NCT01345032

Brief Summary

The purpose of this study is to test two different interventions of nutrition follow up after discharge from geriatric ward in undernourished geriatric patients. The patients are randomized to a home visit arm, a telephone consultation arm, or a control arm. Patients in the home visit arm and their home care helper will get visits from a clinical dietician at one week, two weeks and four weeks after discharge, in order to follow up on the nutrition intervention. Patients in the telephone consultation arm and their home care helper will be contacted by a clinical dietician at one week, two weeks and four weeks after discharge, in order to follow up on the nutrition intervention. The control arm will not be contacted. The primarily outcome is functional ability. Secondary outcomes are quality of life, readmission and mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

April 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 31, 2015

Status Verified

December 1, 2015

Enrollment Period

2.6 years

First QC Date

April 28, 2011

Last Update Submit

December 30, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Functional ability.

    Measurements: Barthel-100 Index, Cumulated Ambulation Score (CAS), handgrip strength, part of senior fitness test,fatigue test (Avlund)

    Between discharge and 8 weeks after discharge

Secondary Outcomes (5)

  • Quality of Life

    Between discharge and 8 weeks after discharge

  • Mortality

    Between discharge and 30 after discharge

  • Readmission to hospital

    Between discharge and 30 days after discharge

  • Readmission

    Between discharge and 90 days after discharge

  • Mortality

    Between discharge and 90 days after discharge

Study Arms (3)

Home visits

EXPERIMENTAL

Nutritional follow-up after discharge, conducted as nutritional counselling performed as in-person counselling in the participants homes

Other: Home visit

Telephone consultation

EXPERIMENTAL

Nutritional follow-up after discharge, conducted as nutritional counselling performed as telephone consultation

Other: Telephone consultation

Control

NO INTERVENTION

No follow-up after discharge

Interventions

Patients and their homecare helper will receive visits from a clinical dietician 1 week, 2 weeks and 4 weeks after discharge. The purpose of the visits is follow up on the individual diet plan distributed at discharge and supply dietary advice.

Also known as: Aged 75 and over, Living alone, Receive help for home care services, Dietary advice after discharge by home visits
Home visits

Patients and their homecare helper will be contacted on telephone from a clinical dietician 1 week, 2 weeks and 4 weeks after discharge. The purpose of the telephone contact is follow up on the individual diet plan distributed at discharge and supply dietary advice.

Also known as: Aged 75 and over, Living alone, Receive help for home care services, Dietary advice after discharge by telephone consultation
Telephone consultation

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • aged 75 and over
  • undernourished according to Mini Nutritional Assessment (MNA)
  • living alone in own home
  • admitted and discharged from geriatric ward Aarhus, Denmark, due to various acute somatic disorders

You may not qualify if:

  • active cancer
  • mental disorder (MMSE\<22)
  • live together with another person
  • live in a nursing home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus Universityhospital, Geriatric Department

Aarhus, 8000, Denmark

Location

Geriatric Department

Aarhus, 8000, Denmark

Location

MeSH Terms

Interventions

House CallsHome EnvironmentHome Care Services

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services AdministrationResidence CharacteristicsDemographyPopulation CharacteristicsFamily CharacteristicsSocioeconomic FactorsEnvironmentEnvironment and Public HealthEpidemiologic MeasurementsPublic HealthCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesNursing Services

Study Officials

  • Jette Lindegaard Pedersen, MHSc.

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR
  • Else Marie S. Damsgaard, Professor

    Aarhus University Hospital

    STUDY CHAIR
  • Preben Ulrich Pedersen, Ph.D.

    University of Aarhus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical research nurse

Study Record Dates

First Submitted

April 28, 2011

First Posted

April 29, 2011

Study Start

June 1, 2011

Primary Completion

January 1, 2014

Study Completion

December 1, 2015

Last Updated

December 31, 2015

Record last verified: 2015-12

Locations