Transitional Care Program in Stroke Patients With Hemiplegia.

NCT06242366 | Recruiting DMC

• 2 other identifiers: COA. MURA2023/337U034hh/66
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Ischemic Stroke; Transitional Care; Hemiplegia

Keywords

Quality Of Life; Self-care behavior; Hospital Readmission; Transitional care; Stroke patients

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Number of Participants with Hospital Readmission.

  4 weeks.

Study Arms (2)

Intervention group

EXPERIMENTAL

In this arm, the participant will receive standard nursing care and the program from an investigator. The program consisted of 2 phases: 1) Phases I during hospital admission when they are stable will receive a program total 4 times for education about stroke, self-care, rehabilitation, and complication prevention and 2\) Phases II following hospital discharge within 24 hours then every 1 week until 4 weeks by Line Application visit. following self-care management, find limit to their self-care. and Outcomes Assessor will visit to collect data 3 times 1. In-hospital period 2. after hospital discharge 4 weeks 3. after hospital discharge 12 weeks

Behavioral: Intervention group

Control group

NO INTERVENTION

In this arm, the participant will receive only standard nursing care. and Outcomes Assessor will visit to collect data 3 times 1. In-hospital period 2. after hospital discharge 4 weeks 3. after hospital discharge 12 weeks

Interventions

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.

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Charoenkrung Pracharak Hospital

Bang Kho Laem, Bangkok, 10120, Thailand

RECRUITING

Related 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.

  PMID: 15086645 BACKGROUND

• 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.

  PMID: 25470529 RESULT

• 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)

  RESULT

MeSH Terms

Conditions

Ischemic Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rungnapa Premkamol

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rungnapa Premkamol

CONTACT

(66)0922705798; rungnapa.pre@student.mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: These Sixty participants are stratified block randomization using NIHSS (5-9) and (10-14) score 30 participant each and then sample random into 2 groups; control group (n=30) and intervention groups (n=30) by Investigator . they do not know that their group. The Outcomes Assessor will be collecting the data for primary and secondary outcome for 4 and 12 weeks and do not who are control or intervention group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study based on Transitional Care Model by Naylor. Sixty participants with stroke patients with hemiplegia and can use Line Application will be recruited. These participants are stratified block randomization using NIHSS (5-9) and (10-14) score 30 participant each and then sample random 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 12 weeks will 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.

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 5, 2024
• Study Start: February 7, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)