NCT02183740

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

June 26, 2014

Last Update Submit

January 25, 2017

Conditions

Fecal Incontinence

Keywords

EducationNursesNursing homesFecal incontinenceCluster-randomized controlled trial

Outcome Measures

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.

    Baseline, after 3 months and after 6 months

Secondary Outcomes (5)

  • Remission of fecal incontinence among patients

    Baseline, after 3 months and after 6 months

  • Change in knowledge among registered nurses and authorized social educators

    Baseline, after 3 months and after 6 months

  • Change in FI-related concerns among patients

    Baseline, after 3 months and after 6 months

  • Correlates of FI among patients

    Baseline, after 3 months and after 6 months

  • Change in behavior among health personnel

    Baseline, after 3 months and after 6 months

Study Arms (2)

Multifaceted educational program

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Multifaceted educational programBEHAVIORAL
Multifaceted educational program

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sor Trondelag University College

Trondheim, 7004, Norway

Location

Related Publications (2)

  • 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.

    PMID: 25887238BACKGROUND

  • 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.

    PMID: 26002520BACKGROUND

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Anne G Vinsnes, Professor

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2014

First Posted

July 8, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

January 26, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)