Transitional Care Program in Stroke Patients With Hemiplegia.

NCT ID: NCT06242366

Last Updated: 2024-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-07

Study Completion Date

2025-08-01

Brief Summary

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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

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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

Conditions

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Ischemic Stroke Transitional Care Hemiplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Intervention group

Intervention Type 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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rungnapa Premkamol

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Charoenkrung Pracharak Hospital

Bang Kho Laem, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Rungnapa Premkamol

Role: CONTACT

(66)0922705798

Facility Contacts

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Rungnapa Premkamol, BA

Role: primary

(66)0922705798

References

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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.

Reference Type BACKGROUND
PMID: 15086645 (View on PubMed)

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.

Reference Type RESULT
PMID: 25470529 (View on PubMed)

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)

Reference Type RESULT

Other Identifiers

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U034hh/66

Identifier Type: OTHER

Identifier Source: secondary_id

COA. MURA2023/337

Identifier Type: -

Identifier Source: org_study_id

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