NCT03321383

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

11 months

First QC Date

October 18, 2017

Last Update Submit

October 24, 2017

Conditions

Keywords

dyspepsiahealth related quality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Anxiety

    2 weeks

  • Depression

    2 weeks

  • Dyspepsia symptoms severity

    2 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Functional dyspepsia patients at Gastroenterology Clinic in Cipto Mangunkusumo Hospital Jakarta

You may qualify if:

  • Dyspepsia patients
  • Normal or non ulcer esophagogastroduodenescopy finding

You may not qualify if:

  • History of GI bleeding
  • History of GI malignancies
  • Hepatobiliary tract disease
  • Diabetes mellitus
  • Chronic kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (1)

  • Hantoro IF, Syam AF, Mudjaddid E, Setiati S, Abdullah M. Factors associated with health-related quality of life in patients with functional dyspepsia. Health Qual Life Outcomes. 2018 May 2;16(1):83. doi: 10.1186/s12955-018-0913-z.

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ari F Syam, MD, PhD

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecture Gastroenterology Division, Principal Investigator, MD, PhD

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 25, 2017

Study Start

August 1, 2016

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations