An Online Self-management Program for Spinal Cord Injury: Feasibility Study of SCI&U
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Skill and Technique Acquisition Scale from the Health Education Impact Questionnaire
研究概览
简要总结
Managing a spinal cord injury (SCI) is a life-long process. Within the first year of injury, more than 50% of people discharged with a SCI may require re-hospitalization due to a secondary complication, such as a urinary tract infection, pressure ulcer or pneumonia. Even 20 years post-injury, re-hospitalization rates remain over 30%. While re-hospitalization rates in Canada have remained high for more than 10 years, the length of stay in inpatient rehabilitation has decreased dramatically, thereby limiting the time for provision of health information and skill acquisition in the inpatient rehabilitation setting. There is growing evidence from two recent pilot trials to suggest that self-management programs that provide appropriate health information, skills and telephone-based support for community-dwelling patients with SCI improves health behaviors and leads to reductions in re-hospitalization.
Goals/Research Aim: To conduct a pilot RCT (feasibility study) that will inform the design of a definitive RCT to determine whether an online self-management program incorporating trained peer health coaches (called "SCI&U") compared to usual care will result in improved self-management skills (short-term outcome) and lead to reduced days of hospitalization (long-term outcome) due to secondary complications.This pilot study is a two-group RCT with an embedded qualitative component. The target population is adults with SCI who have been discharged from inpatient rehabilitation and living in the community. Sixty subjects will be recruited from across Canada with a focus on British Columbia and Ontario and randomly assigned to the SCI&U intervention or usual care.
Evaluations will occur at baseline, 2, 6, and 12 months.
详细描述
Background and Importance: Managing a spinal cord injury (SCI) is a life-long process. Within the first year of injury, more than 50% of people discharged with a SCI may require re-hospitalization due to a secondary complication, such as a urinary tract infection, pressure ulcer or pneumonia. Even 20 years post-injury, re-hospitalization rates remain over 30%. While re-hospitalization rates in Canada have remained high for more than 10 years, the length of stay in inpatient rehabilitation has decreased dramatically, thereby limiting the time for provision of health information and skill acquisition in the inpatient rehabilitation setting. There is growing evidence from two recent pilot trials to suggest that self-management programs that provide appropriate health information, skills and telephone-based support for community-dwelling patients with SCI improves health behaviors and leads to reductions in re-hospitalization.
Goals/Research Aim: To conduct a pilot RCT (feasibility study) that will inform the design of a definitive RCT to determine whether an online self-management program incorporating trained peer health coaches (called "SCI&U") compared to usual care will result in improved self-management skills (short-term outcome) and lead to reduced days of hospitalization (long-term outcome) due to secondary complications.
Secondary outcomes include self-efficacy for self-management, depression, resilience, number and severity of secondary conditions, health-related quality of life, and patient-reported unplanned ED visits.
Methods/Approaches/Expertise: This pilot study is a two-group RCT with an embedded qualitative component. The target population is adults with SCI who have been discharged from inpatient rehabilitation and living in the community. Sixty subjects will be recruited from across Canada with a focus on British Columbia and Ontario and randomly assigned to the SCI&U intervention or usual care.
Evaluations will occur at 0, 2, 6, and 12 months. At 6 and 12 months, interviews will be conducted with SCI&U participants and at 12 months focus groups with health coaches, consumer organizations, and rehabilitation hospital staff to explore the feasibility of the study protocol, understand perceived costs and benefits of SCI&U, and sustainability considerations. The creation of the SCI&U online self-management program is based on a number of studies conducted by the research team. The investigators initially determined implementation considerations in terms of need, content and mode of delivery in a mixed methods study of individuals with SCI, their family members, and hospital managers. The SCI&U team includes rehabilitation researchers, persons with SCI, community-based organizations (SCI BC, SCI Ontario and Praxis Spinal Cord Institute) and clinicians from across Canada. The investigators used an integrated knowledge translation approach where users with SCI co-designed and developed the prototype. The investigators have completed usability testing on 20 participants and trained 5 health coaches and had an additional 11 individuals living with SCI complete 6 sessions of health coaching using the SCI&U prototype.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 6 months post-injury to allow time to adjust to injury;
- •living in the community;
- •age ≥18 years;
- •ability to speak and read English and
- •have a primary care physician
排除标准
- •currently participating in another formal self-management program and
- •self-report of physician diagnosed concurrent traumatic brain injury
结局指标
主要结局
Skill and Technique Acquisition Scale from the Health Education Impact Questionnaire
时间窗: 6 and 12 months after baseline
4-item scale that captures knowledge based skills and techniques that persons acquire to help them cope with health problems. It is a 4-point Likert scale (1-4) ranging from strongly disagree to strongly agree. Score is the sum of the 4 items. A higher score means a better outcome.
Health Care Utilization: Cumulative days re-hospitalized 12 months after baseline
时间窗: 12 months after baseline
Self-report of total days hospitalized for each participant will be obtained as the primary health care utilization outcome. This will be measured at 6 and 12 months after baseline with the qeustion "how many total NIGHTS did you spend in the hospital in the past 6 months? A higher total number of days means a worse outcome.
次要结局
- Secondary Conditions Scale(6 and 12 months after baseline)
- University of Washington Self-Efficacy Scale for People with Disabilities and Chronic Conditions: Short Form(6 and 12 months after baseline)
- International Spinal Cord Injury Datasets Quality of Life Basic Dataset-Data Form (Version 1.0)(6 and 12 months after baseline)
- SCI-QOL Resilience Short Form(6 and 12 months after baseline)
- Personal Health Questionnaire Depression Scale (PHQ-8)(6 and 12 months after baseline)
- Self-reported Emergency department visits(6 and 12 months)
- Social/Role Activities Limitations(6 and 12 months after baseline)
- Positive and Active Engagement in Life from the Health Education Impact Questionnaire(6 and 12 months after baseline)
- Self Monitoring and Insight from the Health Education Impact Questionnaire(6 and 12 months after baseline)
- Health Services Navigation from the Health Education Impact Questionnaire(6 and 12 months after baseline)
- Emotional Distress from the Health Education Impact Questionnaire(6 and 12 months after baseline)
研究者
Susan Jaglal
Professor
University of Toronto