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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 29, 2013
First Posted Date  ICMJE June 10, 2013
Last Update Posted Date February 1, 2019
Study Start Date  ICMJE January 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
  • Nutritional status [ Time Frame: up to 6 months ]
    Assessment of weight
  • 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.
  • 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
  • Activities of Daily Living and cognitive performance [ Time Frame: up to 6 months ]
    Data is collected by Means of the resident assessment instrument
  • physical strength [ Time Frame: up to 6 months ]
    30 seconds chair stand is used
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Is Multifactorial Nutritional Treatment for Undernutrition in Older Adults in Primary Care Cost-effective?
Official Title  ICMJE Is Multifactorial Nutritional Treatment for Undernutrition in Older Adults in Primary Care Cost-effective?
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Frail Older Adults
Intervention  ICMJE Other: multifactorial nutritional intervention
Other Name: dietician, resitance type exercise, dysphagia assessment and treatment
Study Arms  ICMJE
  • Experimental: Multifactorial nutritional intervention
    dietician, resistance type exercise, dysphagia assessment and treatment
    Intervention: Other: multifactorial nutritional intervention
  • No Intervention: usual care
    usual care
Publications * Beck AM, Gøgsig Christensen A, Stenbæk Hansen B, Damsbo-Svendsen S, Kreinfeldt Skovgaard Møller 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2013)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Screening for nutritional risk

Exclusion Criteria:

  • terminal condition or do not wish to participate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01873456
Other Study ID Numbers  ICMJE CES1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christian Bitz, Copenhagen University Hospital at Herlev
Study Sponsor  ICMJE Copenhagen University Hospital at Herlev
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne Marie Beck University of Copenhagen
PRS Account Copenhagen University Hospital at Herlev
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP