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

25 januari 2017 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

300

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

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

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: Multifaceted educational program
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in frequency of fecal incontinence among patients
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Remission of fecal incontinence among patients
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Norwegian University of Science and Technology

Samarbetspartners

Norwegian Nurses Organisation

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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 april 2014

Primärt slutförande (Faktisk)

1 juli 2015

Avslutad studie (Faktisk)

1 augusti 2015

Studieregistreringsdatum

Först inskickad

26 juni 2014

Först inskickad som uppfyllde QC-kriterierna

2 juli 2014

Första postat (Uppskatta)

8 juli 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

26 januari 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 januari 2017

Senast verifierad

1 januari 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HiST05

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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