Continuity of Nutritional CareNCT01584661
The Continuity of Nutritional Care Among Elderly Patients
An observational study of Continuity of Nutritional Care and Health Care Use, run by Bait Balev Hospital at 2 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Continuity of Nutritional Care, Health Care Use, Nutritional Status
- What is being tested?
- Dietary recommendations
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 2 sitesIsrael
- Study dates
- Jul 2012to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Study population Patients over the age of 65 who are members of Maccabi Health Care Services will be recruited for the current study. The 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.
Who may be able to join
None listed.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Bait Balev
Bat Yam
Yulia Ginzburgh, RD, 972526885631, yulia_ginzburg@walla.com
Bait Balev
Bat Yam
Yulia Ginzburgh, RD, 972526885631, yulia_ginzburg@walla.com
Danit R Shahar, PhD
About this study
Official title: The Continuity of Nutritional Care From the Hospital to the Community and Its Impact on Health and Functional Indicators Among Elderly Patients
Objectives:
- To determine the level of compliance with nutritional recommendations (dietary and nutritional supplements) following discharge from hospitalization;
- To identify barriers for post-discharge adherence to professional nutritional recommendations;
- 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.
Read the detailed 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).
- Being tested
- Dietary recommendations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary recommendationsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Compliance with nutritional care | The 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. Receives: Behavioral: Dietary recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary: Compliance with nutritional recommendations
Secondary outcomes (1)
Health status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuity of Nutritional CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Bait Balev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Principal investigator, Danit R Shahar, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584661
- Sponsor's protocol ID
- ABB-1-2012
- Status last verified
- Apr 2012
- First submitted
- 24 Apr 2012
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Continuity of Nutritional Care From the Hospital to the Community and Its Impact on Health and Functional Indicators Among Elderly Patients
- ClinicalTrials.gov ID
- NCT01584661
- Acronym / sponsor ID
- ABB-1-2012
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Bait Balev HospitalUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- Jul 2012
- Primary completion
- Aug 2013 (estimated)
- First posted
- 25 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
- To determine the level of compliance with nutritional recommendations (dietary and nutritional supplements) following discharge from hospitalization;
- To identify barriers for post-discharge adherence to professional nutritional recommendations;
- 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.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compliance with nutritional care | – | Behavioral: Dietary recommendationsThe 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. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Study population Patients over the age of 65 who are members of Maccabi Health Care Services will be recruited for the current study. The 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary recommendations | Behavioural | Compliance with nutritional care |
Primary outcome
Primary: Compliance with nutritional recommendations
1 secondary outcome
Health status
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Continuity of Nutritional Care and Health Care Use, run by Bait Balev Hospital at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary: Compliance with nutritional recommendations. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2012.