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Improvement of Nutritional Status in Elderly Residents of Long-term Facilities (Nutrident)

Primary Purpose

Nutrition Disorders

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dentary
Nutrition
Dentary + Nutrition
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nutrition Disorders focused on measuring elderly, long-term facilities, nutritional status

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Geriatric Nutritional Risk Index = 83.5 to 97.5; minimum age of 70 years old; living in long-term facilities; more than 6 months of anticipated length of stay

Exclusion Criteria:

  • refusal to participate in the study

Sites / Locations

  • Centre gérontologie Les Abondances
  • Institut ROGUET
  • AP-HP, Louis Mourier Hospital
  • Hôpital Bretonneau
  • Hôpital de Puteaux
  • AP-HP, Hôpital René Muret-Bigottini

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Dentary

Nutrition

Dentary + nutrition

Control

Arm Description

Intervention: trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash.

control of the administration of dietary prescriptions, incitement to eat.

cleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed) associated with control of the administration of dietary prescriptions, incitement to eat.

usual care

Outcomes

Primary Outcome Measures

comparison of GNRI mean-score between arms

Secondary Outcome Measures

Full Information

First Posted
April 1, 2009
Last Updated
July 25, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00873717
Brief Title
Improvement of Nutritional Status in Elderly Residents of Long-term Facilities
Acronym
Nutrident
Official Title
Improvement of Nutritional Status in Elderly Residents of Long-term Facilities: Impact of Two Strategies (Oral Care and Dietary Control)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Elderly persons in long-term facilities often have denutrition, associated with a bad oral and dental status. Yet, many elderly persons don't attend dentist care and when they have dental prothesis, do not often use them during meals. The impact of a rehabilitation of dental function on their nutritional status has not been proven. The objective of this study is to assess the impact of 2 strategies aimed to restore a good nutritional status, among patients with slight denutrition.
Detailed Description
Two interventions are evaluated during a 1 year study period, with a 4 arms factorial design. The "Dentary" intervention implies a trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash. The "Nutrition" intervention consists in 1) comparing the meals and oral supplements administered with the dietary prescriptions and 2) Incite patients to eat.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorders
Keywords
elderly, long-term facilities, nutritional status

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dentary
Arm Type
Experimental
Arm Description
Intervention: trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash.
Arm Title
Nutrition
Arm Type
Experimental
Arm Description
control of the administration of dietary prescriptions, incitement to eat.
Arm Title
Dentary + nutrition
Arm Type
Experimental
Arm Description
cleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed) associated with control of the administration of dietary prescriptions, incitement to eat.
Arm Title
Control
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Other
Intervention Name(s)
Dentary
Intervention Description
cleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed).
Intervention Type
Other
Intervention Name(s)
Nutrition
Intervention Description
control of the administration of dietary prescriptions, incitement to eat.
Intervention Type
Other
Intervention Name(s)
Dentary + Nutrition
Other Intervention Name(s)
Dentary and Nutrition
Intervention Description
trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash. associated with control of the administration of dietary prescriptions, incitement to eat.
Primary Outcome Measure Information:
Title
comparison of GNRI mean-score between arms
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Geriatric Nutritional Risk Index = 83.5 to 97.5; minimum age of 70 years old; living in long-term facilities; more than 6 months of anticipated length of stay Exclusion Criteria: refusal to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe CHARRU, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marysette FOLLIGUET, DDS
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Centre gérontologie Les Abondances
City
Boulogne Billancourt
State/Province
Ile de France
ZIP/Postal Code
92100
Country
France
Facility Name
Institut ROGUET
City
Clichy
State/Province
Ile de France
ZIP/Postal Code
92
Country
France
Facility Name
AP-HP, Louis Mourier Hospital
City
Colombes
State/Province
Ile de France
ZIP/Postal Code
92700
Country
France
Facility Name
Hôpital Bretonneau
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75018
Country
France
Facility Name
Hôpital de Puteaux
City
Puteaux
State/Province
Ile de France
ZIP/Postal Code
92
Country
France
Facility Name
AP-HP, Hôpital René Muret-Bigottini
City
Sevran
State/Province
Ile de France
ZIP/Postal Code
93
Country
France

12. IPD Sharing Statement

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Improvement of Nutritional Status in Elderly Residents of Long-term Facilities

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