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Oral Health Intervention Pilot Study for Individuals With Memory Problems

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01808235
Enrollment
12
Registered
2013-03-11
Start date
2012-07-31
Completion date
2017-02-03
Last updated
2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

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.

Interventions

BEHAVIORALOral 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.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in oral healthDay 1, 3 months, and 6 monthsA 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

MeasureTime frameDescription
Changes in subjects' self-efficacyDay 1, 3 months, and 6 monthsQuestionnaires assessing self-efficacy, oral health knowledge, and attitude completed by the individual with memory problems and his or her care partner.

Other

MeasureTime frameDescription
Changes in oral hygiene recorded using a brief questionnaireEvery two weeks for six monthsThe study coordinator or dental hygienist will call the subjects to monitor oral hygiene behavior and reinforce information covered in educational materials.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026