- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02672670
Effects of a Coping-oriented Supportive Programme (COSP) for People With Spinal Cord Injury During Inpatient Rehabilitation
15 août 2016 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Type d'étude
Interventionnel
Inscription (Anticipé)
100
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Hong Kong, Chine
- Recrutement
- Yan Li
-
Sous-enquêteur:
- Wai Tong Chien, PhD
-
Contact:
- Yan LI, PhD student
- Numéro de téléphone: 8184 852-3400
- E-mail: 14900768r@connect.polyu.hk
-
Contact:
- Wai Tong CHIEN, PhD
- Numéro de téléphone: 5648 852-2766
- E-mail: wai.tong.chien@polyu.edu.hk
-
Chercheur principal:
- Yan LI, PhD student
-
Sous-enquêteur:
- Daniel T. Bressington, PhD
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 64 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
|
Autres noms:
|
Comparateur actif: 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).
|
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Changes in coping ability (assessed by the Coping Orientations to Problems Experienced Inventory)during 3-month follow-up
Délai: 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.
|
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
Délai: 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.
|
Baseline, immediately after, 1- and 3-month post intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Changes in mood (assessed by Hospital Anxiety and Depression Scale) during 3-month follow-up
Délai: 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.
|
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
Délai: 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.
|
Baseline, immediately after, 1- and 3-month post intervention
|
Changes in Pain (assessed by the Numerical Rating Scale) during 3-month follow-up
Délai: 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.
|
Baseline, immediately after, 1- and 3-month post intervention
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 août 2016
Achèvement primaire (Anticipé)
1 mars 2017
Achèvement de l'étude (Anticipé)
1 mars 2017
Dates d'inscription aux études
Première soumission
20 janvier 2016
Première soumission répondant aux critères de contrôle qualité
30 janvier 2016
Première publication (Estimation)
3 février 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
16 août 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 août 2016
Dernière vérification
1 août 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HSEARS20151219002
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Lésion de la moelle épinière
-
Universitaire Ziekenhuizen KU LeuvenRecrutementComparaison de différents sites de prélèvement de LCR sur des drains ventriculaires externes (CSF3S)Liquide cérébro-spinalBelgique
-
Assiut UniversityRecrutement
-
First People's Hospital of ChenzhouPas encore de recrutementGravité spécifique | Liquide cérébro-spinalChine
-
Columbia UniversityComplétéSpinal; Crevaison, ComplicationsÉtats-Unis
-
Yi Feng, MDInconnueVieilli | Flurbiprofène Axétil | Anesthésie, Rachis | Liquide cérébro-spinalChine
-
Ahmed talaat ahmed alyInconnue
-
Rennes University HospitalComplétéSpina bifida ou dysraphisme spinalFrance
-
Paropakar Maternity and Women's HospitalInconnueHypotension | Indice de perfusion | Spinal
-
Assistance Publique Hopitaux De MarseillePas encore de recrutementVessie neurogène due à un dysraphisme spinalFrance
-
Yonsei UniversityComplétéRadiculopathie lombaire due à la compression du nerf spinalCorée, République de
Essais cliniques sur Experimental: Intervention group---coping-oriented supportive programme
-
Lady Davis InstituteComplétéSclérodermie systémiqueCanada