Nutritional Intervention in Geriatric Patients

Malnutrition Clinical Trial

Official title:

A Multidisciplinary Nutritional Intervention Programme Across Sectors to Improve the Nutritional Status of Geriatric Patients at Nutritional Risk - A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03131856
• Other study ID #: Geriatric-Project-2012
• Status: Completed
• Phase: N/A
• First received: March 31, 2017
• Last updated: April 24, 2017
• Start date: October 15, 2012
• Est. completion date: December 31, 2015

Study information

• Verified date: April 2017
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the effect of a multi-disciplinary nutritional intervention program in geriatric nutritional at risk patients. The study is carried out as randomized controlled trial. The intervention consists of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2015
• Est. primary completion date: August 17, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age 65 or above

• BMI <20.5 and/or weight loss within the last 3 months and/or a reduced dietary intake in the previous week and/or severely ill

Exclusion Criteria:

• Terminal illness

• Active cancer diagnosis

• Permanently living in a nursing home

• Not willing or able to give an informed consent.

Related Conditions & MeSH terms

• Malnutrition

Intervention

Behavioral:
• Nutritional intervention programme
The intervention consisted of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks) conducted by a district nurse.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional status	Change in body weight (kg)	Three months follow-up
Secondary	Functional status	Barthel Index (scale 0-100)	Three months follow-up
Secondary	Functional status	Handgrip strength (kg)	Three months follow-up
Secondary	Self-rated health	Self-rated health was measured with one single question with 5 possible responses on a Likert scale: In general, how would you rate your Health?	Three months follow-up
Secondary	Re-admission	All-cause unplanned readmissions	Up to three months
Secondary	Mortality	All-cause mortality	1) Up to 90 days after discharge 2) Up to 120 days after discharge