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Trial record 1 of 3 for:    Dyspepsia | Indonesia
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Health Related Quality of Life in Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT03321383
Recruitment Status : Completed
First Posted : October 25, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Ari Fahrial Syam, Indonesia University

Tracking Information
First Submitted Date October 18, 2017
First Posted Date October 25, 2017
Last Update Posted Date October 26, 2017
Actual Study Start Date August 1, 2016
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 24, 2017)
Health related quality of life [ Time Frame: 1 month ]
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
Original Primary Outcome Measures
 (submitted: October 22, 2017)
Health related quality of life [ Time Frame: 1 month ]
Eight health status domains, physical and mental component summary of SF-36 health survey
Change History Complete list of historical versions of study NCT03321383 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 24, 2017)
  • Anxiety [ Time Frame: 2 weeks ]
    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.
  • Depression [ Time Frame: 2 weeks ]
    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.
  • Dyspepsia symptoms severity [ Time Frame: 2 weeks ]
    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).
Original Secondary Outcome Measures
 (submitted: October 22, 2017)
  • Anxiety [ Time Frame: 2 weeks ]
    The Hospital anxiety and depression scale (Anxiety score)
  • Depression [ Time Frame: 2 weeks ]
    The Hospital anxiety and depression scale (Depression score)
  • Dyspepsia symptoms severity [ Time Frame: 2 weeks ]
    Nepean dyspepsia index (NDI) score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Health Related Quality of Life in Functional Dyspepsia
Official Title Factors Associated With Health Related Quality of Life in Patients With Functional Dyspepsia
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.
Detailed 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Functional dyspepsia patients at Gastroenterology Clinic in Cipto Mangunkusumo Hospital Jakarta
Condition Dyspepsia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 22, 2017)
124
Original Actual Enrollment Same as current
Actual Study Completion Date June 30, 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number NCT03321383
Other Study ID Numbers 16-08-126
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Ari Fahrial Syam, Indonesia University
Study Sponsor Indonesia University
Collaborators Not Provided
Investigators
Principal Investigator: Ari F Syam, MD, PhD Indonesia University
PRS Account Indonesia University
Verification Date October 2017