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Nutritional Programme for Dementia Elderly Patient

Primary Purpose

Alzheimer's Disease, Dementia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Nutritional programme
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer's Disease focused on measuring Alzheimer Disease, Dementia, Elderly, Nutrition, Malnutrition, Weight Loss

Eligibility Criteria

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

Inclusion Criteria:

  • The patient has dementia according to DSM IV criteria.
  • The patient has an MMSE less than or equal to 26.
  • The patient lives in his/her home.
  • The patient is in the charge of a carer.
  • Informed consent for participation in the study by the responsible relative and, if possible, from the patient or legal guardian.

Exclusion Criteria:

  • The patient lives in an institution.
  • The patient is in a terminal situation.
  • The patient does not have a main carer.
  • Patient has a nasogastric feed.

Sites / Locations

  • Institut Català de l'envelliment

Outcomes

Primary Outcome Measures

Evaluation of the effectiveness of the intervention -The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale.

Secondary Outcome Measures

-Improvement in the patient's state of nutrition -Reducing the burden on carers with the Zarit scale. -Evaluation of the use of healthcare and social resources with the RUD scale. -Improvement of medical practice regarding nutrition.

Full Information

First Posted
May 25, 2007
Last Updated
January 23, 2014
Sponsor
Société des Produits Nestlé (SPN)
Collaborators
Institut Català de l'envelliment, Barcelona, Spain, Hospital Purpan, NESTEC R&D, Switzerland, Group MAPI-NAXIS, CRO, Lyon, France
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1. Study Identification

Unique Protocol Identification Number
NCT00479843
Brief Title
Nutritional Programme for Dementia Elderly Patient
Official Title
Development of a Programme to Show the Positive Effect of a Nutritional Programme on Preventing Functional and Weight Losses in Patients With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Société des Produits Nestlé (SPN)
Collaborators
Institut Català de l'envelliment, Barcelona, Spain, Hospital Purpan, NESTEC R&D, Switzerland, Group MAPI-NAXIS, CRO, Lyon, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of this study is the improvement of the quality of life and state of health of elderly people with cognitive deterioration and their families through a weight loss prevention programme. The secondary objectives are the improvement of the state of nutrition, a reduction in the use of resources and a reduction in the burden on the main carer.
Detailed Description
Main objective The main objective of this project is the evaluation of the effectiveness of a nutrition programme in patients with Alzheimer's or other dementias. Through the Nutrition Programme the idea is to reduce functional and weight loss in elderly people with cognitive deterioration and their families. Evaluation of the effectiveness of the intervention -The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale. Secondary objectives The secondary objectives of this study are: Improvement in the patient's state of nutrition The measurement criteria which will allow the patient's nutritional state to be evaluated will be their weight, BMI and MNA. Reducing the burden on carers. The Zarit scale will be used for this evaluation. Evaluation of the use of healthcare and social resources. The RUD scale will be used. Improvement of medical practice regarding nutrition. Evaluation of the representatives of our population with regard to the participation in a programme of these characteristics evaluating. Evaluation of the satisfaction of elderly people and their families in relation to the programme.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia
Keywords
Alzheimer Disease, Dementia, Elderly, Nutrition, Malnutrition, Weight Loss

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
946 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Nutritional programme
Primary Outcome Measure Information:
Title
Evaluation of the effectiveness of the intervention -The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale.
Time Frame
Baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
-Improvement in the patient's state of nutrition -Reducing the burden on carers with the Zarit scale. -Evaluation of the use of healthcare and social resources with the RUD scale. -Improvement of medical practice regarding nutrition.
Time Frame
Baseline, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient has dementia according to DSM IV criteria. The patient has an MMSE less than or equal to 26. The patient lives in his/her home. The patient is in the charge of a carer. Informed consent for participation in the study by the responsible relative and, if possible, from the patient or legal guardian. Exclusion Criteria: The patient lives in an institution. The patient is in a terminal situation. The patient does not have a main carer. Patient has a nasogastric feed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoni SALVA, MD
Organizational Affiliation
SPAIN: Institut Català de l'envelliment
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Català de l'envelliment
City
Barcelona
ZIP/Postal Code
08041
Country
Spain

12. IPD Sharing Statement

Citations:
Citation
Salvà A(1) , Fernández E(2), Andrieux S(3), Schiffrin E(4), Vellas B(3), y el grupo Nutrialz. 1. Institut de l'Envelliment. Universitat Autònoma de Barcelona. 2. Service de Gerontologie Clinique. Hôpital Pourpan. Caselardit. Toulouse. France. 3. Nestle Nutrition. Vevey. Switzerland. Estado nutricional de un grupo de pacientes ambulatorios y las principales correlaciones con las variables de la valoración geriátrica: El Estudio Nutrialz.49th Congress from the spanish aging association (6-9 June 2007, Palma de Mallorca) Salvà A(1) , Fernández E(2), Andrieux S(3), Schiffrin E(4), Vellas B(3), y el grupo Nutrialz. 1. Institut de l'Envelliment. Universitat Autònoma de Barcelona. 2. Service de Gerontologie Clinique. Hôpital Pourpan. Caselardit. Toulouse. France. 3. Nestle Nutrition. Vevey. Switzerland Nutritional status for ambulatory dementia patients and its main correlation with caregivers psychosocial variables: The Nutrialz Study INTERNATIONAL ASSOCIATION OF GERONTOLOGY AND GERIATRICS VI EUROPEAN CONGRESS (5-8 July 2007, Saint Petersburg).
Results Reference
result
PubMed Identifier
23538648
Citation
Roque M, Salva A, Vellas B. Malnutrition in community-dwelling adults with dementia (NutriAlz Trial). J Nutr Health Aging. 2013 Apr;17(4):295-9. doi: 10.1007/s12603-012-0401-9.
Results Reference
derived
PubMed Identifier
22354139
Citation
Salva A, Roque M, Rojano X, Inzitari M, Andrieu S, Schiffrin EJ, Guigoz Y, Vellas B. Falls and risk factors for falls in community-dwelling adults with dementia (NutriAlz trial). Alzheimer Dis Assoc Disord. 2012 Jan-Mar;26(1):74-80. doi: 10.1097/WAD.0b013e318215ca90.
Results Reference
derived
PubMed Identifier
22159768
Citation
Salva A, Andrieu S, Fernandez E, Schiffrin EJ, Moulin J, Decarli B, Rojano-i-Luque X, Guigoz Y, Vellas B; NutriAlz group. Health and nutrition promotion program for patients with dementia (NutriAlz): cluster randomized trial. J Nutr Health Aging. 2011 Dec;15(10):822-30. doi: 10.1007/s12603-011-0363-3.
Results Reference
derived

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Nutritional Programme for Dementia Elderly Patient

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