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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01776762
Other study ID # EFFECT.B01.2012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2013
Est. completion date December 2013

Study information

Verified date December 2022
Source Copenhagen University Hospital at Herlev
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 70 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark EFFECT, Copenhagen University Hospital at Herlev Herlev Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View 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.

Outcome

Type Measure Description Time frame Safety issue
Primary Hand grip strength 12 weeks
Secondary Functional status Chair stand, mobility, disability and rehabilitation capacity 12 week
Secondary Nutritional status Weight, BMI, energy and protein intake, distribution of protein intake 12 weeks
Secondary Need of social services Home care, home nursing, meals-on-wheels 12 weeks
Secondary Readmissions 6 months before and 1½ year after intervention
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