Improving Decision Making About Feeding Options for Dementia

October 2, 2023 updated by: University of North Carolina, Chapel Hill
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

256

Phase

  • Not Applicable

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

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

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

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Laura C Hanson, MD, MPH, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

April 15, 2010

First Submitted That Met QC Criteria

April 28, 2010

First Posted (Estimated)

April 30, 2010

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-3105
  • 5R01NR009826 (U.S. NIH Grant/Contract)

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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