year
Number of Joint Bleeds
Measured: 1 year
Presence of inibitors
Measured: 1 year
Number of target joints
Measured: 1 year
Type of sports practiced by PWH
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion22 May 2017
- Study completion22 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemophiliaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sao Joao, Portuguese hemophilia association and other congenital coagulopathies
- Responsible party
- Principal investigator, Patrícia Ribeiro Pinto, University of Minho
- Investigators
- Patrícia R Pinto, PhD, Principal investigator, Life and Health Sciences Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870114
- Sponsor's protocol ID
- 520101.ID1825
- Status last verified
- May 2017
- First submitted
- 9 Aug 2016
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sociodemographic, Clinic and Psychosocial Aspects of People With Haemophilia in Portugal: a National Survey
- ClinicalTrials.gov ID
- NCT02870114
- Acronym / sponsor ID
- 520101.ID1825
- Conditions
- Haemophilia
- Keywords
- Haemophilia, Quality of Life, Distress, Hemarthrosis, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Collaborators
- Hospital Sao Joao, Portuguese hemophilia association and other congenital coagulopathies
- Study start
- Sep 2016
- Primary completion
- 22 May 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 17 Aug 2016 (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 purpose of this study is to implement a national survey to collect information regarding Portuguese people with haemophilia (PWH) on socio-demographic, clinical and psychosocial factors.
Detailed description
This is a cross-sectional design investigation focused on the socio-demographic, clinical and psychosocial characterization of Portuguese people with haemophilia (PWH). All PWH, registered in the Portuguese Hemophilia Association (APH) will be identified in APH registries and contacted through mail, in order to be invited to participate in the first Portuguese survey on haemophilia. In case of acceptance, patients must sign the Informed Consent, fill in the questionnaires and send both back to the investigation team through a pre-paid envelope in the national mail system.
PWH of all ages are invited to participate in this survey. Adults (aged 18 and over) and children/youth from 10 to 17 will answer the questionnaires by self report. Parents of small children (0 to 9) will fill in the proxy versions. All questionnaires are adapted for the specific age groups.
This study will comply with ethic guidelines and was approved by the Life Sciences and Health Ethics Subcommittee (University of Minho) and is registered on the Portuguese authority for data collection (CNPD).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with Haemophilia A or B, of any age and gender, registered in the Portuguese Haemophilia Association
Key inclusion criteria (2 listed)
- Haemophilia A or B
- Portuguese nationality
Key exclusion criteria (2 listed)
- Acquired Haemophilia
- Psychiatric or neurological deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health Related Quality of Life in Adults as assessed by A36Hemofilia-Qol
Time frame: 1 year
Health Related Quality of Life in Children as assessed by Canadian Haemophilia Outcomes-Kids Life Assessment Tool
Time frame: 1 year
Health Related Quality of Life in Children
Pain Intensity
Time frame: 1 year
Pain Questionnaire developed specifically for this investigation to assess PWH (based on Wallny's Pain Questionnaire for PWH and Brief Pain Inventory).
Pain Location
Time frame: 1 year
Pain Questionnaire developed specifically for this investigation to assess PWH (based on Wallny's Pain Questionnaire for PWH and Brief Pain Inventory).
Pain Duration
Time frame: 1 year
Pain Questionnaire developed specifically for this investigation to assess PWH (based on Wallny's Pain Questionnaire for PWH and Brief Pain Inventory).
9 secondary outcomes
Total score of Haemophilia-related functional limitations as assessed by Haemophilia Activities List (HAL) and Pediatric HAL
Time frame: 1 year
Anxiety score as assessed by PROMIS-Anxiety Short Form v1.0
Time frame: 1 week
Depression score as assessed by PROMIS-Depression Short Form v1.0
Time frame: 1 week
Illness Perception as assessed by IPQ-R
Time frame: 1 year
Pain Catastrophizing as assessed by CSQ - Catastrophizing Subscale
Time frame: 1 year
Number of Joint Bleeds
Time frame: 1 year
Presence of inibitors
Time frame: 1 year
Number of target joints
Time frame: 1 year
Type of sports practiced by PWH
Time frame: 1 year
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 24 May 2017.
- Individual participant dataSharing planned: No
Related trials for Haemophilia
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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.
Patrícia R Pinto, PhD principal investigator
Life and Health Sciences Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilia, run by University of Minho at 1 site in Portugal.
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 2 inclusion and 2 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 24 May 2017. 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 Portugal. 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?
Health Related Quality of Life in Adults as assessed by A36Hemofilia-Qol (time frame: 1 year). The study lists 5 primary outcomes in all. 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 24 May 2017.