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

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Sinlge arm

• Study Type: Observational
• Enrollment (Actual): 308

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403-010
      • Hospital das Clínicas da FMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic pain

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single arm	Other: Sinlge arm; application of scales for evaluation of sleep, fatigue and quality of life - Observational study

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Daniel C Andrade, PhD, doctor and investigator

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): September 20, 2019
• Study Completion (Actual): September 20, 2019

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 25, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: CAT (ethic commettee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No