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临床试验/NCT06280599
NCT06280599Unknown不适用

An Experimental Study of the Application of Transitional Care Model on Patients With Stroke

Kaohsiung Medical University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Self-efficacy

研究概览

简要总结

Patients with stroke benefitted from superior improvements in physical function, particularly when performing activities of daily living, fewer visits to the emergency room, less depression symptoms, and improved health-related quality of life thanks to transitional model care. Despite widespread implementation of transitional care for stroke patients, intervention effectiveness remains inconclusive, and another concern with transitional care for patients is the scarcity of effects on specific findings.

详细描述

A stroke may be a profound and life-changing occurrence for both the survivors and those who care for them, mandating participation in the adaptation and reinvention of a new post-stroke lifestyle that is sometimes unpredictable and temperamental. The sudden onset of a stroke and its accompanying treatment in an acute hospital setting can be distressing for both patients and caregivers. Admission after stroke may have a profound impact as patients and their caregiver start to understand the effects of the occurrence, which is scary, puzzling, and stressful. Nonetheless, adjusting to situations or life after a stroke might be made easier by implementing relevant and timely strategies throughout hospitalization, discharge, and the post-discharge period. Both populations, stroke patients and caregivers, may have unmet needs once the patients are discharged at home, such as communication, recovery plan and process, medicine, emotional needs, and stroke information, as well as social involvement. To address unmet needs after discharge from the hospital to a variety of settings, such transitional care is recommended to tackle the adverse outcomes.One of the widely used transitional care models is TCM, which was developed at the University of Pennsylvania under the direction of a nurse and was then made available to patients who were elderly at risk of poor outcomes and suffering from chronic illnesses including stroke patients. Incorporated into the model, TCM were developed to meet the needs that arose during hospitalization and to provide continuity of care for patients, including those with stroke, who were unable to receive it after their acute illness treatment

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Being at least 18 years old, being admitted in neurology department for at least 24 to 48 hours,
  • •Not having cognitive impairment as measured by the Montreal cognitive assessment (score ≥ 23),
  • •Being able to communicate in Indonesia, having the ability to provide informed consent,
  • •Being willing to participate in this study during hospitalization and 8 weeks after hospital discharge

排除标准

  • •Have potentially biased information, such as being unable to provide informed consent due to cognitive impairment,
  • •Having major speech and language problems or aphasia that prevent them from participating in the study,
  • •Having serious psychiatric disorders or other with terminal disease requiring active treatment, and
  • •Being discharged to a nursing home or welfare institution.

研究组 & 干预措施

Transitional care model

Experimental

In-hospital assessments, video-based stroke education, home visits, and weekly telephone follow-up

干预措施: Transitional care model (Behavioral)

Post-stroke usual care

No Intervention

Treatment as usual after discharged home

结局指标

主要结局

Self-efficacy

时间窗: Baseline, at week 4 intervention, and immediately post-intervention at week 8

Self-efficacy has been proposed as an important determinant of the adaptation process in people who have had a stroke. The Indonesian version of Stroke Self-Efficacy Questionnaire (SSEQ-I) will be used in this study to assess participants' beliefs in their ability to perform and manage daily activities following a stroke. Participants rate their confidence in their ability to complete each of the 13 items on a 10-point scale, with 0 representing not at all confident and 10 representing very confident. Higher score indicates a higher level of self-efficacy (range 0-130).

Activities of daily living

时间窗: Baseline, at week 4 intervention, and immediately post-intervention at week 8

The ability to perform ADLs independently is a short-term rehabilitation goal during stroke recovery. The Indonesian version of the Modified Barthel Index (MBI-I) will be used to assess behavior related to activities of daily living in stroke patients or patients with other disabling conditions. The ten functional domains (activities) covered by this questionnaire include bowel and bladder control, grooming assistance, toilet use, feeding, transfers, walking, dressing, climbing stairs, and bathing. Each item is graded on a scale of 0 to a maximum of 15. A total item score of less than or equal to 20 indicates total dependence, 21-60 severe dependence, 61-90 moderate dependence, 91-99 slight dependence and a total 100 indicates independence.

次要结局

  • Instrumental activities of daily living(Baseline, at week 4 intervention, and immediately post-intervention at week 8)
  • Depression symptoms(Baseline, at week 4 intervention, and immediately post-intervention at week 8)
  • Quality of life in stroke patients(Baseline, at week 4 intervention, and immediately post-intervention at week 8)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ita Daryanti Saragih

Principal Investigator

Kaohsiung Medical University

研究点 (1)

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