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Observational Study on Costs and Caregiver Burden in Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
i3 Innovus
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00698165
First received: June 16, 2008
Last updated: February 19, 2009
Last verified: February 2009
History of Changes
  Purpose

Objective of study is to assess the costs of care, objective and subjective caregiver burden and quality of life in relation to disease severity measured by cognitive function, ADL capabilities and presence of behavioral disturbances in Alzheimer's disease


Condition
Alzheimer's Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Observational Study on Costs and Caregiver Burden in Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Mini-Mental State Examination (MMSE), Disability Assessment for Dementia Scale (DAD), Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: Collected one time only ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Resource Utilization in Dementia (RUD) [ Time Frame: collected one time only ] [ Designated as safety issue: No ]
  • Short Form - 12 domains instrument (SF-12) [ Time Frame: collected one time only ] [ Designated as safety issue: No ]
  • World Health Organization Quality of Life instrument (WHO-QoL) [ Time Frame: collected one time only ] [ Designated as safety issue: No ]
  • Zarit Caregiver Burden Interview (ZBI) [ Time Frame: collected one time only ] [ Designated as safety issue: No ]
  • 15 domains Quality of Life Index instrument (15D) [ Time Frame: collected one time only ] [ Designated as safety issue: No ]

Estimated Enrollment: 2400
Study Start Date: June 2007
Study Completion Date: January 2009
Groups/Cohorts
Patients
1200 adults with mild to severe Alzheimer's disease
Caregivers
1200 informal caregivers

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with Alzheimer's Disease and their informal caregivers are recruited from both outpatient settings and long-term residential care settings

Criteria

Inclusion Criteria:

  • Clinical diagnosis of possible or probable Alzheimer's disease, with or without vascular elements
  • The primary caregiver can be identified
  • The patient and his/her primary caregiver are both willing and able to participate in the study

Exclusion Criteria:

  • Patient or caregiver affected by alcohol or narcotics to the extent that it interferes with the completion of the study
  • Patient or caregiver does not understand English
  • Patient and/ or caregiver is the physician or physician's staff
  • Patient and/ or caregiver is a family member of the physician or physician's staff
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698165

  Show 82 Study Locations
Sponsors and Collaborators
AstraZeneca
i3 Innovus
Investigators
Study Director: Linus Jönsson i3 Innovus
  More Information

No publications provided

Responsible Party: Hans-Göran Hårdemark, Medical Science Director, AstraZeneca R&D
ClinicalTrials.gov Identifier: NCT00698165     History of Changes
Other Study ID Numbers: EHE 1100
Study First Received: June 16, 2008
Last Updated: February 19, 2009
Health Authority: Spain: Comité Ético de Investigación Clínica
Sweden: Regional Ethical Review Board
United Kingdom: National Health Service

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013