Fecal Incontinence Clinical Trial
— PEIOfficial title:
A Pilot Study to Evaluate Feasibility of Educational Programs With Regard to Good Fecal Incontinence Care in Nursing Homes
Verified date | January 2017 |
Source | Norwegian University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators are planning to do a cluster randomized trial to test the effect of different educational programs for staff according to nursing home patients FI (fecal incontinence). Since there are very few published trials of treatment of FI in older people, and no rigorously evaluated studies on interventions for FI in nursing homes, or rigorously evaluated continence education program for staff concerning continence care, a pilot study is necessary. The aim for the pilot study is to evaluate feasibility, acceptability and adherence according to the educational intervention, methods used and outcome measures. This is designed to be an external pilot study. External pilot studies are small scale versions of the main study which are not intended to be part of the main study. The pilot intervention period is 3 month.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Nursing homes Wards with 24 hour long term care residency, similar nurse/patient ratio and General Practitioner consultancy, comparable patient groups according to frailty, comparable ward size according to number of patients and staff. - Patients All patients on long term residency (1 month or more) are eligible for measurements. - Registered nurses (RN) and authorized social educators (ASE) RN's and ASE's with position above 50% are eligible according to participation in the educational meeting and to be recruited as a local opinion leader in intervention 2. All staff is invited to the educational outreach meetings throughout the intervention period. Exclusion Criteria: - Nursing homes with diverse staff and patient composition - Patients on short term residency - Registered nurses (RN) and authorized social educators (ASE) RN's and ASE's with position less than 50% |
Country | Name | City | State |
---|---|---|---|
Norway | Sør-Trøndelag University College | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology |
Norway,
Blekken LE, Nakrem S, Gjeilo KH, Norton C, Mørkved 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 contr — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion patients assessed by the clinical guidelines | 90% of the patients assessed by the clinical guideline | 3 months | |
Secondary | Proportion of completed patient health questionnaires | Response rate more than 80% | 3 months | |
Secondary | Acceptable performance of multiple choice test measuring change in staff knowledge. | 80% claim that the test set understandable and relevant | 3 months | |
Secondary | The proportion of missing data in each completed questionnaire | Less than 10% | 3 months |
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