Stroke PatientsNCT05176340
Action Modules on Resilience and Psychological Health
A study testing Specific Thematic Nursing Care Action Modules (STNC-AM) in people with Stroke Patients, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke Patients
- What is being tested?
- Specific Thematic Nursing Care Action Modules (STNC-AM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2019to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- remaining hospitalized within 6 months after a stroke attack.
- being able to communicate verbally.
- being willing to participate.
Who cannot join
- Aphasia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Action Modules on Resilience and Psychological Health of Stroke Patients
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.
Read the 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.
- Conditions
- Stroke Patients
- Being tested
- Specific Thematic Nursing Care Action Modules (STNC-AM)
- Keywords
- anxiety, depression, resilience, illness representation
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific Thematic Nursing Care Action Modules (STNC-AM)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Other: Specific Thematic Nursing Care Action Modules (STNC-AM) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start1 Aug 2019
- Primary completion1 Aug 2019
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiang Chu Pai, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176340
- Sponsor's protocol ID
- CS2-18011
- Status last verified
- Dec 2021
- First submitted
- 4 Dec 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Action Modules on Resilience and Psychological Health of Stroke Patients
- ClinicalTrials.gov ID
- NCT05176340
- Acronym / sponsor ID
- CS2-18011
- Conditions
- Stroke Patients
- Keywords
- anxiety, depression, resilience, illness representation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Specific Thematic Nursing Care Action Modules (STNC-AM)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. |
| 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- remaining hospitalized within 6 months after a stroke attack.
- being able to communicate verbally.
- being willing to participate.
Key exclusion criteria (1 listed)
- Aphasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific Thematic Nursing Care Action Modules (STNC-AM)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. | Other | Intervention group |
Primary outcome
Illness Perception_change is being assessed
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.
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
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.
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
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific Thematic Nursing Care Action Modules (STNC-AM) in people with Stroke Patients, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illness Perception_change is being assessed (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.