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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christian Bitz, Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01776762
First received: January 24, 2013
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Malnutrition
Dietary Supplement: Individual nutritional therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Nutritional Intervention in a Cross-sector Model for the Rehabilitation of Undernourished Geriatric Medical Patients: a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • Hand grip strength [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional status [ Time Frame: 12 week ] [ Designated as safety issue: No ]
    Chair stand, mobility, disability and rehabilitation capacity

  • Nutritional status [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Weight, BMI, energy and protein intake, distribution of protein intake

  • Need of social services [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Home care, home nursing, meals-on-wheels

  • Readmissions [ Time Frame: 6 months before and 1½ year after intervention ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: March 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Individual nutritional therapy
Individual nutritional therapy provided by registered dietician by means of three Home-visits
Dietary Supplement: Individual nutritional therapy
Individual nutritional therapy provided by registered dietician by means of three Home-visits
No Intervention: Standard Follow-home programme
Standard Follow-home programme without individual nutritional therapy

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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776762

Locations
Denmark
EFFECT, Copenhagen University Hospital at Herlev
Herlev, Copenhagen, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
Principal Investigator: Christian Bitz, Cand Scient Copenhagen University Hospital at Herlev
  More Information

No publications provided

Responsible Party: Christian Bitz, Head of research, Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01776762     History of Changes
Other Study ID Numbers: EFFECT.B01.2012
Study First Received: January 24, 2013
Last Updated: January 30, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Copenhagen University Hospital at Herlev:
Nutrition
Rehabilitation
Weightloss

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on August 19, 2014