Effects of a Coping-oriented Supportive Programme (COSP) for People With Spinal Cord Injury During Inpatient Rehabilitation
2016年8月15日 更新者：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.
調査の概要
状態
わからない
研究の種類
介入
入学 (予想される)
100
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Hong Kong、中国
- 募集
- Yan Li
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副調査官：
- Wai Tong Chien, PhD
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コンタクト：
- Yan LI, PhD student
- 電話番号：8184 852-3400
- メール：14900768r@connect.polyu.hk
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コンタクト：
- Wai Tong CHIEN, PhD
- 電話番号：5648 852-2766
- メール：wai.tong.chien@polyu.edu.hk
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主任研究者：
- Yan LI, PhD student
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副調査官：
- Daniel T. Bressington, PhD
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～64年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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他の名前：
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アクティブコンパレータ：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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他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in coping ability (assessed by the Coping Orientations to Problems Experienced Inventory)during 3-month follow-up
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in mood (assessed by Hospital Anxiety and Depression Scale) during 3-month follow-up
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2016年8月1日
一次修了 (予想される)
2017年3月1日
研究の完了 (予想される)
2017年3月1日
試験登録日
最初に提出
2016年1月20日
QC基準を満たした最初の提出物
2016年1月30日
最初の投稿 (見積もり)
2016年2月3日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年8月16日
QC基準を満たした最後の更新が送信されました
2016年8月15日
最終確認日
2016年8月1日
詳しくは
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