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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine:
  PRADAXA
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Nonvalvular AF (NVAF) patients with uncontrolled anticoagulation status treated with VKA, and of NVAF patients with controlled anticoagulation status treated with vitamin K antagonists (VKA) or direct oral anticoagulants (DOAC).; Inclusion criteria were:; 1. The patient is willing and provides written informed consent to participate in this study.; 2. The patient is at least 18 years of age.; 3. The patient has a diagnosis of non-valvular atrial fibrillation.; 4. The patient is on the same anticoagulant therapy (VKA or DOAC) during at least 6 months and maximum 2 years.; 5. If treated with VKA, availability of %TTR in past analytical records or enough amount of INR measures to calculate it.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Non-valvular atrial fibrillation (NVAF) patients
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  The primary objective of the study is to describe the HRQoL in uncontrolled patients treated with VKA and controlled patients treated with VKA or DOAC.
• Outcomes:
  The primary outcome is the health-related quality of life and will be obtained with the results of the sawicki questionnaire at study visit. The questionnaire includes 32 itemsgrouped in 5 dimensions. Patients will estimate the impact of each item on their selfperceived treatment-related quality of life on a scale of 1 (total disagreement) to 6 (total agreement). The secondary outcome is the uncontrolled patient profile and will be defined by thefollowing variables collected from patient medical records.
• Data analysis plan:
  The primary outcome of the study is the health-related quality of life as measured by the Sawicki questionnaire. The scores of each individual question will be summarized descriptively in the controlled and uncontrolled patients. In addition, the summary score for each dimension of the questionnaire will be calculated for each patient by dividing the total score by the number of items included in that dimension and summarized in the same way as the individual questions.

Documents

Study results

1160-0280_c26547692-01