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

NCT05634304 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-12-14

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

A mobile app self-management (mSM) program

The mSM program is developed on Bundura's self-efficacy theory, which provides four sources of information for SM. The strategies of the mSM consist of mobile app to management program including peer support, appraisal, goal setting and self-monitoring of exercise for OA and symptom management.

Sponsors & Collaborators

  • National Science and Technology Council

    collaborator FED

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Junghua SHAO · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05634304 on ClinicalTrials.gov