Improving Resilience and Quality of Life of Stroke Patients

Caregiver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05291442
• Other study ID #: CS1-21079
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver
• Stroke
• Stroke Patient

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3rd day after admission (T1). 2-3 weeks after admission (Time 2). 2-3 days before discharge (Time 3).
Primary	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.	3rd day after admission (T1). 2-3 weeks after admission (Time 2). 2-3 days before discharge (Time 3).
Primary	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.	3rd day after admission (T1). 2-3 weeks after admission (Time 2). 2-3 days before discharge (Time 3).
Primary	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.	3rd day after admission (T1). 2-3 weeks after admission (Time 2). 2-3 days before discharge (Time 3).