Clinical trial NCT00698165: Observational Study on Costs and Caregiver Burden in Alzheimer's Disease
Official title: Observational Study on Costs and Caregiver Burden in Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: i3 Innovus
First posted: 2008-06-17
Enrollment: 2400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Mini-Mental State Examination (MMSE), Disability Assessment for Dementia Scale (DAD), Neuropsychiatric Inventory Questionnaire (NPI-Q)
timeFrame: Collected one time only
Secondary outcomes:
measure: Resource Utilization in Dementia (RUD)
timeFrame: collected one time only
measure: Short Form - 12 domains instrument (SF-12)
timeFrame: collected one time only
measure: World Health Organization Quality of Life instrument (WHO-QoL)
timeFrame: collected one time only
measure: Zarit Caregiver Burden Interview (ZBI)
timeFrame: collected one time only
measure: 15 domains Quality of Life Index instrument (15D)
timeFrame: collected one time only
Other outcomes:
Locations:
city: Northport
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Brentwood
country: United States
facility: Research Site
state: California
city: Fresno
country: United States
facility: Research Site
state: California
city: LaHabra
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Wetherfield
country: United States
facility: Research Site
state: Connecticut
city: Atlantis
country: United States
facility: Research Site
state: Florida
city: Fort Myers
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Port Charlotte
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Titusville
country: United States
facility: Research Site
state: Florida
city: Venice
country: United States
facility: Research Site
state: Florida
city: Canton
country: United States
facility: Research Site
state: Georgia
city: Columbus
country: United States
facility: Research Site
state: Georgia
city: Decatur
country: United States
facility: Research Site
state: Georgia
city: Dunwoody
country: United States
facility: Research Site
state: Georgia
city: Snellville
country: United States
facility: Research Site
state: Georgia
city: Belleville
country: United States
facility: Research Site
state: Illinois
city: Ft Wayne
country: United States
facility: Research Site
state: Indiana
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: Prince Frederick
country: United States
facility: Research Site
state: Maryland
city: Pittsfield
country: United States
facility: Research Site
state: Massachusetts
city: Eaton Rapids
country: United States
facility: Research Site
state: Michigan
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Eatontown
country: United States
facility: Research Site
state: New Jersey
city: Albany
country: United States
facility: Research Site
state: New York
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Syracuse
country: United States
facility: Research Site
state: New York
city: Asheboro
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Hickory
country: United States
facility: Research Site
state: North Carolina
city: Winston Salem
country: United States
facility: Research Site
state: North Carolina
city: Canton
country: United States
facility: Research Site
state: Ohio
city: Centerville
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: East Providence
country: United States
facility: Research Site
state: Rhode Island
city: Beaufort
country: United States
facility: Research Site
state: South Carolina
city: Summerville
country: United States
facility: Research Site
state: South Carolina
city: Port Arthur
country: United States
facility: Research Site
state: Texas
city: Tyler
country: United States
facility: Research Site
state: Texas
city: Witchita Falls
country: United States
facility: Research Site
state: Texas
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Gig Harbor
country: United States
facility: Research Site
state: Washington
city: Richland
country: United States
facility: Research Site
state: Washington
city: Cruces
country: Spain
facility: Research Site
state: Barakaldo
city: Alicante
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Burgos
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Seville
country: Spain
facility: Research Site
city: Bergsjo
country: Sweden
facility: Research Site
city: Bromma
country: Sweden
facility: Research Site
city: Jonkoping
country: Sweden
facility: Research Site
city: Karlstad
country: Sweden
facility: Research Site
city: Kristianstad
country: Sweden
facility: Research Site
city: Lomma
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Ornskoldsvik
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Umea
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Varberg
country: Sweden
facility: Research Site
city: Overton
country: United Kingdom
facility: Research Site
state: Basingstoke
city: Eastbourne
country: United Kingdom
facility: Research Site
state: East Sussex
city: Coney Hill
country: United Kingdom
facility: Research Site
state: Gloucester
city: Barnet
country: United Kingdom
facility: Research Site
state: Hertfordshire
city: Wood Green
country: United Kingdom
facility: Research Site
state: London
city: Brighton
country: United Kingdom
facility: Research Site
city: Chester
country: United Kingdom
facility: Research Site
city: Hove
country: United Kingdom
facility: Research Site
city: Ipswich
country: United Kingdom
facility: Research Site
city: Norwich
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
city: Romsey
country: United Kingdom
facility: Research Site
city: Salisbury
country: United Kingdom
facility: Research Site
city: Stanmore
country: United Kingdom
facility: Research Site
city: Uckfield
country: United Kingdom
facility: Research Site
Study officials:
affiliation: i3 Innovus
name: Linus Jönsson
role: STUDY_DIRECTOR
References: