Oral Health Intervention Pilot Study for Individuals With Memory Problems
29. mars 2017 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
12
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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North Carolina
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Durham, North Carolina, Forente stater, 27705
- Duke University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
60 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in oral health
Tidsramme: Day 1, 3 months, and 6 months
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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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in subjects' self-efficacy
Tidsramme: Day 1, 3 months, and 6 months
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Questionnaires assessing self-efficacy, oral health knowledge, and attitude completed by the individual with memory problems and his or her care partner.
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Day 1, 3 months, and 6 months
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in oral hygiene recorded using a brief questionnaire
Tidsramme: Every two weeks for six months
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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Bei Wu, Ph.D., Duke University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2012
Primær fullføring (Faktiske)
3. februar 2017
Studiet fullført (Faktiske)
3. februar 2017
Datoer for studieregistrering
Først innsendt
7. mars 2013
Først innsendt som oppfylte QC-kriteriene
7. mars 2013
Først lagt ut (Anslag)
11. mars 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. mars 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. mars 2017
Sist bekreftet
1. mars 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00039035
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