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Recruiting NCT05634304

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

Conditions: Osteoarthritis

Sex: All
Ages: 45 Years – N/A
Phase: NA
Enrollment: 66
Sponsor: Chang Gung Memorial Hospital

Location: Taiwan

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.

Eligibility Criteria

Inclusion Criteria:Participants aged 45 years more with primary or secondary diagnosis of OAAt a clinically stable with no signs of disease exacerbation in the last 30 daysAbility to use and learn app for mobile phoneExclusion Criteria:With severe comorbidities such as metastatic disease, pathological fractures, infection, or acute traumaUnstable physical and terminal illnessesSevere cognitive impairments or another debilitating psychiatric disorderContraindication to physical activity such as walkingParticipation in another research protocol

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05634304). StuddyBuddy aggregates publicly available trial information.