Nutritional Programme for Dementia Elderly Patient

Sponsor

Nestlé (Industry)

Overall Status

Completed

CT.gov ID

NCT00479843

Collaborator

Institut Català de l'envelliment, Barcelona, Spain (Other), Hospital Purpan (Other), NESTEC R&D, Switzerland (Other), Group MAPI-NAXIS, CRO, Lyon, France (Other)

946

Enrollment

Location

Duration (Months)

39.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease Dementia	Behavioral: Nutritional programme	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

946 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

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. [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. [Baseline, 6 months, 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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.