Fecal IncontinenceEPSPFINCT02183740
Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence
A study testing Multifaceted educational program in people with Fecal Incontinence, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Multifaceted educational program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Fecal Incontinence
- Being tested
- Multifaceted educational program
- Keywords
- Education, Nurses, Nursing homes, Fecal incontinence, Cluster-randomized controlled trial
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted educational programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, after 3 months and after 6 months
Secondary outcomes (5)
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
Measured: Baseline, after 3 months and after 6 months
Change in knowledge among registered nurses and authorized social educators
Measured my a multiple choice test
Measured: Baseline, after 3 months and after 6 months
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
Measured: Baseline, after 3 months and after 6 months
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
Measured: Baseline, after 3 months and after 6 months
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
Measured: Baseline, after 3 months and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Nurses Organisation
- Responsible party
- Sponsor
- Investigators
- Anne G Vinsnes, Professor, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183740
- Sponsor's protocol ID
- HiST05
- Acronym
- EPSPFI
- Status last verified
- Jan 2017
- First submitted
- 26 Jun 2014
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 25887238Blekken 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence: a Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02183740
- Acronym / sponsor ID
- EPSPFI / HiST05
- Conditions
- Fecal Incontinence
- Keywords
- Education, Nurses, Nursing homes, Fecal incontinence, Cluster-randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Norwegian Nurses Organisation
- Study start
- Apr 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifaceted educational program | Experimental | Behavioral: Multifaceted educational programA 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- patients characteristcs
- care staff/patients ratio
- general practitioner consultancy
- All patients on long term care residency (residency >month)
- All working half time or more
Key exclusion criteria (7 listed)
- With some kind of speciality (eks rehabilitation, dementia)
- Short term care residency
- Working less than half time
- Working only night shifts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifaceted educational program | Behavioural | Multifaceted educational program |
Primary outcome
Change in frequency of fecal incontinence among patients
Time frame: 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.
5 secondary outcomes
Remission of fecal incontinence among patients
Time frame: Baseline, after 3 months and after 6 months
Change in knowledge among registered nurses and authorized social educators
Time frame: Baseline, after 3 months and after 6 months
Change in FI-related concerns among patients
Time frame: Baseline, after 3 months and after 6 months
Correlates of FI among patients
Time frame: Baseline, after 3 months and after 6 months
Change in behavior among health personnel
Time frame: Baseline, after 3 months and after 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Background: PubMed 25887238Blekken 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.
- Background: PubMed 26002520Blekken 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne G Vinsnes, Professor principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted educational program in people with Fecal Incontinence, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of fecal incontinence among patients (time frame: Baseline, after 3 months and after 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02183740, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.