NCT05291442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

March 18, 2022

Last Update Submit

February 6, 2023

Conditions

Keywords

ResilienceFamily system nursingSelf-efficacyQuality of lifeComplexity scienceTransition theoryCaregiverStroke.

Outcome Measures

Primary Outcomes (4)

  • 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).

  • 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).

  • 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).

  • 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).

Study Arms (2)

control group

NO INTERVENTION

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

Intervention group

EXPERIMENTAL

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

Interventions

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 group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Aphasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University

Taichung, 40201, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hsiang Chu Pai

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2022

First Posted

March 22, 2022

Study Start

August 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations