Oral Health Intervention Pilot Study for Individuals With Memory Problems
29 mars 2017 uppdaterad av: Duke University
Developing a Caregiver-assisted Oral Health Intervention 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
12
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
North Carolina
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Durham, North Carolina, Förenta staterna, 27705
- Duke University
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
60 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
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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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in oral health
Tidsram: 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.
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Day 1, 3 months, and 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in subjects' self-efficacy
Tidsram: 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.
|
Day 1, 3 months, and 6 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in oral hygiene recorded using a brief questionnaire
Tidsram: 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.
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Every two weeks for six months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Bei Wu, Ph.D., Duke University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2012
Primärt slutförande (Faktisk)
3 februari 2017
Avslutad studie (Faktisk)
3 februari 2017
Studieregistreringsdatum
Först inskickad
7 mars 2013
Först inskickad som uppfyllde QC-kriterierna
7 mars 2013
Första postat (Uppskatta)
11 mars 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 mars 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 mars 2017
Senast verifierad
1 mars 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00039035
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .