Nutritional Programme for Dementia Elderly Patient

Dementia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00479843
• Other study ID #: 05.19.CLI
• Status: Completed
• Phase: N/A
• First received: May 25, 2007
• Last updated: January 23, 2014
• Start date: July 2005
• Est. completion date: July 2007

Study information

• Verified date: January 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comision de Etica en Ia Experimentacion Animal y HumanaSpain: Universitat Autonoma de Barcelona
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 946
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

Behavioral:
• Nutritional programme

Locations

Country	Name	City	State
Spain	Institut Català de l'envelliment	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Nestlé	Group MAPI-NAXIS, CRO, Lyon, France, Hospital Purpan, Institut Català de l'envelliment, Barcelona, Spain, NESTEC R&D, Switzerland

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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 Nu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Baseline, 6 months, 12 months
Secondary	-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.		Baseline, 6 months, 12 months