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The Long-term Effectiveness of Case Management for Patients With Rheumatoid Arthritis in Taiwan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03446989
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
Information provided by (Responsible Party):
Dalin Tzu Chi General Hospital

Brief Summary:
Case management (CM) has been recommended as a way of inspiring measurable changes in individual behaviors and improving clinical outcomes for patients with chronic diseases. However, data on its effectiveness for Taiwanese patients with rheumatoid arthritis (RA) are limited. This study aimed to determine the long-term effectiveness of CM that focused on nurses' role among Taiwanese RA patients.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Case Management Managed Care Programs Behavioral: Case management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 91 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Department of Nursing, Dalin Tzuchi Hospital
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Case management Behavioral: Case management
completing assessment, detecting the presence of RA complications, consultation about taking medications and exercise, education for patients and their family, assist in formulating a management, and providing a basis for continuing care for each patient. Additionally, the management plan was rationally modified in accordance with the individualized therapeutic alliance of the patient, his/her family, the physician or other members of the medical team.

Primary Outcome Measures :
  1. Depression level [ Time Frame: Up to 12 months ]
    Assessed with Taiwanese Depression Questionnaire (TDQ)

Secondary Outcome Measures :
  1. Self-care efficacy [ Time Frame: Up to 12 months ]
    Assessed with Arthritis Self-Efficacy Scale

  2. Sexual dysfunction [ Time Frame: Up to 12 months ]
    Determined by Changes in Sexual Functioning Questionnaire Short-Form

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Criteria: Inclusion Criteria:

  • being at least 20 years old at the time of recruitment,
  • having no cognitive impairment and severe complications,
  • being able to express opinions in either Mandarin or Taiwanese, and
  • having a diagnosis of RA.

Exclusion Criteria:

  • being unwillingness to participant this work
  • Attending the similar health education program in the past

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03446989

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Contact: Tzung-Yi Tsai, PhD candidate 552648000 ext 3209

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Tzung-Yi Tsai Recruiting
Chiayi City, Chiayi, Taiwan, 62247
Contact: Tzung-Yi Tsai    552648000   
Sponsors and Collaborators
Dalin Tzu Chi General Hospital
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Principal Investigator: Miao-Chiu Lin Dalin Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation

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Responsible Party: Dalin Tzu Chi General Hospital Identifier: NCT03446989     History of Changes
Other Study ID Numbers: DTCRD105(2)-I-16
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to the legal restrictions imposed by government of Taiwan in relation to the "Personal Information Protection Act", all data cannot made publicly available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dalin Tzu Chi General Hospital:
case management
rheumatoid arthritis
Generalized Estimating Equations
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases