Nutritional Programme for Dementia Elderly Patient

Original Study ID : 05.19.CLI

NCT ID : 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

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.

Source : Nestle Research Center

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.

Overall Status : Completed

Start Date : July 2005

End Date : July 2007

Completion Date : July 2007

Official Title : N/A

Phase : Interventional

Study Design : Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Enrollment : 946

Verification Date : April 2008

First Received Date : May 25, 2007

Trial 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.

Gender : Both

Minimum Age : 50 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : Institut Català de l'envelliment

City : Barcelona

Zip Code : 08041

Country : Spain

Clinical Trial Name -Nutritional Programme for Dementia Elderly Patient