Trial record 2 of 28 for:    Open Studies | "Oral Health"

Oral Health Intervention Pilot Study for Individuals With Memory Problems

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01808235
First received: March 7, 2013
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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 Intervention
Mild Cognitive Impairment
Behavioral: Oral Health Intervention

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Developing a Caregiver-assisted Oral Health Intervention for Individuals With Memory Problems

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in oral health [ Time Frame: Day 1, 3 months, and 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1, 3 months, and 6 months ] [ Designated as safety issue: No ]
    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:
  • Changes in oral hygiene recorded using a brief questionnaire [ Time Frame: Every two weeks for six months ] [ Designated as safety issue: No ]
    The study coordinator or dental hygienist will call the subjects to monitor oral hygiene behavior and reinforce information covered in educational materials.


Estimated Enrollment: 5
Study Start Date: July 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 five IMDs and their live-in partners.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01808235

Locations
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Bei Wu, Ph.D.    919-684-7534    bei.wu@dm.duke.edu   
Contact: Brenda Plassman, Ph.D.    (919) 668-1586    brenda.plassman@dm.duke.edu   
Principal Investigator: Bei Wu, Ph.D.         
Sub-Investigator: Brenda Plassman, Ph.D.         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Bei Wu, Ph.D. Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01808235     History of Changes
Other Study ID Numbers: Pro00039035
Study First Received: March 7, 2013
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 22, 2014