Thyroid Eye Disease, TEDNCT07444190
Psychological Burden of Thyroid Eye Disease
An observational study of Thyroid Eye Disease, TED, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This interview study aims to look in depth at the quality of life of people living with TED and their caregivers, with emphasis on impact on mood, relationships, work/education, and leisure. The investigators plan to examine this through a two-part focus group followed by individual interviews. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Eye Disease, TED
- What is being tested?
- focus groups and individual interviews as well as filling out questionnaires
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 31 Dec 2025
- How long will I take part?
- 3 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People living with TED and their loved ones
Who may be able to join
- Age 18 and older
- Clinical diagnosis of Thyroid Eye Disease (patients) OR serving in a caregiving role for someone with a clinical diagnosis of Thyroid Eye Disease (caregivers)
Who cannot join
- Inability to consent or to engage in treatment in English
- Presence of psychotic disorder or symptoms
- Presence of psychiatric disorders that interfere with the participation of the study, judged by the study or treating clinician.
- Presence of other medical conditions that interfere with participation in the study, judged by the study or treating clinician
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Psychological Burden of Thyroid Eye Disease: A Patient and Caregiver Focus Group and Interview Study
This interview study aims to look in depth at the quality of life of people living with TED and their caregivers, with emphasis on impact on mood, relationships, work/education, and leisure. The investigators plan to examine this through a two-part focus group followed by individual interviews. Participants will also complete self-report measures.
Read the detailed description
Thyroid Eye Disease (TED) is an autoimmune disorder in which eye muscles and fatty tissue behind the eye become inflamed and may cause scar tissue to form. Hallmark symptoms of TED include exophthalmos (eye bulging), strabismus (misaligned eyes), diplopia (double vision), dry or gritty eyes, eye pain, eye pressure, sensation of debris in the eye, red eyes, watery eyes, sensitivity to light, blurry vision, eyelid edema (puffy eyes), eyelid retraction, color vision loss, and vision loss. TED affects individuals diagnosed with this condition and their caregivers. This interview study aims to look in depth at the quality of life of people living with TED and their caregivers, with emphasis on impact on mood, relationships, work/education, and leisure. The investigators plan to examine this through a two-part focus group followed by individual interviews. Participants will also complete self-report measures.
- Conditions
- Thyroid Eye Disease, TED
- Being tested
- focus groups and individual interviews as well as filling out questionnaires
- Keywords
- TED, thyroid eye disease
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focus groups and individual interviews as well as filling out questionnairesOther
focus groups and individual interviews as well as filling out questionnaires
| Study group | Role | What they receive |
|---|---|---|
| patients living with TED and their loved ones | interviews, focus groups \& completion of questionnaires by patients living w TED and their loved ones Receives: Other: focus groups and individual interviews as well as filling out questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understand the experience of people living with TED and of caregivers of people living with TED. The investigators aim to define the different facets of TED-specific psychological burden.
Understand the experience of people living with TED and of caregivers of people living with TED. Through semi-structured individual interviews, focus groups, polls during focus groups, and completion of a battery of standardized self-report measures of depressive symptoms (Beck Depression Inventory-II, Patient Health Questionnaire - 9), anxiety (Generalized Anxiety Disorder -7, Beck Anxiety Inventory), value-based living (Valued Living Questionnaire), and psychological flexibility (cognitive fusion questionnaire -13, acceptance and action questionnaire-2), the investigators aim to define the different facets of TED-specific psychological burden as experienced by patients and by loved ones of people living with TED.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye Disease, TEDStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444190
- Sponsor's protocol ID
- iRISID-2024-3013
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified data to be shared w patrick smith, phd mph for statistical analyses
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Burden of Thyroid Eye Disease: A Patient and Caregiver Focus Group and Interview Study
- ClinicalTrials.gov ID
- NCT07444190
- Acronym / sponsor ID
- iRISID-2024-3013
- Conditions
- Thyroid Eye Disease, TED
- Keywords
- TED, thyroid eye disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 2 Mar 2026 (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.
This interview study aims to look in depth at the quality of life of people living with TED and their caregivers, with emphasis on impact on mood, relationships, work/education, and leisure. The investigators plan to examine this through a two-part focus group followed by individual interviews. Participants will also complete self-report measures.
Detailed description
Thyroid Eye Disease (TED) is an autoimmune disorder in which eye muscles and fatty tissue behind the eye become inflamed and may cause scar tissue to form. Hallmark symptoms of TED include exophthalmos (eye bulging), strabismus (misaligned eyes), diplopia (double vision), dry or gritty eyes, eye pain, eye pressure, sensation of debris in the eye, red eyes, watery eyes, sensitivity to light, blurry vision, eyelid edema (puffy eyes), eyelid retraction, color vision loss, and vision loss. TED affects individuals diagnosed with this condition and their caregivers. This interview study aims to look in depth at the quality of life of people living with TED and their caregivers, with emphasis on impact on mood, relationships, work/education, and leisure. The investigators plan to examine this through a two-part focus group followed by individual interviews. Participants will also complete self-report measures.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients living with TED and their loved ones | – | Other: focus groups and individual interviews as well as filling out questionnairesinterviews, focus groups \& completion of questionnaires by patients living w TED and their loved ones |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People living with TED and their loved ones
Key inclusion criteria (2 listed)
- Age 18 and older
- Clinical diagnosis of Thyroid Eye Disease (patients) OR serving in a caregiving role for someone with a clinical diagnosis of Thyroid Eye Disease (caregivers)
Key exclusion criteria (4 listed)
- Inability to consent or to engage in treatment in English
- Presence of psychotic disorder or symptoms
- Presence of psychiatric disorders that interfere with the participation of the study, judged by the study or treating clinician.
- Presence of other medical conditions that interfere with participation in the study, judged by the study or treating clinician
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 |
|---|---|---|
| focus groups and individual interviews as well as filling out questionnairesfocus groups and individual interviews as well as filling out questionnaires | Other | patients living with TED and their loved ones |
Primary outcome
Understand the experience of people living with TED and of caregivers of people living with TED. The investigators aim to define the different facets of TED-specific psychological burden.
Time frame: 3 months
Understand the experience of people living with TED and of caregivers of people living with TED. Through semi-structured individual interviews, focus groups, polls during focus groups, and completion of a battery of standardized self-report measures of depressive symptoms (Beck Depression Inventory-II, Patient Health Questionnaire - 9), anxiety (Generalized Anxiety Disorder -7, Beck Anxiety Inventory), value-based living (Valued Living Questionnaire), and psychological flexibility (cognitive fusion questionnaire -13, acceptance and action questionnaire-2), the investigators aim to define the different facets of TED-specific psychological burden as experienced by patients and by loved ones of people living with TED.
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 2 Mar 2026.
- Individual participant dataSharing planned: Yes. de-identified data to be shared w patrick smith, phd mph for statistical analyses
Related trials for Thyroid Eye Disease, TED
RecruitingObservational study
Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease
Graves' Orbitopathy, Thyroid Eye Disease, TED
RecruitingPhase 1
Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease
Thyroid Eye Disease (TED), Graves' Disease
Not yet recruitingPhase 2
Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)
Graves Disease, Graves Disease (Basedow's Disease)
RecruitingPhase 3
Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
Thyroid Eye Disease, TED, Graves Orbitopathy
RecruitingPhase 3
Treatment of Active Thyroid Eye Disease With MHB018A in a Randomized, Placebo-Controlled Study
Thyroid Eye Disease, TED
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Eye Disease, TED, run by Thomas Jefferson University at 1 site in United States.
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 4 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 2 Mar 2026. 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 United States. 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?
Understand the experience of people living with TED and of caregivers of people living with TED. The investigators aim to define the different facets of TED-specific psychological burden. (time frame: 3 months). 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 2 Mar 2026.