Effect of a Patient-Centered Mobile App Self-Management Program for Osteoarthritis - Trial NCT05634304
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.
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Study Focus
Sponsor & Location
Chang Gung Memorial Hospital
Timeline & Enrollment
N/A
Aug 01, 2019
Jul 31, 2023
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
Data Source
ClinicalTrials.gov
NCT05634304
Non-Device Trial