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Effects of a Rheumatoid Arthritis Self-management Program

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
rheumatoid arthritis self-management program
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthritis, Rheumatoid focused on measuring rheumatoid arthritis, self-management, self-efficacy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

intervention group

control group

Arm Description

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.

The control group received general information on rheumatoid arthritis care and follow-up.

Outcomes

Primary Outcome Measures

Disease Activity
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

Arthritis Self-efficacy- Pain
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.
Arthritis Self-efficacy- Other
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.
SF-36 Quality of life_Physical Component Scores
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.
Physical Functioning
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.
Self-management Behaviors
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.
SF-36 Quality of Life_Mental Component Scores (MCS)
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.

Full Information

First Posted
March 8, 2018
Last Updated
September 11, 2019
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03470740
Brief Title
Effects of a Rheumatoid Arthritis Self-management Program
Official Title
Effects of a Rheumatoid Arthritis Self-management program-a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

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

5. Study Description

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.
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), and self-management behaviors. Through enhance the capacity of self-management program for the RA cases to reduce the health care utilization and patients' and caregivers' burden.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
rheumatoid arthritis, self-management, self-efficacy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomly assigned to experimental group who received a rheumatoid arthritis self-management intervention based on self-efficacy theory for 6 weeks, and a control group receiving standard rheumatology care only.
Masking
Outcomes Assessor
Masking Description
The researcher who collected the data and the researcher who applied the intervention program was never the same.
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Other
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group received general information on rheumatoid arthritis care and follow-up.
Intervention Type
Behavioral
Intervention Name(s)
rheumatoid arthritis self-management program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease Activity
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Arthritis Self-efficacy- Pain
Description
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.
Time Frame
6 months
Title
Arthritis Self-efficacy- Other
Description
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.
Time Frame
6 months
Title
SF-36 Quality of life_Physical Component Scores
Description
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.
Time Frame
6 months
Title
Physical Functioning
Description
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.
Time Frame
6 months
Title
Self-management Behaviors
Description
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.
Time Frame
6 months
Title
SF-36 Quality of Life_Mental Component Scores (MCS)
Description
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.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su-Hui Chen, PhD
Organizational Affiliation
Professor, School of Nursing, Chang Gung University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33303
Country
Taiwan

12. IPD Sharing Statement

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Effects of a Rheumatoid Arthritis Self-management Program

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