NCT05570175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

January 13, 2025

Completed
Last Updated

January 13, 2025

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

October 4, 2022

Results QC Date

September 5, 2023

Last Update Submit

January 8, 2025

Conditions

Keywords

self-management, self-efficacy, mobile application

Outcome Measures

Primary Outcomes (1)

  • 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'. 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 Outcomes (4)

  • Disease Activity

    12 weeks

  • Arthritis Self-efficacy- Pain

    12 weeks

  • Arthritis Self-efficacy- Other

    12 weeks

  • Physical Functioning

    12 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

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.

intervention group

Eligibility Criteria

Age20 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 33303, Taiwan

Location

Related Publications (1)

  • Shao JH, Yu KH, Kao YC, Liang YC, Chen SH. Effects of a Smartphone App-Based Intervention on Rheumatoid Arthritis Self-Management Efficacy: A Randomized Controlled Trial. J Nurs Res. 2024 Oct 1;32(5):e349. doi: 10.1097/jnr.0000000000000638.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Su-Hui Chen
Organization
Chang Gung University of Science and Technology

Study Officials

  • Su-Hui Chen, PhD

    Professor, School of Nursing, Chang Gung University of Science and Technology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The researcher who collected the data and the researcher who applied the intervention program was never the same.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 6, 2022

Study Start

August 1, 2021

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

January 13, 2025

Results First Posted

January 13, 2025

Record last verified: 2022-10

Locations