Integrated Care Approach for Rheumatoid Arthritis Patients

April 6, 2026 updated by: Tzung-Yi Tsai, Dalin Tzu Chi General Hospital

Association Between Pro-inflammatory Cytokines and Depressive Symptoms in Patients With Rheumatoid Arthritis: Evaluating the Impact of an Integrated Care Approach

The goal of this study is to learn about the long-term effects of integrated care approach in persons over the age of 20 who take part in integrated care approach to treat their rheumatoid arthritis (RA). The main question is to explore whether adding the integrated care approach into routine care can lower pro-inflammatory cytokines and depressive symptom in RA persons over age 20 when taken long-term to treat RA?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Chiayi City, Taiwan, 62247
        • Dalin Tzuchi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

age of at least 20 years; willingness to participate in the survey; having the physician-diagnosed RA with the International Classification of Diseases, 9th Revision, Clinical Modification code of 714.0

Exclusion Criteria:

  • having physician-based diagnosis of cognitive impairment and with the ability to express opinion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine care
This consisted of consultation about disease symptoms and conventional disease management.
Experimental: ETLA care
Subhects in the experimental group receive exercise training plus laser acupuncture
Other: ETLA
To assess the long-term effects of integrated case management model involving traditional Chinese medicine (CM-TCM) model. The persons participating will be invited to enroll in this stage, and they will be assigned to receive either the usual care or a usual care plus integrated 3-month CM-TCM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cytokines
Time Frame: From enrollment to the end of treatment at 12 weeks"
Serum cytokine levels contained interleukin (IL)-6, IL-1, IL-17 and tumor necrosis factor (TNF)-alpha,
From enrollment to the end of treatment at 12 weeks"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
depressive symptom
Time Frame: From enrollment to the end of treatment at 12 weeks"
It is measured by self-reported scale
From enrollment to the end of treatment at 12 weeks"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalin Tzu Chi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

October 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

January 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B11204006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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