Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A

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.

Study Overview

• Status: Completed
• Conditions: Hemophilia A
• Intervention / Treatment: Biological: BAY94-9027

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 110605
      • Cleveland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients aged 18+ years who are participating in the BAY94-9027 extension studies or who are within 3 months of exiting the study.

Description

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.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prophylaxis treatment of BAY94-9027_1; 2 infusions per week during the extension study	Biological: BAY94-9027; Intravenous infusion of BAY94-9027
Prophylaxis treatment of BAY94-9027_2; infusion every 5 days during the extension study	Biological: BAY94-9027; Intravenous infusion of BAY94-9027
Prophylaxis treatment of BAY94-9027_3; every 7 days during the extension study	Biological: BAY94-9027; Intravenous infusion of BAY94-9027

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative interviews (with patients) to determine patients' satisfaction	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	up to 4 months
Qualitative interviews (with patients) to determine patients' quality of life	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;	up to 4 months
Qualitative interviews (with treating physicians) to determine patients' satisfaction	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	up to 4 months
Qualitative interviews (with treating physicians) to determine patients' quality of life	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;	up to 4 months

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2017
• Primary Completion (Actual): November 26, 2017
• Study Completion (Actual): December 15, 2017

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: November 21, 2016
• First Posted (Estimate): November 23, 2016

Study Record Updates

• Last Update Posted (Actual): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A; Coagulants; Factor VIII
• Other Study ID Numbers: 19144

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No