NCT01776762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

9 months

First QC Date

January 24, 2013

Last Update Submit

December 20, 2022

Conditions

Malnutrition

Keywords

NutritionRehabilitationWeightloss

Outcome Measures

Primary Outcomes (1)

  • Hand grip strength

    12 weeks

Secondary Outcomes (4)

  • Functional status

    12 week

  • Nutritional status

    12 weeks

  • Need of social services

    12 weeks

  • Readmissions

    6 months before and 1½ year after intervention

Study Arms (2)

Individual nutritional therapy

EXPERIMENTAL

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

Dietary Supplement: Individual nutritional therapy

Standard Follow-home programme

NO INTERVENTION

Standard Follow-home programme without individual nutritional therapy

Interventions

Individual nutritional therapyDIETARY_SUPPLEMENT

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

Individual nutritional therapy

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Dementia
  • Expected readmissions
  • Terminal disease
  • Non-danish speaking
  • Not able to perform Hand grip test
  • Planning weight reducing diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EFFECT, Copenhagen University Hospital at Herlev

Herlev, Copenhagen, 2730, Denmark

Location

Related Publications (3)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 25552522RESULT

MeSH Terms

Conditions

MalnutritionWeight Loss

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christian Bitz, Cand Scient

    Copenhagen University Hospital at Herlev

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of research

Study Record Dates

First Submitted

January 24, 2013

First Posted

January 28, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 21, 2022

Record last verified: 2022-12

Locations

DK(1)