Back to resultsImproving Resilience and Quality of Life of Stroke Patients
Primary Purpose
Stroke Patient, Caregiver
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
To integrate Family System Care and Theme Care Action Module
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke Patient focused on measuring Resilience, Family system nursing, Self-efficacy, Quality of life, Complexity science, Transition theory, Caregiver, Stroke.
Eligibility Criteria
Inclusion Criteria:
stroke patient:
- Those who can use language expression, over 20 years old.
- Within 1-6 months of new onset; (c) Patients willing to participate. Family caregivers
- family members or relatives and friends over 20 years of age who provide the care recipients' personal needs, financial, psychological, emotional care, etc.
Exclusion Criteria:
- Aphasia
Sites / Locations
- Chung Shan Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
Intervention group
Arm Description
The control group received no intervention, except for the regular care followed by the nurses in general in the rehabilitation ward.
To integrate Family System Care and Theme Care Action Module to improve resilience, family function, self-efficacy, and quality of life for stroke patients and their caregivers. First, understand the care needs of patients and caregivers, and apply The Specific Thematic Nursing Care Action Modules (STNC-AM) platform for education and training. The Specific Thematic Nursing Care Action Modules (STNC-AM) platform that we present here is an educational program that integrates education and coaching. STNC-AM has six key aspects: stroke prevention, management of emotions, management of fatigue, physical activity, caregiver training, and integrative resources. Each scope contains detailed care guidance.
Outcomes
Primary Outcome Measures
resilience_change is being assessed
Investigators use the Resilience Scale to evaluate the resilience for stroke patients. Total scores ranged from 25 to 175, with higher scores as indicating greater resilience.
family function_change is being assessed
Investigators use the McMaster family assessment device to evaluate the family function for stroke patients and their caregiver. Total scores ranged from 12 to 48, with higher scores as indicating greater family function.
self-efficacy_change is being assessed
Investigators use the Chronic Disease Self-efficacy Scale to evaluate the self-efficacy for stroke patients. Total scores ranged from 6 to 60, with higher scores as indicating greater self-efficacy.
quality of life_change is being assessed
Investigators use the SF-12 Health Survey Version 2(SF-12v2) to evaluate the quality of life for stroke patients and their caregiver. Total scores ranged from 0 to 100, with higher scores as indicating greater quality of life.
Secondary Outcome Measures
Full Information
NCT ID
NCT05291442
First Posted
March 18, 2022
Last Updated
February 6, 2023
Sponsor
Chung Shan Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05291442
Brief Title
Improving Resilience and Quality of Life of Stroke Patients
Official Title
Improving Resilience and Quality of Life of Stroke Patients: A Mixed Method Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aims to (1) test the effect of Family System Care and Theme Care Action Module on resilience, family function, self-efficacy, and quality of life for stroke patients and their families and caregivers; and (2) interview stroke survivors (experimental group) using a semi-structured questionnaire to achieve a mix of qualitative and quantitative methodologies.
Detailed Description
A randomized control-group pretest-posttest design was adopted. We also used a semi-structured questionnaire to qualitatively interview stroke survivors. The National Institute of Health Stroke Scale (NIHSS), Chronic Disease Self-Efficacy scales, Resilience Scale, McMaster Family Assessment Device, and Quality of Life Scale were used to test the intervention effects. Further, complex scientific concepts will be used to analyze the transition experience of stroke survivors.
Expected outcomes: The Family System Care and Theme Care Action Module can improve family function, resilience, self-efficacy, and quality of life for stroke patients and their caregivers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Patient, Caregiver
Keywords
Resilience, Family system nursing, Self-efficacy, Quality of life, Complexity science, Transition theory, Caregiver, Stroke.
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
To integrate Family System Care and Theme Care Action Module to improve resilience, family function, self-efficacy, and quality of life for stroke patients and their caregivers.
First, understand the care needs of patients and caregivers, and apply The Specific Thematic Nursing Care Action Modules (STNC-AM) platform for education and training.
The Specific Thematic Nursing Care Action Modules (STNC-AM) platform that we present here is an educational program that integrates education and coaching. STNC-AM has six key aspects: stroke prevention, management of emotions, management of fatigue, physical activity, caregiver training, and integrative resources. Each scope contains detailed care guidance.
Masking
Investigator
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group received no intervention, except for the regular care followed by the nurses in general in the rehabilitation ward.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
To integrate Family System Care and Theme Care Action Module to improve resilience, family function, self-efficacy, and quality of life for stroke patients and their caregivers.
First, understand the care needs of patients and caregivers, and apply The Specific Thematic Nursing Care Action Modules (STNC-AM) platform for education and training.
The Specific Thematic Nursing Care Action Modules (STNC-AM) platform that we present here is an educational program that integrates education and coaching. STNC-AM has six key aspects: stroke prevention, management of emotions, management of fatigue, physical activity, caregiver training, and integrative resources. Each scope contains detailed care guidance.
Intervention Type
Other
Intervention Name(s)
To integrate Family System Care and Theme Care Action Module
Intervention Description
First, understand the care needs of patients and caregivers, and apply The Specific Thematic Nursing Care Action Modules (STNC-AM) platform for education and training.
The Specific Thematic Nursing Care Action Modules (STNC-AM) platform that we present here is an educational program that integrates education and coaching. STNC-AM has six key aspects: stroke prevention, management of emotions, management of fatigue, physical activity, caregiver training, and integrative resources. Each scope contains detailed care guidance.
Primary Outcome Measure Information:
Title
resilience_change is being assessed
Description
Investigators use the Resilience Scale to evaluate the resilience for stroke patients. Total scores ranged from 25 to 175, with higher scores as indicating greater resilience.
Time Frame
3rd day after admission (T1). 2-3 weeks after admission (Time 2). 2-3 days before discharge (Time 3).
Title
family function_change is being assessed
Description
Investigators use the McMaster family assessment device to evaluate the family function for stroke patients and their caregiver. Total scores ranged from 12 to 48, with higher scores as indicating greater family function.
Time Frame
3rd day after admission (T1). 2-3 weeks after admission (Time 2). 2-3 days before discharge (Time 3).
Title
self-efficacy_change is being assessed
Description
Investigators use the Chronic Disease Self-efficacy Scale to evaluate the self-efficacy for stroke patients. Total scores ranged from 6 to 60, with higher scores as indicating greater self-efficacy.
Time Frame
3rd day after admission (T1). 2-3 weeks after admission (Time 2). 2-3 days before discharge (Time 3).
Title
quality of life_change is being assessed
Description
Investigators use the SF-12 Health Survey Version 2(SF-12v2) to evaluate the quality of life for stroke patients and their caregiver. Total scores ranged from 0 to 100, with higher scores as indicating greater quality of life.
Time Frame
3rd day after admission (T1). 2-3 weeks after admission (Time 2). 2-3 days before discharge (Time 3).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stroke patient:
Those who can use language expression, over 20 years old.
Within 1-6 months of new onset; (c) Patients willing to participate. Family caregivers
family members or relatives and friends over 20 years of age who provide the care recipients' personal needs, financial, psychological, emotional care, etc.
Exclusion Criteria:
Aphasia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiang Chu Pai
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
12. IPD Sharing Statement
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Improving Resilience and Quality of Life of Stroke Patients
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