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

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ClinicalTrials.gov Identifier: NCT01873456
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Christian Bitz, Copenhagen University Hospital at Herlev

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.

Condition or disease Intervention/treatment Phase
Frail Older Adults Other: multifactorial nutritional intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is Multifactorial Nutritional Treatment for Undernutrition in Older Adults in Primary Care Cost-effective?
Study Start Date : January 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: Multifactorial nutritional intervention
dietician, resistance type exercise, dysphagia assessment and treatment
Other: multifactorial nutritional intervention
Other Name: dietician, resitance type exercise, dysphagia assessment and treatment

No Intervention: usual care
usual care



Primary Outcome Measures :
  1. Quality of life [ Time Frame: up to 6 months ]
    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 :
  1. Nutritional status [ Time Frame: up to 6 months ]
    Assessment of weight

  2. Hand grip strength [ Time Frame: up to 6 months ]
    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.

  3. Costs [ Time Frame: up to 6 months ]
    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

  4. Activities of Daily Living and cognitive performance [ Time Frame: up to 6 months ]
    Data is collected by Means of the resident assessment instrument

  5. physical strength [ Time Frame: up to 6 months ]
    30 seconds chair stand is used



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Screening for nutritional risk

Exclusion Criteria:

  • terminal condition or do not wish to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873456


Locations
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Denmark
Home care and nursing homes
Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
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Principal Investigator: Anne Marie Beck University of Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christian Bitz, Reserarch Director, Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01873456     History of Changes
Other Study ID Numbers: CES1
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders