Plain English Summary
Background and study aims
Stroke is one of the most common chronic diseases. It is one of the leading causes of adult disability and mortality. After the onset of stroke, the patients will have a lot of symptoms. These symptoms have adverse impacts on the patients’ mood, rehabilitation and mortality. We need pay more attention to these symptoms. But most attention of doctors, nurses and researchers have been put into disfunctions and complications these years. Although they are also very important, we need to understand stroke patients from their perspective. This study aims to recruit about 190 stroke patients to investigate the symptom experience and burden. The goals are to find the most prevalent and burdensome symptoms and to find the impact factors of symptom burden. The study's findings will improve the understanding of stroke patients and help to provide information for symptom management.
Who can participate?
Stroke patients over the age of 18 who take a rehabilitation in Shanghai, China.
What does the study involve?
Participants are asked to join this study when they take a rehabilitation in hospitals and rehabilitation centers. After a written informed consent is got, the patient will be investigated by a structured questionnaire. The questionnaire involves the demographic and clinical characteristics, the symptom experience scale for stroke patients and the stroke impact scale.
What are the possible benefits and risks of participating?
Because the investigators are very professional, the patients may correct their misunderstandings and know more about stroke rehabilitation by the communication with the investigators. There will be no risks of participating.
Where is the study run from?
The study takes place in rehabilitation departments of Xuhui District Center Hospital of Shanghai and the Shanghai Sunshine Rehabilitation Center, Shanghai, China.
When is the study starting and how long is it expected to run for?
March 2017 to September 2019
Who is funding the study?
Fuxing Nursing Research Foundation, Fudan University (FNF201611).
Who is the main contact?
1. Prof. Zheng Li
Leez@fudan.edu.cn
2. MS. Dan Shi
15211170003@fudan.edu.cn
Updated PES as of 19/07/2018:
Background and study aims
Stroke is one of the most common chronic diseases, and is one of the leading causes of adult disability and mortality. After having a stroke, patients have various symptoms that can have effects on patient’s mood, rehabilitation process and mortality. These include weakness, paralysis, pain, numbness, fatigue and speech problems, amongst many others. Too little attention has been paid to these symptoms, especially from the perspective of stroke patients themselves.
This study aims to investigate the experience and burden of stroke symptoms in patients, and understand which are the most prevalent, with the aim of furthering understanding of stroke patients and providing information for symptom management.
Who can participate?
Adult stroke patients undergoing rehabilitation in Shanghai, China
What does the study involved?
Participants will be asked to take a structured questionnaire, where they will be asked questions about their symptom experience and burden.
What are the possible benefits and risks of participating?
A possible benefit of participating is that participants may gain a better understanding of stroke rehabilitation through communicating with the investigators. There are no known risks to participants taking part in this study.
Where is the study run from?
1. Xuhui District Center Hospital, Shanghai, China
2. Shanghai Sunshine Rehabilitation Center, Shanghai, China
When is the study starting and how long is it expected to run for?
January 2017 to September 2019
Who is funding the study?
Fuxing Nursing Research Foundation, Fudan University (China)
Who is the main contact?
1. Prof Zheng Li (leez@fudan.edu.cn)
2. Dr Dan Shi (15211170003@fudan.edu.cn)
Trial website
Contact information
Type
Scientific
Primary contact
Dr Dan Shi
ORCID ID
Contact details
No.305
Fenglin Road
Xuhui District
Shanghai
Shanghai
200030
China
+8618221321658
15211170003@fudan.edu.cn
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.0
Study information
Scientific title
Symptom experience and symptom burden of patients following first-ever stroke within 1 year: a cross-sectional study
Acronym
Study hypothesis
Stroke patients have a heavy symptom burden within 1 year. This study aimed to describe the multidimensional symptoms and concurrent symptoms within 1 year after stroke. This is a part of a wider cross-sectional study with the purpose of developing a symptom experience scale for stroke patients and describing symptom experience among stable stroke patients within 1 year.
Ethics approval
Ethics Committee of Nursing School of Fudan University, China, 18/04/2017, IRB#2017-4-3
Study design
Observational study (part of a wider cross-sectional study)
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Stroke
Intervention
Participants were asked to complete a structure questionnaire, designed using the Symptom Experience Model with two sections - demographic and clinical characteristics, and the symptom experience scale. Symptom experience and symptom burden were assessed using the self-made Symptom Experience Scale for Stroke Survivors.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Symptom experience during the preceding week, assessed using a self-made and patient-completed symptom questionnaire (Symptom Experience Scale for Stroke Survivors) at the baseline.
Secondary outcome measures
Symptom burden during the preceding week, assessed using nineteen symptoms in the Symptom Experience Scale, at the baseline. The mean score of symptom burden of these represents the total symptom burden of the patient.
Overall trial start date
01/01/2017
Overall trial end date
01/09/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosed with stroke within one year of study enrolment
2. Aged 18 years or older
3. Attacked by stroke for the first time
4. Accurately communicate by oral expression or writing
5. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
230
Participant exclusion criteria
1. Unstable stage (undergoing medical and surgical treatments, rather than rehabilitation)
2. Dementia or severe cognitive impairment
3. Complications in the rehabilitation process (e.g. gastrointestinal bleeding, fracture, tumor, recurrent infections)
4. Cured of malignant tumor within the last 5 years
Recruitment start date
01/03/2017
Recruitment end date
01/09/2017
Locations
Countries of recruitment
China
Trial participating centre
Rehabilitation Departments of Xuhui District Center Hospital of Shanghai
No. 966, Huaihai Middle Road, Xuhui District
Shanghai
200030
China
Trial participating centre
Shanghai Sunshine Rehabilitation Center in China
No.2209, Guangxing Road, Songjiang District, Shanghai
Shanghai
201600
China
Sponsor information
Organisation
School of Nursing, Fudan University
Sponsor details
No.305
Fenglin Road
Xuhui District
Shanghai
200032
China
+86-18221321658
15211170003@fudan.edu.cn
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Fuxing Nursing Research Foundation of Fudan University of China, No. FNF201611.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from SHI Dan, 15211170003@fudan.edu.cn. This cross-sectional data will become available in 01/01/2021 for two years. Data will be shared with people who are interested in symptom management of stroke patients and want to compare the symptom burden between different groups of patients.
Intention to publish date
30/03/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30233063