Rheumatoid ArthritisNCT03483597
The Survey of Satisfaction in Chinese Rheumatologists and Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Satisfaction, run by Chinese SLE Treatment And Research Group at 1 site in China.
Trial summary
A questionnaire for this research is designed, which initiated from TSQM-II treatment satisfaction questionnaire and based on research launched by rheumatology and immunology departments of Chinese 12 public tertiary hospitals distributed directionally by Chinese Rheumatism Data Center (CRDC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Satisfaction
- What is being tested?
- TSQM-II
- How many people
- 1,365 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2018to 30 Apr 2018
- How long will I take part?
- 1 Day
- 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
- Adult, Older adult
Study population: Subjects come from 12 hospitals in Chinese Rheumatism Data Center.
Who may be able to join
- Doctors - registered rheumatoid specialist physicians subordinated to the 12 designated hospitals Patients - aged over 18, confirming RA for more than 6 months
Who cannot join
- Doctors - N/A Patients - with Chinese reading comprehension barriers (unable to complete the questionnaire independently), without any RA treatment
Trial locations and contacts
1 site in 1 country.
About this study
A questionnaire for this research is designed, which initiated from TSQM-II treatment satisfaction questionnaire and based on research launched by rheumatology and immunology departments of Chinese 12 public tertiary hospitals distributed directionally by Chinese Rheumatism Data Center (CRDC). The research is about treatment satisfaction and its influencing factors for Chinese rheumatoid immunologists and rheumatoid arthritis (RA) patients as well as their expectations for treating this disease. This research will explore the matching degree between treatment satisfaction and expectation about rheumatoid arthritis from doctors and patients.
Read the detailed description
In the last decade, China has made quick progress on treatment of rheumatoid arthritis. However, the improvement of remission rate cannot fully represent needs of patients for health. To meet health demands of patients and improve their satisfaction, an efficacy evaluation system based on the outcome report of patients should be established. A questionnaire for this research is designed and mended in view of TSQM-II treatment satisfaction questionnaire and the actual situation of RA diagnosis and treatment in China. An investigation on treatment satisfaction and its influencing factors for Chinese rheumatoid immunologists and rheumatoid arthritis (RA) patients as well as their expectations for this disease is carried out based on 120 rheumatoid immunologists and 1,200 rheumatoid arthritis patients (1:10) from Chinese 12 public tertiary hospitals distributed directionally by Chinese Rheumatism Data Center (CRDC). The research concludes rheumatoid specialist physicians for doctor population, and persons aged over 18 for patient population who has been confirmed as RA for 6 months above, excluding patients with Chinese reading comprehension barriers or without any RA treatment. Finally, summarize and analyze the total score of satisfaction from doctors and patients, average score of doctors and patients for various medical demands, as well as the satisfaction of patients about communication and service during medical treatment.
- Conditions
- Rheumatoid Arthritis, Satisfaction
- Being tested
- TSQM-II
- Medical subject headings
- Arthritis, Rheumatoid, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSQM-IIOther
Treatment Satisfaction Questionnaire for Medication (TSQM Version II) will be used in all groups
| Study group | Role | What they receive |
|---|---|---|
| rheumatologists | Inclusion criteria: Registered rheumatoid specialist physicians subordinated to the 12 designated hospitals The Treatment Satisfaction Questionnaire for Medication (TSQM-II) will be used in rheumatologists. Receives: Other: TSQM-II | |
| patients | Inclusion criteria: Aged over 18, confirming RA for more than 6 months Exclusion criteria. Patients with Chinese reading comprehension barriers (unable to complete the questionnaire independently), without any RA treatment The Treatment Satisfaction Questionnaire for Medication (TSQM-II) will be used in patients. Receives: Other: TSQM-II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score of patient satisfaction
Total score of patient satisfaction
Measured: 1 day
Secondary outcomes (7)
Average score of patients for various treatment demands
Average score of patients for various treatment demands
Measured: 1 day
Average score of patients for long-term treatment demands
Average score of patients for long-term treatment demands
Measured: 1 day
Average score of patients for new drug demands
Average score of patients for new drug demands
Measured: 1 day
Total score of doctor satisfaction
Total score of doctor satisfaction
Measured: 1 day
Average score of doctors for various treatment demands
Average score of doctors for various treatment demands
Measured: 1 day
Average score of doctors for long-term treatment demands
Average score of doctors for long-term treatment demands
Measured: 1 day
Average score of doctors for new drug demands
Average score of doctors for new drug demands
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start31 Mar 2018
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,365 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaofeng Zeng, Doctor, Study chair, Director of Rheumatology and Immunology Department Chinese Academy of Medical Sciences &Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483597
- Sponsor's protocol ID
- CRDC-satisfaction
- Status last verified
- Mar 2018
- First submitted
- 21 Mar 2018
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Survey of Satisfaction in Chinese Rheumatologists and Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03483597
- Acronym / sponsor ID
- CRDC-satisfaction
- Conditions
- Rheumatoid Arthritis, Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,365 participants (actual)
- Lead sponsor
- Chinese SLE Treatment And Research GroupUniversity, hospital or other
- Study start
- 31 Mar 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 30 Mar 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.
A questionnaire for this research is designed, which initiated from TSQM-II treatment satisfaction questionnaire and based on research launched by rheumatology and immunology departments of Chinese 12 public tertiary hospitals distributed directionally by Chinese Rheumatism Data Center (CRDC). The research is about treatment satisfaction and its influencing factors for Chinese rheumatoid immunologists and rheumatoid arthritis (RA) patients as well as their expectations for treating this disease. This research will explore the matching degree between treatment satisfaction and expectation about rheumatoid arthritis from doctors and patients.
Detailed description
In the last decade, China has made quick progress on treatment of rheumatoid arthritis. However, the improvement of remission rate cannot fully represent needs of patients for health. To meet health demands of patients and improve their satisfaction, an efficacy evaluation system based on the outcome report of patients should be established. A questionnaire for this research is designed and mended in view of TSQM-II treatment satisfaction questionnaire and the actual situation of RA diagnosis and treatment in China. An investigation on treatment satisfaction and its influencing factors for Chinese rheumatoid immunologists and rheumatoid arthritis (RA) patients as well as their expectations for this disease is carried out based on 120 rheumatoid immunologists and 1,200 rheumatoid arthritis patients (1:10) from Chinese 12 public tertiary hospitals distributed directionally by Chinese Rheumatism Data Center (CRDC). The research concludes rheumatoid specialist physicians for doctor population, and persons aged over 18 for patient population who has been confirmed as RA for 6 months above, excluding patients with Chinese reading comprehension barriers or without any RA treatment. Finally, summarize and analyze the total score of satisfaction from doctors and patients, average score of doctors and patients for various medical demands, as well as the satisfaction of patients about communication and service during medical treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rheumatologists | – | Other: TSQM-IIInclusion criteria: Registered rheumatoid specialist physicians subordinated to the 12 designated hospitals The Treatment Satisfaction Questionnaire for Medication (TSQM-II) will be used in rheumatologists. |
| patients | – | Other: TSQM-IIInclusion criteria: Aged over 18, confirming RA for more than 6 months Exclusion criteria. Patients with Chinese reading comprehension barriers (unable to complete the questionnaire independently), without any RA treatment The Treatment Satisfaction Questionnaire for Medication (TSQM-II) will be used in patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects come from 12 hospitals in Chinese Rheumatism Data Center.
Key inclusion criteria (1 listed)
- Doctors - registered rheumatoid specialist physicians subordinated to the 12 designated hospitals Patients - aged over 18, confirming RA for more than 6 months
Key exclusion criteria (1 listed)
- Doctors - N/A Patients - with Chinese reading comprehension barriers (unable to complete the questionnaire independently), without any RA treatment
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 |
|---|---|---|
| TSQM-IITreatment Satisfaction Questionnaire for Medication (TSQM Version II) will be used in all groups | Other | patients, rheumatologists |
Primary outcome
Total score of patient satisfaction
Time frame: 1 day
Total score of patient satisfaction
7 secondary outcomes
Average score of patients for various treatment demands
Time frame: 1 day
Average score of patients for long-term treatment demands
Time frame: 1 day
Average score of patients for new drug demands
Time frame: 1 day
Total score of doctor satisfaction
Time frame: 1 day
Average score of doctors for various treatment demands
Time frame: 1 day
Average score of doctors for long-term treatment demands
Time frame: 1 day
Average score of doctors for new drug demands
Time frame: 1 day
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 31 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Xiaofeng Zeng, Doctor study chair
Director of Rheumatology and Immunology Department Chinese Academy of Medical Sciences &Peking Union Medical College 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 Rheumatoid Arthritis and Satisfaction, run by Chinese SLE Treatment And Research Group 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 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: finished, as of the sponsor's last update on 31 Aug 2023. 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?
Total score of patient satisfaction (time frame: 1 day). 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 31 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.