- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02672670
Effects of a Coping-oriented Supportive Programme (COSP) for People With Spinal Cord Injury During Inpatient Rehabilitation
2016년 8월 15일 업데이트: LI Yan, The Hong Kong Polytechnic University
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.
연구 개요
상태
알려지지 않은
연구 유형
중재적
등록 (예상)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Hong Kong, 중국
- 모병
- Yan Li
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부수사관:
- Wai Tong Chien, PhD
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연락하다:
- Yan LI, PhD student
- 전화번호: 8184 852-3400
- 이메일: 14900768r@connect.polyu.hk
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연락하다:
- Wai Tong CHIEN, PhD
- 전화번호: 5648 852-2766
- 이메일: wai.tong.chien@polyu.edu.hk
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수석 연구원:
- Yan LI, PhD student
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부수사관:
- Daniel T. Bressington, PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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다른 이름들:
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활성 비교기: 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).
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다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in coping ability (assessed by the Coping Orientations to Problems Experienced Inventory)during 3-month follow-up
기간: Baseline, immediately after, 1- and 3-month post intervention
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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.
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Baseline, immediately after, 1- and 3-month post intervention
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Changes in self-efficacy (assessed by the Moorong Self Efficacy Scale)during 3-month follow-up
기간: Baseline, immediately after, 1- and 3-month post intervention
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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.
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Baseline, immediately after, 1- and 3-month post intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in mood (assessed by Hospital Anxiety and Depression Scale) during 3-month follow-up
기간: Baseline, immediately after, 1- and 3-month post intervention
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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.
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Baseline, immediately after, 1- and 3-month post intervention
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Changes in life satisfaction (assessed by Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) during 3-month follow-up
기간: Baseline, immediately after, 1- and 3-month post intervention
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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.
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Baseline, immediately after, 1- and 3-month post intervention
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Changes in Pain (assessed by the Numerical Rating Scale) during 3-month follow-up
기간: Baseline, immediately after, 1- and 3-month post intervention
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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.
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Baseline, immediately after, 1- and 3-month post intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2016년 8월 1일
기본 완료 (예상)
2017년 3월 1일
연구 완료 (예상)
2017년 3월 1일
연구 등록 날짜
최초 제출
2016년 1월 20일
QC 기준을 충족하는 최초 제출
2016년 1월 30일
처음 게시됨 (추정)
2016년 2월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 8월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 8월 15일
마지막으로 확인됨
2016년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .