Case ManagementNCT06341348
Effects of Case Management for Patients With Rheumatoid Arthritis in Taiwan
A study testing Case management in people with Case Management and Rheumatoid Arthritis, run by Dalin Tzu Chi General Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Case Management, Rheumatoid Arthritis, Effectiveness
- What is being tested?
- Case management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Those having no cognitive impairment and severe complications will be excluded.
About this study
Official title: 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.
Read the 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.
- Conditions
- Case Management, Rheumatoid Arthritis, Effectiveness
- Being tested
- Case management
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case managementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Effect of case management for rheumatoid arthritis cases | Other | 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. Receives: Other: Case management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Assessed by Taiwanese Depression Questionnaire
Measured: 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
Assessed by Arthritis Self-Efficacy Scale
Measured: 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
Assessed by Changes in Sexual Functioning Questionnaire
Measured: 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
Measured by Disease Activity Score of 28
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Jan 2016
- Primary completion30 Jun 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Case ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341348
- Sponsor's protocol ID
- Dalin Tzuchi Hospital
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2017
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Case Management for Patients With Rheumatoid Arthritis in Taiwan
- ClinicalTrials.gov ID
- NCT06341348
- Acronym / sponsor ID
- Dalin Tzuchi Hospital
- Conditions
- Case Management, Rheumatoid Arthritis, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effect of case management for rheumatoid arthritis cases | Other | Other: Case managementCase 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Those having no cognitive impairment and severe complications will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case managementCase 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. | Other | Effect of case management for rheumatoid arthritis cases |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Case management in people with Case Management and Rheumatoid Arthritis, run by Dalin Tzu Chi General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.