Health Related Quality of Life in Functional Dyspepsia

Dyspepsia Clinical Trial

Official title:

Factors Associated With Health Related Quality of Life in Patients With Functional Dyspepsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03321383
• Other study ID #: 16-08-126
• Status: Completed
• Phase: N/A
• First received: October 18, 2017
• Last updated: October 24, 2017
• Start date: August 1, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: October 2017
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Previous studies reported health related quality of life impairment in functional dyspepsia patients. Anxiety, depression, disease severity, age, and employment status associated with HRQOL in functional dyspepsia patients. However, data about HRQOL in Asian population was limited.This study aimed to evaluate factors associated with health related quality of life in patients with functional dyspepsia.

Description:

126 functional dyspepsia patients will answer SF-36 HRQOL questionnaire, Hospital Anxiety, and Depression Scale, and Short Form Nepean Dyspepsia Index. Functional dyspepsia and Irritable Bowel Syndrome Rome III diagnostic questionnaire and GERD-Q questionnaire will be used to determine FD type and IBS or GERD overlap.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Dyspepsia patients

• Normal or non ulcer esophagogastroduodenescopy finding

Exclusion Criteria:

• History of GI bleeding

• History of GI malignancies

• Hepatobiliary tract disease

• Diabetes mellitus

• Chronic kidney disease

Related Conditions & MeSH terms

• Dyspepsia

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life	Short Form -36 health survey includes one scale for each of eight measured health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These eight domains aggregates into physical component summary and mental component summary. All health domain scales are scored using norm-based scores ranging 0 to 100 with higher scores indicate better health	1 month
Secondary	Anxiety	The Hospital anxiety and depression scale (Anxiety score) This consists of seven questions on anxiety on 4 point (0-3) response category. Total score range 0-21.	2 weeks
Secondary	Depression	The Hospital anxiety and depression scale (Depression score). This consists of seven questions on depression on 4 point (0-3) response category. Total score range 0-21.	2 weeks
Secondary	Dyspepsia symptoms severity	Nepean dyspepsia index (NDI) score. 10-item questionnaire measuring symptoms and health-related quality of life in functional dyspepsia. Each item is measured on a 5 point Likert Scale ranging from 0 (not at all) to 4 (extremely).	2 weeks