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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00011776 |
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Date of registration:
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05/09/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cognitive stimulation in patients with Parkinson's Disease with cognitive impairment living in long-term care
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Scientific title:
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Cognitive stimulation in patients with Parkinson's Disease with cognitive impairment living in long-term care |
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Date of first enrolment:
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17/01/2017 |
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Target sample size:
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12 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00011776 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: No treatment / Standard of care; Assignment: crossover; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Miriam
Dorn |
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Address:
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Kerpenerstr. 62
50937
Köln
Germany |
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Telephone:
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+49 221 478 32976 |
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Email:
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miriam.dorn@uk-koeln.de |
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Affiliation:
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Medizinische Psychologie | Neuropsychologie und Gender Studies |
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Name:
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Elke
Kalbe |
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Address:
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Kerpenerstraße 62
50937
Köln
Germany |
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Telephone:
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+49 221 478-96244 |
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Email:
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elke.kalbe@uk-koeln.de |
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Affiliation:
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Universitätsklinik Köln, Medizinische Psychologie | Neuropsychologie und Gender Studies |
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Key inclusion & exclusion criteria
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Inclusion criteria: Clinical diagnosis conducted by neurologist or psychiatrist, mild to moderate dementia; Age: 50 years or older, mother tongue Dutch or very good skills in Dutch language; Good or sufficiently corrected vision and hearing
Exclusion criteria: MMSE overall score below 10 points; Major depression (operationalized by the CDS >12) (Rasmus, 2009); Alcohol and drug abuse in the last three years; Acute suicidal tendencies, acute psychotic symptoms, other serious / life-threatening comorbidities that oppose study participation
Age minimum:
50 Years
Age maximum:
100 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson disease
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G20
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Intervention(s)
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Group 1: The study has a cross-over design. The patients are randomized into two groups (A and B) including max.10 patients. Group A receives the cognitive stimulation during the first phase (0 - 8 weeks) of the study, Group B after a waiting time of 8 weeks. The program takes place in small groups (3 - 5 individuals). The cognitive Stimulation program NEUROvitalis sinnreich, translated into Dutch, is used. The intervention extends over a period of eight weeks, twice a week (16 exercise units) for 60 minutes. In addition to cognitively stimulating exercises, the program also includes fine motor skills training as well as multisensory stimulation.
Neuropsychological testing takes place before and after the intervention period as well as a six-week follow-up.
Group 2: Group B receives no intervention ("usual care") during the first phase (week 0 - 8) and the Dutch version of the cognitive stimulation NEUROvitalis sinnreich, during the second phase (week 9 - 16). Neuropsychological testing takes place before and after the first phase (week 0 - 8, cross over design), after the intervention (week 16), and at six-week follow-up.
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Primary Outcome(s)
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Cognition: times of measurement: Baseline, Posttest, Follow up (after 6 weeks) CERAD (+ Trail Making A+B, letter fluency), Clock Drawing Test
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Secondary Outcome(s)
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Patient-Related Endpoints:
Quality of life: measuring instruments: EQ-5D-5L (self-administered), EQ-5D-5L (proxy-administered) Quality of Life in Dementia (Qualidem, proxy-administered)
Depression; Measuring instruments: geriatric depression scale (GDS, self-administered), Cornell depression scale (CDS, proxy-administered);
Behavioral and psychiatric symptoms; Measuring instrument: neuropsychiatric inventory (NPI, proxy-administered);
Activities of daily life (ADLs); Measuring instrument: Barthel Index (proxy-administered);
All endpoints are collected at the time of pre- and post-testing (short-term effect) and after 6 weeks (long-term effect)
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Source(s) of Monetary Support
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Medizinische Psychologie | Neuropsychologie und Gender Studies
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Ethics review
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Status: Approved
Approval date: 07/01/2017
Contact:
meanderextra@mgzl.nl
Ethikkommission Lückerheide (Meander Wonen met Zorg) [Ethikkommission Lückerheide (Meander Wonen met Zorg), Kerkrade, NL
+31 45-574 88 00
meanderextra@mgzl.nl
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