Effects of Case Management for Patients With Rheumatoid Arthritis in Taiwan

March 25, 2024 updated by: Dalin Tzu Chi General Hospital

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

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.

A quasi-experimental pre-post test, control-group study with purposive sampling recruited RA patients from a hospital in Taiwan during 2016-2017. CM program was composed of health education sessions and follow-up telephone consultations over a six-month period. A review of medical records and structured questionnaires yielded data about patient demographics and disease characteristics, and included Chinese version of the Arthritis Self-Efficacy Scale and the Taiwanese Depression Questionnaire. A comparison of the long-term effectiveness of the CM program was made using generalized estimating equation.

This evidence-based study may be beneficial to characterize the long-term effectiveness of CM for Taiwanese patients with RA, and may be a reference for healthcare providers in facilitating the provision of appropriate interventions to improve the adaptation processes and clinical outcomes for them.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Nurse-led case management integrates a multi-component intervention comprised of health education and professional advice, as well as referral of clients to other health care team members, discussion of daily life plans, making an appointment for the next clinic, and conducting follow-up sessions by telephone.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

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:

  • being at least 20 years old at the time of recruitment
  • being able to express opinions in either Mandarin or Taiwanese, and
  • having a diagnosis of rheumatoid arthritis (RA).

Exclusion Criteria:

  • Those having no cognitive impairment and severe complications will be excluded.

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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Effect of case management for rheumatoid arthritis cases

Case management (CM) applied is multi-component interventions, that comprised the provision of health education and professional advice, referring the client to another health care team, discussing a daily life plan, making reservations, and follow-up by telephone.

As the control group, they received usual health education lasting for about 15 minutes per medical visit from ward nurses, which consisted of consultation in terms of disease symptoms, related treatments or the doctor's orders. They were also free to ask questions of the research team, their ward nurses and physicians at any time within the study period.

Case Management (CM) is multi-component interventions, that comprised the provision of health education and professional advice, referring the client to another health care team, discussing a daily life plan, making reservations, and follow-up by telephone. All interventions were delivered by a nursing case manager who had over 5 years of nursing experience and received more than 20 hours of CM training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms
Time Frame: Time 1 (T1): prior to the CM intervention; Time 2 (T2): three days after the CM completion, and Time 3 (T3): three months after CM intervention.
Assessed by Taiwanese Depression Questionnaire
Time 1 (T1): prior to the CM intervention; Time 2 (T2): three days after the CM completion, and Time 3 (T3): three months after CM intervention.
Self-efficacy level
Time Frame: Time 1 (T1): prior to the CM intervention; Time 2 (T2): three days after the CM completion, and Time 3 (T3): three months after CM intervention.
Assessed by Arthritis Self-Efficacy Scale
Time 1 (T1): prior to the CM intervention; Time 2 (T2): three days after the CM completion, and Time 3 (T3): three months after CM intervention.
Sexual dysfunctionform-14
Time Frame: Time 1 (T1): prior to the CM intervention; Time 2 (T2): three days after the CM completion, and Time 3 (T3): three months after CM intervention.
Assessed by Changes in Sexual Functioning Questionnaire
Time 1 (T1): prior to the CM intervention; Time 2 (T2): three days after the CM completion, and Time 3 (T3): three months after CM intervention.
DAS28
Time Frame: Time 1 (T1): prior to the CM intervention; Time 2 (T2): three days after the CM completion, and Time 3 (T3): three months after CM intervention.
Measured by Disease Activity Score of 28
Time 1 (T1): prior to the CM intervention; Time 2 (T2): three days after the CM completion, and Time 3 (T3): three months after CM intervention.

Collaborators and Investigators

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

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)

January 1, 2016

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

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

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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