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Completed

NCT Number: NCT01808235

Oral Health Intervention Pilot Study for Individuals With Memory Problems

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral Health Intervention

Behavioral

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 outcomes

  1. Change in oral health

    Time frame: 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 outcomes

  1. Changes in subjects' self-efficacy

    Time frame: 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 outcomes

  1. Changes in oral hygiene recorded using a brief questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Mar 11, 2013
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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