Nutritional Programme for Dementia Elderly Patient

This study has been completed.
Sponsor:
Collaborators:
Institut Català de l'envelliment, Barcelona, Spain
Service de Gérontologie Clinique, Purpan Casselardit Hospital, Toulouse, France
NESTEC R&D, Switzerland
Group MAPI-NAXIS, CRO, Lyon, France
Information provided by:
Nestlé
ClinicalTrials.gov Identifier:
NCT00479843
First received: May 25, 2007
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Alzheimer's Disease
Dementia
Behavioral: Nutritional programme

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Nestlé:

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. [ Time Frame: Baseline, 6 months, 12 months ]

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. [ Time Frame: Baseline, 6 months, 12 months ]

Enrollment: 946
Study Start Date: July 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479843

Locations
Spain
Institut Català de l'envelliment
Barcelona, Spain, 08041
Sponsors and Collaborators
Nestlé
Institut Català de l'envelliment, Barcelona, Spain
Service de Gérontologie Clinique, Purpan Casselardit Hospital, Toulouse, France
NESTEC R&D, Switzerland
Group MAPI-NAXIS, CRO, Lyon, France
Investigators
Principal Investigator: Antoni SALVA, MD SPAIN: Institut Català de l'envelliment
  More Information

No publications provided by Nestlé

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00479843     History of Changes
Other Study ID Numbers: 05.19.CLI
Study First Received: May 25, 2007
Last Updated: January 23, 2014
Health Authority: Spain: Comision de Etica en Ia Experimentacion Animal y Humana
Spain: Universitat Autonoma de Barcelona

Keywords provided by Nestlé:
Alzheimer Disease
Dementia
Elderly
Nutrition
Malnutrition
Weight Loss

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014