MalnourishedNCT03278678
Nutritional Screening in Older Individuals
An observational study of Malnourished, run by Sanjuan, Silvia Forcano, M.D..
Trial summary
Hospital-based case management programs and home hospitalization services following the risk stratification model of Kaiser Permanente and Kings Fund select an estimated 5% of older individuals living in the community who are at high risk of hospitalization and adverse outcomes. Read more about this study
- Who is it for?
- Ages 65 to 105 years
- Conditions the study is for
- Malnourished
- How many people
- 791 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 30 Jun 2016
- 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 105 years
- All sexes
- Older adult
Study population: The final sample size was of 791 subjects. The baseline characteristics were: Mean age (years): 79.9 +/- 10.86 Female : 397 (50.2%) Mean Body Mass Index : 27.6 +/- 5.75
Who may be able to join
- Patients included at Case Management Program for complex chronic condition
- Must be able to answer questions on the telephone
Who cannot join
- Subjects with no telephone,
- Subjects unable to determine their usual weight
- End-of-life clinical situation
About this study
Official title: Nutritional Screening in Community Living Older Individuals at High Risk of Hospital Admission.
Hospital-based case management programs and home hospitalization services following the risk stratification model of Kaiser Permanente and Kings Fund select an estimated 5% of older individuals living in the community who are at high risk of hospitalization and adverse outcomes. The objective of these services is to avoid deterioration and hospital admissions or visits to the emergency services by regular follow-up, proactive home visits and support of self-care . The prevalence of malnutrition in patients selected using this model of care is unknown.
Read the detailed description
The aim of this study was to estimate the prevalence of malnutrition, using the MNA, in this high-risk community living population, and to explore risk factors that could identify subgroups of individuals at higher risk.
This study was performed in individuals included in a Case Management (CM) Program lead by the Telemedicine Unit of a tertiary university hospital in Valencia. Patients admitted to the hospital with two or more hospital admissions for medical reasons in the previous year are detected by a computerized system and included in the program, an integrated care intervention developed for patients with complex multimorbidity using patient-centred education activities and integrated care interventions, with the support of a Hospital at Home Unit (HHU). Telephone follow-ups by case manager nurses are focused on identifying problems and detecting disease exacerbations. The main aim of this program is to avoid hospital admissions and reduce the number of visits to emergency services
- Conditions
- Malnourished
- Keywords
- Nutritional screening MNA-SF malnutrition Case Management
- Medical subject headings
- Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of malnutrition
prevalence of malnutrition by using MNA-SF
Measured: 2 months
Secondary outcomes (3)
sexBMI
male or female, average age, BMI
Measured: 2 months
age
average age in years
Measured: 2 months
BMI
body mass index in Kg / m^2
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 May 2016
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnourishedStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 791 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanjuan, Silvia Forcano, M.D.
- Collaborators
- Ministerio de Sanidad, Servicios Sociales e Igualdad
- Responsible party
- Principal investigator, Silvia Forcano Sanjuan, Sanjuan, Silvia Forcano, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278678
- Sponsor's protocol ID
- SanjuanS
- Status last verified
- Sep 2017
- First submitted
- 6 Sep 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Screening in Community Living Older Individuals at High Risk of Hospital Admission.
- ClinicalTrials.gov ID
- NCT03278678
- Acronym / sponsor ID
- SanjuanS
- Conditions
- Malnourished
- Keywords
- Nutritional screening MNA-SF malnutrition Case Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 791 participants (actual)
- Lead sponsor
- Sanjuan, Silvia Forcano, M.D.
- Collaborators
- Ministerio de Sanidad, Servicios Sociales e Igualdad
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 12 Sep 2017 (actual)
- 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.
Hospital-based case management programs and home hospitalization services following the risk stratification model of Kaiser Permanente and Kings Fund select an estimated 5% of older individuals living in the community who are at high risk of hospitalization and adverse outcomes. The objective of these services is to avoid deterioration and hospital admissions or visits to the emergency services by regular follow-up, proactive home visits and support of self-care . The prevalence of malnutrition in patients selected using this model of care is unknown.
Detailed description
The aim of this study was to estimate the prevalence of malnutrition, using the MNA, in this high-risk community living population, and to explore risk factors that could identify subgroups of individuals at higher risk.
This study was performed in individuals included in a Case Management (CM) Program lead by the Telemedicine Unit of a tertiary university hospital in Valencia. Patients admitted to the hospital with two or more hospital admissions for medical reasons in the previous year are detected by a computerized system and included in the program, an integrated care intervention developed for patients with complex multimorbidity using patient-centred education activities and integrated care interventions, with the support of a Hospital at Home Unit (HHU). Telephone follow-ups by case manager nurses are focused on identifying problems and detecting disease exacerbations. The main aim of this program is to avoid hospital admissions and reduce the number of visits to emergency services
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 105 years
- Sex
- All
- Age groups
- Older adult
- Study population
- The final sample size was of 791 subjects. The baseline characteristics were: Mean age (years): 79.9 +/- 10.86 Female : 397 (50.2%) Mean Body Mass Index : 27.6 +/- 5.75
Key inclusion criteria (2 listed)
- Patients included at Case Management Program for complex chronic condition
- Must be able to answer questions on the telephone
Key exclusion criteria (3 listed)
- Subjects with no telephone,
- Subjects unable to determine their usual weight
- End-of-life clinical situation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of malnutrition
Time frame: 2 months
prevalence of malnutrition by using MNA-SF
3 secondary outcomes
sexBMI
Time frame: 2 months
age
Time frame: 2 months
BMI
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnourished, run by Sanjuan, Silvia Forcano, M.D..
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of malnutrition (time frame: 2 months). 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 13 Sep 2017.