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NCT03410589 Clinical Trial

Development of a Computerized Adaptive Test (CAT) for Evaluation of Sleep, Fatigue and Quality of Life in Patients With Chronic Pain

Chronic Pain Clinical Trial

— CAT  

Official title:
Desenvolvimento de Teste Adaptativo Computadorizado (CAT) Para avaliação do Sono, Fadiga e Qualidade de Vida em Pacientes Com Dor crônica

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03410589
Other study ID # CAT
Secondary ID
Status Recruiting
Phase N/A
First received January 10, 2018
Last updated January 24, 2018
Start date January 1, 2017
Est. completion date January 1, 2019

Study information
Verified date January 2018
Source University of Sao Paulo
Contact Suzana C Nogueira
Phone +55 11 998899387
Email suzana.curcino.nogueira@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date January 1, 2019
Est. primary completion date July 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

be able to read Portuguese be able to write Portuguese being in treatment for chronic pain

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Sinlge arm
application of scales for evaluation of sleep, fatigue and quality of life - Observational study

Locations
Country Name City State
Brazil Hospital das clinicas da FMUSP São Paulo SP

Sponsors (1)
Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary sleep disorders score in Pittsburgh Sleep Quality Within 1 month before the study start
Primary fatigue score of Multidimensional Fatigue Inventory Within 7 days before the study start
Primary measurement quality of live measurement quality of live will be score the using SF-12 Within 1 month before the study start
Primary sleep disorders score Index and Insomnia Severity Index (ISI) Within 1 month before the study start
Primary measurement quality of live measurement quality of live will be WHOQOL-bref Within 1 month before the study start
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