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Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence (EPSPFI)

25. januar 2017 opdateret af: Norwegian University of Science and Technology

Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence: a Cluster-randomized Controlled Trial

Fecal incontinence (FI) has an increasing prevalence in the geriatric population which cannot be explained by co-morbidity or anatomical and psychological changes of aging alone. In the nursing home population previous studies suggest a prevalence between 10 and 69%, but is most often reported to be between 40 and 55%. FI leads to a high direct and indirect economic burden to the health-care system, and is an important cause og institutionalization of the elderly patients. In addition, FI is associated with shame, social isolation and reduced quality of life.

The importance of identifying treatable causes of FI in the frail elderly, rather than just managing passively, is strongly emphasized. It is indicated that the level of awareness among health personnel regarding appropriate assessment and treatment options is limited, and that FI is considered a normal part of aging.

This study is based on the assumption that FI among nursing home patients can be prevented, cured or ameliorated by offering nursing home staff knowledge of best practise. The primary objective of the study is to test the hypothesis that a multifaceted educational program for staff on assessment and treatment of FI, is associated with a reduction in patients' frequency of FI.

The design of the study is a two armed cluster randomized trail (C-RCT) with a repeated cross-sectional approach.The results will be analysed according to multilevel and longitudinal modelling, and the study will use mixed effect models with the cluster treated as a random effect.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

300

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Norge
      • Trondheim, Norge, 7004
        • Sor Trondelag University College

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Nursing homes with similar:

  • patients characteristcs
  • care staff/patients ratio
  • general practitioner consultancy

Patients:

- All patients on long term care residency (residency >month)

Registered Nurses/authorized social educators:

- All working half time or more

Exclusion Criteria:

Nursing homes:

- With some kind of speciality (eks rehabilitation, dementia)

Patients:

- Short term care residency

Registered nurses/authorized social educator:

  • Working less than half time
  • Working only night shifts

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Multifaceted educational program

A multifaceted educational program for nursing home staff consisting of:

  1. One seven hours educational meeting (interactive workshop) conducted in the nursing home. Theoretical input and case-base discussions considering guidelines for nurse led assessment og interventions of patients fecal incontinence.The content will be made available as educational material.
  2. Recruitment of one local opinion leader per nursing home unit.
  3. Seven educational outreach meetings (1 hour 30 minutes per meeting) during the three months intervention period.
Adfærdsmæssigt: Multifaceted educational program
Ingen indgriben: Control
The control arm will not receive any educational program and will continue with usual care. Data with information about ordinary care will be gathered as part of the data collection procedure in the study.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in frequency of fecal incontinence among patients
Tidsramme: Baseline, after 3 months and after 6 months
As measured by The Long-Term Care Facilities Assessment System (interRAI-LTCF 2012), section H: Continence. Because of relatively high risk of death and movement out of clusters, a repeated cross-sectional opproach to analyses will be used. Frequency of FI will thereby be analysed on a across-sectional group level.
Baseline, after 3 months and after 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Remission of fecal incontinence among patients
Tidsramme: Baseline, after 3 months and after 6 months
For remission of FI a cohort approach to data analyses with only those identified with FI at baseline and still present at 3 and 6 month follow-up, will be included in the analyses
Baseline, after 3 months and after 6 months
Change in knowledge among registered nurses and authorized social educators
Tidsramme: Baseline, after 3 months and after 6 months
Measured my a multiple choice test
Baseline, after 3 months and after 6 months
Change in FI-related concerns among patients
Tidsramme: Baseline, after 3 months and after 6 months
Relevant concerns as measured by The Long-Term Care Facilities Assessment System (interRAI-LTCF 2012) are: Mood and behavior, psycho-social wellbeing, urinary continence, constipation, diarrhea, skin condition, participation in activities
Baseline, after 3 months and after 6 months
Correlates of FI among patients
Tidsramme: Baseline, after 3 months and after 6 months
Relevant correlates as measured by The Long-Term Care Facilities Assessment System (interRAI-LTCF 2012) are: cognitive functioning, communication and vision, functionality and mobility, medical diagnosis, mouth and nutrition status, medications, treatment, examination/procedures
Baseline, after 3 months and after 6 months
Change in behavior among health personnel
Tidsramme: Baseline, after 3 months and after 6 months
Measured by analyses of patient assessments and interventions as documented by health personnel in the electronic patient record and by the Fecal Incontinence in Nursing Home Patients questionnaire
Baseline, after 3 months and after 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Norwegian University of Science and Technology

Samarbejdspartnere

Norwegian Nurses Organisation

Efterforskere

  • Ledende efterforsker: Anne G Vinsnes, Professor, Norwegian University of Science and Technology

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2014

Primær færdiggørelse (Faktiske)

1. juli 2015

Studieafslutning (Faktiske)

1. august 2015

Datoer for studieregistrering

Først indsendt

26. juni 2014

Først indsendt, der opfyldte QC-kriterier

2. juli 2014

Først opslået (Skøn)

8. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HiST05

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Multifaceted educational program

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