Improving Resilience and Quality of Life of Stroke Patients

February 6, 2023 updated by: Hsiang Chu Pai, Chung Shan Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40201
        • Chung Shan Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
resilience_change is being assessed
Time Frame: 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.
3rd day after admission (T1). 2-3 weeks after admission (Time 2). 2-3 days before discharge (Time 3).
family function_change is being assessed
Time Frame: 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.
3rd day after admission (T1). 2-3 weeks after admission (Time 2). 2-3 days before discharge (Time 3).
self-efficacy_change is being assessed
Time Frame: 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.
3rd day after admission (T1). 2-3 weeks after admission (Time 2). 2-3 days before discharge (Time 3).
quality of life_change is being assessed
Time Frame: 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.
3rd day after admission (T1). 2-3 weeks after admission (Time 2). 2-3 days before discharge (Time 3).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Investigators

  • Principal Investigator: Hsiang Chu Pai, Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2021

Primary Completion (ACTUAL)

December 31, 2022

Study Completion (ACTUAL)

December 31, 2022

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (ACTUAL)

March 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS1-21079

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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