Effects of a Coping-oriented Supportive Programme (COSP) for People With Spinal Cord Injury During Inpatient Rehabilitation

Spinal Cord Injury Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02672670
• Other study ID #: HSEARS20151219002
• Status: Recruiting
• Phase: N/A
• First received: January 20, 2016
• Last updated: August 15, 2016
• Start date: August 2016
• Est. completion date: March 2017

Study information

• Verified date: August 2016
• Source: The Hong Kong Polytechnic University
• Contact: Yan LI, PhD student
• Phone: 3400
• Email: 14900768r[@]connect.polyu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: University Grants Committee
• Study type: Interventional

Clinical Trial 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 Xi'an, 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 Xi'an, China. There will be 50 patients in each of the two study groups (i.e., 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 21.0. 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 (ANCOVA).This 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Planned to stay at the hospital for inpatient rehabilitation at least for three months;

• Traumatic injury or nontraumatic injury diagnosed by the physician, and within 2 years onset of the illness;

• Aged 18 to 64 years adults, able to communicate in Mandarin;

• Able to understand and follow the instructions and practices as required by the COSP programme;

• Voluntarily participating and with capacity to provide written or verbal consent.

Exclusion Criteria:

• Cognitively impaired (Mini Mental State Examination test score less than 23);

• Current mental illness (diagnosed as schizophrenia, anxiety disorder, or mood disorders), which can interfere with the understanding and learning provided by the intervention;

• Suffering from severe pain (NRS more than 7), frequent or much somatic complaints, social withdrawal as shown in the patient progressive sheets or physician's recent assessment records;

• High risk of self-harm (i.e., having a plan to hurt him/herself and having suicidal intention or ideas expressed recently);

• Currently engaged in another psychotherapeutic intervention(s) (e.g., psycho-education, social skills training, CBT, structured counseling programme, or other psychotherapies), and currently involved in any interventional trial.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Psychosocial Problem
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Behavioral:
• Experimental: Intervention group---coping-oriented supportive programme

• Active Comparator: Comparison group---a didactic talk (usual care)

Locations

Country	Name	City	State
China	Yan LI	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in coping ability (assessed by the Coping Orientations to Problems Experienced Inventory)during 3-month follow-up	This proposed study will need to have repeated measures to see the short-to-long term effects of the COSP by measuring the changes of participants' coping ability.	Baseline, immediately after, 1- and 3-month post intervention	No
Primary	Changes in self-efficacy (assessed by the Moorong Self Efficacy Scale)during 3-month follow-up	This proposed study will need to have repeated measures to see the short-to-long term effects of the COSP by measuring the changes of participants' self-efficacy.	Baseline, immediately after, 1- and 3-month post intervention	No
Secondary	Changes in mood (assessed by Hospital Anxiety and Depression Scale) during 3-month follow-up	This proposed study will need to have repeated measures to see the short-to-long term effects of the COSP by measuring the changes of participants' mood.	Baseline, immediately after, 1- and 3-month post intervention	No
Secondary	Changes in life satisfaction (assessed by Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) during 3-month follow-up	This proposed study will need to have repeated measures to see the short-to-long term effects of the COSP by measuring the changes of participants' life satisfaction.	Baseline, immediately after, 1- and 3-month post intervention	No
Secondary	Changes in Pain (assessed by the Numerical Rating Scale) during 3-month follow-up	This proposed study will need to have repeated measures to see the short-to-long term effects of the COSP by measuring the changes of participants' pain level.	Baseline, immediately after, 1- and 3-month post intervention	No