Integrated Care Approach for Rheumatoid Arthritis Patients

NCT06791980 | Completed DMC

• 1 other identifier: B11204006
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (1)

• cytokines

  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 Outcomes (1)

• depressive symptom

  From enrollment to the end of treatment at 12 weeks"

Study Arms (2)

Routine care

NO INTERVENTION

This consisted of consultation about disease symptoms and conventional disease management.

ETLA care

EXPERIMENTAL

Subhects in the experimental group receive exercise training plus laser acupuncture

Other: ETLA

Interventions

ETLA OTHER

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

ETLA care

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dalin Tzu Chi General Hospital: lead

Study Sites (1)

Dalin Tzuchi Hospital

Chiayi City, 62247, Taiwan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: To set up an exercise training plus laser acupuncture (ETLA) program and to assess its long-term effects towards changes of metabolic profiles, pro-inflammatory cytokines, and muscle functions among RA persons.

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 24, 2025
• Study Start: October 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)