Weight LossSFNRNCT04516642
Swiss Frailty Network and Repository
An observational study of Weight Loss and Fatigue, run by University of Zurich at 1 site in Switzerland.
Trial summary
Physical frailty is an age-related medical syndrome defined by a decline in multiple body systems, thus causing increased vulnerability, even in the face of minor stressors (1) It has been linked to multiple negative health outcomes, including extended length of stay in acute care due to complications, hospital… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Weight Loss, Fatigue, Physical Frailty
- How many people
- 1,500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2020to 28 Feb 2024
- How long will I take part?
- 12 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Hospitalized patients age 65 and older from all 5 university hospitals in Switzerland (Basel, Bern, Geneva, Lausanne and Zurich)
Who may be able to join
- Men and women age 65 and older
- Admission as inpatients to acute care at any partnering university hospital (eFI - subgroup)
- Admission as inpatients to acute geriatric care (cFI - subgroup)
- Patients or proxies need to provide a written informed consent (geriatric patients (cFI and eFI): project consent; non-geriatric patients ((eFI): general consent)
Who cannot join
- Documented objection of participating in the project and/or subsequent use of personal health data
- Not fluent in local language (i.e. German, French)
- Patient is uncooperative or presence of inability to perform functional tests due to severe cognitive and/or physical impairment/acute medical illness
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dept. of Geriatrics and Aging Research, University of Zurich / Geriatric Clinic University Hospital Zurich
Zurich, Canton of Zurich, 8037
About this study
Physical frailty is an age-related medical syndrome defined by a decline in multiple body systems, thus causing increased vulnerability, even in the face of minor stressors (1) It has been linked to multiple negative health outcomes, including extended length of stay in acute care due to complications, hospital re-admissions, and mortality among older patients. About 10-30% of community-dwelling seniors are considered frail(2) with an additional 40% being at risk for the condition (pre-frailty). By 2030, the number of older adults with frailty is expected to at least double, in parallel to the projected growth of the older segment of the population. Frail seniors consume 3-times more health care resources then their robust counterparts. Thus, the health economic impact of frailty is expected to be enormous and a call to action has been posed. Big data in healthcare provides important opportunities for the identification of frailty among the growing number of older patients. This is relevant as frailty is considered a better predictor of adverse outcomes than chronological age alone. Therefore, several medical specialties have started to assess frailty in cancer patients, heart surgery candidates and potential organ transplant recipients.
Read the detailed description
The Swiss Frailty Network and Repository is a Swiss Personalized Health Network (SPHN) driver project. The investigators aim to promote the sustainable implementation of a frailty data network for research and clinical purposes in strong partnership between all Swiss geriatric academic centers.
One of the five main goals of this project is to validate an electronic frailty index (eFI) as a screening tool against a clinical frailty instrument (cFI) (validation study) and the investigation of the correlation of the two instruments with the important endpoints in-hospital mortality and length of stay in hospital (association study) is at the core of the project. For the validation study (4), the investigators will include patients 65 and older admitted to acute geriatric care at all partnering sites, where both, the cFI and the eFI is collected. For the validation study (4), the investigators will include only patients with written project informed consent and consent for subsequent use of the project data (the investigators will also ask for general consent whenever possible. For the correlation study (5) regarding the cFI and the 2 outcomes. The same requirements apply as for the validation study (4). For the association study (5) regarding the eFI screening tool, the investigators will utilize data from all patients age 65 and older admitted to acute care at all partnering sites. For the eFI, the investigators will only include participants with available written general consent for further use of routinely collected health data, or established permission for use in exceptional cases by an ethics committee (HRA Art. 34).
Due to time constraints and great complexity of the local integration of the clinical frailty instrument (cFI) as a reference measure at the five different clinic information systems, the investigators will only integrate the cFI into the primary system at University Hospital Zurich (USZ) during the three-year duration of the project. At all other partner sites, an electronic case report form in REDCap will be in place for data entry of the cFI assessment.
In summary, the investigators will categorize the collection of data for the clinical Frailty Instrument (cFI) and the electronic Frailty Index (eFI) screening tool in geriatric inpatients 65 years and older (validation study plus correlation study) at all sites as a category A research project (not a clinical trial) with only minimal risks at all partner sites and the collection of the eFI screening tool in all other acute care patients 65 years and older as a further use of non-genetic personal health data in patients where a general consent is available.
- Conditions
- Weight Loss, Fatigue, Physical Frailty, Weakness, Muscle
- Keywords
- Frailty, Frailty-Index
- Medical subject headings
- Weight Loss, Fatigue, Muscle Weakness, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and negative predictive value of the eFI
Validation Study
Measured: year 2-3
sensitivity and specificity of the eFI
Validation Study
Measured: year 2-3
The correlation between the cFI and the eFI with length of stay and in-hospital mortality
Correlation Study
Measured: year 2-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start1 Jun 2020
- Primary completion30 May 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, University Department of Geriatric Medicine FELIX PLATTER, University Hospital, Geneva, University of Lausanne Hospitals
- Responsible party
- Sponsor
- Investigators
- Heike Bischoff-Ferrari, MD, DrPH, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516642
- Sponsor's protocol ID
- SPHN Project-ID 2017DRI02
- Acronym
- SFNR
- Status last verified
- May 2023
- First submitted
- 21 Jul 2020
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will categorize the collection of the data for the clinical Frailty Instrument (cFI) and the electronic Frailty Index (eFI) screening tool in geriatric inpatients 65 years and older (validation study plus association study) at all sites as a category A research project (not a clinical trial) with only minimal risks at all partner sites and the collection of the eFI screening tool in all other acute care patients 65 years and older as a further use of non-genetic personal health data in patients where a general consent is available.
Publications
Gagesch M, Edler K, Chocano-Bedoya PO, Abderhalden LA, Seematter-Bagnoud L, Meyer T, Bertschi D, Zekry D, Bula CJ, Gold G, Kressig RW, Stuck AE, Bischoff-Ferrari HA. Swiss Frailty Network and Repository: protocol of a Swiss Personalized Health Network's driver project observational study. BMJ Open. 2021 Jul 14;11(7):e047429. doi: 10.1136/bmjopen-2020-047429.
PubMed 34261684
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Frailty Network and Repository
- ClinicalTrials.gov ID
- NCT04516642
- Acronym / sponsor ID
- SFNR / SPHN Project-ID 2017DRI02
- Conditions
- Weight Loss, Fatigue, Physical Frailty, Weakness, Muscle
- Keywords
- Frailty, Frailty-Index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, University Department of Geriatric Medicine FELIX PLATTER, University Hospital, Geneva, University of Lausanne Hospitals
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 18 Aug 2020 (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.
Physical frailty is an age-related medical syndrome defined by a decline in multiple body systems, thus causing increased vulnerability, even in the face of minor stressors (1) It has been linked to multiple negative health outcomes, including extended length of stay in acute care due to complications, hospital re-admissions, and mortality among older patients. About 10-30% of community-dwelling seniors are considered frail(2) with an additional 40% being at risk for the condition (pre-frailty). By 2030, the number of older adults with frailty is expected to at least double, in parallel to the projected growth of the older segment of the population. Frail seniors consume 3-times more health care resources then their robust counterparts. Thus, the health economic impact of frailty is expected to be enormous and a call to action has been posed. Big data in healthcare provides important opportunities for the identification of frailty among the growing number of older patients. This is relevant as frailty is considered a better predictor of adverse outcomes than chronological age alone. Therefore, several medical specialties have started to assess frailty in cancer patients, heart surgery candidates and potential organ transplant recipients.
Detailed description
The Swiss Frailty Network and Repository is a Swiss Personalized Health Network (SPHN) driver project. The investigators aim to promote the sustainable implementation of a frailty data network for research and clinical purposes in strong partnership between all Swiss geriatric academic centers.
One of the five main goals of this project is to validate an electronic frailty index (eFI) as a screening tool against a clinical frailty instrument (cFI) (validation study) and the investigation of the correlation of the two instruments with the important endpoints in-hospital mortality and length of stay in hospital (association study) is at the core of the project. For the validation study (4), the investigators will include patients 65 and older admitted to acute geriatric care at all partnering sites, where both, the cFI and the eFI is collected. For the validation study (4), the investigators will include only patients with written project informed consent and consent for subsequent use of the project data (the investigators will also ask for general consent whenever possible. For the correlation study (5) regarding the cFI and the 2 outcomes. The same requirements apply as for the validation study (4). For the association study (5) regarding the eFI screening tool, the investigators will utilize data from all patients age 65 and older admitted to acute care at all partnering sites. For the eFI, the investigators will only include participants with available written general consent for further use of routinely collected health data, or established permission for use in exceptional cases by an ethics committee (HRA Art. 34).
Due to time constraints and great complexity of the local integration of the clinical frailty instrument (cFI) as a reference measure at the five different clinic information systems, the investigators will only integrate the cFI into the primary system at University Hospital Zurich (USZ) during the three-year duration of the project. At all other partner sites, an electronic case report form in REDCap will be in place for data entry of the cFI assessment.
In summary, the investigators will categorize the collection of data for the clinical Frailty Instrument (cFI) and the electronic Frailty Index (eFI) screening tool in geriatric inpatients 65 years and older (validation study plus correlation study) at all sites as a category A research project (not a clinical trial) with only minimal risks at all partner sites and the collection of the eFI screening tool in all other acute care patients 65 years and older as a further use of non-genetic personal health data in patients where a general consent is available.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Hospitalized patients age 65 and older from all 5 university hospitals in Switzerland (Basel, Bern, Geneva, Lausanne and Zurich)
Key inclusion criteria (4 listed)
- Men and women age 65 and older
- Admission as inpatients to acute care at any partnering university hospital (eFI - subgroup)
- Admission as inpatients to acute geriatric care (cFI - subgroup)
- Patients or proxies need to provide a written informed consent (geriatric patients (cFI and eFI): project consent; non-geriatric patients ((eFI): general consent)
Key exclusion criteria (3 listed)
- Documented objection of participating in the project and/or subsequent use of personal health data
- Not fluent in local language (i.e. German, French)
- Patient is uncooperative or presence of inability to perform functional tests due to severe cognitive and/or physical impairment/acute medical illness
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
Positive and negative predictive value of the eFI
Time frame: year 2-3
Validation Study
sensitivity and specificity of the eFI
Time frame: year 2-3
Validation Study
The correlation between the cFI and the eFI with length of stay and in-hospital mortality
Time frame: year 2-3
Correlation Study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Derived from this study: PubMed 34261684Gagesch M, Edler K, Chocano-Bedoya PO, Abderhalden LA, Seematter-Bagnoud L, Meyer T, Bertschi D, Zekry D, Bula CJ, Gold G, Kressig RW, Stuck AE, Bischoff-Ferrari HA. Swiss Frailty Network and Repository: protocol of a Swiss Personalized Health Network's driver project observational study. BMJ Open. 2021 Jul 14;11(7):e047429. doi: 10.1136/bmjopen-2020-047429.
- Individual participant dataSharing planned: Yes. The investigators will categorize the collection of the data for the clinical Frailty Instrument (cFI) and the electronic Frailty Index (eFI) screening tool in geriatric inpatients 65 years and older (validation study plus association study) at all sites as a category A research project (not a clinical trial) with only minimal risks at all partner sites and the collection of the eFI screening tool in all other acute care patients 65 years and older as a further use of non-genetic personal health data in patients where a general consent is available.
Related trials for Weight Loss
RecruitingPhase 2
Targeting Muscle Strength Loss Due to Hospitalization in Older Adults by Blood-flow Restriction Combined With an Electromyography-driven Serious Game.
Hospital Associated Disability, Immobility
Recruiting
Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
Overweight, Obesity
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
Recruiting
Time Restricted Eating for WeIght LoSs MainTenance-2
Weight Loss, Weight Gain
Not yet recruiting
Gut-Liver-Muscle Axis in Cancer Cachexia
Head & Neck Cancer
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.
Heike Bischoff-Ferrari, MD, DrPH principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Loss and Fatigue, run by University of Zurich at 1 site in Switzerland.
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 4 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: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
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?
Positive and negative predictive value of the eFI (time frame: year 2-3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04516642, which also lists 1 linked publication.
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 16 May 2023.