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NCT05634304Recruiting

Effect of a Patient-Centered Mobile App Self-Management Program for Osteoarthritis

MyOsteoarthritisMyWay: Needs Exploring, Program Developing, and Implementing of a Patient-Centered Mobile App Self-Management Program for Osteoarthritis
Chang Gung Memorial HospitalClinicalTrials.govbehavioral
Study focus
Disease/Condition
Osteoarthritis
Drug/Device/Intervention
A mobile app self-management (mSM) program
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
Chang Gung Memorial Hospital
Location
Taoyuan, Taiwan
Timeline & enrollment
Phase
N/A
Start date
Aug 01, 2019
End date
Jul 31, 2023
Enrollment
66 participants
Primary outcome

OsteoArthritis Quality Indicator (OA-QI) questionnaire version 2 (v2),Arthritis Self-efficacy Scale (ASE),Self-management behaviors scale

Summary

Aim: The aim of this study is to develop and evaluate the efficacy of a mobile app
 self-management (mSM) program focusing on patients' needs in OA patients over a 6 months'
 follow-up.
 
 Methods: This study will be conducted in three years. In the first year, a qualitative needs
 assessment will be conducted to explore 20 parents' needs for improvements of the SM program
 until the saturation is reached. The specific requirements of the mSM users based on the
 parents' needs will be identified. In the second year, after patients' needs identified, the
 mSM program focusing on patients' needs will be developed through the literature searched and
 experts consulted. The mSM program contents, prototype, mobile application, field usability,
 and user acceptance will be tested by a 4-month pilot study. To ensure the protocol is
 realistic and whether any modifications of the program procedure are required by running
 pilot study with 10 OA patients. In the third year, we will test a patient-needs mobile app
 SM program for OA by randomized controlled trial of 6 months' duration. The total 66 patients
 with OA will be recruited while the participant in orthopedics clinic of a hospital. The
 experimental group (N=33) will receive a mSM program, and the control group (N=33) will
 receive with the usual care only. In order to examine the effects of mSM program, data will
 be collected with 4 time points which will be conducted at baseline (pre-discharge hospital)
 and at 1, 3, and 6 months, and by seven health- related outcomes that include physical
 function, quality of OA care, self-efficacy, quality of life, SM behaviors, and health
 services use. Outcome measures of this study will be analyzed using descriptive and
 inferential statistics with the generalized estimating equations analysis.

ICD-10 classifications
Other hypertrophic osteoarthropathyOther specified osteochondropathiesPolyarthritis, unspecifiedOther osteochondropathiesOsteochondritis dissecans
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05634304
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05634304 through Pure Global AI's free database. This phase not specified trial is sponsored by Chang Gung Memorial Hospital and is currently Recruiting. The study focuses on Osteoarthritis. Target enrollment is 66 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.