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

NCT00698165 | Completed

• 1 other identifier: EHE 1100
• Study Type: observational
• Target: 2,400
• Locations: 4 countries
• Sites: 82

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

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Mini-Mental State Examination (MMSE), Disability Assessment for Dementia Scale (DAD), Neuropsychiatric Inventory Questionnaire (NPI-Q)

  Collected one time only

Secondary Outcomes (5)

• Resource Utilization in Dementia (RUD)

  collected one time only

• Short Form - 12 domains instrument (SF-12)

  collected one time only

• World Health Organization Quality of Life instrument (WHO-QoL)

  collected one time only

• Zarit Caregiver Burden Interview (ZBI)

  collected one time only

• 15 domains Quality of Life Index instrument (15D)

  collected one time only

Study Arms (2)

Patients

1200 adults with mild to severe Alzheimer's disease

Caregivers

1200 informal caregivers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• i3 Innovus: collaborator

Study Sites (82)

Research Site

Northport, Alabama, United States

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Phoenix, Arizona, United States

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Brentwood, California, United States

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Fresno, California, United States

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La Habra, California, United States

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Long Beach, California, United States

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Denver, Colorado, United States

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Wetherfield, Connecticut, United States

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Atlantis, Florida, United States

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Fort Myers, Florida, United States

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Miami, Florida, United States

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Port Charlotte, Florida, United States

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Tampa, Florida, United States

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Titusville, Florida, United States

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Venice, Florida, United States

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Canton, Georgia, United States

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Columbus, Georgia, United States

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Decatur, Georgia, United States

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Dunwoody, Georgia, United States

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Snellville, Georgia, United States

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Belleville, Illinois, United States

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Fort Wayne, Indiana, United States

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Shreveport, Louisiana, United States

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Bethesda, Maryland, United States

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Prince Frederick, Maryland, United States

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Pittsfield, Massachusetts, United States

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Eaton Rapids, Michigan, United States

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St Louis, Missouri, United States

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Eatontown, New Jersey, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Syracuse, New York, United States

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Asheboro, North Carolina, United States

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Charlotte, North Carolina, United States

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Hickory, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Canton, Ohio, United States

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Centerville, Ohio, United States

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Oklahoma City, Oklahoma, United States

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East Providence, Rhode Island, United States

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Beaufort, South Carolina, United States

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Summerville, South Carolina, United States

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Port Arthur, Texas, United States

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Tyler, Texas, United States

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Witchita Falls, Texas, United States

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Norfolk, Virginia, United States

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Gig Harbor, Washington, United States

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Richland, Washington, United States

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Cruces, Barakaldo, Spain

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Alicante, Spain

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Barcelona, Spain

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Burgos, Spain

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Madrid, Spain

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Seville, Spain

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Bergsjö, Sweden

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Bromma, Sweden

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Jönköping, Sweden

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Karlstad, Sweden

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Kristianstad, Sweden

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Lomma, Sweden

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Lund, Sweden

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Malmo, Sweden

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Örnsköldsvik, Sweden

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Stockholm, Sweden

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Umeå, Sweden

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Uppsala, Sweden

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Varberg, Sweden

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Overton, Basingstoke, United Kingdom

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Eastbourne, East Sussex, United Kingdom

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Coney Hill, Gloucester, United Kingdom

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Barnet, Hertfordshire, United Kingdom

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Wood Green, London, United Kingdom

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Brighton, United Kingdom

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Chester, United Kingdom

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Hove, United Kingdom

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Ipswich, United Kingdom

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Norwich, United Kingdom

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Oxford, United Kingdom

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Romsey, United Kingdom

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Salisbury, United Kingdom

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Stanmore, United Kingdom

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Uckfield, United Kingdom

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MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Linus Jönsson

  i3 Innovus

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 16, 2008
• First Posted: June 17, 2008
• Study Start: June 1, 2007
• Study Completion: January 1, 2009
• Last Updated: February 20, 2009

Record last verified: 2009-02

Locations

SE (13); GB (15); US (48); ES (6)