Transitional Care Model for Patients With Stroke

NCT06280599 | Recruiting DMC

• 1 other identifier: SON KMU
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• 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 Arms (2)

Transitional care model

EXPERIMENTAL

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

Behavioral: Transitional care model

Post-stroke usual care

NO INTERVENTION

Treatment as usual after discharged home

Interventions

Transitional care model BEHAVIORAL

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

Transitional care model

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Medical University: lead

Study Sites (1)

RSUD Prof. Dr. W Z Johannes Kupang

Kupang, 308, Indonesia

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bih-O Lee, Professor

  Kaohsiung Medical University

  STUDY CHAIR

Central Study Contacts

Ita Saragih, PhD student

CONTACT

+886 986 226143; itadaryanti05@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The patients were divided into two groups: intervention (n=40) and contrast (n=40). Both groups received post-stroke usual care. The intervention group received an 8-week transitional care model for stroke patients, which included comprehensive discharge planning and home follow-up

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: September 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 29, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)