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NCT05634304
Effect of a Patient-Centered Mobile App Self-Management Program for Osteoarthritis
NA trial testing A mobile app self-management (mSM) program in Osteoarthritis in 66 participants. Status unknown.
31 July 2023
Quick facts
| Lead sponsor | Chang Gung Memorial Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 66 |
| Start date | 1 August 2019 |
| Primary completion | 31 July 2023 |
| Estimated completion | 31 July 2023 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- A mobile app self-management (mSM) program
Conditions studied
- Osteoarthritis — all drugs for Osteoarthritis →
Sponsor
Chang Gung Memorial Hospital
Who can join
45 and older, any sex, with Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05634304
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05634304 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chang Gung Memorial Hospital
- Last refreshed: 14 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05634304.
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