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Is Multifactorial Nutritional Treatment for Undernutrition in Older Adults in Primary Care Cost-effective? (CES)

Primary Purpose

Frail Older Adults

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
multifactorial nutritional intervention
Sponsored by
Copenhagen University Hospital at Herlev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frail Older Adults

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Screening for nutritional risk

Exclusion Criteria:

  • terminal condition or do not wish to participate

Sites / Locations

  • Home care and nursing homes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multifactorial nutritional intervention

usual care

Arm Description

dietician, resistance type exercise, dysphagia assessment and treatment

usual care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Nutritional status
Assessment of weight
Hand grip strength
Residents and clients hand grip strength is determined using the dynamometer The dynamometer consists of a narrow handle with two strings as the older must squeezing so hard, they manage three times. The highest value will be used.
Costs
Here is used information on additional costs of nutrition efforts, which on the one hand involves all costs associated with the effort, while on the other hand also be seen on the savings that can be attached to the outcome of the effort. Since the purpose is to illustrate the cost-effectiveness, the net profit on the cost side is also compared with the effect of nutritional intervention in terms of improved quality of life, and hence would be able to shed light on efforts from both resource use and a health effect
Activities of Daily Living and cognitive performance
Data is collected by Means of the resident assessment instrument
physical strength
30 seconds chair stand is used

Full Information

First Posted
May 29, 2013
Last Updated
December 20, 2022
Sponsor
Copenhagen University Hospital at Herlev
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1. Study Identification

Unique Protocol Identification Number
NCT01873456
Brief Title
Is Multifactorial Nutritional Treatment for Undernutrition in Older Adults in Primary Care Cost-effective?
Acronym
CES
Official Title
Is Multifactorial Nutritional Treatment for Undernutrition in Older Adults in Primary Care Cost-effective?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen University Hospital at Herlev

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Older Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multifactorial nutritional intervention
Arm Type
Experimental
Arm Description
dietician, resistance type exercise, dysphagia assessment and treatment
Arm Title
usual care
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Other
Intervention Name(s)
multifactorial nutritional intervention
Other Intervention Name(s)
dietician, resitance type exercise, dysphagia assessment and treatment
Primary Outcome Measure Information:
Title
Quality of life
Description
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
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Nutritional status
Description
Assessment of weight
Time Frame
up to 6 months
Title
Hand grip strength
Description
Residents and clients hand grip strength is determined using the dynamometer The dynamometer consists of a narrow handle with two strings as the older must squeezing so hard, they manage three times. The highest value will be used.
Time Frame
up to 6 months
Title
Costs
Description
Here is used information on additional costs of nutrition efforts, which on the one hand involves all costs associated with the effort, while on the other hand also be seen on the savings that can be attached to the outcome of the effort. Since the purpose is to illustrate the cost-effectiveness, the net profit on the cost side is also compared with the effect of nutritional intervention in terms of improved quality of life, and hence would be able to shed light on efforts from both resource use and a health effect
Time Frame
up to 6 months
Title
Activities of Daily Living and cognitive performance
Description
Data is collected by Means of the resident assessment instrument
Time Frame
up to 6 months
Title
physical strength
Description
30 seconds chair stand is used
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Screening for nutritional risk Exclusion Criteria: terminal condition or do not wish to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Marie Beck
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Home care and nursing homes
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
background
PubMed Identifier
25163483
Citation
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.
Results Reference
result
PubMed Identifier
26553461
Citation
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.
Results Reference
result

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Is Multifactorial Nutritional Treatment for Undernutrition in Older Adults in Primary Care Cost-effective?

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