Observational Study on Costs and Caregiver Burden in Alzheimer's Disease - Full Text View

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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Caregivers Alzheimer's Disease Caregivers

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

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 ]

Secondary Outcome Measures:

Resource Utilization in Dementia (RUD) [ Time Frame: collected one time only ]
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 ]


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


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698165

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Locations


United States, Alabama
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Northport, Alabama, United States
United States, Arizona
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Phoenix, Arizona, United States
United States, California
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Brentwood, California, United States
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Fresno, California, United States
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LaHabra, California, United States
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Long Beach, California, United States
United States, Colorado
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Denver, Colorado, United States
United States, Connecticut
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Wetherfield, Connecticut, United States
United States, Florida
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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
United States, Georgia
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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
United States, Illinois
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Belleville, Illinois, United States
United States, Indiana
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Ft Wayne, Indiana, United States
United States, Louisiana
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Shreveport, Louisiana, United States
United States, Maryland
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Bethesda, Maryland, United States
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Prince Frederick, Maryland, United States
United States, Massachusetts
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Pittsfield, Massachusetts, United States
United States, Michigan
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Eaton Rapids, Michigan, United States
United States, Missouri
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St. Louis, Missouri, United States
United States, New Jersey
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Eatontown, New Jersey, United States
United States, New York
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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
United States, North Carolina
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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
United States, Ohio
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Canton, Ohio, United States
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Centerville, Ohio, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
United States, Rhode Island
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East Providence, Rhode Island, United States
United States, South Carolina
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Beaufort, South Carolina, United States
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Summerville, South Carolina, United States
United States, Texas
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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
United States, Virginia
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Norfolk, Virginia, United States
United States, Washington
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Gig Harbor, Washington, United States
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Richland, Washington, United States
Spain
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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
Sweden
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Bergsjo, Sweden
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Bromma, Sweden
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Jonkoping, 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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Ornskoldsvik, Sweden
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Stockholm, Sweden
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Umea, Sweden
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Uppsala, Sweden
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Varberg, Sweden
United Kingdom
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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

Sponsors and Collaborators

AstraZeneca

i3 Innovus

Investigators


Study Director:	Linus Jönsson	i3 Innovus

More Information


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

Additional relevant MeSH terms:


Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases	Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 19, 2017