NCT03446989

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

February 10, 2022

Status Verified

February 1, 2018

Enrollment Period

1.7 years

First QC Date

February 12, 2018

Last Update Submit

January 27, 2022

Conditions

Keywords

case managementrheumatoid arthritisEffectivenessGeneralized Estimating Equations

Outcome Measures

Primary Outcomes (1)

  • Depression level

    Assessed with Taiwanese Depression Questionnaire (TDQ)

    Up to 12 months

Secondary Outcomes (2)

  • Self-care efficacy

    Up to 12 months

  • Sexual dysfunction

    Up to 12 months

Study Arms (1)

Case management

EXPERIMENTAL

Those who did not agree to participate in the NLCM were enrolled into the control group and received the standard care: visits to their RA physicians on a regular basis with health education administered by a ward nurse during each visit. The education sessions lasted for approximately 15 minutes and consisted of consultation about disease symptoms, related treatments, and disease management.

Behavioral: Case management

Interventions

Case managementBEHAVIORAL

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.

Case management

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tzung-Yi Tsai

Chiayi City, Chiayi, 62247, Taiwan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Case Management

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Miao-Chiu Lin

    Dalin Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2018

First Posted

February 27, 2018

Study Start

August 1, 2016

Primary Completion

April 30, 2018

Study Completion

June 30, 2018

Last Updated

February 10, 2022

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Due to the legal restrictions imposed by government of Taiwan in relation to the "Personal Information Protection Act", all data cannot made publicly available.

Locations