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Effects of a Rheumatoid Arthritis Self-management Program

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ClinicalTrials.gov Identifier: NCT03470740
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : March 23, 2018
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:

Rheumatoid arthritis (RA) is a persistent systemic disease. WHO (World Health Organization) commented that a crucial goal of heath care for RA is prevention of loss of daily function by patients' self-management (SM) skills; however, a comprehensive rheumatoid arthritis self-management (RASm) for RA patients' day-to-day self-managing is limited in Taiwan.

Aims: The aims of the study are: (1) to implement the RASm program, (2) to determine the effectiveness of the program with 6 months follow-up, and (3) to understand participants' experiences when receiving the RASm program for the experimental group.


Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Behavioral: rheumatoid arthritis self-management program Not Applicable

Detailed Description:
Rheumatoid arthritis (RA) is a persistent systemic disease. WHO (World Health Organization) commented that a crucial goal of heath care for RA is prevention of loss of daily function by patients' self-management (SM) skills; however, a comprehensive rheumatoid arthritis self-management program for RA patients' day-to-day self-managing is limited in Taiwan. The aims of the study are: (1) to implement the rheumatoid arthritis self-management program, and (2) to determine the effectiveness of the program with 6 months follow-up. The project will design to implement and evaluate the rheumatoid arthritis self-management program for RA patients using two groups experimental design. A medical center in northern Taiwan will be selected and patients who visited the RA departments will be eligible for the study if they are: (1) diagnosed with RA, (2) age of 20 years or over, (3) disease considered have been stable for at least 3 months, and (4) able to understand and comply with the study treatment. After completion of baseline data, patients will be randomly allocated to the intervention or control group using a computerized allocation procedure and follow the CONSORT flow diagram. Control patients received usual care, and the intervention group will receive the 6-week rheumatoid arthritis self-management program which based on self-efficacy theory. The independent variable of the program will be the four information include mastery experience, social modeling, social persuasion and physical and emotional states, and the strategies involve education, goal setting and attainment, self-monitoring, and phone calls. All participants will follow up for 6 months, and the data will be collected at the baseline, and 2, 3, and 6 months. The statistics with the GEE (generalized estimating equation) analysis will be used to evaluate the outcomes such as the disease activity (DAS-28), arthritis self-efficacy (ASE), physical functioning (MHAQ), quality of life (SF-36), self-management behaviors, and health care utilization. Through enhance the capacity of self-management program for the RA cases to reduce the health care utilization and patients' and caregivers' burden.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Effects of a Rheumatoid Arthritis Self-management program-a Randomized Controlled Trial
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
intervention group
An individualized home-based rheumatoid arthritis self-management program for managing RA patients' physical behavioral problems was applied for the intervention group. The program was based on the self-efficacy theory and the four resources were incorporated to emphasize patients' knowledge, skill, and responsibility in managing their RA situations.
Behavioral: rheumatoid arthritis self-management program
The intervention group received the rheumatoid arthritis self-management program which was based on Bandura's theory of self-efficacy and proposes that self-efficacy is influenced by four information sources: mastery of experience, social modeling, social persuasion and one's physical and emotional states. To enhance participants' self-management skill, the following strategies were employed: peer story-telling, assessment, family involvement, goal setting, self-monitoring, self-evaluation, and phone calls consultation.

No Intervention: control group
The control group received general information on rheumatoid arthritis care and follow-up.



Primary Outcome Measures :
  1. Disease activity [ Time Frame: 6 months ]
    Disease activity was measured using the DAS-28 (Disease Activity Score-28) which evaluated 28 tender and swollen joint counts of rheumatoid arthritis patients. This scale was used to calculate the 28 tender and swollen joint counts. Scores can range from 0 to 9.4. The lower score represent a better RA outcome.


Secondary Outcome Measures :
  1. Arthritis Self-efficacy- pain [ Time Frame: 6 months ]
    We used the arthritis self-efficacy-pain (ASE-pain) to measure RA patients' pain self-efficacy. The ASE-pain used visual analogue scales (0-10), in which 0 means 'very uncertain' and 10 means 'very certain'; a higher score refers to higher self-efficacy.

  2. Arthritis Self-efficacy- other [ Time Frame: 6 months ]
    We used the arthritis self-efficacy-other (ASE-OS) to measure RA patients' other symptoms self-efficacy. The ASE-OS used visual analogue scales (0-10), in which 0 means 'very uncertain' and 10 means 'very certain'; a higher score refers to higher self-efficacy.

  3. Quality of life [ Time Frame: 6 months ]
    The Short-form 36 includes one multi-item scale that assesses 8 dimensions of health: physical functioning (PF), social functioning (SF), role limitations because of physical health problems (RP), bodily pain (BP), general mental health (psychological distress and well-being; MH), limitations in usual role activities because of emotional problems (RE), vitality (energy and fatigue; VT), and general health perceptions (GH), was used to assess the quality of life in this study.

  4. Physical functioning [ Time Frame: 6 months ]
    The Modified Health Assessment Questionnaire was used to measure the physical functioning for this study.

  5. Self-management behaviors [ Time Frame: 6 months ]
    To assess self-management behaviors the researchers developed a joint activity and protection self-management behaviors scale. The scale consists of eight items and ranges from zero for 'never' to four for 'always'. Higher scores indicate a higher level of use of each of the self-management behavior.

  6. Health care utilization [ Time Frame: 6 months ]
    Four items of the Stanford Health Care Utilization scale was measured from the self-reported number of contacts with general physicians including clinical and emergency visits as well as hospitalizations. We calculated the number of patients' medical visits, and the score can be from zero to the number of actual medical visits.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with RA
  • Age of 20 years or over
  • Disease considered have been stable for at least 3 months
  • Able to understand and comply with the study treatment

Exclusion Criteria:

  • Suffering from other terminal illnesses, severe dementia or another debilitating psychiatric disorder
  • Living in a long-term care facility
  • Participation in another research protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470740


Contacts
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Contact: Su-Hui Chen, PhD +886-3-2118999 ext 3216 sophee@mail.cgust.edu.tw

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 33303
Contact: Su-Hui Chen, PhD    +886-3-2118999 ext 3216    sophee@mail.cgust.edu.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan
Investigators
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Principal Investigator: Su-Hui Chen, PhD Professor, School of Nursing, Chang Gung University of Science and Technology

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03470740     History of Changes
Other Study ID Numbers: ChangGungMHRA
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases