Cognitive Behavioural Therapy of Early Dementia (KORDIAL)
| Tracking Information | |||||
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| First Received Date ICMJE | August 13, 2008 | ||||
| Last Updated Date | January 13, 2011 | ||||
| Start Date ICMJE | April 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Functional ability in the everyday context [ Time Frame: Baseline, post treatment, 6 months post treatment ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00735046 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Quality of life, depression, neuro-psychiatric symptoms [ Time Frame: Same as for primary outcome ] [ Designated as safety issue: No ] | ||||
| 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 | Cognitive Behavioural Therapy of Early Dementia | ||||
| Official Title ICMJE | Cognitive Behavioural Resource-based Therapy of Early Dementia in the Everyday Setting | ||||
| Brief Summary | A randomized, controlled, parallel-group trial to evaluate the efficacy of a cognitive behavioral therapy for patients with early dementia. |
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| Detailed Description | The KORDIAL study is a randomized, controlled, parallel-group trial evaluating the efficacy of a cognitive behavioral therapy for patients at the early stage of Alzheimer's disease. The 3-month experimental intervention consists of 12 individual sessions with regular involvement of carers or other patient proxies. Strategies for improving the patient's coping ability and for enhancing their psychological well-being are combined. The primary outcome criterion is functioning in the everyday context after completion of the intervention and after another 6 months. The control condition will be treatment as usual. The study will be conducted in 5 university outpatient units and in 5 specialist offices. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: None Retained Description: not required |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients referred to memory clinics and specialist (psychiatrist, neurologist) offices |
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| Condition ICMJE | Dementia | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * |
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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 | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | April 2010 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 95 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00735046 | ||||
| Other Study ID Numbers ICMJE | KOR-683-KUR-0000-I | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Alexander Kurz M.D., klinikum rechts der Isar | ||||
| Study Sponsor ICMJE | Technische Universität München | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Technische Universität München | ||||
| Verification Date | July 2008 | ||||
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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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