Follow-up Home Visits With Nutrition (OHE)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AAstrup, University of Copenhagen

ClinicalTrials.gov Identifier:

NCT01249716

First received: November 29, 2010

Last updated: March 27, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 29, 2010
Last Updated Date	March 27, 2012
Start Date ^ICMJE	December 2010
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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01249716 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 29, 2010)	body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 Arm (s)	Not Provided
Publications *	Beck AM, Kjær S, Hansen BS, Storm RL, Thal-Jantzen K. Study protocol: follow-up home visits with nutrition: a randomised controlled trial. BMC Geriatr. 2011 Dec 28;11:90.
* 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
Enrollment ^ICMJE	152
Completion Date	March 2012
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
Gender	Both
Ages	65 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT01249716
Other Study ID Numbers ^ICMJE	22
Has Data Monitoring Committee	Yes
Responsible Party	AAstrup, University of Copenhagen
Study Sponsor ^ICMJE	University of Copenhagen
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	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

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