Oral Health Intervention Pilot Study for Individuals With Memory Problems

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Oral Health Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral health intervention<br>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. | Behavioral: Oral Health Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in oral health | 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. | Day 1, 3 months, and 6 months | 

Secondary Outcome Measures

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