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

February 19, 2009 updated by: AstraZeneca
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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

2400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Burgos, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Seville, Spain
        • Research Site
    • Barakaldo
      • Cruces, Barakaldo, Spain
        • Research Site
  • Sweden
      • Bergsjo, Sweden
        • Research Site
      • Bromma, Sweden
        • Research Site
      • Jonkoping, Sweden
        • Research Site
      • Karlstad, Sweden
        • Research Site
      • Kristianstad, Sweden
        • Research Site
      • Lomma, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site
      • Malmo, Sweden
        • Research Site
      • Ornskoldsvik, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Umea, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
      • Varberg, Sweden
        • Research Site
  • United Kingdom
      • Brighton, United Kingdom
        • Research Site
      • Chester, United Kingdom
        • Research Site
      • Hove, United Kingdom
        • Research Site
      • Ipswich, United Kingdom
        • Research Site
      • Norwich, United Kingdom
        • Research Site
      • Oxford, United Kingdom
        • Research Site
      • Romsey, United Kingdom
        • Research Site
      • Salisbury, United Kingdom
        • Research Site
      • Stanmore, United Kingdom
        • Research Site
      • Uckfield, United Kingdom
        • Research Site
    • Basingstoke
      • Overton, Basingstoke, United Kingdom
        • Research Site
    • East Sussex
      • Eastbourne, East Sussex, United Kingdom
        • Research Site
    • Gloucester
      • Coney Hill, Gloucester, United Kingdom
        • Research Site
    • Hertfordshire
      • Barnet, Hertfordshire, United Kingdom
        • Research Site
    • London
      • Wood Green, London, United Kingdom
        • Research Site
  • United States
    • Alabama
      • Northport, Alabama, United States
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States
        • Research Site
    • California
      • Brentwood, California, United States
        • Research Site
      • Fresno, California, United States
        • Research Site
      • LaHabra, California, United States
        • Research Site
      • Long Beach, California, United States
        • Research Site
    • Colorado
      • Denver, Colorado, United States
        • Research Site
    • Connecticut
      • Wetherfield, Connecticut, United States
        • Research Site
    • Florida
      • Atlantis, Florida, United States
        • Research Site
      • Fort Myers, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Port Charlotte, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
      • Titusville, Florida, United States
        • Research Site
      • Venice, Florida, United States
        • Research Site
    • Georgia
      • Canton, Georgia, United States
        • Research Site
      • Columbus, Georgia, United States
        • Research Site
      • Decatur, Georgia, United States
        • Research Site
      • Dunwoody, Georgia, United States
        • Research Site
      • Snellville, Georgia, United States
        • Research Site
    • Illinois
      • Belleville, Illinois, United States
        • Research Site
    • Indiana
      • Ft Wayne, Indiana, United States
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States
        • Research Site
      • Prince Frederick, Maryland, United States
        • Research Site
    • Massachusetts
      • Pittsfield, Massachusetts, United States
        • Research Site
    • Michigan
      • Eaton Rapids, Michigan, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • New Jersey
      • Eatontown, New Jersey, United States
        • Research Site
    • New York
      • Albany, New York, United States
        • Research Site
      • Brooklyn, New York, United States
        • Research Site
      • Syracuse, New York, United States
        • Research Site
    • North Carolina
      • Asheboro, North Carolina, United States
        • Research Site
      • Charlotte, North Carolina, United States
        • Research Site
      • Hickory, North Carolina, United States
        • Research Site
      • Winston Salem, North Carolina, United States
        • Research Site
    • Ohio
      • Canton, Ohio, United States
        • Research Site
      • Centerville, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Rhode Island
      • East Providence, Rhode Island, United States
        • Research Site
    • South Carolina
      • Beaufort, South Carolina, United States
        • Research Site
      • Summerville, South Carolina, United States
        • Research Site
    • Texas
      • Port Arthur, Texas, United States
        • Research Site
      • Tyler, Texas, United States
        • Research Site
      • Witchita Falls, Texas, United States
        • Research Site
    • Virginia
      • Norfolk, Virginia, United States
        • Research Site
    • Washington
      • Gig Harbor, Washington, United States
        • Research Site
      • Richland, Washington, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients
1200 adults with mild to severe Alzheimer's disease
Caregivers
1200 informal caregivers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mini-Mental State Examination (MMSE), Disability Assessment for Dementia Scale (DAD), Neuropsychiatric Inventory Questionnaire (NPI-Q)
Time Frame: Collected one time only
Collected one time only

Secondary Outcome Measures

Outcome Measure
Time Frame
Resource Utilization in Dementia (RUD)
Time Frame: collected one time only
collected one time only
Short Form - 12 domains instrument (SF-12)
Time Frame: collected one time only
collected one time only
World Health Organization Quality of Life instrument (WHO-QoL)
Time Frame: collected one time only
collected one time only
Zarit Caregiver Burden Interview (ZBI)
Time Frame: collected one time only
collected one time only
15 domains Quality of Life Index instrument (15D)
Time Frame: collected one time only
collected one time only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

i3 Innovus

Investigators

  • Study Director: Linus Jönsson, i3 Innovus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 16, 2008

First Submitted That Met QC Criteria

June 16, 2008

First Posted (Estimate)

June 17, 2008

Study Record Updates

Last Update Posted (Estimate)

February 20, 2009

Last Update Submitted That Met QC Criteria

February 19, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHE 1100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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