Implementation of Nutritional Guidelines and Effects in Nursing Home Residents

May 22, 2013 updated by: Uppsala University

Clinical Outcome in Nursing Home Residents After Implementation of Nutritional Guidelines

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 75185
        • Uppsala University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: External facilitator
The external facilitation is a one year multifaceted intervention, including support, guidance, practice audit and feedback, training targeted to a team of practitioners involving the unit manager, the nurses and diet aides at the nursing home. The facilitator is a researcher and dietician.
Other: A one year multifaceted implementation strategy
Active Comparator: Educational outreach visit
The outreach visit is a three hour lecture about the nutritional guidelines targeted to a team of practitioners including the unit manager, the nurses and diet aides at the nursing home. The trained person giving the lecture is a researcher and dietician.
Other: A three hour lecture about the guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status
Time Frame: 2 years
Nutritional status is assessed with the Mini Nutritional Assessment-Short Form tool
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional status
Time Frame: 2 years
Functional status is assessed with ADL (Activities in Daily Living) Barthel index.
2 years
Cognitive status
Time Frame: 2 years
Cognitive status is assessed with Short Portable Mental Status Questionnaire (SPMSQ).
2 years
Health-related Quality of Life
Time Frame: 2 years
Health-related Quality of Life is assessed with EQ-5D.
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical markers
Time Frame: 2 years
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
Morbidity
Time Frame: 2 years
Morbidity is assessed with Charlson Comorbidity Index (CCI).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Tommy Cederholm, Prof, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 21, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (Estimate)

May 23, 2013

Study Record Updates

Last Update Posted (Estimate)

May 23, 2013

Last Update Submitted That Met QC Criteria

May 22, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MuMs07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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