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

June 16, 2008
February 19, 2009
June 2007
Not Provided
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 ]
Mini-Mental State Examination (MMSE), Disability Assessment for Dementia Scale (DAD), Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: Collected one time only ]
Complete list of historical versions of study NCT00698165 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • World Health Organization Quality of Life instrument (WHO-QoL) [ Time Frame: collected one time only ]
  • Zarit Caregiver Burden Interview (ZBI) [ Time Frame: collected one time only ]
  • 15 domains Quality of Life Index instrument (15D) [ Time Frame: collected one time only ]
Not Provided
Not Provided
 
Observational Study on Costs and Caregiver Burden in Alzheimer's Disease
Observational Study on Costs and Caregiver Burden in Alzheimer's Disease

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

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

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

Alzheimer's Disease
Not Provided
  • Patients
    1200 adults with mild to severe Alzheimer's disease
  • Caregivers
    1200 informal caregivers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2400
January 2009
Not Provided

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Spain,   Sweden,   United Kingdom
 
NCT00698165
EHE 1100
No
Hans-Göran Hårdemark, Medical Science Director, AstraZeneca R&D
AstraZeneca
i3 Innovus
Study Director: Linus Jönsson i3 Innovus
AstraZeneca
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP