search
Back to results

Effects of a Mobile Application RA Joint Protection and Activity Self-management Program

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Mobile application RA joint protection and activity 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 self-management, self-efficacy, mobile application

Eligibility Criteria

20 Months - undefined (Child, 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
  • Use a mobile

Exclusion Criteria:

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

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

The intervention group received a mobile application RA joint protection and activity self-management program based on self-efficacy theory for 6 weeks.

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

Outcomes

Primary Outcome Measures

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.

Secondary 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.
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.
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.
Taiwanese Depression Questionnaire (TDQ)
The 18-item Taiwanese Depression Questionnaire (TDQ) was used to measure the level of depression. Patients were guided to rate each item, scored from 0 (not at all) to 3 (always) and possible range of scores is 0 to 54.

Full Information

First Posted
October 4, 2022
Last Updated
October 5, 2022
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan
search

1. Study Identification

Unique Protocol Identification Number
NCT05570175
Brief Title
Effects of a Mobile Application RA Joint Protection and Activity Self-management Program
Official Title
Effectiveness of Mobile Application Self-management Program (App) for Joint Protection and Physical Activity in Patients With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to evaluate the effectiveness of mobile application self-management program (App) for joint protection and physical activity in patients with rheumatoid arthritis. Intervention group received an app self-management program. The researchers compared the effects of the experimental group and the control group in disease activity, physical functioning, self-efficacy, depression, and self-management behavior.
Detailed Description
Rheumatoid arthritis (RA) is a persistent systemic disease. 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, the evidences from literature presented that there are some limitations in traditional self-management interventions, and a comprehensive rheumatoid arthritis online self-management program for RA patients' day-to-day self-managing is limited in Taiwan. The goal of this clinical trial is to evaluate the effectiveness of mobile application self-management program (App) for joint protection and physical activity in patients with rheumatoid arthritis. The project was designed to implement and evaluate the app rheumatoid arthritis self-management program for RA patients using two groups experimental design. A medical center in northern Taiwan was selected and patients who visited the RA departments were eligible for the study if they are diagnosis of RA, age of 20 years or over, disease considered by the treating rheumatologist to have been stable for at least 12 weeks, able to communicate with researcher, and use a mobile. Patients were excluded if they are suffering from other terminal illnesses, severe dementia or another debilitating psychiatric disorder, or living in a long-term care facility. After completion of baseline data, patients were 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 received the 6-week app rheumatoid arthritis self-management program which based on self-efficacy theory. The independent variable of the program was 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 were followed up for 6 months, and the data were collected at the baseline, 8, and 12 weeks. The statistics with the generalized estimating equation analysis was used to evaluate the outcomes such as the disease activity (DAS-28), arthritis self-efficacy (ASE), physical functioning (MHAQ), depression, and self-management behaviors.

6. Conditions and Keywords

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

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 mobile application RA joint protection and activity self-management program 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
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
The intervention group received a mobile application RA joint protection and activity self-management program based on self-efficacy theory for 6 weeks.
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)
Mobile application RA joint protection and activity self-management program
Intervention Description
The intervention group received a mobile application RA joint protection and activity self-management program based on self-efficacy theory for 6 weeks. The program was based on self-efficacy theory 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
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
12 weeks
Secondary 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
12 weeks
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
12 weeks
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
12 weeks
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
12 weeks
Title
Taiwanese Depression Questionnaire (TDQ)
Description
The 18-item Taiwanese Depression Questionnaire (TDQ) was used to measure the level of depression. Patients were guided to rate each item, scored from 0 (not at all) to 3 (always) and possible range of scores is 0 to 54.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Months
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 Use a mobile Exclusion Criteria: Suffering from other terminal illnesses, severe dementia or another debilitating psychiatric disorder Living in a long-term care facility
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

Learn more about this trial

Effects of a Mobile Application RA Joint Protection and Activity Self-management Program

We'll reach out to this number within 24 hrs