Clinical trial NCT02971930: Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A
Official title: Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-11-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Qualitative interviews (with patients) to determine patients' satisfaction
timeFrame: up to 4 months
measure: Qualitative interviews (with patients) to determine patients' quality of life
timeFrame: up to 4 months
measure: Qualitative interviews (with treating physicians) to determine patients' satisfaction
timeFrame: up to 4 months
measure: Qualitative interviews (with treating physicians) to determine patients' quality of life
timeFrame: up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland
state: Ohio
Study officials:
References: