Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions (Component 3)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Psychosocial Outcomes-Change of Function Ratings Over Time as assessed by Function or Physical Independence questionnaire.
研究概览
简要总结
This study will assess the benefits of using mobile health system designed for individuals with chronic and complex health conditions (such as those with Spinal Cord Injury,Cerebral Palsy, Spina Bifida, and Traumatic Brain Injury) to improve their wellness and self-management skills compared to those who receive standard of care only.
详细描述
Individuals with chronic and complex conditions such as those with spinal cord injury (SCI),Cerebral Palsy (CP), Spina Bifida (SB), and Traumatic Brain Injury (TBI), often require complex self-management routines to manage various needs such as bowel and bladder, skin integrity, and general health and wellness. Tasks such as self-catheterization, bowel regimens, skin checks, and routine administration of medications require consistent follow-through to prevent complications. Early detection and treatment of problems such as urinary tract infections (UTIs) or wounds, can prevent serious complications like osteomyelitis and sepsis which can result in hospitalization, death, and expensive medical care. The investigators have developed an innovative mobile health (mHealth) system aimed at improving self-management skills and preventing and detecting early signs of secondary medical complications. The system consist of a mobile health applications (apps), a clinician portal and a two-way secure communication system between the two. People with complex care regimens can use the apps to get reminders or cues to carry out their self care routines such as bowel/bladder routines, take medications, report success with their activities or new problems (e.g. new wound, UTI symptoms etc.), and track symptoms of depression. A clinician can use the portal to view the report and communicate with the users through a secure communication system that is embedded in the apps.
This study will assess the benefits of using the system in improving users' wellness and self-management skills compared to those who receive standard of care only.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •12 years or older.
- •have a diagnosis of a chronic and complex condition such as Spina Bifida, Spinal Cord Injury, Cerebral Palsy and Traumatic Brain Injury, etc.
- •live in a community setting (not within a residential facility that provides care to them).
- •pass all the functional screening tests which include basic usage of a smart phone, and impairment severity assessments
排除标准
- •Diagnosis of severe intellectual disability or severe and persistent psychiatric illness.
- •Failing all the screening tests due to severe impairments that cannot be accommodated by the mHealth system (for patient participants)
研究组 & 干预措施
MHealth Group
Participants randomized into this group will use the mHealth system throughout the study in conjunction with their standard of care
干预措施: MHealth (Device)
Control
Participants randomized into this group will not use the mHealth system throughout the study, but will continue with their standard of care.
结局指标
主要结局
Psychosocial Outcomes-Change of Function Ratings Over Time as assessed by Function or Physical Independence questionnaire.
时间窗: At baseline and repeated on a schedule (approximately every three months) for up to 12 months
Scale of Function measured at baseline, and approximately every three months for up to 12 months.
Psychosocial Outcomes-Change of Perceived Function and Satisfaction Over Time as assessed by Perceived Function and Satisfaction questionnaire.
时间窗: At baseline and repeated on a schedule (approximately every three months) for up to 12 months
Self ratings on perceived function and satisfaction questionnaire, assessed at baseline, and approximately every three months for up to 12 months.
Psychosocial Outcomes-Change of Quality of Life Over Time as assessed by Quality of Life questionnaire.
时间窗: At baseline and repeated on a schedule (approximately every three months) for up to 12 months
Quality of life ratings measured at baseline, and approximately every three months for up to 12 months.
Psychosocial Outcomes-Change of Self Management Skills Over Time as assessed by Self Management Questionnaire
时间窗: At baseline and repeated on a schedule (approximately every three months) for up to 12 months
Self management skill ratings measured at baseline, and approximately every three months for up to 12 months.
Psychosocial Outcomes- Change of Depressive Symptoms Over time as assessed by Depressive Symptoms questionnaire.
时间窗: At baseline and repeated on a schedule (approximately every three months) for up to 12 months
Questionnaire of Depressive symptoms administered at baseline, and approximately every three months for up to 12 months.
Medical Outcomes-Improvements in Length of Health Care Utilization based on Medical Record Review
时间窗: Through study completion, an average of 1 year.
Medical Record Review on Length of stay of hospitalizations.
Medical Outcomes-Improvements in Preventable Conditions based on Medical Record Review
时间窗: Through study completion, an average of 1 year.
Medical record review of number of wounds, number of urinary tract infections and occurrences of sepsis.
Medical Outcomes-Improvements in Frequency of Health Care Utilization based on Medical Record Review and Questionnaire.
时间窗: Through study completion, an average of 1 year.
Medical Record Review and questionnaire on Number of hospitalizations, number of visits to emergency room and urgent care centers.
次要结局
- Change of Participants' experience using the mHealth system over time as assessed by questionnaire(At baseline and repeated on a schedule (approximately every three months) for up to 12 months))
- Usage of the system as assessed by questionnaire and record review of the system usage (a built-in function in the system)(Through study completion, an average of 1 year.)
- Cost of care(Through study completion, an average of 1 year.)
研究者
Andi Saptono
Assistant Professor
University of Pittsburgh