Oral Health Intervention Pilot Study for Individuals With Memory Problems

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808235
• Other study ID #: Pro00039035
• Status: Completed
• Phase: N/A
• First received: March 7, 2013
• Last updated: March 29, 2017
• Start date: July 2012
• Est. completion date: February 3, 2017

Study information

• Verified date: March 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 3, 2017
• Est. primary completion date: February 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in oral hygiene recorded using a brief questionnaire	The study coordinator or dental hygienist will call the subjects to monitor oral hygiene behavior and reinforce information covered in educational materials.	Every two weeks for six months
Primary	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	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