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

NCT ID: NCT00873717

Last Updated: 2012-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Nutrition Disorders

Keywords

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elderly long-term facilities nutritional status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Dentary

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.

Group Type EXPERIMENTAL

Dentary

Intervention Type OTHER

cleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed).

Nutrition

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

Group Type EXPERIMENTAL

Nutrition

Intervention Type OTHER

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

Dentary + nutrition

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.

Group Type EXPERIMENTAL

Dentary + Nutrition

Intervention Type OTHER

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.

Control

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dentary

cleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed).

Intervention Type OTHER

Nutrition

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

Intervention Type OTHER

Dentary + Nutrition

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.

Intervention Type OTHER

Other Intervention Names

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Dentary and Nutrition

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe CHARRU, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Marysette FOLLIGUET, DDS

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Locations

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Centre gérontologie Les Abondances

Boulogne-Billancourt, Île-de-France Region, France

Site Status

Institut ROGUET

Clichy, Île-de-France Region, France

Site Status

AP-HP, Louis Mourier Hospital

Colombes, Île-de-France Region, France

Site Status

Hôpital Bretonneau

Paris, Île-de-France Region, France

Site Status

Hôpital de Puteaux

Puteaux, Île-de-France Region, France

Site Status

AP-HP, Hôpital René Muret-Bigottini

Sevran, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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K070103

Identifier Type: OTHER

Identifier Source: secondary_id

2008-A00039-46

Identifier Type: OTHER

Identifier Source: secondary_id

AOM07055

Identifier Type: -

Identifier Source: org_study_id