|- candidate number||27904|
|- NTR Number||NTR6720|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-sep-2017|
|- Secondary IDs||15-N-114 METC Zuyderland Medisch Centrum te Heerlen|
|- Public Title||Decision tool topklinische GGZ voor ouderen met een persoonlijkheidsstoornis: Ontwikkeling en validering.
|- Scientific Title||A decision tool to identify elderly patients with personality disorders in need of highly specialized care: development and validation of an age-specific checklist. |
|- hypothesis||The aim of this study is to develop and validate an age-specific checklist that can help clinicians to identify elderly patients with personality disorders in need of highly specialized mental health care. |
|- Healt Condition(s) or Problem(s) studied||Personality disorder|
|- Inclusion criteria||Phase 1: Development of the checklist(Delphi-study):|
- The clinician is a member of the Expertpanel Persoonlijkheid & Ouderen (EPO).
- The clinician works in Mental Health Care.
- The clinician works in the Netherlands
Phase 2: Validation of the checklist:
- Clincians fill out the checklist for outpatients referred to (highly) specialized mental health care because of a (suspicion of a) personality disorder.
|- Exclusion criteria||None, for both phases there are no additional exclusion criteria. |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-sep-2016|
|- planned closingdate||31-dec-2017|
|- Target number of participants||90|
|- Interventions||Phase 1: patricipation in an expertmeeting by selected experts.|
Phase 2: filling out the checklist by the clinician.
|- Primary outcome||Phase 1: |
The primary outcome of the Delphi-study is an age-specific checklist to identify elderly patients with a personality disorder in need of highly specialized care.
The primary outcome of the validation study is a cut-off point for the checklist with optimal specifity and sensitivity.
|- Secondary outcome||Phase 2:|
In the second fase the interrater reliability of the checklist will be determined as well.
|- Timepoints||The expertmeeting is planned in september 2016. |
Inclusion for the validition study starts in january 2017.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Mw. drs. L.A.E. Laheij-Rooijakkers|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. S.P.J. van Alphen |
|- Sponsor/Initiator ||Mondriaan Hospital, Department of Old Age Psychiatry|
(Source(s) of Monetary or Material Support)
|- Brief summary||Recently a decision tool has been developed to identify adults with personality disorders in need of highly specialized care. Because of age-specific aspects of personality disorders (for example because of ) it can not be assumed without question that this decision tool is suitable for elderly. In the first part of this study, based on expert opinion, the decison tool for adults will be adjusted for an elderly population. The second part of this study is a validation study of this new tool.|
|- Main changes (audit trail)|
|- RECORD||11-sep-2017 - 12-okt-2017|