- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02214758
Optimising Nutrition, Oral Health and Medication for Older Home Care Clients (NutOrMed) (NutOrMed)
8. august 2014 oppdatert av: Irma Nykänen, University of Eastern Finland
Optimising Nutrition, Oral Health and Medication for Older Home Care Clients
The aim of the study is to evaluate the impact of six month long nutritional and oral health intervention on nutritional status, oral health, functional performance and hospital admission/costs on older persons using home care services.
Additionally, participants are interviewed at home regarding their drugs use and this information will be compared with medication information in electronic patient records.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
300
Fase
- Ikke aktuelt
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
75 år og eldre (Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- home care clients
Exclusion Criteria:
- under 75 years
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Dietary counseling
|
On the basis of a blood test, Mini Nutritional Assessment, and nutritional anamnesis, the nutritionist developed a plan for individualised nutritional care and discussed with the participant and her/his nurse or family members.
If the participants seemed unable to increase the energy and/or protein of their diet, daily complementary dietary drinks were recommended to them.
After the dental hygienist interview and oral health examination, the participants in need were targeted for oral health intervention.
The intervention included individualised instructions on either dental hygiene, denture hygiene, cleaning of the oral mucosa or for dry mouth.
The participants were re-examined six months after the baseline interviews to evaluate the effectiveness of the interventions.
Both the intervention and control groups had the same examinations as with the exception of the nutritional and oral health intervention.
|
|
Annen: Oral health counseling
|
On the basis of a blood test, Mini Nutritional Assessment, and nutritional anamnesis, the nutritionist developed a plan for individualised nutritional care and discussed with the participant and her/his nurse or family members.
If the participants seemed unable to increase the energy and/or protein of their diet, daily complementary dietary drinks were recommended to them.
After the dental hygienist interview and oral health examination, the participants in need were targeted for oral health intervention.
The intervention included individualised instructions on either dental hygiene, denture hygiene, cleaning of the oral mucosa or for dry mouth.
The participants were re-examined six months after the baseline interviews to evaluate the effectiveness of the interventions.
Both the intervention and control groups had the same examinations as with the exception of the nutritional and oral health intervention.
|
|
Ingen inngripen: nutrition no counseling
|
|
|
Ingen inngripen: oral health no counseling
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in nutritional status on the Mini Nutritional Assessment (MNA) test and s-albumin level at months 6
Tidsramme: Baseline, Month 6
|
Using MNA test and s-albumin level test
|
Baseline, Month 6
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in oral health status on clinical oral health examination and in-home interview at months 6
Tidsramme: Baseline, Month 6
|
Clinical oral health examination included type and location of removable dental prosthesis, examination of the oral mucosa, number and location of teeth, condition of teeth, presence of plaque, gingival bleeding and measurement of periodontal pockets.
In-home interview included questions about dental and denture hygiene, a subjective feeling of dry mouth and pain in mouth
|
Baseline, Month 6
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The agreement between medication in-home interview and EMR in baseline
Tidsramme: baseline
|
A pharmacist recorded each prescription and non-prescription medication and complementary and alternative medicine supplements used regularly, as-needed within a week or in the past on the basis of the interview, medication lists, packages and prescriptions at the baseline.
All medications were encoded using the ATC (Anatomic Therapeutic Chemical) classification (WHO).
The medication list from the locally used electronic medical record (EMR) was gathered from the same day than in-home interview
|
baseline
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Irma Nykänen, PhD, University of Eastern Finland
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Salmi A, Komulainen K, Nihtila A, Tiihonen M, Nykanen I, Hartikainen S, Suominen AL. Eating problems among old home care clients. Clin Exp Dent Res. 2022 Aug;8(4):959-968. doi: 10.1002/cre2.585. Epub 2022 May 8.
- Kaipainen T, Hartikainen S, Tiihonen M, Nykanen I. Effect of individually tailored nutritional counselling on protein and energy intake among older people receiving home care at risk of or having malnutrition: a non-randomised intervention study. BMC Geriatr. 2022 May 4;22(1):391. doi: 10.1186/s12877-022-03088-2.
- Luukkonen A, Tiihonen M, Rissanen T, Hartikainen S, Nykanen I. Orthostatic Hypotension and Associated Factors among Home Care Clients Aged 75 Years or Older - A Population-Based Study. J Nutr Health Aging. 2018;22(1):154-158. doi: 10.1007/s12603-017-0953-9.
- Miettinen M, Tiihonen M, Hartikainen S, Nykanen I. Prevalence and risk factors of frailty among home care clients. BMC Geriatr. 2017 Nov 17;17(1):266. doi: 10.1186/s12877-017-0660-8.
- Tiihonen M, Hartikainen S, Nykanen I. Chair rise capacity and associated factors in older home-care clients. Scand J Public Health. 2018 Nov;46(7):699-703. doi: 10.1177/1403494817718072. Epub 2017 Jul 12.
- Polonen S, Tiihonen M, Hartikainen S, Nykanen I. Individually Tailored Dietary Counseling among Old Home Care Clients - Effects on Nutritional Status. J Nutr Health Aging. 2017;21(5):567-572. doi: 10.1007/s12603-016-0815-x.
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. november 2012
Primær fullføring (Faktiske)
1. mai 2013
Studiet fullført (Faktiske)
1. juni 2014
Datoer for studieregistrering
Først innsendt
4. august 2014
Først innsendt som oppfylte QC-kriteriene
8. august 2014
Først lagt ut (Anslag)
12. august 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
12. august 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. august 2014
Sist bekreftet
1. august 2014
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- RECID84/2012
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