Clinical trial NCT01776762: 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
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Nutrition
Rehabilitation
Weightloss
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 72
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hand grip strength
timeFrame: 12 weeks
Secondary outcomes:
measure: Functional status
timeFrame: 12 week
measure: Nutritional status
timeFrame: 12 weeks
measure: Need of social services
timeFrame: 12 weeks
measure: Readmissions
timeFrame: 6 months before and 1½ year after intervention
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: EFFECT, Copenhagen University Hospital at Herlev
state: Copenhagen
Study officials:
affiliation: Copenhagen University Hospital at Herlev
name: Christian Bitz, Cand Scient
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.