Oral Health Intervention Pilot Study for Individuals With Memory Problems

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment

• Registration Number: NCT01808235
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-03-07
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-11
• Primary Completion: 2017-02-03
• Study Completion: 2017-02-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in oral health	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 Outcome Measures

Name	Time	Method
Changes in subjects' self-efficacy	Day 1, 3 months, and 6 months	Questionnaires assessing self-efficacy, oral health knowledge, and attitude completed by the individual with memory problems and his or her care partner.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States