Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B (MIND)

March 5, 2024 updated by: Swedish Orphan Biovitrum

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2300

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

  • Denmark
      • Copenhagen, Denmark
        • Swedish Orphan Biovitrum Research site
  • Finland
      • Helsinki, Finland
        • Swedish Orphan Biovitrum Research site
  • Sweden
      • Göteborg, Sweden
        • Swedish Orphan Biovitrum Research site
      • Malmö, Sweden
        • Swedish Orphan Biovitrum Research site
      • Stockholm, Sweden
        • Swedish Orphan Biovitrum Research site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All PwH in Sweden, Norway, Denmark and Finland

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • NA

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Use of medication for pain, depression and anxiety (yes/no?)
Time Frame: Retrospectively 10 years
Based on Registry data
Retrospectively 10 years
Annualised consumption of pain medications as assessed by filled prescription
Time Frame: Retrospectively 10 years
Based on Registry data
Retrospectively 10 years
Annualised consumption of anti-anxiety medications as assessed by filled prescription
Time Frame: Retrospectively 10 years
Based on Registry data
Retrospectively 10 years
Annualised consumption of anti-depressive medications as assessed by filled prescription
Time Frame: Retrospectively 10 years
Based on Registry data
Retrospectively 10 years
Duration of pain medications as measured by expected doses of medicines.
Time Frame: Retrospectively 10 years
Based on Registry data
Retrospectively 10 years
Duration of anti-depressive medications as measured by expected doses of medicines.
Time Frame: Retrospectively 10 years
Based on Registry data
Retrospectively 10 years
Duration of anti-anxiety medications as measured by expected doses of medicines.
Time Frame: Retrospectively 10 years
Based on Registry data
Retrospectively 10 years
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
Inclusion in survey study
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
Inclusion in survey study
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
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
Time Frame: Inclusion in survey study
Assessed by HCP survey in Part B1
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
Time Frame: Inclusion in survey study
Assessed by HCP survey in Part B1
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
Time Frame: Inclusion in survey study
Assessed by HCP survey in Part B1
Inclusion in survey study
Self-reported current and previous use of medications for pain
Time Frame: Inclusion in survey study
Assessed by patient survey in Part B2
Inclusion in survey study
Self-reported current and previous use of medications for anxiety
Time Frame: Inclusion in survey study
Assessed by patient survey in Part B2
Inclusion in survey study
Self-reported current and previous use of medications for depression
Time Frame: Inclusion in survey study
Assessed by patient survey in Part B2
Inclusion in survey study
Social and physical activity level
Time Frame: Inclusion in survey study
Assessed by patient survey in Part B2
Inclusion in survey study
Euro-QoL 5 Dimensions 5 Levels (EQ-5D-5L)
Time Frame: Inclusion in survey study
Assessed by patient survey in Part B2
Inclusion in survey study
Patient satisfaction with current management of pain
Time Frame: Inclusion in survey study
Assessed by patient survey in Part B2
Inclusion in survey study
Patient satisfaction with current management anxiety
Time Frame: Inclusion in survey study
Assessed by patient survey in Part B2
Inclusion in survey study
Patient satisfaction with current management of depression
Time Frame: Inclusion in survey study
Assessed by patient survey in Part B2
Inclusion in survey study
Patient satisfaction of received treatment for pain
Time Frame: Inclusion in Survey study
Assessed by patient survey in Part B2
Inclusion in Survey study
Patient satisfaction of received treatment for anxiety
Time Frame: Inclusion in Survey study
Assessed by patient survey in Part B2
Inclusion in Survey study
Patient satisfaction of received treatment for depression
Time Frame: Inclusion in Survey study
Assessed by patient survey in Part B2
Inclusion in Survey study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swedish Orphan Biovitrum

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bent Winding, Swedish Orphan Biovitrum

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.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Sobi.HAEM89-003

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.

Clinical Trials on Haemophilia A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings