NCT01873456

Brief Summary

The hypothesis is that there is a profit potential by implementing a multifactorial nutritional intervention among frail elderly since this will result in an improved nutritional status, functional capacity and improved quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

May 29, 2013

Last Update Submit

December 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    EuroQol (EQ-5D) is a questionnaire with five questions to be answered in three categories. The five questions deal of movement, self-care, usual activities, pain / discomfort and anxiety / depression and any problems with this

    up to 6 months

Secondary Outcomes (5)

  • Nutritional status

    up to 6 months

  • Hand grip strength

    up to 6 months

  • Costs

    up to 6 months

  • Activities of Daily Living and cognitive performance

    up to 6 months

  • physical strength

    up to 6 months

Study Arms (2)

Multifactorial nutritional intervention

EXPERIMENTAL

dietician, resistance type exercise, dysphagia assessment and treatment

Other: multifactorial nutritional intervention

usual care

NO INTERVENTION

usual care

Interventions

Also known as: dietician, resitance type exercise, dysphagia assessment and treatment
Multifactorial nutritional intervention

Eligibility Criteria

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

You may qualify if:

  • Screening for nutritional risk

You may not qualify if:

  • terminal condition or do not wish to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Home care and nursing homes

Frederiksberg, 2000, Denmark

Location

Related Publications (3)

  • Beck AM, Keiding H, Christensen AG, Hansen BS, Svendsen SD, et al. (2015) Multidisciplinary Nutritional Support for Page 2 of 7 Undernutrition in Older Adults in Nursing Home and Home-Care is Cost-Effective. SOJ Nur Health Care 1(1): 1-7.

    BACKGROUND
  • Beck AM, Gogsig Christensen A, Stenbaek Hansen B, Damsbo-Svendsen S, Kreinfeldt Skovgaard Moller T, Boll Hansen E, Keiding H. Study protocol: cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care: cluster randomized controlled trial. Nutr J. 2014 Aug 28;13:86. doi: 10.1186/1475-2891-13-86.

  • Beck AM, Christensen AG, Hansen BS, Damsbo-Svendsen S, Moller TK. Multidisciplinary nutritional support for undernutrition in nursing home and home-care: A cluster randomized controlled trial. Nutrition. 2016 Feb;32(2):199-205. doi: 10.1016/j.nut.2015.08.009. Epub 2015 Sep 3.

MeSH Terms

Interventions

NutritionistsTherapeutics

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Anne Marie Beck

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reserarch Director

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 10, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

December 21, 2022

Record last verified: 2022-12

Locations