Ignite Creation Date:
2024-05-06 @ 8:08 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02672670
Status:
UNKNOWN
Last Update Posted:
2016-08-16
First Post:
2016-01-20
Brief Title:
Effects of a Coping-oriented Supportive Programme COSP for People With Spinal Cord Injury During Inpatient Rehabilitation
Sponsor:
The Hong Kong Polytechnic University
Organization:
The Hong Kong Polytechnic University
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2016-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this proposed PhD study is to test the effectiveness of a newly developed coping-oriented supportive programme COSP for Chinese people with SCI during their early period of inpatient rehabilitation in Xian China The objectives of this study are to develop and validate the COSP in the inpatient rehabilitation hospitals and to evaluate the effectiveness of this COSP for the SCI inpatients in two rehabilitation wards on their coping abilities self-efficacy mood status and life satisfaction when compared to those receiving routine care in another two rehabilitation wards This proposed PhD study is a quasi-experimental study using repeated-measures comparison group design The study will be conducted in two rehabilitation hospitals in Xian China There will be 50 patients in each of the two study groups ie one intervention and one comparison group The intervention group will receive the COSP including 8 weekly sessions and the comparison group will receive usual rehabilitation care in brief didactic group-based education Outcome measures will be examined at baseline and immediately 1- and 3-month after completion of the interventions The primary outcomes of this proposed study are coping ability and self-efficacy while the secondary outcomes include mood status life satisfaction and pain All data will be analysed using SPSS for Windows version 210 Descriptive statistics will be employed for demographic and disease-related data and outcome scores Data analysis for intervention effects will be based on both Per-protocol PP analyses and Intention-To-Treat ITT The missing data will be handled by the Last Observation Carried Forward LOCF strategy Inferential statistics will be conducted for between-group and within-group comparison with specific considerations with the measurement level of the data and the fulfillment of the statistical assumptions of parametric or non-parametric tests and further consider to use multivariate analysis of covariance MANCOVA or the analysis of covariance ANCOVAThis study will provide evidence on the clinical effectiveness of the coping-oriented supportive programme in improving patients psychological adjustment to SCI during earlier stage of inpatient rehabilitation enhancing their psychosocial adaptation to the illness and subsequent life satisfaction and hence integrating this psychosocial intervention into the conventional treatment and SCI rehabilitation practices
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None