Improving Decision Making About Feeding Options for Dementia

NCT ID: NCT01113749

Last Updated: 2023-10-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Decision support

Structured decision aid with prompting to share information in discussion with primary treating health care providers.

Group Type EXPERIMENTAL

Feeding Options in Dementia Decision Aid

Intervention Type OTHER

Structured decision aid on feeding options in dementia care with prompting to share information in discussion with primary treating health care provider.

Control

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura C Hanson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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Hanson LC, Ersek M, Lin FC, Carey TS. Outcomes of feeding problems in advanced dementia in a nursing home population. J Am Geriatr Soc. 2013 Oct;61(10):1692-7. doi: 10.1111/jgs.12448. Epub 2013 Sep 19.

Reference Type DERIVED
PMID: 24083403 (View on PubMed)

Hanson LC, Carey TS, Caprio AJ, Lee TJ, Ersek M, Garrett J, Jackman A, Gilliam R, Wessell K, Mitchell SL. Improving decision-making for feeding options in advanced dementia: a randomized, controlled trial. J Am Geriatr Soc. 2011 Nov;59(11):2009-16. doi: 10.1111/j.1532-5415.2011.03629.x. Epub 2011 Sep 15.

Reference Type DERIVED
PMID: 22091750 (View on PubMed)

Hanson LC, Gilliam R, Lee TJ. Successful clinical trial research in nursing homes: the Improving Decision-Making Study. Clin Trials. 2010 Dec;7(6):735-43. doi: 10.1177/1740774510380241. Epub 2010 Aug 20.

Reference Type DERIVED
PMID: 20729251 (View on PubMed)

Other Identifiers

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5R01NR009826

Identifier Type: NIH

Identifier Source: secondary_id

View Link

05-3105

Identifier Type: -

Identifier Source: org_study_id

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