Back to resultsAction Modules on Resilience and Psychological Health
Primary Purpose
Stroke Patients
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Specific Thematic Nursing Care Action Modules (STNC-AM)
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke Patients focused on measuring anxiety, depression, resilience, illness representation
Eligibility Criteria
Inclusion Criteria:
- remaining hospitalized within 6 months after a stroke attack.
- being able to communicate verbally.
- being willing to participate.
Exclusion Criteria:
- Aphasia
Sites / Locations
- Chung Shan Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Participants in the experimental group were provided an education program through the Care Action Module during their hospitalization period, and follow-up was conducted one and two months after discharge.
The control group received no intervention, except for the regular care followed by the nurses in general in the rehabilitation ward.
Outcomes
Primary Outcome Measures
Illness Perception_change is being assessed
Investigators used the Illness Perception Questionnaire-Revised (IPQ-R) to evaluate stroke patients' positive illness representation.
Investigators used the three positive domains (personal control, treatment control, and illness coherence) of illness representation to evaluate stroke patients' positive illness representation. Total scores ranged from 16 to 80 in each domain. High scores on all three dimensions (personal control, treatment control, and illness coherence) indicated a more positive illness representation.
Depression and Anxiety_change is being assessed
Investigators used the Hospital Anxiety and Depression Scale (HADS) to evaluate stroke patients' depression and anxiety.Total scores ranged from 0 to 21 in each domain, and higher scores indicated higher anxiety or depression.
Resilience_change is being assessed
Investigators used the Resilience Scale (RS) to evaluate stroke patients' resilience.Total scores ranged from 25 to 175, with higher scores as indicating greater resilience
Secondary Outcome Measures
Full Information
NCT ID
NCT05176340
First Posted
December 4, 2021
Last Updated
December 16, 2021
Sponsor
Chung Shan Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05176340
Brief Title
Action Modules on Resilience and Psychological Health
Official Title
Effect of Action Modules on Resilience and Psychological Health of Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aimed to determine whether interventions that use the Specific Thematic Nursing Care Action Modules (STNC-AM) platform improve patients' psychological health over a two-month period.
Detailed Description
The STNC-AM platform that investigator 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. The nurse coaching component was based on the six key aspects detailed above. This online platform can guide nurses' health education for the comprehensive care of stroke patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Patients
Keywords
anxiety, depression, resilience, illness representation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants in the experimental group were provided an education program through the Care Action Module during their hospitalization period, and follow-up was conducted one and two months after discharge.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group received no intervention, except for the regular care followed by the nurses in general in the rehabilitation ward.
Intervention Type
Other
Intervention Name(s)
Specific Thematic Nursing Care Action Modules (STNC-AM)
Intervention Description
The STNC-AM platform that investigators present here is an educational program that integrates education and coaching.
The nurse coaching component was based on the STNC-AM platform. This online platform can guide nurses' health education for the comprehensive care of stroke patients. Nurses can use an iPad and enter the STNC-AM platform website, where they can directly access the Care Action Module.
Primary Outcome Measure Information:
Title
Illness Perception_change is being assessed
Description
Investigators used the Illness Perception Questionnaire-Revised (IPQ-R) to evaluate stroke patients' positive illness representation.
Investigators used the three positive domains (personal control, treatment control, and illness coherence) of illness representation to evaluate stroke patients' positive illness representation. Total scores ranged from 16 to 80 in each domain. High scores on all three dimensions (personal control, treatment control, and illness coherence) indicated a more positive illness representation.
Time Frame
The data collection was conducted at three time points: first week (baseline; Time 1) of admission to the rehabilitation ward and then first month (Time 2) and second month (Time 3) follow-up after discharge.
Title
Depression and Anxiety_change is being assessed
Description
Investigators used the Hospital Anxiety and Depression Scale (HADS) to evaluate stroke patients' depression and anxiety.Total scores ranged from 0 to 21 in each domain, and higher scores indicated higher anxiety or depression.
Time Frame
The data collection was conducted at three time points: first week (baseline; Time 1) of admission to the rehabilitation ward and then first month (Time 2) and second month (Time 3) follow-up after discharge.
Title
Resilience_change is being assessed
Description
Investigators used the Resilience Scale (RS) to evaluate stroke patients' resilience.Total scores ranged from 25 to 175, with higher scores as indicating greater resilience
Time Frame
The data collection was conducted at three time points: first week (baseline; Time 1) of admission to the rehabilitation ward and then first month (Time 2) and second month (Time 3) follow-up after discharge.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
remaining hospitalized within 6 months after a stroke attack.
being able to communicate verbally.
being willing to participate.
Exclusion Criteria:
Aphasia
Facility Information:
Facility Name
Chung Shan Medical University
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Action Modules on Resilience and Psychological Health
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