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

Sobi

Status: Completed

Conditions: Haemophilia B; Haemophilia A

Study type: Observational

Funder types: Industry

Identifiers

NCT03276130

Sobi.HAEM89-003

Details and patient eligibility

About

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.

Enrollment: 2,300 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,300 participants in 3 patient groups

Part A: Retrospective register study

Description:

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

Description:

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

Description:

All People with Haemophilia (PwH) listed at HTCs will be invited to participate in the patient survey.