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

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: Completed
• Conditions: Haemophilia A; Haemophilia B

• Study Type: Observational
• Enrollment (Actual): 2300

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
Use of medication for pain, depression and anxiety (yes/no?)	Based on Registry data	Retrospectively 10 years
Annualised consumption of pain medications as assessed by filled prescription	Based on Registry data	Retrospectively 10 years
Annualised consumption of anti-anxiety medications as assessed by filled prescription	Based on Registry data	Retrospectively 10 years
Annualised consumption of anti-depressive medications as assessed by filled prescription	Based on Registry data	Retrospectively 10 years
Duration of pain medications as measured by expected doses of medicines.	Based on Registry data	Retrospectively 10 years
Duration of anti-depressive medications as measured by expected doses of medicines.	Based on Registry data	Retrospectively 10 years
Duration of anti-anxiety medications as measured by expected doses of medicines.	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	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	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	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	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	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	Assessed by HCP survey in Part B1	Inclusion in survey study
Self-reported current and previous use of medications for pain	Assessed by patient survey in Part B2	Inclusion in survey study
Self-reported current and previous use of medications for anxiety	Assessed by patient survey in Part B2	Inclusion in survey study
Self-reported current and previous use of medications for depression	Assessed by patient survey in Part B2	Inclusion in survey study
Social and physical activity level	Assessed by patient survey in Part B2	Inclusion in survey study
Euro-QoL 5 Dimensions 5 Levels (EQ-5D-5L)	Assessed by patient survey in Part B2	Inclusion in survey study
Patient satisfaction with current management of pain	Assessed by patient survey in Part B2	Inclusion in survey study
Patient satisfaction with current management anxiety	Assessed by patient survey in Part B2	Inclusion in survey study
Patient satisfaction with current management of depression	Assessed by patient survey in Part B2	Inclusion in survey study
Patient satisfaction of received treatment for pain	Assessed by patient survey in Part B2	Inclusion in Survey study
Patient satisfaction of received treatment for anxiety	Assessed by patient survey in Part B2	Inclusion in Survey study
Patient satisfaction of received treatment for depression	Assessed by patient survey in Part B2	Inclusion in Survey study

Collaborators and Investigators

• Sponsor: Swedish Orphan Biovitrum
• Investigators: Study Director: Bent Winding, Swedish Orphan Biovitrum

Publications and helpful links

General Publications

• Steen 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Genetic diseases, inborn; Blood coagulation disorder; Haematologic diseases; Coagulation protein disorder; Hemorrhagic disorder; Pain medication; Anxiety medication
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Blood Coagulation Disorders; Hemophilia A; Hemophilia B
• Other Study ID Numbers: Sobi.HAEM89-003