Assessment of the Burden Within the Dyad Patient/Caregiver (RAPSODIE)
This study has been completed.
Sponsor:
Centre Oscar Lambret
Collaborators:
Unité de REcherche en sciences Cognitives et Affectives URECA EA1059
Université Lille Nord de France - Université de Lille 3
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT00921232
First received: May 29, 2009
Last updated: July 20, 2012
Last verified: July 2012
| Tracking Information | |||||
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| First Received Date ICMJE | May 29, 2009 | ||||
| Last Updated Date | July 20, 2012 | ||||
| Start Date ICMJE | April 2007 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Caregiver Reaction Assessment (CRA scale) completed by patient (hetero-perception) and its caregiver (auto-perception) [ Time Frame: At baseline, to the announcement of the exclusive palliative care ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00921232 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assessment of the Burden Within the Dyad Patient/Caregiver | ||||
| Official Title ICMJE | Crossed Assessment of the Burden Within the Dyad Patient/Caregiver: Analysis of Explanatory Factors and Consequences for Return at Home of the Life-ending Patient | ||||
| Brief Summary | This study is about the patients life ending and their caregiver, when a return to home is planned. This is a behavioral sciences study (= interventional study for french law) |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE | Palliative Care | ||||
| Intervention ICMJE | Behavioral: Questionnaires
During a consultation:
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| Study Arm (s) | dyad
life-ending patient and its caregiver
Intervention: Behavioral: Questionnaires |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 139 | ||||
| Completion Date | February 2008 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00921232 | ||||
| Other Study ID Numbers ICMJE | RAPSODIE | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Centre Oscar Lambret | ||||
| Study Sponsor ICMJE | Centre Oscar Lambret | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Centre Oscar Lambret | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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