Social InteractionNCT04426370
The Effects of Social Role Participation on Life Quality
An observational study of Social Interaction, run by Recep Tayyip Erdogan University Training and Research Hospital.
Trial summary
The study was carried out among 100 RA patients (age from 20 to 70 years) by fulfilling the American College of Rheumatology 1987 revised criteria admitted to our outpatient clinic. RA patients were compared with 95 healthy volunteer control group. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Social Interaction
- What is being tested?
- Observational
- How many people
- 195 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 1 Feb 2017
- How long will I take part?
- 4 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 20 to 70 years
- All sexes
- Adult, Older adult
Study population: 100 RA patients and 95 healthy volunteer control
Inclusion Criteria:The study was carried out among RA patients (age from 20 to 70 years) by fulfilling the American College of Rheumatology 1987 revised criteria admitted to our outpatient clinic -
Exclusion Criteria:This study did not include all participants who had accompanying of other rheumatic diseases, musculoskeletal diseases, the presence of another chronic disease, cancer.
-
About this study
Official title: The Effects of Social Role Participation on Life Quality in Rheumatoid Arthritis Patients
The study was carried out among 100 RA patients (age from 20 to 70 years) by fulfilling the American College of Rheumatology 1987 revised criteria admitted to our outpatient clinic. RA patients were compared with 95 healthy volunteer control group. Participants were asked to complete interview based questionnaires regarding pain, life quality, and social role participation to obtain additional information during the interview to participate in the study in 20 min.
Read the detailed description
The study was carried out among 100 RA patients (age from 20 to 70 years) by fulfilling the American College of Rheumatology 1987 revised criteria admitted to our outpatient clinic. RA patients were compared with 95 healthy volunteer control group. Healthy volunteers were recruited from the partners next to the patients who came to our outpatient clinic for examination. The same physician carried out the physical examinations on all participations and conducted a interview, acquiring information on age, gender, body mass index (BMI), marriage status, living alone, working, and education. Participants were asked to complete interview based questionnaires regarding pain, life quality, and social role participation to obtain additional information during the interview to participate in the study in 20 min. Examinations took place at the our outpatient clinic. This study did not include all participants who had accompanying of other rheumatic diseases, musculoskeletal diseases, the presence of another chronic disease, cancer.
- Conditions
- Social Interaction
- Being tested
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Physical examination and questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Case | 100 rheumatoid arthritis patients (age from 20 to 70 years) Receives: Other: Observational | |
| Control | 95 healthy volunteer Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social role participation
Social role participation questionnaire
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Oct 2016
- Primary completion1 Jan 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social InteractionStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 195 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gul Devrimsel, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426370
- Sponsor's protocol ID
- gd230863
- Status last verified
- Jun 2020
- First submitted
- 7 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Social Role Participation on Life Quality in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT04426370
- Acronym / sponsor ID
- gd230863
- Conditions
- Social Interaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 11 Jun 2020 (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 study was carried out among 100 RA patients (age from 20 to 70 years) by fulfilling the American College of Rheumatology 1987 revised criteria admitted to our outpatient clinic. RA patients were compared with 95 healthy volunteer control group. Participants were asked to complete interview based questionnaires regarding pain, life quality, and social role participation to obtain additional information during the interview to participate in the study in 20 min.
Detailed description
The study was carried out among 100 RA patients (age from 20 to 70 years) by fulfilling the American College of Rheumatology 1987 revised criteria admitted to our outpatient clinic. RA patients were compared with 95 healthy volunteer control group. Healthy volunteers were recruited from the partners next to the patients who came to our outpatient clinic for examination. The same physician carried out the physical examinations on all participations and conducted a interview, acquiring information on age, gender, body mass index (BMI), marriage status, living alone, working, and education. Participants were asked to complete interview based questionnaires regarding pain, life quality, and social role participation to obtain additional information during the interview to participate in the study in 20 min. Examinations took place at the our outpatient clinic. This study did not include all participants who had accompanying of other rheumatic diseases, musculoskeletal diseases, the presence of another chronic disease, cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: Observational100 rheumatoid arthritis patients (age from 20 to 70 years) |
| Control | – | Other: Observational95 healthy volunteer |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 100 RA patients and 95 healthy volunteer control
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 |
|---|---|---|
| ObservationalPhysical examination and questionnaires | Other | Case, Control |
Primary outcome
Social role participation
Time frame: 4 months
Social role participation questionnaire
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 11 Jun 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Social Interaction, run by Recep Tayyip Erdogan University Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Social role participation (time frame: 4 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 11 Jun 2020.