Thyroid Related Eye DiseaseNCT03426696
Psychological Status and Related Factors of Thyroid Related Eye Disease
An observational study of Thyroid Related Eye Disease, run by Huijing Ye at 1 site in China.
Trial summary
The purpose of this study is to evaluate the psychological status of Thyroid Related Eye Disease. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Thyroid Related Eye Disease
- What is being tested?
- psychological condition
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 31 Dec 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients in Sun Yat-sen University that diagnosed as Thyroid Related Eye Disease
Who may be able to join
- over 16 years old
- diagnosed as Thyroid Related Eye Disease
Who cannot join
- any uncontrolled clinical problems
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the psychological status of Thyroid Related Eye Disease.
Read the detailed description
The purpose of this study is to evaluate the psychological status of patients of Thyroid Related Eye Disease over 16 years old, and to analyze the related factors of them.
- Conditions
- Thyroid Related Eye Disease
- Being tested
- psychological condition
- Keywords
- psychological status, Related Factors, Thyroid Related Eye Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychological conditionBehavioural
Graves ́ ophthalmopathy quality of life questionnaire, Symptom checklist 90(SLC-90), Hamilton anxiety scale(HAMA), Somatic self-rating scale(SSS), MATRICS Consensus Cognitive Battery (MCCB), Hamilton depression scale(HAMD)
| Study group | Role | What they receive |
|---|---|---|
| Thyroid Related Eye Disease | Survey about the psychological condition would done with the patients of Thyroid Related Eye Disease Receives: Behavioral: psychological condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life questionnaire of patients of Thyroid Related Eye Disease
Graves ́ ophthalmopathy quality of life questionnaire (GO-QoL) , The GO-QoL contains 8 questions on visual functioning and 8 questions on appearance; answers on each subscale are transformed to scores ranging from 0 (worst) to 100 (best).
Measured: immediately
Secondary outcomes (5)
Symptom checklist 90(SLC-90)
It consists of 90 items yielding nine scores along primary symptom dimensions and three scores among global distress indices. The primary symptom dimensions that are assessed are somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and a category of "additional items" which helps clinicians assess other aspect of the clients symptoms. Positive standard includes: total score 160 points or more, or positive items > 43 points, or any item > 2 points.
Measured: immediately
Hamilton anxiety scale(HAMA)
This scale includes 14 items. All projects rated as: asymptomatic, light, medium, heavy, or very heavy. If the total score more than 29 points, there could be severe anxiety; more than 21 points, affirmation have obvious anxiety; more than 14 points, there must be some anxious; more than 7 points might be anxious; if less than 6 points, patients without anxiety symptoms.
Measured: immediately
Somatic self-rating scale(SSS)
Somatic self-rating scale can let the doctor fully understand patients' mood and somatization symptoms. If the selected items scores more than 30 points, the patient may need to clinic treatment.
Measured: immediately
Hamilton depression scale(HAMD)
It is the most common depression clinical application scale. Lower score presents lighter condition, and if the illness is heavier, the higher is the score. There is no depression symptoms for score less than eight points.
Measured: immediately
Young manic rating scale(YMRS)
The Young Mania Rating Scale (YMRS) is a diagnostic questionnaire commonly used to evaluate manic symptoms in patients with bipolar 1 disorder and to assess treatment efficacy in clinical trials. This rating scale comprises eleven items (elevated mood, increased motor activity - energy, sexual interest, sleep, irritability, speech - rate and amount, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight). The total YMRS score is calculated as the summation of each of the eleven individual item scores.Lower score presents lighter condition, and if the illness is heavier, the higher is the score.There is no manic symptoms for score less than five points.
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start1 Dec 2017
- Primary completion1 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Related Eye DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huijing Ye
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huijing Ye, Sun Yat-sen University
- Investigators
- Huijing Ye, Master, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426696
- Sponsor's protocol ID
- 201701
- Status last verified
- May 2020
- First submitted
- 1 Feb 2018
- Last updated
- 21 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Status and Related Factors of Thyroid Related Eye Disease
- ClinicalTrials.gov ID
- NCT03426696
- Acronym / sponsor ID
- 201701
- Conditions
- Thyroid Related Eye Disease
- Keywords
- psychological status, Related Factors, Thyroid Related Eye Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Huijing YeUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 8 Feb 2018 (actual)
- 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.
The purpose of this study is to evaluate the psychological status of Thyroid Related Eye Disease.
Detailed description
The purpose of this study is to evaluate the psychological status of patients of Thyroid Related Eye Disease over 16 years old, and to analyze the related factors of them.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thyroid Related Eye Disease | – | Behavioral: psychological conditionSurvey about the psychological condition would done with the patients of Thyroid Related Eye Disease |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients in Sun Yat-sen University that diagnosed as Thyroid Related Eye Disease
Key inclusion criteria (2 listed)
- over 16 years old
- diagnosed as Thyroid Related Eye Disease
Key exclusion criteria (1 listed)
- any uncontrolled clinical problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychological conditionGraves ́ ophthalmopathy quality of life questionnaire, Symptom checklist 90(SLC-90), Hamilton anxiety scale(HAMA), Somatic self-rating scale(SSS), MATRICS Consensus Cognitive Battery (MCCB), Hamilton depression scale(HAMD) | Behavioural | Thyroid Related Eye Disease |
Primary outcome
Quality of life questionnaire of patients of Thyroid Related Eye Disease
Time frame: immediately
Graves ́ ophthalmopathy quality of life questionnaire (GO-QoL) , The GO-QoL contains 8 questions on visual functioning and 8 questions on appearance; answers on each subscale are transformed to scores ranging from 0 (worst) to 100 (best).
5 secondary outcomes
Symptom checklist 90(SLC-90)
Time frame: immediately
Hamilton anxiety scale(HAMA)
Time frame: immediately
Somatic self-rating scale(SSS)
Time frame: immediately
Hamilton depression scale(HAMD)
Time frame: immediately
Young manic rating scale(YMRS)
Time frame: immediately
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
Huijing Ye, Master principal investigator
Sun Yat-sen University
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 Thyroid Related Eye Disease, run by Huijing Ye at 1 site in China.
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 2 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: finished, as of the sponsor's last update on 21 May 2020. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life questionnaire of patients of Thyroid Related Eye Disease (time frame: immediately). 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 21 May 2020.