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- Ensaio Clínico NCT07642726
Change in Cognition and Frailty After Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus (iNPH)
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Frailty is a consequence of cumulative decline in many physiological systems during a lifetime and implies an increased vulnerability to poor resolution of homoeostasis after a stressor event. Frailty is emerging as an important risk factor for mortality and postoperative complications but has to a limited degree been studied in iNPH.
The investigators have previously, in a cross-sectional design, described cognitive profile and frailty status in patients with iNPH accepted for shunt surgery at Oslo University Hospital. The aims of this longitudinal follow-up of the same patient cohort are twofold:
- to describe changes in cognitive profile and frailty from pre shunt to one year after the shunt surgery, and
- to identify clinical predictors of an improvement in terms of cognition and frailty during the same period.
The patient sample consists of 276 patients that were accepted for shunt surgery at Oslo University Hospital in the period from September 2018 to December 2023. Their mean age was 73.1 years (range 52-85), 61% were men, and their mean length of education was 12.5 years.
For frailty, the investigators used a 35 items Frailty Index (FI). Most of the items (frailty indicators) are scored 0 (not present) or 1 (present), while some of them have a graded score. The index is the sum score divided by the number of items, varying from 0.0 (no frailty) to 1.0 (extreme frailty). The investigators used the same approach for assessment of the degree of frailty within each frailty domain. Cognitive decline is considered as one component of frailty. Accordingly, the Mini Mental State Examination (MMSE) is part of the FI and has a graded score. MMSE sum score <21 gives a score of 1 at this particular FI item, an MMSE score of 21-23 gives an item score of 0.7, an MMSE score of 24-26 gives an item score of 0.3, whereas an MMSE score of 27-30 does not contribute to the FI. MMSE is a screening test covering several cognitive domains. The investigators will use MMSE to evaluate the cognitive dimension of frailty as described here, whereas more specific cognitive tests are utilised to assess failure in particular cognitive domains.
Preoperatively, the mean FI score was 0.23, and the most common frailty markers were in the domains of physical function and instrumental activities of daily living (iADL). On the group level, the iNPH patients were impaired on all cognitive domains preoperatively, but compared to patients with Alzheimer's disease, they had relatively better-preserved memory and more severe impairments in phonemic fluency.
224 (83%) patients were assessed one year postoperatively. The same cognitive tests and frailty assessments were carried out, making it possible to calculate simple change scores as score(postop) - score(preop). The investigators will compare baseline characteristics of patients lost to follow-up descriptively with those followed, to assess potential attrition bias.
A detailed Statistical Analysis Plan (SAP) describes the planned analytical approach.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Oslo, Noruega
- Department of Geriatric Medicine, Oslo University Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
• Diagnosed with iNPH and accepted for shunt surgery according to the American-European guidelines at Department of Neurosurgery, Oslo University Hospital, Rikshospitalet.
Exclusion Criteria:
- Non-native speakers of Norwegian
- Patients who had completed ≤ 3 cognitive tests
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Patients with idiopathic normal pressure hydrocephalus accepted for shunt surgery
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Patients are already accepted for shunt surgery.
The investigators will describe changes in cognitve profile and frailty from pre shunt to one year after to identify clinical predictors for shunt response.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Trail Making Test A (TMT A) from preoperative to postoperative in patients with idiopathic normal pressure hydrocephalus (iNPH).
Prazo: 12 month
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TMT A is a cognitive test assessing attention and psychomotor speed and is scored in seconds.
The investigators have defined a Minimum Clinically Important Difference (MCID) as an improvement of 20 seconds.
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12 month
|
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Change in Frailty Index (FI) from preoperative to postoperative in patients with idiopathic normal pressure hydrocephalus (iNPH).
Prazo: 12 months
|
For frailty, a 35 items FI was used.
Most of the items (frailty indicators) are scored 0 (not present) or 1 (present), while some of them have a graded score.
The index is the sum score divided by the numbers of items, varying from 0.0 (no frailty) to 1.0 (extreme frailty).
The investigators have defined a Minimum Clinically Important Difference (MCID) as a decrease in the FI of 0.05 (5 %) or more.
|
12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Other measures of cognition and frailty
Prazo: 12 months
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Mini Mental State Examination (MMSE-NR3) is a cognitive screening test from 0 - 30 covering several cognitive domains.
Higher score indicates better function.
MMSE is part of the FI and has a graded score.
MMSE sum score <21 gives a score of 1 at this particular FI item, an MMSE score of 21-23 gives an item score of 0.7, an MMSE score of 24-26 gives an item score of 0.3, whereas an MMSE score of 27-30 does not contribute to the FI.
MCID: 2 points.
|
12 months
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Other measures of cognition and frailty
Prazo: 12 months
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Personal activities in daily living (pADL) are subscales of the FI and are scored from 0-7, higher score indicates more need for help in daily living.
An improvement is set to at least 5 % for subscale as a limit for MCID.
|
12 months
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Other measures of cognition and frailty
Prazo: 12 months
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Instrumental activities in daily living (iADL) are subscales of the FI and are scored from 0-7, higher score indicates more need for help in daily living.
An improvement is set to at least 5 % for subscale as a limit for MCID.
|
12 months
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Other measures of cognition and frailty
Prazo: 12 months
|
Gait speed (m/s) is measured from 10 m walk and 0.1 m/s or more is accepted as clinically meaningful.
MCID is set to 0.1 m/s.
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12 months
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Other measures of cognition and frailty
Prazo: 12 months
|
Cognitive variables: For assessing memory, delayed word recall is assessed using a normalized score ranging from 0 to 1. This score is derived from either the Ten-Word Test from Consortium to Establish a Registry for Alzheimer's disease (CERAD) or the Rey Auditory Learning Test. These scores are min/max normalized in order to achieve one common measure of delayed word recall: Normalized score = (raw score - lowest possible score)/(higest possible score - lowest possible score). The investigators have defined MCID of 0.2 words. |
12 months
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Other measures of cognition and frailty
Prazo: 12 months
|
Figure Construction Test from CERAD is a cognitive test assessing visuoconstructive abilities and its scored from 0 to 11.
Higher score reflects better performance.
MCID: 2 points.
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12 months
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Other measures of cognition and frailty
Prazo: 12 months
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Trail Making Test B is a cognitive test assessing attention, psychomotor speed and executive function and is scored in seconds.
MCID: 60 seconds.
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12 months
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Other measures of cognition and frailty
Prazo: 12 months
|
The Phonemic Fluency Test is a cognitive test assessing language abilities and executive function.
Higher score reflects better performance.
MCID:10 words.
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12 months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Responder analysis
Prazo: 12 months
|
Based on the MCID limits for each outcome, the investigators will define a responder for each outcome as a patient improving that much or more from the preoperative to the one-year postoperative assessment and will calculate the percentage of responders for each of the outcomes. The investigators will then analyse predictors for shunt response on each of the ten outcome variables. Candidate variables in the prediction models are: 1. Age. 2. Sex. 3. Education. 4. MMSE-NR3 score. 5. Gait speed. 6. FI score. 7. Difference in z-score between phonemic fluency and delayed recall at baseline. 8. Cluster affiliation (based on a previously published cluster analysis. The analytic strategy is described in detail in the Statistical Analysis Plan (SAP) that is uploaded as a separate document. |
12 months
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Transtornos Mentais, Desordem Mental
- Processos Patológicos
- Distúrbios Neurocognitivos
- Distúrbios Cognitivos
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Fragilidade
- Disfunção cognitiva
- Limitação de Mobilidade
- Demência
- Procedimentos cirúrgicos, operatórios
- Procedimentos neurocirúrgicos
- Anastomose, cirúrgica
- Desvios de líquido cefalorraquidiano
- Derivação ventriculoperitoneal
Outros números de identificação do estudo
- 10150 (formerly 2019/547)
- Funded by (Outro identificador: Department of Geriatric Medicine Oslo University Hospital)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
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