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

January 8, 2025 updated by: Chang Gung Memorial Hospital

Effectiveness of Mobile Application Self-management Program (App) for Joint Protection and Physical Activity in Patients With Rheumatoid Arthritis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 33303
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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
  • Use a mobile

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control group
The control group received general information on rheumatoid arthritis care and follow-up.
Experimental: intervention group
The intervention group received a mobile application RA joint protection and activity self-management program based on self-efficacy theory for 6 weeks.
Behavioral: Mobile application RA joint protection and activity self-management program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-management Behaviors
Time Frame: 12 weeks
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'. The range of the score will be 0-32, higher scores indicate a better level of use of each of the self-management behavior.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease Activity
Time Frame: 12 weeks
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.
12 weeks
Arthritis Self-efficacy- Pain
Time Frame: 12 weeks
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 better self-efficacy. This scale have 5 items, therefore, the score range will be 0-50.
12 weeks
Arthritis Self-efficacy- Other
Time Frame: 12 weeks
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 better self-efficacy. This scale have 6 items, therefore, the score range will be 0-60.
12 weeks
Physical Functioning
Time Frame: 12 weeks
The 8-item Modified Health Assessment Questionnaire (MHAQ) 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 better ability to conduct daily activities. The range of the score will be 8-32.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Science Council, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Su-Hui Chen, PhD, Professor, School of Nursing, Chang Gung University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ChangGungMHappRA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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