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Clinical Trials/NCT02672670
NCT02672670
Unknown
Not Applicable

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

The Hong Kong Polytechnic University1 site in 1 country100 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injury
Sponsor
The Hong Kong Polytechnic University
Enrollment
100
Locations
1
Primary Endpoint
Changes in coping ability (assessed by the Coping Orientations to Problems Experienced Inventory)during 3-month follow-up
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
March 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

LI Yan

PhD student

The Hong Kong Polytechnic University

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Changes in life satisfaction (assessed by Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) during 3-month follow-up(Baseline, immediately after, 1- and 3-month post intervention)
  • Changes in mood (assessed by Hospital Anxiety and Depression Scale) during 3-month follow-up(Baseline, immediately after, 1- and 3-month post intervention)
  • Changes in Pain (assessed by the Numerical Rating Scale) during 3-month follow-up(Baseline, immediately after, 1- and 3-month post intervention)

Study Sites (1)

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