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CompletedNCT02183740EPSPFIUpdated Jan 26, 2017

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

An interventional study of Multifaceted educational program in Fecal Incontinence, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Per ClinicalTrials.gov, last updated 2017-01-26.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Sex
All
01

Study summary

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.

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Conditions studied

  • Fecal Incontinence

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Keywords

  • Education
  • Nurses
  • Nursing homes
  • Fecal incontinence
  • Cluster-randomized controlled trial
03

In context

Fecal Incontinence

312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.

This study's enrollment of 300 is above the median of 50 across 216 interventional studies indexed under Fecal Incontinence.

Browse Fecal Incontinence studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Multifaceted educational program

  • No intervention
    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.

Interventions

  • BehavioralMultifaceted educational program
06

What researchers measure

Primary outcomes

  1. Change in frequency of fecal incontinence among patients

    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.

    Time frame: Baseline, after 3 months and after 6 months

Secondary outcomes

  1. Remission of fecal incontinence among patients

    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

    Time frame: Baseline, after 3 months and after 6 months

  2. Change in knowledge among registered nurses and authorized social educators

    Measured my a multiple choice test

    Time frame: Baseline, after 3 months and after 6 months

  3. Change in FI-related concerns among patients

    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

    Time frame: Baseline, after 3 months and after 6 months

  4. Correlates of FI among patients

    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

    Time frame: Baseline, after 3 months and after 6 months

  5. Change in behavior among health personnel

    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

    Time frame: Baseline, after 3 months and after 6 months

07

Study locations

1 site
  • Sor Trondelag University College
    Trondheim, 7004, Norway
08

References and documents

Publications

  • Blekken LE, Vinsnes AG, Gjeilo KH, Morkved S, Salvesen O, Norton C, Nakrem S. Effect of a multifaceted educational program for care staff concerning fecal incontinence in nursing home patients: study protocol of a cluster randomized controlled trial. Trials. 2015 Mar 1;16:69. doi: 10.1186/s13063-015-0595-3. PubMed 25887238 ↗
  • Blekken LE, Nakrem S, Gjeilo KH, Norton C, Morkved S, Vinsnes AG. Feasibility, acceptability, and adherence of two educational programs for care staff concerning nursing home patients' fecal incontinence: a pilot study preceding a cluster-randomized controlled trial. Implement Sci. 2015 May 23;10:72. doi: 10.1186/s13012-015-0263-8. PubMed 26002520 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02183740
Lead sponsor
Norwegian University of Science and Technology
Collaborators
Norwegian Nurses Organisation
Responsible party
Sponsor
First posted
Jul 8, 2014
Start date
Apr 2014
Primary completion
Jul 2015
Completion
Aug 2015
Last update
Jan 26, 2017

Study contacts

Anne G Vinsnes, Professor
principal investigator · Norwegian University of Science and Technology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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