- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06341348
Effects of Case Management for Patients With Rheumatoid Arthritis in Taiwan
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dalin Tzuchi Hospital
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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