Haemophilia AMINDNCT03276130
Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B
An observational study of Haemophilia A and Haemophilia B, run by Swedish Orphan Biovitrum at 5 sites in 3 countries.
Trial summary
The puropse of this non-interventional register and survey study is to identify the patterns of prescribed pain, anti-depressive and anti-anxiety medication and management of pain, depression and anxiety for people with haemophilia. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Haemophilia A, Haemophilia B
- How many people
- 2,300 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 30 Oct 2018to 30 Jan 2020
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All PwH in Sweden, Norway, Denmark and Finland
Who may be able to join
- Part A population will be defined by having:
- at least one health care contact with main diagnosis haemophilia A or haemophilia B, and/or;
- at least one prescription of factor VIII or factor IX concentrates, or;
- bypassing agents used in the treatment of PwH during the inclusion period.
- Part B1 population: Relevant physician at each HTC with direct and frequent patient contact.
- Part B2 population: PwH 5 years or older listed at participating HTCs
Who cannot join
- NA
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Sweden3 sites
Swedish Orphan Biovitrum Research Site
Gothenburg
Swedish Orphan Biovitrum Research Site
Malmö
Swedish Orphan Biovitrum Research Site
Stockholm
About this study
Official title: Management of Health-Related Quality of LIfe Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B
The puropse of this non-interventional register and survey study is to identify the patterns of prescribed pain, anti-depressive and anti-anxiety medication and management of pain, depression and anxiety for people with haemophilia. The study will be conducted in the Nordic countries (Sweden, Norway, Denmark, Finland) and the aim is to cover the entire haemophilia population in the register part of the study.
- Conditions
- Haemophilia A, Haemophilia B
- Keywords
- Blood coagulation disorder, Haematologic diseases, Coagulation protein disorder, Hemorrhagic disorder, Genetic diseases, inborn, Pain, Anxiety, Pain medication, Anxiety medication
- Medical subject headings
- Hemophilia A, Hemophilia B, Blood Coagulation Disorders, Coagulation Protein Disorders, Hemorrhagic Disorders, Genetic Diseases, Inborn, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Retrospective register study | To describe the usage of prescribed pain, anti-depressive and anti-anxiety medication during a 10-year period based on retrospective data from patient and drug registries. Population: All People with Haemophilia A and B identified through national administrative register or from local register at each treatment centre. The People with Haemophilia group will be compared against an age and gender matched control group from the general population. | |
| Part B1: Survey to HTC | The survey will be sent out to the relevant physician at each Haemophilia Treatment Centers (HTC) with direct and frequent patient contacts. | |
| Part B2: Survey to PwH | All People with Haemophilia (PwH) listed at HTCs will be invited to participate in the patient survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of medication for pain, depression and anxiety (yes/no?)
Based on Registry data
Measured: Retrospectively 10 years
Annualised consumption of pain medications as assessed by filled prescription
Based on Registry data
Measured: Retrospectively 10 years
Annualised consumption of anti-anxiety medications as assessed by filled prescription
Based on Registry data
Measured: Retrospectively 10 years
Annualised consumption of anti-depressive medications as assessed by filled prescription
Based on Registry data
Measured: Retrospectively 10 years
Duration of pain medications as measured by expected doses of medicines.
Based on Registry data
Measured: Retrospectively 10 years
Duration of anti-depressive medications as measured by expected doses of medicines.
Based on Registry data
Measured: Retrospectively 10 years
Duration of anti-anxiety medications as measured by expected doses of medicines.
Based on Registry data
Measured: Retrospectively 10 years
Pharmacological and non-pharmacological treatments for management of Health-Related Quality of Life (HRQoL) impairment, including treatment of pain
Assessed by Health Care Professional (HCP) survey in Part B1
Measured: Inclusion in survey study
Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of anxiety
Assessed by HCP survey in Part B1
Measured: Inclusion in survey study
Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of depression
Assessed by HCP survey in Part B1
Measured: Inclusion in survey study
The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of pain at each Haemophlia Treatment Centre
Assessed by HCP survey in Part B1
Measured: Inclusion in survey study
The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of anxiety at each Haemophlia Treatment Centre
Assessed by HCP survey in Part B1
Measured: Inclusion in survey study
The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of depression at each Haemophlia Treatment Centre
Assessed by HCP survey in Part B1
Measured: Inclusion in survey study
Self-reported current and previous use of medications for pain
Assessed by patient survey in Part B2
Measured: Inclusion in survey study
Self-reported current and previous use of medications for anxiety
Assessed by patient survey in Part B2
Measured: Inclusion in survey study
Self-reported current and previous use of medications for depression
Assessed by patient survey in Part B2
Measured: Inclusion in survey study
Social and physical activity level
Assessed by patient survey in Part B2
Measured: Inclusion in survey study
Euro-QoL 5 Dimensions 5 Levels (EQ-5D-5L)
Assessed by patient survey in Part B2
Measured: Inclusion in survey study
Patient satisfaction with current management of pain
Assessed by patient survey in Part B2
Measured: Inclusion in survey study
Patient satisfaction with current management anxiety
Assessed by patient survey in Part B2
Measured: Inclusion in survey study
Patient satisfaction with current management of depression
Assessed by patient survey in Part B2
Measured: Inclusion in survey study
Patient satisfaction of received treatment for pain
Assessed by patient survey in Part B2
Measured: Inclusion in Survey study
Patient satisfaction of received treatment for anxiety
Assessed by patient survey in Part B2
Measured: Inclusion in Survey study
Patient satisfaction of received treatment for depression
Assessed by patient survey in Part B2
Measured: Inclusion in Survey study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start30 Oct 2018
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Haemophilia AStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 2,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276130
- Sponsor's protocol ID
- Sobi.HAEM89-003
- Acronym
- MIND
- Status last verified
- Mar 2024
- First submitted
- 7 Sep 2017
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Steen Carlsson K, Astermark J, Baghaei F, Brodin E, Funding E, Holmstrom M, Osterholm K, Bergenstrale S, Lethagen S. Comorbidity and Mortality in Men and Women With Haemophilia in Three Nordic Countries-Comparisons to Matched Controls. Haemophilia. 2025 May;31(3):401-411. doi: 10.1111/hae.70023. Epub 2025 Mar 18.
PubMed 40099856Steen Carlsson K, Winding B, Astermark J, Baghaei F, Brodin E, Funding E, Holmstrom M, Osterholm K, Bergenstrale S, Andersson E, Lethagen S. Pain, depression and anxiety in people with haemophilia from three Nordic countries: Cross-sectional survey data from the MIND study. Haemophilia. 2022 Jul;28(4):557-567. doi: 10.1111/hae.14571. Epub 2022 Apr 23.
PubMed 35460313
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Health-Related Quality of LIfe Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B
- ClinicalTrials.gov ID
- NCT03276130
- Acronym / sponsor ID
- MIND / Sobi.HAEM89-003
- Conditions
- Haemophilia A, Haemophilia B
- Keywords
- Blood coagulation disorder, Haematologic diseases, Coagulation protein disorder, Hemorrhagic disorder, Genetic diseases, inborn, Pain, Anxiety, Pain medication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,300 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 8 Sep 2017 (actual)
- 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 puropse of this non-interventional register and survey study is to identify the patterns of prescribed pain, anti-depressive and anti-anxiety medication and management of pain, depression and anxiety for people with haemophilia. The study will be conducted in the Nordic countries (Sweden, Norway, Denmark, Finland) and the aim is to cover the entire haemophilia population in the register part of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: Retrospective register study | – | –To describe the usage of prescribed pain, anti-depressive and anti-anxiety medication during a 10-year period based on retrospective data from patient and drug registries. Population: All People with Haemophilia A and B identified through national administrative register or from local register at each treatment centre. The People with Haemophilia group will be compared against an age and gender matched control group from the general population. |
| Part B1: Survey to HTC | – | –The survey will be sent out to the relevant physician at each Haemophilia Treatment Centers (HTC) with direct and frequent patient contacts. |
| Part B2: Survey to PwH | – | –All People with Haemophilia (PwH) listed at HTCs will be invited to participate in the patient survey. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All PwH in Sweden, Norway, Denmark and Finland
Key inclusion criteria (6 listed)
- Part A population will be defined by having:
- at least one health care contact with main diagnosis haemophilia A or haemophilia B, and/or;
- at least one prescription of factor VIII or factor IX concentrates, or;
- bypassing agents used in the treatment of PwH during the inclusion period.
- Part B1 population: Relevant physician at each HTC with direct and frequent patient contact.
Key exclusion criteria (1 listed)
- NA
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
Use of medication for pain, depression and anxiety (yes/no?)
Time frame: Retrospectively 10 years
Based on Registry data
Annualised consumption of pain medications as assessed by filled prescription
Time frame: Retrospectively 10 years
Based on Registry data
Annualised consumption of anti-anxiety medications as assessed by filled prescription
Time frame: Retrospectively 10 years
Based on Registry data
Annualised consumption of anti-depressive medications as assessed by filled prescription
Time frame: Retrospectively 10 years
Based on Registry data
Duration of pain medications as measured by expected doses of medicines.
Time frame: Retrospectively 10 years
Based on Registry data
Duration of anti-depressive medications as measured by expected doses of medicines.
Time frame: Retrospectively 10 years
Based on Registry data
Duration of anti-anxiety medications as measured by expected doses of medicines.
Time frame: Retrospectively 10 years
Based on Registry data
Pharmacological and non-pharmacological treatments for management of Health-Related Quality of Life (HRQoL) impairment, including treatment of pain
Time frame: Inclusion in survey study
Assessed by Health Care Professional (HCP) survey in Part B1
Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of anxiety
Time frame: Inclusion in survey study
Assessed by HCP survey in Part B1
Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of depression
Time frame: Inclusion in survey study
Assessed by HCP survey in Part B1
The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of pain at each Haemophlia Treatment Centre
Time frame: Inclusion in survey study
Assessed by HCP survey in Part B1
The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of anxiety at each Haemophlia Treatment Centre
Time frame: Inclusion in survey study
Assessed by HCP survey in Part B1
The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of depression at each Haemophlia Treatment Centre
Time frame: Inclusion in survey study
Assessed by HCP survey in Part B1
Self-reported current and previous use of medications for pain
Time frame: Inclusion in survey study
Assessed by patient survey in Part B2
Self-reported current and previous use of medications for anxiety
Time frame: Inclusion in survey study
Assessed by patient survey in Part B2
Self-reported current and previous use of medications for depression
Time frame: Inclusion in survey study
Assessed by patient survey in Part B2
Social and physical activity level
Time frame: Inclusion in survey study
Assessed by patient survey in Part B2
Euro-QoL 5 Dimensions 5 Levels (EQ-5D-5L)
Time frame: Inclusion in survey study
Assessed by patient survey in Part B2
Patient satisfaction with current management of pain
Time frame: Inclusion in survey study
Assessed by patient survey in Part B2
Patient satisfaction with current management anxiety
Time frame: Inclusion in survey study
Assessed by patient survey in Part B2
Patient satisfaction with current management of depression
Time frame: Inclusion in survey study
Assessed by patient survey in Part B2
Patient satisfaction of received treatment for pain
Time frame: Inclusion in Survey study
Assessed by patient survey in Part B2
Patient satisfaction of received treatment for anxiety
Time frame: Inclusion in Survey study
Assessed by patient survey in Part B2
Patient satisfaction of received treatment for depression
Time frame: Inclusion in Survey study
Assessed by patient survey in Part B2
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 6 Mar 2024.
- Derived from this study: PubMed 40099856Steen Carlsson K, Astermark J, Baghaei F, Brodin E, Funding E, Holmstrom M, Osterholm K, Bergenstrale S, Lethagen S. Comorbidity and Mortality in Men and Women With Haemophilia in Three Nordic Countries-Comparisons to Matched Controls. Haemophilia. 2025 May;31(3):401-411. doi: 10.1111/hae.70023. Epub 2025 Mar 18.
- Derived from this study: PubMed 35460313Steen Carlsson K, Winding B, Astermark J, Baghaei F, Brodin E, Funding E, Holmstrom M, Osterholm K, Bergenstrale S, Andersson E, Lethagen S. Pain, depression and anxiety in people with haemophilia from three Nordic countries: Cross-sectional survey data from the MIND study. Haemophilia. 2022 Jul;28(4):557-567. doi: 10.1111/hae.14571. Epub 2022 Apr 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilia A and Haemophilia B, run by Swedish Orphan Biovitrum at 5 sites in 3 countries.
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 6 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 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden, Denmark, Finland. 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?
Use of medication for pain, depression and anxiety (yes/no?) (time frame: Retrospectively 10 years). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03276130, which also lists 2 linked publications.
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 6 Mar 2024.