The Effect of Transitional Care Model-Based Interventions for Stroke Patients and Their Caregivers on Increasing Caregivers' Competence and on Patient Outcomes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Patients' assessed bedsore develop in your patient after being discharged
研究概览
简要总结
Stroke affects both the patient's and the caregiver's whole life by creating permanent damages. Patients and their families need further information and support in the transition from hospital to home. For stroke patients and their families after discharge, transition models can be used to provide continuously and rapidly the service by establishing a communication network between the institutions. In this study, the feasibility and impact of a transitional care model from hospital to home for stroke patients and caregivers will be tested.
The purpose of the project is to assess the effect of Transitional Care Model (TCM)-based interventions for stroke patients and their caregivers on caregivers' competence, in increasing their readiness to care and electronic health literacy, in reducing their burnout, and on patient results. Types of interventions that are applied to stroke patients and caregivers based on Transitional Care Model are hospital interview, home visit, telephone interview and web-based training. As stated in TCM, the intervention was planned to be performed three months after discharge.
Multiple interventions including at least three face-to-face interviews at the hospital, distance education via Web and telephone communication for three months, and one home visit within seven days after discharge will be performed in order to increase health literacy levels and caregiving competence of the caregivers and to reduce burnout. In pre-tests and post-tests to be applied to the caregivers, the effectiveness of the support programs provided will be assessed quantitatively by the electronic health literacy, caregiving competence, and burnout scales. The satisfaction with the intervention will be evaluated qualitatively. Rate of return to the hospital, risk of pressure sore, and time of access to home health services will be assessed in stroke patients.
As a result of web-based distance education, home visit, telephone communication service and informing at the hospital, caregivers of stroke patients will begin to receive information about what patients experience during their treatment and about all what patients need after treatment. The website to be prepared for caregivers of stroke patients will be put into service also for the control group upon completion of the data collection of the intervention group and the website will also continue to be used after the project is completed.
详细描述
Study Protocol
Minimum three interviews would be carried out in the hospital with the caregivers meeting the inclusion criteria after stroke patients are hospitalized.
The first interview would be carried out within 24-48 hours after the hospitalization.
The second interview would be carried out on the following day after the first interview.
The third interview would be carried out two days after the second interview. If required, interview would be carried out in the hospital every day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The result will be evaluated by the statistician
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For patients;
- •Being voluntary to participate in the study,
- •Being hospitalized in Health Sciences University Antalya Training and Research Hospital Neurology Clinic due to the diagnoses of (stroke, hemorrhage, infarct, cerebrovascular event and cerebral infarction),
- •Residing in central districts of Antalya city
- •Having a stroke for the first time,
- •Being at level 3 and 4 according to theModified Rankin Scale (Yalın, 2011).
- •Being at least semi-dependent according to the functional independence measure
- •Having a score of ≥10 according to LACE index (Van Walraven et al.,) (length of stay [L], acuity of the admission [A], comorbidity of the patient [C] and emergency department use in the duration of 6 months before admission [E]),
- •For caregivers;
- •Being primarily responsible for the care of the patient (fulfilling the activities of daily living of the patient during the intervention),
- •Providing care to a stroke patient for the first time,
- •Having an internet access,
- •Minimum one member of the family uses the internet,
排除标准
- •The patient have a dependence history other than stroke,
- •The caregiver has no internet access and/or does not use the internet,
- •The care is provided for a fee,
- •The patient and the caregiver do not reside in the same house or apartment building or in a near building
结局指标
主要结局
Patients' assessed bedsore develop in your patient after being discharged
时间窗: Three months after discharge
Did bedsore develop in your patient after being discharged? 1. Yes 2. No
Caregivers' Preparedness assessed by Preparedness for Caregiving Scale
时间窗: Three months after discharge
Preparedness for Caregiving Scale: The scale, developed by Archold et al., (1990) and adapted to Turkish by Karaman and Karadakovan (2014), is a Likert type scale consisting of 9 questions. It is rated as "0"=Not ready, "1"=Not ready enough, "2"=Partly ready "3"=Quite ready, and "4"=Completely ready. While the lowest score to be obtained from the scale is 0, the highest score is 32. Higher scores signify higher competence of caregiving.
Caregivers' Competence assessed by Caregiving Competence Scale
时间窗: Three months after discharge
Caregiver Competence Scale: The scale, developed by Pearling et al., (1990), is a Likert type scale consisting of four questions. It is rated as "1" = Not at all competent "2" = Just a Little Competent "3" = Fairly Competent, and "4" = Very competent ". While the lowest score to be obtained from the scale is 4, the highest score is 16. Higher scores signify higher competence of caregiving.
Caregivers' e-Health Literacy assessed by e-Health Literacy Scale
时间窗: Three months after discharge
e-Health Literacy Scale: The scale developed by Norman and Skinner (2006) was adapted to Turkish by Coşkun and Bebiş (2015). The scale consists of eight items and measures the internet usage with two items and the internet attitude with six items. Scale items are rated with 5-point Likert type scaling method as "1"=Strongly disagree ''2"=Disagree, "3" = Neutral, "4"= Agree, "5"= Strongly agree. The lowest score of the scale is 8 and the highest score is 40.
Patients' assessed emergency service visiting after being discharged.
时间窗: Three months after discharge
1. Did you take your patient to the emergency service after being discharged apart from the outpatient clinic appointments (neurology and physiotherapy clinics) required to be performed routinely 1. No 2. Yes If yes, how many times did you apply to the emergency department within the three months after discharge of your patient?............................................... What is the reason for your patient's application to the emergency department? 2. Was your patient hospitalized again? 1. No 2. Yes If yes, how many times was he/she hospitalized and why? (Routine control, emergency service, hospitalization in the clinic, etc.)
Caregivers' Burnout assessed by Maslach Burnout Inventory-General Form
时间窗: Three months after discharge
Maslach Burnout Inventory-General Form (MBI-GF): The inventory, developed by Schaufeli et al., (1996) and adapted to Turkish by Gündüz et al., (2013), is a Likert-type scale consisting of 15 items and three subscales. The emotional exhaustion subscale is composed of 5 items (1, 4, 7, 10, and 13), the depersonalization subscale is composed of 5 items (2, 5, 8, and 11) and the personal accomplishment subscale is composed of 5 items (3, 6, 9, 12, 14, and 15). The views on each item are scored as "1"=Never, "2"=Sometimes, "3"=Usually, "4"=Mostly, "5"=Always. The high score in the emotional exhaustion and depersonalization subscales and the low score in the personal accomplishment (reverse scored) subscale indicate burnout. In the scoring, three separate burnout scores are calculated for each person.
次要结局
- Caregivers' System Usability Scale (SUS)(Three months after discharge)
研究者
Yasemin Demir
The Scientific and Technological Research Council of Turkey
The Scientific and Technological Research Council of Turkey