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

Primary Purpose

Spinal Cord Injury, Psychosocial Problem

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Experimental: Intervention group---coping-oriented supportive programme
Active Comparator: Comparison group---a didactic talk (usual care)
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Yan LIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Coping-oriented supportive programme

A didactic group

Arm Description

Coping-oriented supportive programme: education of the SCI disease information, learning from role model by watching a well-established DVD, discussion about how to break down stressors and used appropriate coping strategies (problem-solving training, cognitive re-constructing, relaxation exercises, and activity scheduling) to manage the stressors relating to SCI. Social skills training and ways of maintaining and improving social support will also be discussed and practiced in the COSP.

Usual rehabilitation care--routine inpatient rehabilitation care and brief education in groups (structured by both the rehabilitation nurses and the researcher), which will consist of similar professional contacts as the intervention (COSP) group, and thus can balance between the two study groups for the effect of social contacts and attention to SCI patients during group sessions. The intervention in the comparison group will be conducted by a rehabilitation nurse in the SCI wards. The knowledge/didactic education presented to the patients in the comparison group will be the basic health education and relevant information provided by the rehabilitation nurses in their routine care (mainly including knowledge of SCI, nutritional needs, skin care, bowel and bladder training, and other physical and psychological care of patients with SCI provided by the inpatient rehabilitation wards).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 20, 2016
Last Updated
August 15, 2016
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02672670
Brief Title
Effects of a Coping-oriented Supportive Programme (COSP) for People With Spinal Cord Injury During Inpatient Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Psychosocial Problem

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coping-oriented supportive programme
Arm Type
Experimental
Arm Description
Coping-oriented supportive programme: education of the SCI disease information, learning from role model by watching a well-established DVD, discussion about how to break down stressors and used appropriate coping strategies (problem-solving training, cognitive re-constructing, relaxation exercises, and activity scheduling) to manage the stressors relating to SCI. Social skills training and ways of maintaining and improving social support will also be discussed and practiced in the COSP.
Arm Title
A didactic group
Arm Type
Active Comparator
Arm Description
Usual rehabilitation care--routine inpatient rehabilitation care and brief education in groups (structured by both the rehabilitation nurses and the researcher), which will consist of similar professional contacts as the intervention (COSP) group, and thus can balance between the two study groups for the effect of social contacts and attention to SCI patients during group sessions. The intervention in the comparison group will be conducted by a rehabilitation nurse in the SCI wards. The knowledge/didactic education presented to the patients in the comparison group will be the basic health education and relevant information provided by the rehabilitation nurses in their routine care (mainly including knowledge of SCI, nutritional needs, skin care, bowel and bladder training, and other physical and psychological care of patients with SCI provided by the inpatient rehabilitation wards).
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Intervention group---coping-oriented supportive programme
Other Intervention Name(s)
COSP
Intervention Type
Behavioral
Intervention Name(s)
Active Comparator: Comparison group---a didactic talk (usual care)
Other Intervention Name(s)
UC
Primary Outcome Measure Information:
Title
Changes in coping ability (assessed by the Coping Orientations to Problems Experienced Inventory)during 3-month follow-up
Description
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.
Time Frame
Baseline, immediately after, 1- and 3-month post intervention
Title
Changes in self-efficacy (assessed by the Moorong Self Efficacy Scale)during 3-month follow-up
Description
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.
Time Frame
Baseline, immediately after, 1- and 3-month post intervention
Secondary Outcome Measure Information:
Title
Changes in mood (assessed by Hospital Anxiety and Depression Scale) during 3-month follow-up
Description
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.
Time Frame
Baseline, immediately after, 1- and 3-month post intervention
Title
Changes in life satisfaction (assessed by Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) during 3-month follow-up
Description
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.
Time Frame
Baseline, immediately after, 1- and 3-month post intervention
Title
Changes in Pain (assessed by the Numerical Rating Scale) during 3-month follow-up
Description
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.
Time Frame
Baseline, immediately after, 1- and 3-month post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan LI, PhD student
Phone
3400
Ext
8184
Email
14900768r@connect.polyu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Wai Tong CHIEN, PhD
Phone
2766
Ext
5648
Email
wai.tong.chien@polyu.edu.hk
Facility Information:
Facility Name
Yan LI
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan LI, PhD student
Phone
852-3400
Ext
8184
Email
14900768r@connect.polyu.hk
First Name & Middle Initial & Last Name & Degree
Wai Tong CHIEN, PhD
Phone
852-2766
Ext
5648
Email
wai.tong.chien@polyu.edu.hk
First Name & Middle Initial & Last Name & Degree
Yan LI, PhD student
First Name & Middle Initial & Last Name & Degree
Wai Tong Chien, PhD
First Name & Middle Initial & Last Name & Degree
Daniel T. Bressington, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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