Relationship between Disease Severity and Quality of Life in Japanese Patients with Ulcerative Colitis

Relationship between Disease Severity and Quality of Life in Japanese Patients with Ulcerative Colitis - Relationship between Disease Severity and Quality of Life in Japanese Patients with Ulcerative Colitis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000027750

Enrollment

300

Registered

2017-06-30

Start date

2017-06-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Individuals between the ages of 18 and 80 upon time of informed consent obtained. 2. Individuals diagnosed with either pan-colitis or left colitis subtype, within the ulcerative colitis diagnostic definition of 2015 revision provided by the Intractable inflammatory intestinal tract disease working group by the Japanese Ministry of Health, Labor and Welfare by the time of informed consent obtained. 3. Individuals with at least three months of medical records available prior to informed consent obtained. 4. Individuals able to sign and date the consensus and explanation forms prior to the research operation. 5. Individuals able to read and understand patient questionnaires.

Exclusion criteria

Exclusion criteria: 1. Individuals determined by the research supervisor or researcher to have potential comorbid conditions besides ulcerative colitis that may influence QoL. 2. Individuals participating in other interventional studies such as physician-investigator initiated clinical trials 3. The study investigator, any researcher member or aforementioned close relatives, as well as any reporting members of researchers (or their close relatives) 4. Individuals with prior registration for this study 5. Any individual the study investigator or researcher deems ineligible

Design outcomes

Primary

Measure	Time frame
Observational evaluation by research investigator or researcher -Partial Mayo score Patient reported Outcomes -IBDQ (QoL questionaire for IBD) -EQ-5D (European Quality of Life -5 Dimensions Questionnaire) -WPAI (Work productivity activity impairment questionaire) -SF36 (Health related QoL questionaire) Healthcare resource utilization	—

Secondary

Measure	Time frame
Assess the relation between disease severity and work productivity/activity impairment (WPAI). Assess the relation between disease severity and health related QoL (SF-36). Assess the relation between IBDQ, EQ-5D or SF-36. Assess disease severity and healthcare resource utilization.	—

Countries

Japan

Contacts

Public ContactHiromasa Takahashi

CMIC Company Limited Academic clinical research headquarters

hiromasa-takahashi@cmic.co.jp+81-090-5788-5787

Outcome results