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Nutritional Intervention in a Cross-sector Model for the Rehabilitation of Geriatric Patients

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Individual nutritional therapy
Sponsored by
Copenhagen University Hospital at Herlev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Nutrition, Rehabilitation, Weightloss

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • EFFECT, Copenhagen University Hospital at Herlev

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Individual nutritional therapy

Standard Follow-home programme

Arm Description

Individual nutritional therapy provided by registered dietician by means of three Home-visits

Standard Follow-home programme without individual nutritional therapy

Outcomes

Primary Outcome Measures

Hand grip strength

Secondary Outcome Measures

Functional status
Chair stand, mobility, disability and rehabilitation capacity
Nutritional status
Weight, BMI, energy and protein intake, distribution of protein intake
Need of social services
Home care, home nursing, meals-on-wheels
Readmissions

Full Information

First Posted
January 24, 2013
Last Updated
December 20, 2022
Sponsor
Copenhagen University Hospital at Herlev
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1. Study Identification

Unique Protocol Identification Number
NCT01776762
Brief Title
Nutritional Intervention in a Cross-sector Model for the Rehabilitation of Geriatric Patients
Official Title
Effect of Nutritional Intervention in a Cross-sector Model for the Rehabilitation of Undernourished Geriatric Medical Patients: a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen University Hospital at Herlev

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Nutrition, Rehabilitation, Weightloss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual nutritional therapy
Arm Type
Experimental
Arm Description
Individual nutritional therapy provided by registered dietician by means of three Home-visits
Arm Title
Standard Follow-home programme
Arm Type
No Intervention
Arm Description
Standard Follow-home programme without individual nutritional therapy
Intervention Type
Dietary Supplement
Intervention Name(s)
Individual nutritional therapy
Intervention Description
Individual nutritional therapy provided by registered dietician by means of three Home-visits
Primary Outcome Measure Information:
Title
Hand grip strength
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Functional status
Description
Chair stand, mobility, disability and rehabilitation capacity
Time Frame
12 week
Title
Nutritional status
Description
Weight, BMI, energy and protein intake, distribution of protein intake
Time Frame
12 weeks
Title
Need of social services
Description
Home care, home nursing, meals-on-wheels
Time Frame
12 weeks
Title
Readmissions
Time Frame
6 months before and 1½ year after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Bitz, Cand Scient
Organizational Affiliation
Copenhagen University Hospital at Herlev
Official's Role
Principal Investigator
Facility Information:
Facility Name
EFFECT, Copenhagen University Hospital at Herlev
City
Herlev
State/Province
Copenhagen
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Citations:
Citation
Beck A, Rask KØ, Leedo E, Jensen LL, Martins K, Vedelspang A (2014) Study Protocol: Nutritional Support in a Cross-sector Model for the Rehabilitation of Geriatric Patients: A Randomized Controlled Trial. J Clin Trials 4: 165.
Results Reference
background
Citation
Pohju A, Belqaid K, Brandt C, Lugnet K, Nielsen AL, et al. (2016) Adding a Dietitian to a Danish Liaison-Team after discharge of geriatric patients at nutritional risk may save health care costs. Aging Sci 4: 159.
Results Reference
background
PubMed Identifier
25552522
Citation
Beck A, Andersen UT, Leedo E, Jensen LL, Martins K, Quvang M, Rask KO, Vedelspang A, Ronholt F. Does adding a dietician to the liaison team after discharge of geriatric patients improve nutritional outcome: a randomised controlled trial. Clin Rehabil. 2015 Nov;29(11):1117-28. doi: 10.1177/0269215514564700. Epub 2014 Dec 31.
Results Reference
result

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Nutritional Intervention in a Cross-sector Model for the Rehabilitation of Geriatric Patients

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