Observational Study on Costs and Caregiver Burden in Alzheimer's Disease
This study has been completed.
Sponsor:
AstraZeneca
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
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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:
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
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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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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 | |
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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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| United States, Illinois | |
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| Belleville, Illinois, United States | |
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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 | |
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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
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 Brain Diseases Central Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Dementia |
Mental Disorders Nervous System Diseases Neurodegenerative Diseases Tauopathies |
ClinicalTrials.gov processed this record on February 27, 2015