Observational Study on Costs and Caregiver Burden in Alzheimer's Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00698165 |
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Recruitment Status
:
Completed
First Posted
: June 17, 2008
Last Update Posted
: February 20, 2009
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Sponsor:
AstraZeneca
Collaborator:
i3 Innovus
Information provided by:
AstraZeneca
- Study Details
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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
| Condition or disease |
|---|
| Alzheimer's Disease |
| Study Type : | Observational |
| Estimated Enrollment : | 2400 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Cross-Sectional |
| Official Title: | Observational Study on Costs and Caregiver Burden in Alzheimer's Disease |
| Study Start Date : | June 2007 |
| Actual Study Completion Date : | January 2009 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Alzheimer disease
U.S. FDA Resources
| Group/Cohort |
|---|
|
Patients
1200 adults with mild to severe Alzheimer's disease
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Caregivers
1200 informal caregivers
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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 ]
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698165
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Locations
| United States, Alabama | |
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| Northport, Alabama, United States | |
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| LaHabra, California, United States | |
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| Venice, Florida, United States | |
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| Shreveport, Louisiana, United States | |
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| Bethesda, Maryland, United States | |
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| Eaton Rapids, Michigan, United States | |
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| Eatontown, New Jersey, United States | |
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| Asheboro, 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 | |
| United States, Rhode Island | |
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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 | |
| 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 | |
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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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| Seville, Spain | |
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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 | |
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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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| 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 |
| Responsible Party: | Hans-Göran Hårdemark, Medical Science Director, AstraZeneca R&D |
| ClinicalTrials.gov Identifier: | NCT00698165 History of Changes |
| Other Study ID Numbers: |
EHE 1100 |
| First Posted: | June 17, 2008 Key Record Dates |
| Last Update Posted: | February 20, 2009 |
| Last Verified: | February 2009 |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |