NCT03131856

Brief 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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

2.8 years

First QC Date

March 31, 2017

Last Update Submit

April 24, 2017

Conditions

Malnutrition

Keywords

GeriatricsNutritional riskMulti-disciplinary interventionRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Nutritional status

    Change in body weight (kg)

    Three months follow-up

Secondary Outcomes (5)

  • Functional status

    Three months follow-up

  • Functional status

    Three months follow-up

  • Self-rated health

    Three months follow-up

  • Re-admission

    Up to three months

  • Mortality

    1) Up to 90 days after discharge 2) Up to 120 days after discharge

Study Arms (2)

Nutritional intervention programme

EXPERIMENTAL

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).

Behavioral: Nutritional intervention programme

Usual care

NO INTERVENTION

Usual care which means no individual dietary plan and no nutrition follow-up visits after discharge.

Interventions

Nutritional intervention programmeBEHAVIORAL

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.

Nutritional intervention programme

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Terminal illness
  • Active cancer diagnosis
  • Permanently living in a nursing home
  • Not willing or able to give an informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Eligible patients were randomized to either the intervention group or control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigater

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 27, 2017

Study Start

October 15, 2012

Primary Completion

August 17, 2015

Study Completion

December 31, 2015

Last Updated

April 27, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share