StrokeNCT06538025
Correlation Between Family Functioning and PSF
An observational study of Stroke, run by Meichun Shu at 2 sites in China.
Trial summary
In the present study, the investigators investigate the effect of family functioning on PSF in neurologic stroke patients in the early stages of the disease by surveying the current status of post-stroke fatigue to provide theoretical support for clinical care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- How many people
- 212 participants
- Where
- 2 sitesChina
- Study dates
- 18 Oct 2021to 10 Aug 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with first-episode stroke admitted to the Department of Neurology of our hospital between October 2021 and July 2022 were rigorously screened using convenience sampling.
Who may be able to join
- patients whose clinical manifestations met the diagnostic criteria for stroke and whose stroke was confirmed by imaging (cranial computed tomography or cranial magnetic resonance imaging)
- those with first-episode stroke and in a stable condition
- those who were conscious and able to cooperate with the investigation
- those who gave informed consent and volunteered to participate in the study
Who cannot join
- patients with severe aphasia
- those with severe cognitive impairment who were unable to cooperate with examinations or questionnaires
- those with malignant tumours
- those with degenerative diseases of the central nervous system, such as Parkinson's disease
- those who were unable to cooperate with the doctor in the examination for other reasons
- those with a previous history of mental illness
- those with other recent major stressful life events, such as divorce or death of a loved one
- those with pre-stroke fatigue (PrSF)
Trial locations and contacts
2 sites in 1 country.
China2 sites
Meichun Shu
Wenzhou, Zhejiang, 325000
Xianchai Hong
Wenzhou, Zhejiang, 325000
About this study
Official title: Post-stroke Fatigue and Its Correlation With Family Functioning in Patients With First-episode Stroke
In the present study, the investigators investigate the effect of family functioning on PSF in neurologic stroke patients in the early stages of the disease by surveying the current status of post-stroke fatigue to provide theoretical support for clinical care.
- Conditions
- Stroke
- Keywords
- post-stroke fatigue, family functioning
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
activities of daily living
modified Barthel index (MBI) is a tool most commonly used to assess the ability of stroke patients to perform activities of daily living. The measurement consists of 10 items, namely feeding, bed-to-wheelchair transfer, personal hygiene, toileting, bathing, walking, walking up and down stairs, dressing and bowel control, with a total score of 100. The lower the MBI score is, the more severe the dysfunction and the greater the dependence. The degree of dependence was categorised into four grades, with ≤40 points categorised as severe dependence (all items required care from others - poor), 41-60 points categorised as moderate dependence (most items required care from others - fair) and 61-90 points and 90-100 points, categorised as mild or no dependence, respectively (few or no items required care from others - good).
Measured: Before hospitalization
family adaptation, partnership, growth, affection and resolve (APGAR) score
assess patients' satisfaction with family functioning. It was developed to measure the five dimensions of adaptation, partnership, growth, affection and resolve in five separate questions. Each question was assigned a score of 0-2, with a total score of 0-10 points. The degree of family dysfunction was divided based on the total score, with 7-10 points defined as good family function, 4-6 points as moderate family dysfunction and 0-3 points as severe family dysfunction, with a Cronbach's α coefficient of 0.94
Measured: First day after hospitalization
Post-stroke fatigue
Post-stroke fatigue was scored using the Fatigue Severity Scale, which is mainly designed to assess the severity of physical and mental fatigue felt by patients as a result of the disease. When assessing stroke patients using the FSS, some scholars have diagnosed a score of ≥36 points as indicative of PSF. The FSS is comprised of a total of nine entries, each of which is scored on a 7-point Likert scale ranging from 1 to 7. A score of 1 indicates a 'strongly disagree' response to the corresponding entry, and a score of 7 represents a 'strongly agree' response to the corresponding entry. The final FSS score for the patient was obtained by summing the total score of the nine entries. The higher the score is, the more severe the patient's fatigue。
Measured: Day 5 of hospitalization
Sleep Disturbances
The Athens Insomnia Scale (AIS) is used to measure the sleep quality of patients during the study period. AIS is an internationally recognized self-assessment scale for sleep quality, consisting of 8 items. The scale is a 4-point Likert scale, scored 0, 1, 2, or 3, with 0 representing "not at all" and 3 representing a "severe" impact. The total score is 24 points. Scores ranging from 0-4 indicate no sleep disturbances, 4-6 suggest possible insomnia, and scores above 6 represent insomnia. The higher the score, the poorer the sleep quality and the more severe the sleep problems. The Cronbach's alpha coefficient for this scale is 0.875.
Measured: Day 5 of hospitalization
Anxiety and Depression
The Hospital Anxiety and Depression Scale (HADS) is composed of 14 items divided into two subscales: the depression subscale (7 items) and the anxiety subscale (7 items). Scores from 0 to 7 indicate no symptoms, 8 to 10 suggest possible symptoms, and 11 to 21 indicate definite symptoms. The overall Cronbach's alpha coefficient for the scale, as well as those of the anxiety and depression subscales, are 0.88 and 0.81, respectively.
Measured: Day 5 of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start18 Oct 2021
- Primary completion20 Jul 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meichun Shu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Meichun Shu, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538025
- Sponsor's protocol ID
- Meichun Shu
- Status last verified
- Oct 2024
- First submitted
- 31 Jul 2024
- Last updated
- 26 Oct 2024
- 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 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-stroke Fatigue and Its Correlation With Family Functioning in Patients With First-episode Stroke
- ClinicalTrials.gov ID
- NCT06538025
- Acronym / sponsor ID
- Meichun Shu
- Conditions
- Stroke
- Keywords
- post-stroke fatigue, family functioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Meichun ShuUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 5 Aug 2024 (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.
In the present study, the investigators investigate the effect of family functioning on PSF in neurologic stroke patients in the early stages of the disease by surveying the current status of post-stroke fatigue to provide theoretical support for clinical care.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with first-episode stroke admitted to the Department of Neurology of our hospital between October 2021 and July 2022 were rigorously screened using convenience sampling.
Key inclusion criteria (4 listed)
- patients whose clinical manifestations met the diagnostic criteria for stroke and whose stroke was confirmed by imaging (cranial computed tomography or cranial magnetic resonance imaging)
- those with first-episode stroke and in a stable condition
- those who were conscious and able to cooperate with the investigation
- those who gave informed consent and volunteered to participate in the study
Key exclusion criteria (8 listed)
- patients with severe aphasia
- those with severe cognitive impairment who were unable to cooperate with examinations or questionnaires
- those with malignant tumours
- those with degenerative diseases of the central nervous system, such as Parkinson's disease
- those who were unable to cooperate with the doctor in the examination for other reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
activities of daily living
Time frame: Before hospitalization
modified Barthel index (MBI) is a tool most commonly used to assess the ability of stroke patients to perform activities of daily living. The measurement consists of 10 items, namely feeding, bed-to-wheelchair transfer, personal hygiene, toileting, bathing, walking, walking up and down stairs, dressing and bowel control, with a total score of 100. The lower the MBI score is, the more severe the dysfunction and the greater the dependence. The degree of dependence was categorised into four grades, with ≤40 points categorised as severe dependence (all items required care from others - poor), 41-60 points categorised as moderate dependence (most items required care from others - fair) and 61-90 points and 90-100 points, categorised as mild or no dependence, respectively (few or no items required care from others - good).
family adaptation, partnership, growth, affection and resolve (APGAR) score
Time frame: First day after hospitalization
assess patients' satisfaction with family functioning. It was developed to measure the five dimensions of adaptation, partnership, growth, affection and resolve in five separate questions. Each question was assigned a score of 0-2, with a total score of 0-10 points. The degree of family dysfunction was divided based on the total score, with 7-10 points defined as good family function, 4-6 points as moderate family dysfunction and 0-3 points as severe family dysfunction, with a Cronbach's α coefficient of 0.94
Post-stroke fatigue
Time frame: Day 5 of hospitalization
Post-stroke fatigue was scored using the Fatigue Severity Scale, which is mainly designed to assess the severity of physical and mental fatigue felt by patients as a result of the disease. When assessing stroke patients using the FSS, some scholars have diagnosed a score of ≥36 points as indicative of PSF. The FSS is comprised of a total of nine entries, each of which is scored on a 7-point Likert scale ranging from 1 to 7. A score of 1 indicates a 'strongly disagree' response to the corresponding entry, and a score of 7 represents a 'strongly agree' response to the corresponding entry. The final FSS score for the patient was obtained by summing the total score of the nine entries. The higher the score is, the more severe the patient's fatigue。
Sleep Disturbances
Time frame: Day 5 of hospitalization
The Athens Insomnia Scale (AIS) is used to measure the sleep quality of patients during the study period. AIS is an internationally recognized self-assessment scale for sleep quality, consisting of 8 items. The scale is a 4-point Likert scale, scored 0, 1, 2, or 3, with 0 representing "not at all" and 3 representing a "severe" impact. The total score is 24 points. Scores ranging from 0-4 indicate no sleep disturbances, 4-6 suggest possible insomnia, and scores above 6 represent insomnia. The higher the score, the poorer the sleep quality and the more severe the sleep problems. The Cronbach's alpha coefficient for this scale is 0.875.
Anxiety and Depression
Time frame: Day 5 of hospitalization
The Hospital Anxiety and Depression Scale (HADS) is composed of 14 items divided into two subscales: the depression subscale (7 items) and the anxiety subscale (7 items). Scores from 0 to 7 indicate no symptoms, 8 to 10 suggest possible symptoms, and 11 to 21 indicate definite symptoms. The overall Cronbach's alpha coefficient for the scale, as well as those of the anxiety and depression subscales, are 0.88 and 0.81, respectively.
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 26 Oct 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Meichun Shu at 2 sites 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 4 inclusion and 8 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 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
activities of daily living (time frame: Before hospitalization). The study lists 5 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 26 Oct 2024.