DyspepsiaNCT02737683
Heterogeneous Distribution of Health Literacy and Emotional State on Patients With Functional Dyspepsia.
An observational study of Dyspepsia, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Patients with indigestion were often found in gastroenterology clinic, those who about 20 % was caused by organic, while the rest of patients are showed abnormal inspection, and these are so called functional dyspepsia. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspepsia
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2016to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with functional dyspepsia , can Self-reading and the self-administered questionnaire.
Who may be able to join
- Patients diagnosed with functional dyspepsia , can Self-reading and the self-administered questionnaire.
Who cannot join
- Due to physical illness, cognitive ability is limited and other factors can not were completed self-administered questionnaires.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
WanFangH
Taipei, 116
Ming Shun Wu, Dr, 886970746512, mswu@tmu.edu.tw
About this study
Patients with indigestion were often found in gastroenterology clinic, those who about 20 % was caused by organic, while the rest of patients are showed abnormal inspection, and these are so called functional dyspepsia. Functional dyspepsia is a chronic and repeated occurrence of digestive disorders, patients often visit hospitals frequently and unable to get fully cured. Current Symptom diagnoses are based on Rome III criteria as diagnostic criteria. Although functional dyspepsia condition should combine with physical and mental treatments, due to the reasons behind the complex, there is still no effective classification could be acted in health education and drug intervention.
Read the detailed description
Health literacy can be defined as "ability for obtaining basic health information and understanding medical services." Within 10 years, healthy development and application of knowledge used in medical care and public health fields that have raised more attentions, many European countries set health knowledge as one of the main indicators for health care policy in the future. To promote behavior of self-care health for people, enhance the effective use of medical service , also reduce health care cost and unequally medical information.
Anxiety and depression are two common reactions when it comes to negative emotional states, which related to a body and caused a vicious cycle of disease. Some patients suffer from functional dyspepsia symptoms were diagnosed with anxiety or depression symptoms often ignore body care due to lack of health literacy. The purpose of this study is to investigate the distribution of functional dyspepsia patients with health literacy and emotional status, in order to provide more effective health education mode, thereby reducing the waste of medical resources, and promote patient health.
- Conditions
- Dyspepsia
- Keywords
- Disease, anxiety, depression, combine, negative emotional states, functional dyspepsia
- Medical subject headings
- Dyspepsia, Disease, Anxiety Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom diagnoses are based on Rome III criteria as diagnostic criteria
Measured: up to 10 months to collect data and perform an analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Shun Wu, Taipei Medical University WanFang Hospital
- Investigators
- Ming Shun Wu, Dr, Study chair, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737683
- Sponsor's protocol ID
- N201601022
- Status last verified
- Mar 2017
- First submitted
- 17 Mar 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heterogeneous Distribution of Health Literacy and Emotional State on Patients With Functional Dyspepsia.
- ClinicalTrials.gov ID
- NCT02737683
- Acronym / sponsor ID
- N201601022
- Conditions
- Dyspepsia
- Keywords
- Disease, anxiety, depression, combine, negative emotional states, functional dyspepsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with indigestion were often found in gastroenterology clinic, those who about 20 % was caused by organic, while the rest of patients are showed abnormal inspection, and these are so called functional dyspepsia. Functional dyspepsia is a chronic and repeated occurrence of digestive disorders, patients often visit hospitals frequently and unable to get fully cured. Current Symptom diagnoses are based on Rome III criteria as diagnostic criteria. Although functional dyspepsia condition should combine with physical and mental treatments, due to the reasons behind the complex, there is still no effective classification could be acted in health education and drug intervention.
Detailed description
Health literacy can be defined as "ability for obtaining basic health information and understanding medical services." Within 10 years, healthy development and application of knowledge used in medical care and public health fields that have raised more attentions, many European countries set health knowledge as one of the main indicators for health care policy in the future. To promote behavior of self-care health for people, enhance the effective use of medical service , also reduce health care cost and unequally medical information.
Anxiety and depression are two common reactions when it comes to negative emotional states, which related to a body and caused a vicious cycle of disease. Some patients suffer from functional dyspepsia symptoms were diagnosed with anxiety or depression symptoms often ignore body care due to lack of health literacy. The purpose of this study is to investigate the distribution of functional dyspepsia patients with health literacy and emotional status, in order to provide more effective health education mode, thereby reducing the waste of medical resources, and promote patient health.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with functional dyspepsia , can Self-reading and the self-administered questionnaire.
Key inclusion criteria (1 listed)
- Patients diagnosed with functional dyspepsia , can Self-reading and the self-administered questionnaire.
Key exclusion criteria (1 listed)
- Due to physical illness, cognitive ability is limited and other factors can not were completed self-administered questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptom diagnoses are based on Rome III criteria as diagnostic criteria
Time frame: up to 10 months to collect data and perform an analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Dyspepsia
Active, not recruitingPhase 1
AutoSTEA for Adults With Functional Dyspepsia
Functional Dyspepsia
Recruiting
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Shun Wu, Dr study chair
Taipei Medical University WanFang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspepsia, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Shun Wu, Dr (886970746512, mswu@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom diagnoses are based on Rome III criteria as diagnostic criteria (time frame: up to 10 months to collect data and perform an analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.