NCT01861366

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2013

Completed
Last Updated

May 23, 2013

Status Verified

May 1, 2013

Enrollment Period

2.1 years

First QC Date

May 21, 2013

Last Update Submit

May 22, 2013

Conditions

Keywords

ImplementationGuidelinesNutritionNursing home

Outcome Measures

Primary Outcomes (1)

  • Nutritional status

    Nutritional status is assessed with the Mini Nutritional Assessment-Short Form tool

    2 years

Secondary Outcomes (3)

  • Functional status

    2 years

  • Cognitive status

    2 years

  • Health-related Quality of Life

    2 years

Other Outcomes (2)

  • Biochemical markers

    2 years

  • Morbidity

    2 years

Study Arms (2)

External facilitator

EXPERIMENTAL

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

Educational outreach visit

ACTIVE COMPARATOR

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

Interventions

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • age of 65 or older
  • nursing home resident
  • persons who manage the examination methods (interviews and blood samples)

You may not qualify if:

  • \- persons in terminal stage of life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University

Uppsala, Uppsala County, 75185, Sweden

Location

Related Publications (1)

  • Torma J, Winblad U, Saletti A, Cederholm T. Strategies to implement community guidelines on nutrition and their long-term clinical effects in nursing home residents. J Nutr Health Aging. 2015 Jan;19(1):70-6. doi: 10.1007/s12603-014-0522-4.

Study Officials

  • Tommy Cederholm, Prof

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2013

First Posted

May 23, 2013

Study Start

May 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 23, 2013

Record last verified: 2013-05

Locations