Back to resultsOral Health Intervention Pilot Study for Individuals With Memory Problems
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral Health Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Mild Cognitive Impairment
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.
Sites / Locations
- Duke University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oral health intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01808235
Brief Title
Oral Health Intervention Pilot Study for Individuals With Memory Problems
Official Title
Developing a Caregiver-assisted Oral Health Intervention for Individuals With Memory Problems
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
February 3, 2017 (Actual)
Study Completion Date
February 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral health intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Oral Health Intervention
Intervention Description
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 Outcome Measure Information:
Title
Change in oral health
Description
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.
Time Frame
Day 1, 3 months, and 6 months
Secondary Outcome Measure Information:
Title
Changes in subjects' self-efficacy
Description
Questionnaires assessing self-efficacy, oral health knowledge, and attitude completed by the individual with memory problems and his or her care partner.
Time Frame
Day 1, 3 months, and 6 months
Other Pre-specified Outcome Measures:
Title
Changes in oral hygiene recorded using a brief questionnaire
Description
The study coordinator or dental hygienist will call the subjects to monitor oral hygiene behavior and reinforce information covered in educational materials.
Time Frame
Every two weeks for six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bei Wu, Ph.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
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Oral Health Intervention Pilot Study for Individuals With Memory Problems
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