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.
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
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Charoenkrung Pracharak Hospital | Bang Kho Laem | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
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
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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Recruiting |
NCT05518305 -
Platelet Expression of FcγRIIa and Arterial Hemodynamics to Predict Recurrent Stroke in Intracranial Atherosclerosis
|
||
Recruiting |
NCT06029959 -
Stroke and CPAP Outcome Study 3
|
N/A | |
Recruiting |
NCT03728738 -
Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke
|
Phase 3 | |
Terminated |
NCT03396419 -
IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
|
||
Recruiting |
NCT05065216 -
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
|
Phase 2/Phase 3 | |
Recruiting |
NCT04897334 -
Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke
|
N/A | |
Not yet recruiting |
NCT06462599 -
Osteopontin Gene Polymorphism in Stroke Patients in Egypt
|
||
Not yet recruiting |
NCT06032819 -
Differentiating Between Brain Hemorrhage and Contrast
|
||
Not yet recruiting |
NCT06026696 -
Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
|
||
Recruiting |
NCT02910180 -
Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
|
||
Withdrawn |
NCT01866189 -
Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke
|
N/A | |
Completed |
NCT03554642 -
Walkbot Robotic Training for Improvement in Gait
|
Phase 3 | |
Completed |
NCT02922452 -
A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT03041753 -
Reperfusion Injury After Stroke Study
|
N/A | |
Completed |
NCT02549846 -
AdminiStration of Statin On Acute Ischemic stRoke patienT Trial
|
Phase 4 | |
Completed |
NCT01678534 -
Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial
|
Phase 2 | |
Completed |
NCT02610803 -
Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke
|
N/A |