Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-28 @ 10:10 AM
Study NCT ID:
NCT06242366
Status:
RECRUITING
Last Update Posted:
2024-11-21
First Post:
2024-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transitional Care Program in Stroke Patients With Hemiplegia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.\n\nThe 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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).\n\nThe 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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2024-01-24', 'studyFirstSubmitQcDate': '2024-02-02', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare Mean differences of Quality Of Life on stroke patient.', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': '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.'}, {'measure': 'Compare Mean differences of self-care behavior on stroke patient.', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Hospital Readmission.', 'timeFrame': '4 weeks.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quality Of Life', 'Self-care behavior', 'Hospital Readmission', 'Transitional care', 'Stroke patients'], 'conditions': ['Ischemic Stroke', 'Transitional Care', 'Hemiplegia']}, 'referencesModule': {'references': [{'pmid': '15086645', 'type': 'BACKGROUND', '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.'}, {'pmid': '25470529', 'type': 'RESULT', '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.'}, {'type': 'RESULT', '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)'}]}, 'descriptionModule': {'briefSummary': 'This study examines the effects of a transitional care program in stroke patients on self-care behavior, quality of life, and hospital readmission.\n\nThe 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).\n\nThe program consisted of 2 phases: 1) Phase I during hospital admission and 2) Phase II following hospital discharge', 'detailedDescription': '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.\n\nThe 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).\n\nThe 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.\n\nThe 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18 years old.\n* The first diagnosis is acute ischemic stroke.\n* Hemiplegia\n* NIHSS 5-14 point (moderate impairment)\n* Telephone and Line Application used.\n* Can read and communicate in Thai language\n* Accept participants to research and inform consent.\n\nExclusion Criteria:\n\n* Aphasia\n* The Six Item Cognitive Impairment Test: 6CIT from 8 points in age from 60 years old.\n* Participants with illness severity or dead during the study.\n* Reject the study'}, 'identificationModule': {'nctId': 'NCT06242366', 'briefTitle': 'Transitional Care Program in Stroke Patients With Hemiplegia.', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Effects of Transitional Care Program in Stroke Patients on Self-care Behavior, Quality of Life, and Hospital Readmission: A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'COA. MURA2023/337'}, 'secondaryIdInfos': [{'id': 'U034hh/66', 'type': 'OTHER', 'domain': 'BMA Human Research Ethics Committee.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'In this arm, the participant will receive standard nursing care and the program from an investigator.\n\nThe 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\n\n2\\) 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.\n\nand Outcomes Assessor will visit to collect data 3 times\n\n1. In-hospital period\n2. after hospital discharge 4 weeks\n3. after hospital discharge 12 weeks', 'interventionNames': ['Behavioral: Intervention group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'In this arm, the participant will receive only standard nursing care. and Outcomes Assessor will visit to collect data 3 times\n\n1. In-hospital period\n2. after hospital discharge 4 weeks\n3. after hospital discharge 12 weeks'}], 'interventions': [{'name': 'Intervention group', 'type': 'BEHAVIORAL', 'description': '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.\n\nPhases 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.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10120', 'city': 'Bang Kho Laem', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Rungnapa Premkamol, BA', 'role': 'CONTACT', 'email': 'rungnapa.pre@student.mahidol.ac.th', 'phone': '(66)0922705798'}, {'name': 'Rungnapa Premkamol, BA', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Apinya Siripitayakunkit, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nipaporn Butsing, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Charoenkrung Pracharak Hospital', 'geoPoint': {'lat': 13.69347, 'lon': 100.5022}}], 'centralContacts': [{'name': 'Rungnapa Premkamol', 'role': 'CONTACT', 'email': 'rungnapa.pre@student.mahidol.ac.th', 'phone': '(66)0922705798'}], 'overallOfficials': [{'name': 'Rungnapa Premkamol', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}