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Improving Decision Making About Feeding Options for Dementia

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ClinicalTrials.gov Identifier: NCT01113749
Recruitment Status : Completed
First Posted : April 30, 2010
Results First Posted : August 10, 2012
Last Update Posted : August 10, 2012
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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Brief Summary:
This study is a randomized trial to test whether a decision aid can help to improve the quality of decision making about feeding options in care of patients with dementia.

Condition or disease Intervention/treatment Phase
Dementia Other: Feeding Options in Dementia Decision Aid Not Applicable

Detailed Description:
This research study is a cluster randomized controlled trial of a decision aid to improve decision-making about feeding options for patients with advanced dementia. Surrogate decision-makers in the nursing homes randomized to the intervention will review the decision aid and be prompted to discuss it with the primary health care provider, while those in the control sites receive usual care. We measure the immediate, 1 and 3 month effects of the decision aid on the quality of surrogate decision-making for nursing home residents with advanced dementia.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Improving Decision Making About Feeding Options for Dementia
Study Start Date : May 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Decision support
Structured decision aid with prompting to share information in discussion with primary treating health care providers.
 Other: Feeding Options in Dementia Decision Aid
Structured decision aid on feeding options in dementia care with prompting to share information in discussion with primary treating health care provider.
No Intervention: Control
Usual care


Outcome Measures
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Primary Outcome Measures :
  1. Decisional Conflict Scale [ Time Frame: 3 months ]
    Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict.


Secondary Outcome Measures :
  1. Percent With Treatment Decisions [ Time Frame: 3 months ]
    Treatment decisions are expressed as percentage of subjects with discussions of new tube feeding, new orders to forego tube feeding, and new choices for assisted feeding.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • dementia diagnosis
  • advanced cognitive impairment
  • feeding problem
  • age >= 65
  • surrogate decision maker

Exclusion Criteria:

  • feeding tube decision made
  • hospice
  • BMI > 26
  • major psychosis or developmental delay
Contacts and Locations
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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): NCT01113749


Locations
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United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Laura C Hanson, MD, MPH University of North Carolina, Chapel Hill
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01113749    
Other Study ID Numbers: 05-3105
5R01NR009826 ( U.S. NIH Grant/Contract )
First Posted: April 30, 2010    Key Record Dates
Results First Posted: August 10, 2012
Last Update Posted: August 10, 2012
Last Verified: April 2012
Keywords provided by University of North Carolina, Chapel Hill:
Dementia
Nutrition
Feeding
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders