Effects of a Coping-oriented Supportive Programme (COSP) for People With Spinal Cord Injury During Inpatient Rehabilitation
15. august 2016 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Studietype
Intervensjonell
Registrering (Forventet)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Hong Kong, Kina
- Rekruttering
- Yan Li
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Underetterforsker:
- Wai Tong Chien, PhD
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Ta kontakt med:
- Yan LI, PhD student
- Telefonnummer: 8184 852-3400
- E-post: 14900768r@connect.polyu.hk
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Ta kontakt med:
- Wai Tong CHIEN, PhD
- Telefonnummer: 5648 852-2766
- E-post: wai.tong.chien@polyu.edu.hk
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Hovedetterforsker:
- Yan LI, PhD student
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Underetterforsker:
- Daniel T. Bressington, PhD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 64 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Andre navn:
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Aktiv komparator: 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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Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in coping ability (assessed by the Coping Orientations to Problems Experienced Inventory)during 3-month follow-up
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in mood (assessed by Hospital Anxiety and Depression Scale) during 3-month follow-up
Tidsramme: 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
Tidsramme: 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.
|
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
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Studierekorddatoer
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Studer hoveddatoer
Studiestart
1. august 2016
Primær fullføring (Forventet)
1. mars 2017
Studiet fullført (Forventet)
1. mars 2017
Datoer for studieregistrering
Først innsendt
20. januar 2016
Først innsendt som oppfylte QC-kriteriene
30. januar 2016
Først lagt ut (Anslag)
3. februar 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
16. august 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. august 2016
Sist bekreftet
1. august 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HSEARS20151219002
Plan for individuelle deltakerdata (IPD)
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