- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03470740
Effects of a Rheumatoid Arthritis Self-management Program
Effects of a Rheumatoid Arthritis Self-management program-a Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Taoyuan, Taiwan, 33303
- Chang Gung Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: intervention group
An individualized 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.
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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.
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No Intervention: control group
The control group received general information on rheumatoid arthritis care and follow-up.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Activity
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arthritis Self-efficacy- Pain
Time Frame: 6 months
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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.
This scale have 5 items, therefore, the score range will be 0-50.
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6 months
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Arthritis Self-efficacy- Other
Time Frame: 6 months
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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.
This scale have 6 items, therefore, the score range will be 0-60.
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6 months
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SF-36 Quality of life_Physical Component Scores
Time Frame: 6 months
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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.
The original scale using the Likert scoring method, the score is from 1-3 or 1-5.
Before the scores are added, we follow the SF-36 manual, adjust each item scored from 0 to 100, with 0 indicating extreme problems and 100 indicating no problems.
The physical component scores (PCS) included GH, PF, RP, and BP, then the scores of each sub-question under the Physical Component Scores are summed together, and the range after adjustment from 0 (extreme problems) to 400 (no problems) for the Physical Component Scores.
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6 months
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Physical Functioning
Time Frame: 6 months
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The 8-item Modified Health Assessment Questionnaire was used to measure the physical functioning for this study.
The MHAQ measures eight activities such as dressing and grooming, arising, eating, walking, hygiene, reach grip, and common daily activities.
Items are rated from 1 = without difficulty, to 4 = unable to do; a lower score indicates a greater ability to conduct daily activities.
The range of the score will be 8-32.
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6 months
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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.
The range of the score will be 0-32.
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6 months
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SF-36 Quality of Life_Mental Component Scores (MCS)
Time Frame: 6 Months
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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.
The original scale using the Likert scoring method, the score is from 1-3 or 1-5.
Before the scores are added, we follow the SF-36 manual, adjust each item scored from 0 to 100, with 0 indicating extreme problems and 100 indicating no problems.
The mental component scores (MCS) included RE, SF, VT, and MH, then the scores of each sub-question under the Mental Component Scores are summed together, and the range after adjustment from 0 (extreme problems) to 400 (no problems) for the Mental Component Scores.
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6 Months
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Collaborators and Investigators
Sponsor
Collaborators
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
- ChangGungMHRA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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