A prospective cohort study on incidence and outcome of patients with post-stroke depression in China
| ISRCTN | ISRCTN62169508 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62169508 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/12/2007
- Registration date
- 21/12/2007
- Last edited
- 24/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Wang Yongjun
Scientific
Scientific
Department of Neurology of Beijing Tiantan Hospital
Capital Medical University
Beijing
100050
China
Study information
| Study design | Multi-centre, observational, prospective, nested case-control study. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A prospective cohort study on incidence and outcome of patients with post-stroke depression in China |
| Study acronym | PRIOD- China |
| Study objectives | 1. Incidence of Post-Stroke Depression (PSD) in China may be different between 3 months and 6 months following onset of stroke 2. Patients with PSD may have poorer outcome than patients without PSD 3. Incidence of PSD may be correlated with stroke subtype, lesion location and other risk factors |
| Ethics approval(s) | Tiantan Hospital Ethics Committee. Date of approval: 12/05/2008 |
| Health condition(s) or problem(s) studied | Post-stroke depression |
| Intervention | 1. The participants are classified into the following groups: Group A: Stroke inpatients with PSD during follow up at 3 months or 6 months Group B: Stroke inpatients without PSD during follow up at 3 months or 6 months 2. Diagnostic process & criteria: 2.1. Assessment through scales: 2.1.1. Hamilton Rating Scale for Depression (HRSD). HRSD is used as preliminary screening scale. Trained qualified neurological doctors make standard depression diagnosis of all doctor-visitors with >=8 HRSD scores. Timepoints of assessment: Baseline at 14 days, 3, 6 and 12 months following onset 2.1.2. World Health Organization-Composite International Diagnostic Interview (WHO-CIDI). Trained qualified neurological doctors make standard depression diagnosis of all doctor-visitors with >=8 HRSD scores through CIDI at 3 and 6 months. 2.2. Patient self-assessment scale. Patients assess their mental state through BDI-13 scale biweekly for 3 months and monthly during 3 months - 1 year. Assessment results are recorded in follow-up diary. In case of BDI>=5 during this period, patients should visit hospital for follow-up and CIDI diagnosis by trained qualified neurological doctors. 3. Possible risk factors will be compared between group A and group B, these will include: 3.1. Stroke subtype 3.2. National Institutes of Health Stroke Scale (NIHSS) at 12 months 3.3. Medical history 3.4. Complications 3.5. Lesion location 4. Outcome will be compared between group A and group B, these will include: 4.1 Modified Rankin Scale (mRS) at 3, 6 and 12 months 4.2 Quality of life: Medical Outcome Study Short Form 36 (SF-36) at 12 months 4.3 Stroke recurrence at 3, 6 and 12 months |
| Intervention type | Other |
| Primary outcome measure | 1. Onset: Incidence of depression within 3 months and 6 months of stroke onset 2. Scale score: Score tendency based on HRSD scale within 14 days, 3 months, 6 months, and 1 year of stroke onset |
| Secondary outcome measures | 1. Quality of life: Medical Outcome Study Short Form 36 (SF-36) 2. mRS score |
| Overall study start date | 10/01/2008 |
| Completion date | 01/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2,500 |
| Key inclusion criteria | 1. New stroke onset 2. Stroke onset time: Within 14d from doctor-visiting date 3. Patients age 18 years or older 4. Sign informed consent, cooperate with examination, and complete follow-ups |
| Key exclusion criteria | 1. Unable to complete examination due to the influence of eyesight, hearing, expression, consciousness, and apprehension 2. Stroke patient presenting no sign or symptom |
| Date of first enrolment | 10/01/2008 |
| Date of final enrolment | 01/06/2009 |
Locations
Countries of recruitment
- China
Study participating centre
Department of Neurology of Beijing Tiantan Hospital
Beijing
100050
China
100050
China
Sponsor information
Beijing Tian Tan Hospital, Capital Medical University (China)
Hospital/treatment centre
Hospital/treatment centre
No.6 Tiantanxili
Chongwen District
Beijing
100050
China
"ROR" |
https://ror.org/003regz62 |
|---|
Funders
Funder type
Government
Wyeth pharmaceuticals
No information available
Minister of the Science and Technology of the People's Republic of China, National Key Technology R&D Program (ref: 2006BA101A11)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2012 | Yes | No | |
| Results article | results | 08/01/2019 | Yes | No |
Editorial Notes
24/01/2019: Publication reference added.
