NCT01113749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 30, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 10, 2012

Completed
Last Updated

October 4, 2023

Status Verified

April 1, 2012

Enrollment Period

3.1 years

First QC Date

April 15, 2010

Results QC Date

April 17, 2012

Last Update Submit

October 2, 2023

Conditions

Dementia

Keywords

DementiaNutritionFeeding

Outcome Measures

Primary Outcomes (1)

  • Decisional Conflict Scale

    Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict.

    3 months

Secondary Outcomes (1)

  • Percent With Treatment Decisions

    3 months

Study Arms (2)

Decision support

EXPERIMENTAL

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

Other: Feeding Options in Dementia Decision Aid

Control

NO INTERVENTION

Usual care

Interventions

Feeding Options in Dementia Decision AidOTHER

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

Decision support

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • feeding tube decision made
  • hospice
  • BMI \> 26
  • major psychosis or developmental delay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (3)

  • 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.

    PMID: 24083403DERIVED

  • 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.

    PMID: 22091750DERIVED

  • 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.

    PMID: 20729251DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Limitations and Caveats

Cluster randomization required, preventing double-blinding.

Results Point of Contact

Title
Laura C. Hanson, MD, MPH
Organization
University of North Carolina Chapel Hill
lhanson@med.unc.edu
9199665945

Study Officials

  • Laura C Hanson, MD, MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2010

First Posted

April 30, 2010

Study Start

May 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

October 4, 2023

Results First Posted

August 10, 2012

Record last verified: 2012-04

Locations

US(1)