MyOsteoarthritisMyWay: Needs Exploring, Program Developing, and Implementing of a Patient-Centered Mobile App Self-Management Program for Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- OsteoArthritis Quality Indicator (OA-QI) questionnaire version 2 (v2)
研究概览
简要总结
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.
详细描述
Background: Osteoarthritis (OA) is a progressively degenerative disease, and is a leading cause of disability with incidence and prevalence rising in most elderly populations which contribute the number of OA continue increasing at a rapid rate. Indeed, the symptoms of OA can cause disability, pain, and joint stiffness, even results poorer quality of life. Self-management (SM) is worldwide reported as an effective approach to utilize for those with chronic disease. However, we had been conducted a program that granted by the Ministry of Science and Technology (NSC 102-2628-B-182-019-MY3), which showed the traditional SM program have some limitation such as patients can't get help immediately, follow up the patients' needs, fraud issue, involving all patients because geographical barriers, and the effectiveness don't remain long term. Therefore, it is need to develop of scalable eHealth SM models and practices seems mandatory in order to cope with the change in population needs and reduce the burden of OA. 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. 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. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Single (Outcomes Assessor) The researcher who applied the intervention program and the researcher who collected the data was never the same.
入排标准
- 年龄范围
- 45 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
OsteoArthritis Quality Indicator (OA-QI) questionnaire version 2 (v2)
时间窗: 6 months
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.
Arthritis Self-efficacy Scale (ASE)
时间窗: 6 months
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.
Self-management behaviors scale
时间窗: 6 months
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.
次要结局
- 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)
- EuroQol 5 Dimensions, European Quality of Life Five Dimension, and EuroQol five-dimensional. (EQ-5D-5L)(6 months)
