Transitional Care Program in Stroke Patients With Hemiplegia.

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06242366
• Other study ID #: COA. MURA2023/337
• Secondary ID: U034hh/66
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2024
• Source: Mahidol University
• Contact: Rungnapa Premkamol
• Phone: (66)0922705798
• Email: rungnapa.pre[@]student.mahidol.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Ischemic Stroke
• Stroke
• Transitional Care

Intervention

Behavioral:
• Intervention group
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.

Locations

Country	Name	City	State
Thailand	Charoenkrung Pracharak Hospital	Bang Kho Laem	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

Naylor MD, Brooten DA, Campbell RL, Maislin G, McCauley KM, Schwartz JS. Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial. J Am Geriatr Soc. 2004 May;52(5):675-84. doi: 10.1111/j.1532-5415.2004.52202.x. Erratum In: J Am Geriatr Soc. 2004 Jul;52(7):1228. — View Citation

Suphimol P. The Effect of Healtth Education Program for Hypertension Prevention Among Risk Group Aged 35-59 Years in Songdao District Of Sakonnakhon Province.: Konkaen University; 2009. (In Thai)

Wong FK, Yeung SM. Effects of a 4-week transitional care programme for discharged stroke survivors in Hong Kong: a randomised controlled trial. Health Soc Care Community. 2015 Nov;23(6):619-31. doi: 10.1111/hsc.12177. Epub 2014 Dec 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare Mean differences of Quality Of Life on stroke patient.	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.	Baseline, 4 weeks, 12 weeks
Primary	Compare Mean differences of self-care behavior on stroke patient.	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.	Baseline, 4 weeks, 12 weeks
Secondary	Number of Participants with Hospital Readmission.	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.	4 weeks.