Feasibility of a Stroke Specific Self-management Program
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Feasibility: Eligible Patients
研究概览
简要总结
Stroke is a leading cause of disability, institutionalization, readmission and death. This research is being completed to accelerate the adoption of evidence-based therapy practices that improve overall stroke care and outcomes. We will implement a feasibility randomized controlled trial (RCT) studying the implementation of a stroke specific chronic disease self-management program. Specifically, if the person is identified to have a chronic vision impairment identified on the vision screen, a specific low vision self-management program will be used. Otherwise the program that will be used is the generic chronic disease self-management program.
详细描述
Approximately 75% of people are living with a prevalent chronic disease like diabetes or hypertension. Despite this high percentage, there is a projected increase of 37% by 2030. There are approximately 795,000 people sustaining a stroke each year, in the United States. Surviving a stroke can cost an estimated $34 billion dollars a year in medical costs and loss of productivity. While there is a sharp decline in mortality rate following stroke, the rate of long-term residual impairments, disabilities and risk for developing high rates of secondary chronic conditions remains high. People living with a new stroke can also have chronic conditions in their past medical histories. Management of prior and new conditions may not become evident until the stroke survivor has returned to the community and are no longer receiving medical services. Additionally, management of chronic conditions, especially for people who now are recovering from a stroke, may require different management plans altogether. The Center for Disease Control and Prevention called for a public health action to address chronic illness. One type of community rehabilitation intervention method is self-management.
Self-management was first developed for well-elderly with chronic diseases. These programs support individuals managing their independently managing symptoms as well as help with the emotional and physical stress associated with chronic disease. Multiple research reports conclude that self-management interventions improve health outcomes, help with management of self-identity and reduce health care costs.
There are existing stroke specific self-management programs, however minimal reported research regarding the best way to implement and measure a stroke specific chronic disease self-management program to optimize health outcomes and improve quality of life. Recently, a qualitative study concluded that any stroke specific self-management program should include 3 conceptual layers to address individual, external and environmental factors essential to enable successful implementation. The first conceptual layer is individual capacity or readiness to respond to the demands to self-management. The second is having external support for self-management. And the third is being in an environment that supports and facilitates success. Another study reported strong feasibility evidence for stroke specific self-management programs versus a standard program for community dwelling stroke survivors. A small study reported a program administered to stroke patients that led to changes in self-efficacy.
Consistent with a feasibility study for implementing evidence based intervention, this project intends to address a need to bridge the translation gap between research evidence and clinical practice. This project intends to provide information to add to existing literature regarding implementation. Thus we plan to use the Determinant Framework, which will help specify determinants which act as barriers and enablers that influence implementation outcomes. Additionally, implementation theories will help us assess the implementation context, as we plan to use a checklist to evaluate factors influencing implementation across different domains (e.g. fidelity). This study also intends to provide preliminary data regarding efficacy in order to determine if a stroke specific program was superior to standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (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
- •Acute hospitalization due to diagnosis of stroke
- •at least one chronic medical condition
- •must be able to consent independently
- •be alert and oriented x 3
- •be ≥ 18 years old
排除标准
- •unable to independently consent
- •they do not speak English
- •discharged from acute care to nursing home
研究组 & 干预措施
Standard Care
The standard care group will receive baseline testing #1, standard care, baseline testing #2 and follow up testing approximately 8 weeks later.
干预措施: Standard care (Other)
Experimental
Experimental group will baseline testing #1, standard care, baseline testing #2 however then participate in a 6-week self-management intervention (either generic or vision specific self-management based) and then get 8 week follow up testing.
干预措施: Self- management program (Other)
结局指标
主要结局
Feasibility: Eligible Patients
时间窗: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)
number of patients eligible
Feasibility: Patients Screened
时间窗: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)
number of patients screened
Feasibility: Patients Approached
时间窗: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)
number of patients approached
Feasibility: Patient Withdrawals
时间窗: Collected at follow-up (2 weeks from last day of intervention)
number of patient withdrawals
Feasibility: Patients Enrolled
时间窗: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)
number of patients enrolled
Feasibility: Patient Refusals
时间窗: Collected at follow-up (2 weeks from last day of intervention)
number of patient refusals
次要结局
- Change in self-reported vision, as measured by the national eye institute vision function questionnaire -25(change in vision quality of life from base line 2 (3 months) to follow-up (2 weeks from last day of intervention))
- Change in self-reported sleep, as measured by the PROMIS sleep disturbance and sleep-related impairments(change in sleep from base line 2 (3 months) to follow-up (2 weeks from last day of intervention))
- Change in self-reported self-efficacy, as measured by the Patient Reported Outcome Measure Information System (PROMIS) self-efficacy scale(change in self-efficacy from base line 2 (3 months) to follow-up (2 weeks from last day of intervention))
- Change in self-reported self-management, as measured by the Southampton Stroke Self-Management Questionnaire(change in self-management from base line 2 (3 months) to follow-up (2 weeks from last day of intervention))
- Change in self-reported self-management, as measured by the Southampton Stroke Self-Management Questionnaire(change in self- management from base line 1 (24 hours prior to discharge from acute care) to base line 2 (3 months))
- Change in self-reported self-efficacy, as measured by the Patient Reported Outcome Measure Information System (PROMIS) self-efficacy scale(change in self-efficacy from base line 1 (24 hours prior to discharge from acute care), base line 2 (3 months))
- Change in self-reported sleep, as measured by the PROMIS sleep disturbance and sleep-related impairments(change in sleep from base line 1 (24 hours prior to discharge from acute care), base line 2 (3 months))
- Change in self-reported vision, as measured by the national eye institute vision function questionnaire -25(change in vision quality of life from base line 1 (24 hours prior to discharge from acute care) to base line 2 (3 months))