Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02696551
Other study ID # The IMPACT2 Project
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 23, 2016
Last updated March 1, 2016
Start date March 2016
Est. completion date December 2016

Study information

Verified date February 2016
Source Shanxi Dayi Hospital
Contact Liyun Zhang, MD
Phone 86-351-8368114
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a retrospective and prospective designed study, included hospitals are 1:1 assigned into two groups: ①Interventional hospital, which will receive 3-month medical education; ②Non-interventional hospital, which will not receive 3-month medical education. During 1 month before education, all the electronic records of outpatients and inpatients who visit the included rheumatologists will be collected and the data of test and evaluation results of spondyloarthritis (SpA) patients diagnosed according to new Assessment of Spondylo-Arthritis International Society (ASAS) criteria will be collected from outpatient electronic records and inpatients medical charts; in the 3 months after education, the same data will be collected and compared with the data before education, and the impact of medical education on physician behaviour will be analyzed. Meanwhile, the understanding and acceptance level will be evaluated by the questionnaire, the differences before and after education and the impact of education on physician cognition will be evaluated.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Interventional hospital will be selected based on following criteria:

1. having complete outpatients and inpatients electronic records;

2. more than 50% of registrars and/or consultants in the department participated the professional education event;

3. the department head is willing to participate the clinical audit and provide the information from outpatients and inpatients records for data collection;

4. except for rheumatic diseases have been clearly diagnosed.

Non-interventional hospital will be selected based on following criteria:

1. having complete outpatients and inpatients electronic records;

2. no professional education event covered;

3. the department head is willing to participate the clinical audit and provide the information from outpatients and inpatients records for data collection;

4. except for rheumatic diseases have been clearly diagnosed.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
Medical education


Locations

Country Name City State
China Shanxi Dayi Hospital Taiyuan Shanxi

Sponsors (1)

Lead Sponsor Collaborator
Shanxi Dayi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean of number of positive SpA feature of newly diagnosed patients with inflammatory back pain, before and after the (no-)event 1 month before (no-) education vs. 3 months after (no-) education No
Primary Proportion of patients with a image examination of sacroiliitis ( x-rays, CT, or MRI) in the audit period, before and after the (no-)event 1 month before (no-) education vs. 3 months after (no-) education No
Primary Proportion of patients with a assessment of disease activity in the audit period, before and after the (no-)event 1 month before (no-) education vs. 3 months after (no-) education No
Secondary Proportion of patients with a clear diagnosis (Diagnostic for Spondyloarthritis with new ASAS criteria) or receiving a new diagnosis in the audit period, before and after the (no-)event 1 month before (no-) education vs. 3 months after (no-) education No
Secondary Mean of the number of physical examinations of disease activity in the audit period, before and after the (no-)event 1 month before (no-) education vs. 3 months after (no-) education No
Secondary Change of questionnaire scores of physician in the audit period, before and after the (no-)event 1 month before (no-) education vs. 3 months after (no-) education No
Secondary Change of utilization rate of Non Steroidal Anti Inflammatory Drugs (NSAIDs) before and after the (no-)event 1 month before (no-) education vs. 3 months after (no-) education No
Secondary Change of utilization rate of biological medication before and after the (no-)event 1 month before (no-) education vs. 3 months after (no-) education No
See also
  Status Clinical Trial Phase
Completed NCT03564743 - Description of Spondylarthritis and Validation of ASAS Criteria in West Indian Patients Seen in Consultation of Rheumatology.
Completed NCT01219257 - Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting Biological Therapy
Recruiting NCT05433168 - Study Evaluating the Effectiveness of Shiatsu on Fatigue in Patients With Axial Spondyloarthritis N/A
Terminated NCT03232580 - 99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis Phase 2
Recruiting NCT05039216 - Biobank for Inflammatory Chronic Diseases and Osteoporosis
Completed NCT04483648 - Cervical Stabilization Exercises in Patients With Spondyloarthritis N/A
Recruiting NCT04602091 - Observational Study in Patients Treated With JAK Inhibitors for Inflammatory Rheumatism (MAJIK)
Not yet recruiting NCT04077957 - Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs Phase 4
Recruiting NCT05290363 - The Role of IL-23 in Chronic Inflammatory Disease: Exploring the Cellular and Molecular Targets of IL-23 Signaling in Peripheral and Axial Spondyloarthritis N/A
Not yet recruiting NCT05006690 - Telerehabilitation, Face-to-Face and Home-Based Spinal Stabilization Exercise Training in Patients With Spondyloarthritis N/A
Completed NCT02998398 - Evaluation of the Switch From the Original Infliximab to Its Biosimilar in Daily Practice at Cochin Hospital
Completed NCT02148640 - The NOR-SWITCH Study Phase 4
Completed NCT01174186 - Intestinal Inflammation in Ankylosing Spondylitis and the Effects of Adalimumab on Mucosal Healing Phase 4
Recruiting NCT04499001 - Effect of Pharmaceutical Consultations Just Before Rheumatology Consultations on Improving Knowledge and Skills for Patients With Inflammatory Arthritis With Subcutaneous Biologic DMARDs
Completed NCT03253796 - Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (GO-BACK) (MK-8259-038) Phase 4
Active, not recruiting NCT04169373 - A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis Phase 3
Recruiting NCT04292067 - Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis
Completed NCT04946539 - Value of Ultrasonographic Enthesitis Assessment in Spondyloarthritis
Recruiting NCT03983473 - Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease. N/A
Terminated NCT03345355 - MRI of Sacroiliac Joints: Evaluation of Accuracy of Dixon Sequences in the Diagnosis of Axial Spondyloarthritis