Oral Health Intervention Pilot Study for Individuals With Memory Problems

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT01808235
Collaborator
(none)
12
1
1
55.1
0.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Oral Health Intervention
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Developing a Caregiver-assisted Oral Health Intervention for Individuals With Memory Problems
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Feb 3, 2017
Actual Study Completion Date :
Feb 3, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Other Outcome Measures

  1. Changes in oral hygiene recorded using a brief questionnaire [Every two weeks for six months]

    The study coordinator or dental hygienist will call the subjects to monitor oral hygiene behavior and reinforce information covered in educational materials.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Durham North Carolina United States 27705

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Bei Wu, Ph.D., Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT01808235
Other Study ID Numbers:
  • Pro00039035
First Posted:
Mar 11, 2013
Last Update Posted:
Mar 30, 2017
Last Verified:
Mar 1, 2017
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 30, 2017