Atrial FibrillationRE-QUOLNCT03134911
Health-related Quality of Life in Patients on Anticoagulants
An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 39 sites in Spain.
Trial summary
The present study has been designed to describe the health-related quality of life in patients with non valvular atrial fibrillation who have been prescribed a specific anticoagulant treatment for their non valvular atrial fibrilation at least 6 months prior to study initiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- DOAC or VKA and VKA
- How many people
- 535 participants
- Where
- 39 sitesSpain
- Study dates
- 24 Apr 2017to 31 Jan 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed of non valvular atrial fibrillation and prescribed DOACs or VKA, who are seen in internal medicine from hospitals of 3 Autonomous Communities in Spain (Madrid, Comunidad Valenciana, Andalucía)
Who may be able to join
- The patient is willing and provides written informed consent to participate in this study.
- The patient is at least 18 years of age
- The patient has a diagnosis of non-valvular atrial fibrillation
- The patient is on the same anticoagulant therapy (VKA or DOAC) during at least 6 months and maximum 2 years.
- If treated with VKA, availability of % Time in Therapeutic Range (TTR) in past analytical records or enough amount of International Normalized Ratio (INR) measures to calculate it.
Who cannot join
- Current participation in any clinical trial of a drug or device
- Contraindication to the use of DOAC or VKA as described in the Summary of Product Characteristics (SmPC).
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
Spain39 sites
Hospital Universitario Príncipe de Asturias
Alcalá de Henares (Madrid), 28805
HospitalUniversitario Príncipe de Asturias
Alcalá de Henares (Madrid), 28805
Hospita Universitario Fundación Alcorcón
Alcorcón (Madrid), 28922
Hospital Público Virgen de los Lirios
Alcoy (Alicante), 03804
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Universitario San Juan de Alicante
Alicante, 03550
Complejo Hospitalario Torrecárdenas
Almería, 04009
Hospital Universitario Monteprincipe
Boadilla Del Monte (Madrid), 28660
Hospital San Juan de Dios
Bormujos (Sevilla), 41930
Hospital General Universitario de Castellón
Castellón de La Plana (Castellón), 12004
Hospital Universitario Reina Sofía
Córdoba, 14004
Hospital General Universitario de Elche
Elche (Alicante), 03203
Hospital Universitario de Fuenlabrada
Fuenlabrada (Madrid), 28942
Hospital Comarcal Francesc de Borja
Gandía (València), 46702
Hospital Universitario Virgen de las Nieves
Granada, 18014
Hospital Universitari Arnau de Vilanova
Lleida, 25198
Hospital De Llíria (depende del Arnau de Vilanova)
Llíria (Valencia), 46160
Hospital de La Princesa
Madrid, 28006
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hopital Clinico San Carlos
Madrid, 28040
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario Doce de Octubre
Madrid, 28041
Hospital Universitario Puerta de Hierro
Majadahonda (Madrid), 28222
Complejo Hospitalario de Especialidades Virgen de la Victoria
Málaga, 29010
Hospital Regional de Málaga (Carlos Haya)
Málaga, 29010
Hospital Costa del Sol
Marbella (Málaga), 29603
Hospital Universitario Rey Juan Carlos
Móstoles (Madrid), 28933
Hospital Universitario de Móstoles
Móstoles (Madrid), 28935
Hospital Vega Baja
Orihuela (Alicante), 03314
Hospital Virgen del Camino
Pamplona (Navarra), 31008
Hospital General de Requena
Requena (Valencia), 46340
Hospital de Sagunto
Sagunto (Valencia), 46520
Hospital Universitario Infanta Sofia
San Sebastián de Los Reyes (Madrid), 28703
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitario de Torrevieja
Torrrevieja (Alicante), 03186
Hospital Clínico Universitariio de Valencia
Valencia, 46010
Consorcio Hospital General Universitario de Valencia
Valencia, 46014
Hospital Universitario de La Plana
Villarreal (Castellón), 12540
Hospital Lluis Alcanyis
Xàtiva (Valencia), 46800
About this study
Official title: 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.
The present study has been designed to describe the health-related quality of life in patients with non valvular atrial fibrillation who have been prescribed a specific anticoagulant treatment for their non valvular atrial fibrilation at least 6 months prior to study initiation. It will be conducted in Departments of Internal Medicine from approximately 50 centers in Spain. It consists of an only visit that will coincide with one of those performed by the patients as part of routine follow-up of their disease. 500 patients seen in internal medicine are planned to be included in the study
- Conditions
- Atrial Fibrillation
- Being tested
- DOAC or VKA, VKA
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOAC or VKADrug
6 months - 2 years
VKADrug
6 months - 2 years
| Study group | Role | What they receive |
|---|---|---|
| anticoagulation controlled patients | Treated with DOAC or VKA Receives: Drug: DOAC or VKA | |
| anticoagulation non controlled patients | Treated with VKA Receives: Drug: VKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire
Sawicki questionnaire includes 32 items grouped in 5 dimensions: 1) general treatment satisfaction, 2) self-efficacy, 3) strained social network, 4) daily hassles and 5) distress. Patients estimated the impact of each item on their self-perceived treatment-related QoL on a scale of 1 (total disagreement) to 6 (total agreement). Response options for each question were: 1=not at all, 2=very little, 3=a little, 4=somewhat, 5=a lot, 6=very much. High scores in general treatment satisfaction and self-efficacy dimensions indicate high perceived HRQoL. Low scores in the strained social network, daily hassles and distress dimensions indicate high perceived HRQoL. The summary score for each dimension was calculated by dividing the total score of the sum of the items that comprise each dimension into the number of items included in that dimension. For the general treatment satisfaction dimension, the scores of individual questions have to be inverted first to calculate the dimension score.
Measured: The study consisted of a single visit between April 2017 and January 2018
Secondary outcomes (20)
Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Age group, work status and life status of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Measured: The study consisted of a single visit between April 2017 and January 2018
Height of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Height of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Measured: The study consisted of a single visit between April 2017 and January 2018
Weight of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Weight of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Measured: The study consisted of a single visit between April 2017 and January 2018
Body Mass Index (BMI) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
BMI of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Measured: The study consisted of a single visit between April 2017 and January 2018
Kidney Function (Creatinine Clearance) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Kidney function of uncontrolled non-valvular atrial fibrillation (NVAF) patients measured by creatinine clearance is presented.
Measured: The study consisted of a single visit between April 2017 and January 2018
History of Non-valvular Atrial Fibrillation (NVAF) - Time Since Diagnosis
Analysis of data regarding the specific NVAF profile of uncontrolled patients indicated that the average (± SD) time since diagnosis (calculated as the time from the date of diagnosis to the date of the baseline visit).
Measured: The study consisted of a single visit between April 2017 and January 2018
History of Non-valvular Atrial Fibrillation (NVAF) - Age at Diagnosis
Age at diagnosis of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Measured: The study consisted of a single visit between April 2017 and January 2018
Left Ventricular Ejection Fraction (LVEF) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Left ventricular ejection fraction (LVEF) of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Measured: The study consisted of a single visit between April 2017 and January 2018
Percentage of Patients With Left Ventricular Ejection Fraction (LVEF) Depression of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Percentage of patients with left ventricular ejection fraction (LVEF) depression (% of LVEF depression) of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented qualitatively.
Measured: The study consisted of a single visit between April 2017 and January 2018
CHA2DS2-VASc Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.
Measured: The study consisted of a single visit between April 2017 and January 2018
HAS-BLED Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio (INR), Elderly (>65 years), Drugs and Alcohol. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome.
Measured: The study consisted of a single visit between April 2017 and January 2018
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories
Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with history of thromboembolic events by categories are presented.
Measured: The study consisted of a single visit between April 2017 and January 2018
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Haemorrhagic Events by Categories
Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with history of haemorrhagic events by categories are presented.
Measured: The study consisted of a single visit between April 2017 and January 2018
Number of Visits to the Physician of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Number of visits to the internal medicine specialist per year of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Measured: The study consisted of a single visit between April 2017 and January 2018
Therapeutic Time in Range (TTR%) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Therapeutic time in range (TTR%) of uncontrolled non-valvular atrial fibrillation (NVAF) patients determined by the Rosendaal method (poor control < 65%) or by the direct method (poor control < 60%).
Measured: The study consisted of a single visit between April 2017 and January 2018
Time Since Treatment Initiation of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Time since treatment initiation of uncontrolled non-valvular atrial fibrillation (NVAF) patients was calculated as the time from the start date of treatment to the date of the baseline visit.
Measured: The study consisted of a single visit between April 2017 and January 2018
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients Received Type of VKA Treatment
Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients received type VKA treatment is presented.
Measured: The study consisted of a single visit between April 2017 and January 2018
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases
The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with at least one other concomitant diseases recorded in the medical history.
Measured: The study consisted of a single visit between April 2017 and January 2018
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day
The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with active concomitant diseases on visit day. The percentage was calculated on total patients who presented each of the diseases.
Measured: The study consisted of a single visit between April 2017 and January 2018
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Treatment
The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with concomitant treatment is presented.
Measured: The study consisted of a single visit between April 2017 and January 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start24 Apr 2017
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mireia Canals, +34607550925, Study chair, mireia.canals@boehringer-ingelheim.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134911
- Sponsor's protocol ID
- 1160-0280
- Acronym
- RE-QUOL
- Status last verified
- Jan 2019
- First submitted
- 1 Mar 2017
- Last updated
- 18 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03134911
- Acronym / sponsor ID
- RE-QUOL / 1160-0280
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Posted 18 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study has been designed to describe the health-related quality of life in patients with non valvular atrial fibrillation who have been prescribed a specific anticoagulant treatment for their non valvular atrial fibrilation at least 6 months prior to study initiation. It will be conducted in Departments of Internal Medicine from approximately 50 centers in Spain. It consists of an only visit that will coincide with one of those performed by the patients as part of routine follow-up of their disease. 500 patients seen in internal medicine are planned to be included in the study
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anticoagulation controlled patients | – | Drug: DOAC or VKATreated with DOAC or VKA |
| anticoagulation non controlled patients | – | Drug: VKATreated with VKA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed of non valvular atrial fibrillation and prescribed DOACs or VKA, who are seen in internal medicine from hospitals of 3 Autonomous Communities in Spain (Madrid, Comunidad Valenciana, Andalucía)
Key inclusion criteria (5 listed)
- The patient is willing and provides written informed consent to participate in this study.
- The patient is at least 18 years of age
- The patient has a diagnosis of non-valvular atrial fibrillation
- The patient is on the same anticoagulant therapy (VKA or DOAC) during at least 6 months and maximum 2 years.
- If treated with VKA, availability of % Time in Therapeutic Range (TTR) in past analytical records or enough amount of International Normalized Ratio (INR) measures to calculate it.
Key exclusion criteria (2 listed)
- Current participation in any clinical trial of a drug or device
- Contraindication to the use of DOAC or VKA as described in the Summary of Product Characteristics (SmPC).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOAC or VKA6 months - 2 years | Drug | anticoagulation controlled patients |
| VKA6 months - 2 years | Drug | anticoagulation non controlled patients |
Primary outcome
Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire
Time frame: The study consisted of a single visit between April 2017 and January 2018
Sawicki questionnaire includes 32 items grouped in 5 dimensions: 1) general treatment satisfaction, 2) self-efficacy, 3) strained social network, 4) daily hassles and 5) distress. Patients estimated the impact of each item on their self-perceived treatment-related QoL on a scale of 1 (total disagreement) to 6 (total agreement). Response options for each question were: 1=not at all, 2=very little, 3=a little, 4=somewhat, 5=a lot, 6=very much. High scores in general treatment satisfaction and self-efficacy dimensions indicate high perceived HRQoL. Low scores in the strained social network, daily hassles and distress dimensions indicate high perceived HRQoL. The summary score for each dimension was calculated by dividing the total score of the sum of the items that comprise each dimension into the number of items included in that dimension. For the general treatment satisfaction dimension, the scores of individual questions have to be inverted first to calculate the dimension score.
20 secondary outcomes
Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Time frame: The study consisted of a single visit between April 2017 and January 2018
Height of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Time frame: The study consisted of a single visit between April 2017 and January 2018
Weight of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Time frame: The study consisted of a single visit between April 2017 and January 2018
Body Mass Index (BMI) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Time frame: The study consisted of a single visit between April 2017 and January 2018
Kidney Function (Creatinine Clearance) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Time frame: The study consisted of a single visit between April 2017 and January 2018
History of Non-valvular Atrial Fibrillation (NVAF) - Time Since Diagnosis
Time frame: The study consisted of a single visit between April 2017 and January 2018
History of Non-valvular Atrial Fibrillation (NVAF) - Age at Diagnosis
Time frame: The study consisted of a single visit between April 2017 and January 2018
Left Ventricular Ejection Fraction (LVEF) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Time frame: The study consisted of a single visit between April 2017 and January 2018
Percentage of Patients With Left Ventricular Ejection Fraction (LVEF) Depression of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Time frame: The study consisted of a single visit between April 2017 and January 2018
CHA2DS2-VASc Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Time frame: The study consisted of a single visit between April 2017 and January 2018
HAS-BLED Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Time frame: The study consisted of a single visit between April 2017 and January 2018
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories
Time frame: The study consisted of a single visit between April 2017 and January 2018
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Haemorrhagic Events by Categories
Time frame: The study consisted of a single visit between April 2017 and January 2018
Number of Visits to the Physician of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Time frame: The study consisted of a single visit between April 2017 and January 2018
Therapeutic Time in Range (TTR%) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Time frame: The study consisted of a single visit between April 2017 and January 2018
Time Since Treatment Initiation of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Time frame: The study consisted of a single visit between April 2017 and January 2018
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients Received Type of VKA Treatment
Time frame: The study consisted of a single visit between April 2017 and January 2018
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases
Time frame: The study consisted of a single visit between April 2017 and January 2018
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day
Time frame: The study consisted of a single visit between April 2017 and January 2018
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Treatment
Time frame: The study consisted of a single visit between April 2017 and January 2018
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mireia Canals, +34607550925 study chair
mireia.canals@boehringer-ingelheim.com
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 39 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire (time frame: The study consisted of a single visit between April 2017 and January 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.