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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01584661
Other study ID # ABB-1-2012
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 24, 2012
Last updated April 24, 2012
Start date July 2012

Study information

Verified date April 2012
Source Bait Balev Hospital
Contact n/a
Is FDA regulated No
Health authority Israel: The Israel National Institute for Health Policy Research and Health Services Research
Study type Observational

Clinical Trial Summary

Objectives:

1. To determine the level of compliance with nutritional recommendations (dietary and nutritional supplements) following discharge from hospitalization;

2. To identify barriers for post-discharge adherence to professional nutritional recommendations;

3. To determine the impact of adherence (high vs. low) to the nutritional treatment guidelines on functional and health indicators.

Working hypothesis:

High adherence to nutritional care after hospitalization will be associated with better functional and health outcomes.


Description:

The proposed study will follow patients who were hospitalized in the rehabilitation departments at "Bait Balev". Patients who were treated with nutritional supplements by a dietitian during hospitalization and received dietary recommendations upon discharge will be followed for their adherence with the treatment recommendations. The impact of the level of adherence to the nutritional recommendations on health will be assessed.

C2. Experimental design:

This shall be a retrospective and prospective cohort study. Patients from the orthopedic and neurologic rehabilitation departments, who received nutritional intervention by nutritional supplements during hospitalization and were advised to receive nutritional enrichment at discharge, will be enrolled to the study. The main criteria for nutritional intervention during hospitalization and recommendation for supplements upon discharge include, among others, withdrawal of alternative nourishment, underweight, undernutrition, non-voluntary weight loss, low protein status and other criteria typical among this population during hospitalization. In order to assess the level of compliance with dietitian's recommendations upon discharge, only patients who were discharged to their homes will be followed. In order to increase the sample size, a retrospective cohort study will be conducted, in which patients from the same departments who were discharged in the last 3 months will be followed both retrospectively and prospectively.

Home visits will take place 3 and 6 months after discharge, during which the dietitian shall complete a questionnaire measuring the level of patient compliance to the nutritional recommendations, and in addition the patient or their legal guardian shall provide anamnesis in order to review the effect of compliance on health, functional, nutritional and social status (it should be noted that approx. 90% of the patients in the hospital belong to the Maccabi Health Care Services group, so the follow up of discharged patients in the community will be conducted with Maccabi Health Care Services).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 0
Est. completion date
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 65 Years to 95 Years
Eligibility Inclusion Criteria:comprise patients who were treated nutritionally with food enrichment supplements during their hospitalization in "Bait Balev" and were discharged to their homes with dietary recommendations. Participants who are willing to participate will sign an informed consent form. For patients with cognitive impairment or dementia, as reported in their medical records, their formal primary caregiver or proxy will sign the informed consent form.

Exclusion Criteria:

- 1. Patients who were discharged to a Retirement home; 2. Palliative patients; 3. Patients who are not members of Maccabi Health Care Services. 4. Patients with enteral nutrition (PZ / PEG / PEJ)

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Behavioral:
Dietary recommendations


Locations

Country Name City State
Israel Bait Balev Bat-Yam
Israel Bait Balev Bat-Yam

Sponsors (2)

Lead Sponsor Collaborator
Bait Balev Hospital Ben-Gurion University of the Negev

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary: Compliance with nutritional recommendations
Secondary Health status
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