Non-Interventional, cross-sectional study to describe health-related quality of life among controlled and uncontrolled patients with nonvalvular atrial fibrillation on anticoagulants (RE-QUOL study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/32062
• EU PAS number:
  EUPAS16988
• Study ID:
  32062
• Official title and acronym:
  Non-Interventional, cross-sectional study to describe health-related quality of life among controlled and uncontrolled patients with nonvalvular atrial fibrillation on anticoagulants (RE-QUOL study)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  The present study has been designed to describe the HRQoL in patients with non valvular AF receiving conventional VKA but no controlled and those controlled who received VKA or DOAC. Approximately 500 patients seen in internal medicine are planned to be included in the study. Patients should be included in a ratio 2:1, 2 patients controlled (VKA patients with a Time in Therapeutic range TTR ≥ 65% and all DOAC patients) per 1 patient uncontrolled (VKA patients with a TTR < 65%), due to the controlled patients comprise more treatments. The design of the study impose an only visit to be performed that will coincide with one of those performed by the patients as part of routine follow-up of their disease, without interfering with usual clinical practice of the investigator. HRQoL will be based on the patients’ ratings on Sawicki questionnaire completed during the only study visit. This questionnaire includes 32 items grouped in 5 dimensions – treatment satisfaction, self-efficacy, strained social network, daily hassles and distress. Higher scores indicate lower HRQoL. The scores of each individual question will be summarized descriptively in thecontrolled and uncontrolled patients.
• Study status:
  Finalised

Research institutions and networks

Institutions

Hospital Costa del Sol

Multiple centres: 50 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/11/2016

Actual: 01/11/2016

Study start date

Planned: 30/04/2017

Actual: 26/04/2017

Data analysis start date

Planned: 02/04/2018

Actual: 12/04/2018

Date of final study report

Planned: 31/01/2019

Actual: 28/01/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable