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Trial record 1 of 1 for:    NCT01776762
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Nutritional Intervention in a Cross-sector Model for the Rehabilitation of Geriatric Patients

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ClinicalTrials.gov Identifier: NCT01776762
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : January 31, 2014
Sponsor:
Information provided by (Responsible Party):
Christian Bitz, Copenhagen University Hospital at Herlev

Tracking Information
First Submitted Date  ICMJE January 24, 2013
First Posted Date  ICMJE January 28, 2013
Last Update Posted Date January 31, 2014
Study Start Date  ICMJE March 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2013)
Hand grip strength [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2013)
  • Functional status [ Time Frame: 12 week ]
    Chair stand, mobility, disability and rehabilitation capacity
  • Nutritional status [ Time Frame: 12 weeks ]
    Weight, BMI, energy and protein intake, distribution of protein intake
  • Need of social services [ Time Frame: 12 weeks ]
    Home care, home nursing, meals-on-wheels
  • Readmissions [ Time Frame: 6 months before and 1½ year after intervention ]
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 Nutritional Intervention in a Cross-sector Model for the Rehabilitation of Geriatric Patients
Official Title  ICMJE Effect of Nutritional Intervention in a Cross-sector Model for the Rehabilitation of Undernourished Geriatric Medical Patients: a Randomized Controlled Trial.
Brief Summary

Based on an established Follow-home-programme offered at discharge from hospital the aim of this study is to test a model of how nutritional intervention in elderly patients can be systematized and quality assured in the transition between sectors. Furthermore the aim is to demonstrate that this model has a positive effect on the functioning and well-being of the elderly patient.

The purpose of the Follow-home-programme is to facilitate the transition of the elderly patient between hospital and private home in order to follow-up on any medical, nursing- or retraining-related intervention necessary to the rehabilitation of the patient. However this offer does not focus on nutrition in particular. This is a problem as many elderly patients are known to develop a poor nutritional status due to low appetite, disease etc. Our hypothesis is that adding a systematic nutritional focus to the Follow-home intervention programme will promote the rehabilitation of the elderly patient further.

The nutritional intervention in our study will focus on improving energy- and protein intake and we will measure the effect on the patient's functional abilities, quality of life and rate of hospital readmissions. The intervention model will be based on individualized nutritional counselling by a registered dietician in the patients home.

Detailed Description

The study is designed as a 12 week randomized, controlled intervention study. The study sample will consist of 80 geriatric patients admitted to a medical ward at Herlev University Hospital in Copenhagen, Denmark. The patients will be equally distributed into the control and the intervention group. The control group will follow the usual follow-home programme. The intervention group will also follow this programme, but will additionally be offered 3 home visits by a registered dietician. Interdisciplinary information exchange will take place through established communication channels eg. patient records, visitations.

Before and after the intervention data on the patient eg. hand-grip strength, nutritional status, dietary intake, functional abilities, well-being and activities of daily living will be gathered.

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 registered dietician by means of three Home-visits
Study Arms  ICMJE
  • Experimental: Individual nutritional therapy
    Individual nutritional therapy provided by registered dietician by means of three Home-visits
    Intervention: Dietary Supplement: Individual nutritional therapy
  • No Intervention: Standard Follow-home programme
    Standard Follow-home programme without individual nutritional therapy
Publications * Not Provided

*   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: January 30, 2014)
72
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2013)
80
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Geriatric medical patients
  • Age +70 years
  • Nutritional risk according to the level 1 screen in Nutritional Risk Screening 2002 (NRS2002)
  • Nutritional therapy for at least 3 days and at least in two daily meals during the hospitalization period
  • Participation in the standard Follow-home programme

Exclusion Criteria:

  • Dementia
  • Expected readmissions
  • Terminal disease
  • Non-danish speaking
  • Not able to perform Hand grip test
  • Planning weight reducing diet
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 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 NCT01776762
Other Study ID Numbers  ICMJE EFFECT.B01.2012
Has Data Monitoring Committee Yes
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: Christian Bitz, Cand Scient Copenhagen University Hospital at Herlev
PRS Account Copenhagen University Hospital at Herlev
Verification Date January 2014

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