Transitional Care Model for Patients With Stroke

April 1, 2024 updated by: Ita Daryanti Saragih, Kaohsiung Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transitional care model
In-hospital assessments, video-based stroke education, home visits, and weekly telephone follow-up
Behavioral: Transitional care model
In-hospital assessments, video-based stroke education, home visits, and weekly telephone follow-up
No Intervention: Post-stroke usual care
Treatment as usual after discharged home

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline, at week 4 intervention, and immediately post-intervention at week 8
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.
Baseline, at week 4 intervention, and immediately post-intervention at week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Instrumental activities of daily living
Time Frame: Baseline, at week 4 intervention, and immediately post-intervention at week 8
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
Depression symptoms
Time Frame: Baseline, at week 4 intervention, and immediately post-intervention at week 8
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
Quality of life in stroke patients
Time Frame: Baseline, at week 4 intervention, and immediately post-intervention at week 8
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Bih-O Lee, Professor, Kaohsiung Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SON KMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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