Implementation of Nutritional Guidelines and Effects in Nursing Home Residents

Implementation Strategies Clinical Trial

Official title:

Clinical Outcome in Nursing Home Residents After Implementation of Nutritional Guidelines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861366
• Other study ID #: MuMs07
• Status: Completed
• Phase: N/A
• First received: May 21, 2013
• Last updated: May 22, 2013
• Start date: May 2009
• Est. completion date: June 2011

Study information

• Verified date: May 2013
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to examine two implementation strategies (external facilitation and educational outreach visit) when introducing nutritional guidelines in the elderly care setting and to evaluate the results of the implementation by clinical outcome measures of the nursing home residents.

The hypothesis is that the residents affected by the external facilitation strategy will stay stable in the measured clinical outcomes, while the residents influenced by the educational outreach visit will deteriorate during the implementation process.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• age of 65 or older

• nursing home resident

• persons who manage the examination methods (interviews and blood samples)

Exclusion Criteria:

• persons in terminal stage of life

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Implementation Strategies
• Nutritional Outcome of Nursing Home Residents

Intervention

Other:
• A one year multifaceted implementation strategy

• A three hour lecture about the guidelines

Locations

Country	Name	City	State
Sweden	Uppsala University	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biochemical markers	Blood samples are collected for analysis of vitamin D, albumin, CRP (C-reactive protein), insulin-like growth factor 1 (IGF-1), creatinine and cystatin C, which gives biochemical information on the nutritional status, inflammation activity and renal function.	2 years	No
Other	Morbidity	Morbidity is assessed with Charlson Comorbidity Index (CCI).	2 years	No
Primary	Nutritional status	Nutritional status is assessed with the Mini Nutritional Assessment-Short Form tool	2 years	No
Secondary	Functional status	Functional status is assessed with ADL (Activities in Daily Living) Barthel index.	2 years	No
Secondary	Cognitive status	Cognitive status is assessed with Short Portable Mental Status Questionnaire (SPMSQ).	2 years	No
Secondary	Health-related Quality of Life	Health-related Quality of Life is assessed with EQ-5D.	2 years	No