Skip to main content
OpenTrials
Completed

NCT Number: NCT01113749

Improving Decision Making About Feeding Options for Dementia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Feeding Options in Dementia Decision Aid

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 30, 2010
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.