StressNCT05834387
The Impact of a Transitional Care Management Programme on the Migration Stress of Family Members of Patients
A study testing EICU Transfer Routine Care and Implementing interventions based on a 'health care-family-environment' linkage in people with Stress, run by Zunyi Medical College at 1 site in China.
Trial summary
This study investigated the impact of the establishment and application of the "health care-family-environment" linkage mechanism on the level of migration stress, coping styles and care satisfaction of families of patients transferred from the EICU, in order to provide a reference for improving the physical and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- EICU Transfer Routine Care and Implementing interventions based on a 'health care-family-environment' linkage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to May 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Family members of trauma patients scheduled to be transferred from the EICU to a general unit within 24h;
- Family members of patients aged ≥ 18 years;
- Family members who are responsible for the main care tasks and medical decisions of the patient during hospitalisation;
- Family members of patients with clear language and good communication skills;
- Families of patients who volunteered to participate in this study.
Who cannot join
- Family members of patients temporarily transferred out of the EICU or temporarily discharged from trauma
- Families of patients who voluntarily request termination of treatment;
- Family members of patients with cognitive impairment, speech impairment or mental abnormalities.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zunyi Medical College
Zunyi, Guizhou, 563000
Xu Ren, 18311639591, r19921115x@qq.com
About this study
Official title: The Impact of a Transitional Care Management Programme on the Migration Stress of Family Members of Patients Transferred Out of the EICU Under the "Health Care-family-environment" Linkage Model
This study investigated the impact of the establishment and application of the "health care-family-environment" linkage mechanism on the level of migration stress, coping styles and care satisfaction of families of patients transferred from the EICU, in order to provide a reference for improving the physical and psychological health of families and to promote the role of family members in the social support of patients transferred out of this category.
- Conditions
- Stress
- Being tested
- EICU Transfer Routine Care, Implementing interventions based on a 'health care-family-environment' linkage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EICU Transfer Routine CareProcedure or surgery
EICU Transfer Routine Care
Implementing interventions based on a 'health care-family-environment' linkageProcedure or surgery
Nursing interventions in the experimental group The interventions were based on the "health care-family-environment" linkage
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Not described Receives: Procedure: EICU Transfer Routine Care |
| Experimental group | Experimental | Not described Receives: Procedure: Implementing interventions based on a 'health care-family-environment' linkage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress assessment
Stress assessment assessed by ICU Transfer Stress Assessment Scale for Families of Patients Transferring Out
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 May 2023
- Primary completionNov 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zunyi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Ren, Zunyi Medical College
- Investigators
- Xu Ren, Study director, Zunyi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834387
- Sponsor's protocol ID
- Zunyi001
- Status last verified
- Jul 2023
- First submitted
- 11 Apr 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Transitional Care Management Programme on the Migration Stress of Family Members of Patients Transferred Out of the EICU Under the "Health Care-family-environment" Linkage Model
- ClinicalTrials.gov ID
- NCT05834387
- Acronym / sponsor ID
- Zunyi001
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zunyi Medical CollegeUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 28 Apr 2023 (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 investigated the impact of the establishment and application of the "health care-family-environment" linkage mechanism on the level of migration stress, coping styles and care satisfaction of families of patients transferred from the EICU, in order to provide a reference for improving the physical and psychological health of families and to promote the role of family members in the social support of patients transferred out of this category.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Procedure: EICU Transfer Routine Care |
| Experimental group | Experimental | Procedure: Implementing interventions based on a 'health care-family-environment' linkage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Family members of trauma patients scheduled to be transferred from the EICU to a general unit within 24h;
- Family members of patients aged ≥ 18 years;
- Family members who are responsible for the main care tasks and medical decisions of the patient during hospitalisation;
- Family members of patients with clear language and good communication skills;
- Families of patients who volunteered to participate in this study.
Key exclusion criteria (3 listed)
- Family members of patients temporarily transferred out of the EICU or temporarily discharged from trauma
- Families of patients who voluntarily request termination of treatment;
- Family members of patients with cognitive impairment, speech impairment or mental abnormalities.
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 |
|---|---|---|
| EICU Transfer Routine CareEICU Transfer Routine Care | Procedure or surgery | Control group |
| Implementing interventions based on a 'health care-family-environment' linkageNursing interventions in the experimental group The interventions were based on the "health care-family-environment" linkage | Procedure or surgery | Experimental group |
Primary outcome
Stress assessment
Time frame: 48 hours
Stress assessment assessed by ICU Transfer Stress Assessment Scale for Families of Patients Transferring Out
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Xu Ren study director
Zunyi Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EICU Transfer Routine Care and Implementing interventions based on a 'health care-family-environment' linkage in people with Stress, run by Zunyi Medical College at 1 site in China.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Jul 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Ren (18311639591, r19921115x@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress assessment (time frame: 48 hours). 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 11 Jul 2023.