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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06341348
Other study ID # Dalin Tzuchi Hospital
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2018

Study information

Verified date March 2024
Source Dalin Tzu Chi General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date December 31, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design


Intervention

Other:
Case management
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Dalin Tzu Chi General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Depressive symptoms 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.
Primary Self-efficacy level 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.
Primary Sexual dysfunctionform-14 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.
Primary DAS28 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.
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