Improving Resilience and Quality of Life of Stroke Patients

Sponsor

Chung Shan Medical University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05291442

Collaborator

(none)

180

Enrollment

Location

Arms

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Patient Caregiver	Other: To integrate Family System Care and Theme Care Action Module	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

Improving Resilience and Quality of Life of Stroke Patients: A Mixed Method Study

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control group The control group received no intervention, except for the regular care followed by the nurses in general in the rehabilitation ward.
Experimental: Intervention group 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.	Other: To integrate Family System Care and Theme Care Action Module 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.

Arm

Intervention/Treatment

No Intervention: control group

The control group received no intervention, except for the regular care followed by the nurses in general in the rehabilitation ward.

Experimental: Intervention group

Other: To integrate Family System Care and Theme Care Action Module

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.

Outcome Measures

Primary Outcome Measures

resilience_change is being assessed [3rd day after admission (T1). 2-3 weeks after admission (Time 2). 2-3 days before discharge (Time 3).]
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 [3rd day after admission (T1). 2-3 weeks after admission (Time 2). 2-3 days before discharge (Time 3).]
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 [3rd day after admission (T1). 2-3 weeks after admission (Time 2). 2-3 days before discharge (Time 3).]
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 [3rd day after admission (T1). 2-3 weeks after admission (Time 2). 2-3 days before discharge (Time 3).]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.