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

NCT05634304 | Unknown DMC

• 1 other identifier: ChangGungMHOA
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Osteoarthritis

Keywords

osteoarthritis; self-management; mobile app; self-efficacy

Outcome Measures

Primary Outcomes (3)

• OsteoArthritis Quality Indicator (OA-QI) questionnaire version 2 (v2)

  The OA-QI v2 is a joint specific outcome measure tool designed to assess patient-reported quality of OA care and to provide quality indicator in pass rates. Each item has three response option with 'Yes', 'No' and a third response which item is not applicable (for example, 'Not overweight' for the items on weight management) or the participant do not remember in 16 QI items. Scoring involves summating the total for each item score between 0-100, with a higher score indicating greater disability.

  6 months

• Arthritis Self-efficacy Scale (ASE)

  The 11-items ASE scale is made up of two subscale including "ASE: Pain" and "ASE: Other Symptoms" will be used in current study. The research subjects will be asked to respond using a visual analogue scales (1-10) ranging from 1 "very uncertain", to 10 "very certain". Scores are summed across the items for each subscale to give a total score with a range of 5-50 for ASE- Pain (5 items), and 6-60 for ASE- Other Symptoms (6 items), with higher scores indicating higher confidence in arthritis self-efficacy.

  6 months

• Self-management behaviors scale

  Cognitive symptom managements will assess using scales with each item rated in a six-point scale (0-5) anchored by "never" and "always". Scoring involves summating the total for each item score between 0-30, with a higher score indicating greater behaviors of self-management.

  6 months

Secondary Outcomes (4)

• EuroQol 5 Dimensions, European Quality of Life Five Dimension, and EuroQol five-dimensional. (EQ-5D-5L)

  6 months

• Sit-to-stand. 30 second chair stand test

  6 months

• Walking short distances. 4x10m fast-paced walk test

  6 months

• Health services use

  6 months

Study Arms (2)

The mobile app self-management (mSM) program focusing on patients' needs in OA patients

EXPERIMENTAL

An individualized mobile app self-management (mSM) program for managing OA patients' physical behavioral problems was applied for the intervention group. The program was based on the self-efficacy theory and the four resources were incorporated to emphasize patients' knowledge, skill, and responsibility in managing their OA situations.

Behavioral: A mobile app self-management (mSM) program

Control group for mSM program

NO INTERVENTION

The control group will receive with the usual care only and follow-up 6 months.

Interventions

A mobile app self-management (mSM) program BEHAVIORAL

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.

The mobile app self-management (mSM) program focusing on patients' needs in OA patients

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged 45 years more with primary or secondary diagnosis of OA
• At a clinically stable with no signs of disease exacerbation in the last 30 days
• Ability to use and learn app for mobile phone

You may not qualify if:

• With severe comorbidities such as metastatic disease, pathological fractures, infection, or acute trauma
• Unstable physical and terminal illnesses
• Severe cognitive impairments or another debilitating psychiatric disorder
• Contraindication to physical activity such as walking
• Participation in another research protocol

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 33303, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

dimethyl sulfone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Junghua SHAO

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junghua SHAO, PhD

CONTACT

886-3-2118800; shao@mail.cgu.edu.tw

Junghua SHAO

CONTACT

+88632118800; shao@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor) The researcher who applied the intervention program and the researcher who collected the data was never the same.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: December 2, 2022
• Study Start: August 1, 2019
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)