- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07465744
Evaluation of the Support Program to Enhance Self-management Capacity Among Stroke Survivors
The goal of this interventional study is to develop and evaluate a post-stroke patient support program aimed at enhancing patients' ability to self-management after discharge to home. The main question it aim to answer are:
After participating in the support program, do patients show improvements in stroke-related knowledge, independence in activities of daily living, and self-efficacy in managing their health?
Researchers will compare intervention to control group. The control group receive usual care. The intervention group receive usual care and support self management program to see enhance self-efficacy and recovery.
Participants will:
- Answer a self-report questionnaire
- Attend to support self management program during 5 sessions in 5 weeks
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 years or older;
- Clinically diagnosed with ischemic stroke or intracerebral hemorrhage (first-ever or recurrent episode);
- Assessed by the treating physician as being clinically stable following the acute phase;
- Mini-Mental State Examination (MMSE) score > 18;
- Scheduled for follow-up after discharge at the Neurology Outpatient Clinic or the Neurology Clinic, Department of Outpatient Services, University Medical Center Ho Chi Minh City;
- Able to speak and read Vietnamese;
- Willing to participate in educational sessions within the health self-management program;
- Able to use a telephone;
- Having a family member or caregiver accompanying the patient who is able to recognize changes in the patient's physical and mental condition;
- Providing informed consent to participate in the study.
Exclusion Criteria:
- Diagnosed with stroke secondary to cerebrovascular pathology related to malignancy;
- Diagnosed with psychiatric disorders such as depression, schizophrenia, bipolar disorder, or personality disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
The intervention group receive usual care and support self management program
|
Usual care
Five sessions per five weeks of support self management program included stroke education and action planning; deliver rehabilitation, fall prevention, and problem-solving guidance; review progress and refine weekly action plans; reinforce adherence through follow-up; and summarize outcomes while establishing a continued self-management plan.
|
|
Other: Control
The control group receive usual care.
|
Usual care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self - Efficacy
Time Frame: Five weeks after stroke
|
Using Stroke self-efficacy questionnaire (SSEQ).
Total score ranging from 0 to 130, which is positive corelation to self-efficacy level.
|
Five weeks after stroke
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stroke self - management behaviors
Time Frame: Five weeks after stroke
|
The level of independence in activities of daily living (Barthel Index)
|
Five weeks after stroke
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stroke Knowledge
Time Frame: Five weeks after stroke
|
Stroke Knowledge test
|
Five weeks after stroke
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2820/UMP-BOARD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
Clinical Trials on Usual care
-
Charite University, Berlin, GermanyCompletedMultiple Sclerosis | FatigueGermany
-
Charite University, Berlin, GermanyMammazentrum Hamburg am Krankenhaus Jerusalem, Germany; Dorit und Alexander...Completed
-
European Institute for Evidence Based Osteopathic...Unknown
-
Suzanna ZickUniversity of MichiganTerminatedQuality of Life | Fatigue | Lupus Erythematosus, Systemic | Sleep | Pain, ChronicUnited States
-
Centers for Disease Control and PreventionCompleted
-
University Hospital, MontpellierCompletedOsteoarthritis | Mindfulness | MBSRFrance
-
Gachon University Gil Oriental Medical HospitalKorea Health Industry Development InstituteCompletedKnee Replacement | AcupunctureKorea, Republic of
-
Mayo ClinicCompleted
-
The Miriam HospitalNational Institute on Aging (NIA)CompletedHeart FailureUnited States
-
Lawson Health Research InstituteUnknownDepression | Quality of Life | Sleep | Anxiety | Dry EyeCanada