Spinal Cord InjuryNCT02672670
Effects of a Coping-oriented Supportive Programme (COSP) for People With Spinal Cord Injury During Inpatient Rehabilitation
A study testing Experimental: Intervention group---coping-oriented supportive programme in people with Spinal Cord Injury and Psychosocial Problem, run by The Hong Kong Polytechnic University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury, Psychosocial Problem
- What is being tested?
- Experimental: Intervention group---coping-oriented supportive programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yan LI
Hong Kong
Yan LI, PhD student, 852-3400 ext. 8184, 14900768r@connect.polyu.hk
Wai Tong CHIEN, PhD, 852-2766 ext. 5648, wai.tong.chien@polyu.edu.hk
About this study
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.
- Conditions
- Spinal Cord Injury, Psychosocial Problem
- Being tested
- Experimental: Intervention group---coping-oriented supportive programme, Active Comparator: Comparison group---a didactic talk (usual care)
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Intervention group---coping-oriented supportive programmeBehavioural
Also called COSP
Active Comparator: Comparison group---a didactic talk (usual care)Behavioural
Also called UC
| Study group | Role | What they receive |
|---|---|---|
| Coping-oriented supportive programme | Experimental | 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. Receives: Behavioral: Experimental: Intervention group---coping-oriented supportive programme |
| A didactic group | Active comparator | 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). Receives: Behavioral: Active Comparator: Comparison group---a didactic talk (usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately after, 1- and 3-month post intervention
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.
Measured: Baseline, immediately after, 1- and 3-month post intervention
Secondary outcomes (3)
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.
Measured: Baseline, immediately after, 1- and 3-month post intervention
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.
Measured: Baseline, immediately after, 1- and 3-month post intervention
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.
Measured: Baseline, immediately after, 1- and 3-month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI Yan, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672670
- Sponsor's protocol ID
- HSEARS20151219002
- Status last verified
- Aug 2016
- First submitted
- 20 Jan 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Coping-oriented Supportive Programme (COSP) for People With Spinal Cord Injury During Inpatient Rehabilitation
- ClinicalTrials.gov ID
- NCT02672670
- Acronym / sponsor ID
- HSEARS20151219002
- Conditions
- Spinal Cord Injury, Psychosocial Problem
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coping-oriented supportive programme | Experimental | Behavioral: Experimental: Intervention group---coping-oriented supportive programmeCoping-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. |
| A didactic group | Active comparator | Behavioral: Active Comparator: Comparison group---a didactic talk (usual care)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). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Intervention group---coping-oriented supportive programmeAlso: COSP | Behavioural | Coping-oriented supportive programme |
| Active Comparator: Comparison group---a didactic talk (usual care)Also: UC | Behavioural | A didactic group |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Intervention group---coping-oriented supportive programme in people with Spinal Cord Injury and Psychosocial Problem, run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan LI, PhD student (3400 ext. 8184, 14900768r@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.