Development and evaluation of a mobile health application (m-health app) for rehabilitation of patients with multiple sclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Gait: Timed 25-Foot Walk (T25FW)
研究概览
简要总结
The aim of this research is to develop and evaluate e a new service delivery tool for providing rehabilitation in patient with MS. Mobile health may complement or replace center based rehabilitation for patients with MS such as outpatient clinics, especially when access to specialized health services is limited or difficult, and encourage the exercise adherence. This novel approach has the potential to widen access, promote adherence and offer patients an opportunity to exercise in their home environment that too in cost effective manner. This is the first study to apply mobile health technology for rehabilitation in MS patients in India. This study will be carried out in two phases at MS special clinic, Dept. of Neurology, PGIMER, Chandigarh. The first phase will be carried out in two sub phases i.e. preliminary phase to develop mobile app content and pilot phase is to assess the usability and designing of the final mobile app. The second phase of the study would be pragmatic, Prospective Randomized Open labeled with Blinded End point assessment (PROBE) design to assess the effectiveness of mobile app in delivering the rehabilitation.This mobile health application (m-Health app) which is to be developed and evaluated for this research purpose, will deliver education and information about the rehabilitation measures to the patients who are living in the most remote and resource poor settings of the country in a cost effective manner, thus it would effectively tackle the burden of chronic progressive nature of this disease. Findings from this study would make several contributions to the current literature about how mobile health programs can influence access and outcomes for MS patients. In addition, the results of this research work would increases the scope of mobile health in other chronic diseases, and open a new window in health care delivery in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Confirmed diagnosis of multiple sclerosis, according to the Mc Donald 2010 criteria.
- •2 RRMS, with an Expanded Disability Status Scale (EDSS) scores of between 1.0 and 5.
- •3 Clinically stable or relapse free for at least 4 weeks prior to entering the study; 4 Mini Mental Status Examination (MMSE) scores more than
- •5 Free of contraindications for physical activity (e.g. no underlying cardio-vascular disease, severe pulmonary disease, renal failure); 6 Physician permission to participate in the study.
- •7 Patients who will provide written informed consent.
- •8 The patients must have a smartphone with internet facility and should be competent as well as willing to use an app as health care tool.
- •(For Phase Ib (Pilot phase) and Phase II).
排除标准
- •1 Patients who are not receiving any Disease Modifying Therapy (DMT), and immunosuppression drugs.
- •2 Patients with progressive forms of MS (SPMS, PPMS and PRMS) will be excluded.
- •3 Patients with chronic illness, like TB, HIV, and Hepatitis B & C will be excluded.
- •4 Currently pregnant; 5 Patients who are localized in poor network connectivity area.
- •(For Phase Ib (Pilot phase) and Phase II).
结局指标
主要结局
Gait: Timed 25-Foot Walk (T25FW)
时间窗: 6 months
次要结局
- Quality of life: Multiple Sclerosis Quality of(Life - 54 questionnaires (MSQOL-54).)
- Hand function: Nine Hole Peg Test (NHPT).(6 months)
- Fatigue: Modified fatigue impact scale. (MFIS)(6 months)
- Balance, Berg Balance Scale (BBS)(6 months)
- Cognitive function: Paced Auditory Serial Addition Test (PASAT)(6 months)