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NCT Number: NCT06242366

Transitional Care Program in Stroke Patients With Hemiplegia.

This study examines the effects of a transitional care program in stroke patients on self-care behavior, quality of life, and hospital readmission.

The research conceptual framework is based on the Transitional Care Model by Naylor. Sixty participants with stroke patients at Charoenkrung Pracharak Hospital will be recruited. These participants are stratified by block randomization using NIHSS score and divided into 2 groups; a control group (n=30) and an intervention group (n=30).

The program consisted of 2 phases: 1) Phase I during hospital admission and 2) Phase II following hospital discharge

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charoenkrung Pracharak Hospital

Bang Kho Laem, Bangkok, 10120, Thailand

Location status: Recruiting

Location contact

Apinya Siripitayakunkit, PhD

SUB_INVESTIGATOR

Nipaporn Butsing, PhD

SUB_INVESTIGATOR

Rungnapa Premkamol, BA

CONTACT

[email protected]

(66)0922705798

Rungnapa Premkamol, BA

PRINCIPAL_INVESTIGATOR

About this study

This study is to examine the effects of a transitional care program in stroke patients on self-care behavior, quality of life, and hospital readmission.

The research conceptual framework base on Transitional Care Model by Naylor. Sixty participants with stroke patients at Charoenkrung Pracharak Hospital will be recruited. These participants are stratified block randomization using NIHSS score and divide into 2 groups; control group (n=30) and intervention groups (n=30).

The program consisted of 2 phases: 1) Phases I during hospital admission and 2) Phases II following hospital discharge for 4 weeks. The instruments used in this study for collecting the data are 1) The Personal Data Form, 2) The Self-care Behavior Questionare and 3) The Stroke Impact Scale (SIS) 3.0. Data will be analyzed using descriptive statistics and two-way repeated measures ANOVA.

The result of this study will be used to develop guideline for nursing care in stroke patients during the transition from hospital to home. This program will help the patients improve their self-care, quality of life, and reduce hospital readmission

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 18 years old.
  • The first diagnosis is acute ischemic stroke.
  • Hemiplegia
  • NIHSS 5-14 point (moderate impairment)
  • Telephone and Line Application used.
  • Can read and communicate in Thai language
  • Accept participants to research and inform consent.

Exclusion criteria

  • Aphasia
  • The Six Item Cognitive Impairment Test: 6CIT from 8 points in age from 60 years old.
  • Participants with illness severity or dead during the study.
  • Reject the study

Treatment and study plan

Intervention Group

Behavioral

Intervention 2 phases Phases 1) In-hospital period (4 times and 30-60 mins/times) intervention includes Stroke education, Rehabilitation, environmental management, and complication prevention. Intervention participants will receive a booklet (choose between hard copy or electronic copy) self-care for stroke patients, Rehabilitation clip, and Self-care record form.

Phases 2) after hospital discharge 5 times (first times within 24 hours after hospital discharge) and (second-fifth time: 1 time/weekly)15-30 mins/times by Line Application for repeat and following education, rehabilitation complication prevention and finding limit to self-care management.

Primary outcomes

  1. Compare Mean differences of Quality Of Life on stroke patient.

    Time frame: Baseline, 4 weeks, 12 weeks

    Each participant was asked using by The Stroke Impact Scale: SIS 3.0 develop by Duncan, Bode, Lai, & Perera, 2003 (Thai version by Garnjanagoonchorn A, and Dajpratham P, 2015) is a 59-item self-report assessment of stroke outcome used to assess HRQoL. There are 8 domains: strength, hand function, mobility, physical and instrumental activities of daily living, memory and thinking, communication, emotion, and social participation. Each item is rated using a 5-point Likert scale. The patient rates his/her difficulty completing each item, where: 1 = an inability to complete the item, 5 = no difficulty experienced at all. An extra question on stroke recovery asks that the client rate on a scale from 0 - 100 how much the client feels that he/she has recovered from his/her stroke. Scores for each domain range from 0 to 100; 0 = no recovery, 100 = full recovery. and higher scores indicate a better HRQoL. will use two-way repeated-measures ANOVA statistics for data analysis.

  2. Compare Mean differences of self-care behavior on stroke patient.

    Time frame: Baseline, 4 weeks, 12 weeks

    Each participant was asked using by self-care behavior questionnaire (Thai version) develop by Kasama Chiangtong (2011) is a 15-item self-report assessment of self-care behavior. Each item is rated using a 4-point Likert scale, where: 0 = never, 1= sometimes (1-2 times/week), 2= often (3-5 times/week), 3= regular. Scores range from 11 to 45 and higher scores indicate a high self-care behavior management. will use two-way repeated-measures ANOVA statistics for data analysis.

Secondary outcomes

  1. Number of Participants with Hospital Readmission.

    Time frame: 4 weeks.

    Each participants were monitored for up to 4 weeks after hospital discharge. This is the number of participants who have had ischemic stroke with readmission within 28 days after hospital discharge with recurrence of the disease or complications from stroke. rate of Hospital Readmission will use descriptive statistics for data analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Rungnapa Premkamol

CONTACT

[email protected]

(66)0922705798

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Effects of Transitional Care Program in Stroke Patients on Self-care Behavior, Quality of Life, and Hospital Readmission: A Randomized Controlled Trial.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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