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NCT Number: NCT05291442

Improving Resilience and Quality of Life of Stroke Patients

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.

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Key information

Conditions

Stroke Patient Brain Diseases Cardiovascular Diseases Caregiver Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, 40201, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

To integrate Family System Care and Theme Care Action Module

Other

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 outcomes

  1. 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.

  2. 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.

  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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2022
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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