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Clinical Trials/NCT01808235
NCT01808235
Completed
Not Applicable

Developing a Caregiver-assisted Oral Health Intervention for Individuals With Memory Problems

Duke University1 site in 1 country12 target enrollmentJuly 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
Duke University
Enrollment
12
Locations
1
Primary Endpoint
Change in oral health
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to pilot test an intervention to improve oral health for individuals with memory problems. The results from this study will assist in developing prevention and intervention programs aimed at maintaining good oral health, or at least slowing its deterioration.

Detailed Description

This project will involve two phases. The main purpose of Phase 1 is to conduct a focus group with 6 individuals with mild dementia (IMDs) and their live-in partners (usually spouse) and conduct in-depth interviews with staff at community organizations (e.g., dementia caregiver support group staff) to develop the protocol. Information from Phase 1 will provide input to refine the proposed pilot intervention that will be Phase 2 of this project. The pilot oral health intervention will last 6 months and will be conducted with up to ten IMDs and their live-in partners.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
February 3, 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • A diagnosis of mild dementia within the past year.
  • Have at least four natural teeth.
  • 60 years and older.
  • Living with an informal caregiver who is willing to participate.
  • Community-dwelling
  • Physically able to brush own teeth.

Exclusion Criteria

  • Edentulism
  • Unable to have an oral health evaluation done.
  • Sensory or physical problems that prevent participation in the intervention.
  • Terminal illness or hospitalization for a psychiatric disorder in the prior year.

Outcomes

Primary Outcomes

Change in oral health

Time Frame: Day 1, 3 months, and 6 months

A licensed dental hygienist will perform an oral health examination at the beginning, mid-point, and end of the intervention, to assess any changes in the subject's teeth and gums.

Secondary Outcomes

  • Changes in subjects' self-efficacy(Day 1, 3 months, and 6 months)

Study Sites (1)

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