Improvement of Nutritional Status in Elderly Residents of Long-Term Facilities - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00873717

Purpose

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 stratégies aimed to restore a good nutritional status, among patients with slight denutrition.

Condition	Intervention
Nutrition Disorders	Other: Dentary Other: Nutrition Other: Dentary + Nutrition

MedlinePlus related topics: Diets

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:	Improvement of Nutritional Status in Elderly Residents of Long-Term Facilities: Impact of Two Strategies (Oral Care and Dietary Control)

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

comparison of GNRI mean-score between arms [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	January 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Dentaire: Experimental 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.	Other: Dentary cleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed).
Nutrition: Experimental control of the administration of dietary prescriptions, incitement to eat.	Other: Nutrition control of the administration of dietary prescriptions, incitement to eat.
Both: Experimental 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.	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.
Control: No Intervention usual care

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.

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873717

Contacts

Contact: Laurence SALOMON, MD, PhD	0033147606727	laurence.salomon@lmr.aphp.fr
Contact: Lucia Lopes	0033140676529	lucia.lopes@lmr.aphp.fr

Locations

France, Ile de France
AP-HP, Louis Mourier Hospital	Recruiting
Colombes, Ile de France, France, 92700
Contact: Philippe Charru philippe.charru@lmr.aphp.fr
Sub-Investigator: Agnès Bodineau, DDS
Hôpital de Puteaux	Recruiting
Puteaux, Ile de France, France, 92
Contact: Arash MAJDLESSI, MD amadjlessi@ch-puteaux.fr
Sub-Investigator: Agnès Bodineau, DDS
Institut ROGUET	Not yet recruiting
Clichy, Ile de France, France, 92
Contact: Philippe EISCHEN philippe.eischen@fondation-roguet.fr
Sub-Investigator: Agnès Bodineau, DDS
AP-HP, Hôpital René Muret-Bigottini	Not yet recruiting
Sevran, Ile de France, France, 93
Contact: Henri-Pierre Cornu, MD hp.cornu@rmb.aphp.fr
Sub-Investigator: Rafik Allal, DDS

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:	Philippe CHARRU, MD	Assistance Publique - Hôpitaux de Paris
Study Chair:	Marysette FOLLIGUET, DDS	Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Department Clinical Research of Developpement ( Aurélie Guimfack )
Study ID Numbers:	AOM07055, K070103, 2008-A00039-46
Study First Received:	April 1, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00873717 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

elderly
long-term facilities
nutritional status

Study placed in the following topic categories:

Nutrition Disorders

Additional relevant MeSH terms:

Nutrition Disorders

ClinicalTrials.gov processed this record on May 07, 2009