Clinical trial NCT06242366: Transitional Care Program in Stroke Patients With Hemiplegia.
Official title: Effects of Transitional Care Program in Stroke Patients on Self-care Behavior, Quality of Life, and Hospital Readmission: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Transitional Care
Hemiplegia
Keywords: Quality Of Life
Self-care behavior
Hospital Readmission
Transitional care
Stroke patients
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Compare Mean differences of Quality Of Life on stroke patient.
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Compare Mean differences of self-care behavior on stroke patient.
timeFrame: Baseline, 4 weeks, 12 weeks
Secondary outcomes:
measure: Number of Participants with Hospital Readmission.
timeFrame: 4 weeks.
Other outcomes:
Locations:
city: Bang Kho Laem
country: Thailand
facility: Charoenkrung Pracharak Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Rungnapa Premkamol
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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)