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Clinical Trials/NCT06280599
NCT06280599
Recruiting
Not Applicable

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

Kaohsiung Medical University1 site in 1 country80 target enrollmentSeptember 1, 2023
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Kaohsiung Medical University
Enrollment
80
Locations
1
Primary Endpoint
Self-efficacy
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
April 29, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ita Daryanti Saragih

Principal Investigator

Kaohsiung Medical University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Self-efficacy

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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