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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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ClinicalTrials.gov Identifier: NCT02672670
Recruitment Status : Unknown
Verified August 2016 by LI Yan, The Hong Kong Polytechnic University.
Recruitment status was:  Recruiting
First Posted : February 3, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
LI Yan, The Hong Kong Polytechnic University

Tracking Information
First Submitted Date  ICMJE January 20, 2016
First Posted Date  ICMJE February 3, 2016
Last Update Posted Date August 16, 2016
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2016)
  • Changes in coping ability (assessed by the Coping Orientations to Problems Experienced Inventory)during 3-month follow-up [ Time Frame: Baseline, immediately after, 1- and 3-month post intervention ]
    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 [ Time Frame: Baseline, immediately after, 1- and 3-month post intervention ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2016)
  • Changes in mood (assessed by Hospital Anxiety and Depression Scale) during 3-month follow-up [ Time Frame: Baseline, immediately after, 1- and 3-month post intervention ]
    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 [ Time Frame: Baseline, immediately after, 1- and 3-month post intervention ]
    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 [ Time Frame: Baseline, immediately after, 1- and 3-month post intervention ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of a Coping-oriented Supportive Programme (COSP) for People With Spinal Cord Injury During Inpatient Rehabilitation
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Spinal Cord Injury
  • Psychosocial Problem
Intervention  ICMJE
  • Behavioral: Experimental: Intervention group---coping-oriented supportive programme
    Other Name: COSP
  • Behavioral: Active Comparator: Comparison group---a didactic talk (usual care)
    Other Name: UC
Study Arms  ICMJE
  • Experimental: Coping-oriented supportive programme
    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.
    Intervention: Behavioral: Experimental: Intervention group---coping-oriented supportive programme
  • Active Comparator: A didactic group
    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: Behavioral: Active Comparator: Comparison group---a didactic talk (usual care)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 30, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2017
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02672670
Other Study ID Numbers  ICMJE HSEARS20151219002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party LI Yan, The Hong Kong Polytechnic University
Study Sponsor  ICMJE The Hong Kong Polytechnic University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Hong Kong Polytechnic University
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP