Ischemic StrokeNCT06242366
Transitional Care Program in Stroke Patients With Hemiplegia.
A study testing Intervention group in people with Ischemic Stroke and Transitional Care, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Transitional Care, Hemiplegia
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 7 Feb 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Charoenkrung Pracharak Hospital
Bang Kho Laem, Bangkok, 10120
Rungnapa Premkamol, BA, (66)0922705798, rungnapa.pre@student.mahidol.ac.th
Rungnapa Premkamol, BA
About this study
Official title: Effects of Transitional Care Program in Stroke Patients on Self-care Behavior, Quality of Life, and Hospital Readmission: A Randomized Controlled Trial.
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
Read the 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
- Conditions
- Ischemic Stroke, Transitional Care, Hemiplegia
- Being tested
- Intervention group
- Keywords
- Quality Of Life, Self-care behavior, Hospital Readmission, Transitional care, Stroke patients
- Medical subject headings
- Ischemic Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 4 weeks, 12 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start7 Feb 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rungnapa Premkamol, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242366
- Sponsor's protocol ID
- COA. MURA2023/337
- Other IDs
- U034hh/66
- Status last verified
- Nov 2024
- First submitted
- 24 Jan 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15086645Wong 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.
PubMed 25470529Suphimol 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)
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transitional Care Program in Stroke Patients on Self-care Behavior, Quality of Life, and Hospital Readmission: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06242366
- Acronym / sponsor ID
- COA. MURA2023/337
- Conditions
- Ischemic Stroke, Transitional Care, Hemiplegia
- Keywords
- Quality Of Life, Self-care behavior, Hospital Readmission, Transitional care, Stroke patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention groupIn 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 |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age from 18 years old.
- The first diagnosis is acute ischemic stroke.
- Hemiplegia
- NIHSS 5-14 point (moderate impairment)
- Telephone and Line Application used.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupIntervention 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. | Behavioural | Intervention group |
Primary outcome
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.
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.
1 secondary outcome
Number of Participants with Hospital Readmission.
Time frame: 4 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Background: PubMed 15086645Naylor 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.
- Results publication: PubMed 25470529Wong 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.
- Results publicationSuphimol 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)
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rungnapa Premkamol principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Ischemic Stroke and Transitional Care, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rungnapa Premkamol ((66)0922705798, rungnapa.pre@student.mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Mean differences of Quality Of Life on stroke patient. (time frame: Baseline, 4 weeks, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06242366, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.