Transitional Care Model for Patients With Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06280599
• Other study ID #: SON KMU
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: April 29, 2024

Study information

• Verified date: April 2024
• Source: Kaohsiung Medical University
• Contact: Ita Saragih, PhD student
• Phone: +886 986 226143
• Email: itadaryanti05[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 29, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Transitional care model
In-hospital assessments, video-based stroke education, home visits, and weekly telephone follow-up

Locations

Country	Name	City	State
Indonesia	RSUD Prof. Dr. W Z Johannes Kupang	Kupang

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-efficacy	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).	Baseline, at week 4 intervention, and immediately post-intervention at week 8
Primary	Activities of daily living	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.	Baseline, at week 4 intervention, and immediately post-intervention at week 8
Secondary	Instrumental activities of daily living	The Lawton IADL-Indonesian Version will be used to assess engagement in more complex activities in stroke patients. Each item is graded on a 2-point scale. The total score can range between 0 and 8. A total score is obtained by adding the items and normalizing to 8 for high function or independence for woman and 5 for man. For women, a score of 0 indicates total dependence or low function, 1-7 dependence or mild to moderate function, and a total 8 indicates independence or high function. For men, a score of 0 indicates total dependence or low function, 1-4 dependence or mild to moderate function, and a total 5 indicates independence or high function.	Baseline, at week 4 intervention, and immediately post-intervention at week 8
Secondary	Depression symptoms	Depression symptoms following a stroke covers roughly one-third of stroke survivors at any given time after the stroke. The Indonesian version of Geriatric Depression Scale (GDS), will be used to assess depression in stroke patients. Each item with 15 questions was scored on a 2-point scale (0 = "no," 1 = "yes"). Scores between 0 and 4 are considered normal, scores between 5-8, 9 to 11, and 12 to 15 indicate mild, moderate, and severe depression (range 0-15).	Baseline, at week 4 intervention, and immediately post-intervention at week 8
Secondary	Quality of life in stroke patients	The 26-item Indonesian version of World Health Organization Quality of Life-BREF (WHOQoL-BREF) will be used to assess the quality of life of stroke patients. This questionnaire comprises on four dimensions including physical health, psychological health, social relationships, and environmental health. Each dimension had five Likert response options, which were recoded into scores ranging from 0 to 4, with 0 being "never" and 4 being "always". Higher score indicates more severe of frequent problems or lower level of quality of life (range 0-104).	Baseline, at week 4 intervention, and immediately post-intervention at week 8