Overview

This trial is active, not recruiting.

Condition mild cognitive impairment
Treatment oral health intervention
Sponsor Duke University
Start date July 2012
End date February 2017
Trial size 12 participants
Trial identifier NCT01808235, Pro00039035

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
The dental hygienist will assess the IMD's tooth brushing technique and will provide specific feedback on the tooth brushing technique, including areas of the dentition missed in brushing. The IMDs will be given a powered toothbrush that records time, date and duration of toothbrushing activity, along with the direction and extent of motion of the toothbrushing activity. In addition, use of interdental cleaning aids will be recommended. The dental hygienist will review the findings from the oral health evaluation with the IMDs and caregivers, and provide detailed feedback on treatment and prevention of the oral health conditions and symptoms. The dental hygienist or study coordinator will call subjects by telephone biweekly to monitor oral hygiene practices and to provide coaching, if needed. Oral hygiene technique assessments will be conducted again three months after the first visit, and once more three months later, at the end of the intervention.
oral health intervention
The dental hygienist will assess the IMD's tooth brushing technique and will provide specific feedback on the tooth brushing technique, including areas of the dentition missed in brushing. The IMDs will be given a powered toothbrush that records time, date and duration of toothbrushing activity, along with the direction and extent of motion of the toothbrushing activity. In addition, use of interdental cleaning aids will be recommended. The dental hygienist will review the findings from the oral health evaluation with the IMDs and caregivers, and provide detailed feedback on treatment and prevention of the oral health conditions and symptoms. The dental hygienist or study coordinator will call subjects by telephone biweekly to monitor oral hygiene practices and to provide coaching, if needed. Oral hygiene technique assessments will be conducted again three months after the first visit, and once more three months later, at the end of the intervention.

Primary Outcomes

Measure
Change in oral health
time frame: Day 1, 3 months, and 6 months

Secondary Outcomes

Measure
Changes in subjects' self-efficacy
time frame: Day 1, 3 months, and 6 months

Eligibility Criteria

Male or female participants at least 60 years old.

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.

Additional Information

Official title Developing a Caregiver-assisted Oral Health Intervention for Individuals With Memory Problems
Principal investigator Bei Wu, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Duke University.