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

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ClinicalTrials.gov Identifier: NCT03276130
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Swedish Orphan Biovitrum

Tracking Information
First Submitted Date September 7, 2017
First Posted Date September 8, 2017
Last Update Posted Date January 16, 2019
Actual Study Start Date October 30, 2018
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 2017)
  • 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
Original Primary Outcome Measures
 (submitted: September 7, 2017)
  • Use of medication for pain, depression and anxiety (yes/no?) [ Time Frame: Retrospectively 10 years ]
    Based on Registry data
  • Annualised consumption of pain, anti-depressive and anti-anxiety medications and type of drug groups prescribed [ Time Frame: Retrospectively 10 years ]
    Based on Registry data
  • Duration of pain, anti-depressive and 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, depression and anxiety [ Time Frame: Inclusion in survey study ]
    Assessed by Health Care Professional (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, depression and anxiety 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, anxiety and 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, anxiety and depression [ Time Frame: Inclusion in survey study ]
    Assessed by patient survey in Part B2
  • Patient satisfaction of received treatment for pain, anxiety and depression [ Time Frame: Inclusion in Survey study ]
    Assessed by patient survey in Part B2
Change History Complete list of historical versions of study NCT03276130 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B
Official Title Management of Health-Related Quality of LIfe Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B
Brief 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. 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All PwH in Sweden, Norway, Denmark and Finland
Condition
  • Haemophilia A
  • Haemophilia B
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 7, 2017)
2300
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sofia Bergenstråle +46 8 697 2000 sofia.bergenstrale@sobi.com
Listed Location Countries Denmark,   Finland,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT03276130
Other Study ID Numbers Sobi.HAEM89-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Swedish Orphan Biovitrum
Study Sponsor Swedish Orphan Biovitrum
Collaborators Not Provided
Investigators
Study Director: Bent Winding Swedish Orphan Biovitrum
PRS Account Swedish Orphan Biovitrum
Verification Date January 2019