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Follow-up Home Visits With Nutrition (OHE)

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ClinicalTrials.gov Identifier: NCT01249716
Recruitment Status : Completed
First Posted : November 30, 2010
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):
AAstrup, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE November 29, 2010
First Posted Date  ICMJE November 30, 2010
Last Update Posted Date March 29, 2012
Study Start Date  ICMJE December 2010
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2010)
hospital readmissions [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2010)
body weight [ Time Frame: 12 weeks ]
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 Follow-up Home Visits With Nutrition
Official Title  ICMJE Follow-up Home Visits With Nutrition (OHE)
Brief Summary

To assess the effect on geriatric patients of follow-up home visit including nutrition.

The hypothesis is that this can prevent hospital readmissions, and has a positive impact on functional abilities and quality of life

Detailed Description Before and after the intervention the participants nutritional status, hand grip strength, functional abilities, well-being, dietary intake, level of tiredness,and activities of daily living will be assessed
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Malnutrition
Intervention  ICMJE Dietary Supplement: individual nutritional therapy
individual nutritional therapy provided by a registered dietician by means of three follow-up home visits
Study Arms  ICMJE Not Provided
Publications *

*   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: March 27, 2012)
152
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2010)
160
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Geriatric patients in nutritional risk

Exclusion Criteria:

  • Dementia
  • Expected readmissions
  • Terminal disease
  • Non-Danish speaking
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 NCT01249716
Other Study ID Numbers  ICMJE 22
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AAstrup, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Copenhagen
Verification Date March 2012

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