Chronic PainCATNCT03410589
Development of a Computerized Adaptive Test (CAT) for Evaluation of Sleep, Fatigue and Quality of Life in Patients With Chronic Pain
An observational study of Chronic Pain, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate quality of life, sleep and fadigue in patients with chronic pain using an Item-Response Theory methodology and also generating a Computer Adaptive Testing System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Sinlge arm
- How many people
- 308 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2019to 20 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 with chronic pain
Who may be able to join
- be able to read Portuguese be able to write Portuguese being in treatment for chronic pain
Who cannot join
- hearing impairment that impairs ability to respond to tests visual impairment that impairs ability to respond to tests physical impairment that impairs ability to respond to tests cognitive impairment that impairs ability to respond to tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Desenvolvimento de Teste Adaptativo Computadorizado (CAT) Para avaliação do Sono, Fadiga e Qualidade de Vida em Pacientes Com Dor crônica
The purpose of this study is to evaluate quality of life, sleep and fadigue in patients with chronic pain using an Item-Response Theory methodology and also generating a Computer Adaptive Testing System
- Conditions
- Chronic Pain
- Being tested
- Sinlge arm
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinlge armOther
application of scales for evaluation of sleep, fatigue and quality of life - Observational study
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Not described Receives: Other: Sinlge arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep disorders
score in Pittsburgh Sleep Quality
Measured: Within 1 month before the study start
fatigue
score of Multidimensional Fatigue Inventory
Measured: Within 7 days before the study start
measurement quality of live
measurement quality of live will be score the using SF-12
Measured: Within 1 month before the study start
sleep disorders
score Index and Insomnia Severity Index (ISI)
Measured: Within 1 month before the study start
measurement quality of live
measurement quality of live will be WHOQOL-bref
Measured: Within 1 month before the study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start1 Jan 2019
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Ciampi Araujo de Andrade, MD, PhD, University of Sao Paulo
- Investigators
- Daniel C Andrade, PhD, Principal investigator, doctor and investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410589
- Sponsor's protocol ID
- CAT
- Acronym
- CAT
- Status last verified
- Jun 2025
- First submitted
- 10 Jan 2018
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desenvolvimento de Teste Adaptativo Computadorizado (CAT) Para avaliação do Sono, Fadiga e Qualidade de Vida em Pacientes Com Dor crônica
- ClinicalTrials.gov ID
- NCT03410589
- Acronym / sponsor ID
- CAT / CAT
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 25 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate quality of life, sleep and fadigue in patients with chronic pain using an Item-Response Theory methodology and also generating a Computer Adaptive Testing System
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | – | Other: Sinlge arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic pain
Key inclusion criteria (1 listed)
- be able to read Portuguese be able to write Portuguese being in treatment for chronic pain
Key exclusion criteria (1 listed)
- hearing impairment that impairs ability to respond to tests visual impairment that impairs ability to respond to tests physical impairment that impairs ability to respond to tests cognitive impairment that impairs ability to respond to tests
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 |
|---|---|---|
| Sinlge armapplication of scales for evaluation of sleep, fatigue and quality of life - Observational study | Other | Single arm |
Primary outcome
sleep disorders
Time frame: Within 1 month before the study start
score in Pittsburgh Sleep Quality
fatigue
Time frame: Within 7 days before the study start
score of Multidimensional Fatigue Inventory
measurement quality of live
Time frame: Within 1 month before the study start
measurement quality of live will be score the using SF-12
sleep disorders
Time frame: Within 1 month before the study start
score Index and Insomnia Severity Index (ISI)
measurement quality of live
Time frame: Within 1 month before the study start
measurement quality of live will be WHOQOL-bref
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- 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.
Daniel C Andrade, PhD principal investigator
doctor and investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by University of Sao Paulo at 1 site in Brazil.
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 1 inclusion and 1 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 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
sleep disorders (time frame: Within 1 month before the study start). The study lists 5 primary outcomes in all. 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 29 Jun 2025.