Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A

Completed

• Conditions: Hemophilia A
• Interventions: Biological: BAY94-9027

• Registration Number: NCT02971930
• Lead Sponsor: Bayer

Brief Summary

This study is to generate qualitative data to evaluate the impact of frequency of FVIII infusions on patients' satisfaction with treatment and their quality of life.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-27
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-23
• Study Start: 2017-06-20
• Primary Completion: 2017-11-26
• Study Completion: 2017-12-15
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patient is enrolled in the BAY94-9027 extension studies or is within 3 months of having completed participation in the BAY94-9027 extension studies;

• Patient allocated to Arm 2, Arm 3 or Arm 4 of BAY94-9027 extension studies.

  • Arm 2 Prophylaxis treatment of BAY94-9027; 2 infusions per week during the extension study
  • Arm 3 Prophylaxis treatment of BAY94-9027; infusion every 5 days during the extension study
  • Arm 4 Prophylaxis treatment of BAY94-9027; every 7 days during the extension study

• Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;

• Patient must be willing and able to participate in a telephone interview lasting up to 30 minutes;

• Patient must have sufficient cognitive and linguistic capacities to allow them to actively participate in an interview lasting 30 minutes.

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Exclusion Criteria

• Patient is part of Arm 1: On-demand treatment of BAY94-9027 at individual dose and number of infusions based upon location and severity of bleeds;
• Patient is unlikely to comply with the study protocol (e.g. uncooperative attitude) or unlikely to complete the study for any reason in the opinion of the recruiter;
• Patient has great difficulty hearing or reading;
• Patient has any significant comorbid condition (including uncontrolled psychiatric conditions) that might limit or interfere with their ability to talk about their Hemophilia A and participate in the study;
• Patient has severe neurological or cognitive deficits that might affect their ability to participate in an interview.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prophylaxis treatment of BAY94-9027_2	BAY94-9027	infusion every 5 days during the extension study
Prophylaxis treatment of BAY94-9027_1	BAY94-9027	2 infusions per week during the extension study
Prophylaxis treatment of BAY94-9027_3	BAY94-9027	every 7 days during the extension study

Primary Outcome Measures

Name	Time	Method
Qualitative interviews (with patients) to determine patients' quality of life	up to 4 months	To conduct qualitative interviews with patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences quality of life;
Qualitative interviews (with patients) to determine patients' satisfaction	up to 4 months	To conduct qualitative interviews with patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences satisfaction
Qualitative interviews (with treating physicians) to determine patients' satisfaction	up to 4 months	To conduct qualitative interview with clinicians who treat patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate the clinician perspective of patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences their patients' satisfaction
Qualitative interviews (with treating physicians) to determine patients' quality of life	up to 4 months	To conduct qualitative interview with clinicians who treat patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate the clinician perspective of patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences their patients' quality of life;

Trial Locations

Locations (1)

Cleveland; 🇺🇸 Cleveland, Ohio, United States