- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00479843
Nutritional Programme for Dementia Elderly Patient
Development of a Programme to Show the Positive Effect of a Nutritional Programme on Preventing Functional and Weight Losses in Patients With Dementia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Barcelona, Spain, 08041
- Institut Català de l'envelliment
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Baseline, 6 months, 12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
-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
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Baseline, 6 months, 12 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Antoni SALVA, MD, SPAIN: Institut Català de l'envelliment
Publications and helpful links
General Publications
- 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).
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05.19.CLI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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