Improvement of Nutritional Status in Elderly Residents of Long-term Facilities (Nutrident)
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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 strategies aimed to restore a good nutritional status, among patients with slight denutrition.
| Condition | Intervention |
|---|---|
|
Nutrition Disorders |
Other: Dentary Other: Nutrition Other: Dentary + Nutrition |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Improvement of Nutritional Status in Elderly Residents of Long-term Facilities: Impact of Two Strategies (Oral Care and Dietary Control) |
- comparison of GNRI mean-score between arms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 114 |
| Study Start Date: | January 2009 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Other: Dentary
cleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed).
Other Name: Dentary
|
|
Experimental: Nutrition
control of the administration of dietary prescriptions, incitement to eat.
|
Other: Nutrition
control of the administration of dietary prescriptions, incitement to eat.
Other Name: Nutrition
|
|
Experimental: 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.
|
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. Other Name: Dentary and Nutrition
|
|
No Intervention: Control
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 |
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| France | |
| Centre gérontologie Les Abondances | |
| Boulogne Billancourt, Ile de France, France, 92100 | |
| Institut ROGUET | |
| Clichy, Ile de France, France, 92 | |
| AP-HP, Louis Mourier Hospital | |
| Colombes, Ile de France, France, 92700 | |
| Hôpital Bretonneau | |
| Paris, Ile de France, France, 75018 | |
| Hôpital de Puteaux | |
| Puteaux, Ile de France, France, 92 | |
| AP-HP, Hôpital René Muret-Bigottini | |
| Sevran, Ile de France, France, 93 | |
| 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: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00873717 History of Changes |
| Other Study ID Numbers: | AOM07055, K070103, 2008-A00039-46 |
| Study First Received: | April 1, 2009 |
| Last Updated: | July 25, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
elderly long-term facilities nutritional status |
Additional relevant MeSH terms:
|
Nutrition Disorders |
ClinicalTrials.gov processed this record on June 18, 2013