FrailtyFRIENDNCT06507527
Frailty in Outpatient Digestive Endoscopy
An observational study of Frailty and Comorbidities and Coexisting Conditions, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
The increase in our society of the proportion of frail people who suffer from disability and dependency forces us to detect modifiable factors and therefore subject to intervention that can adapt health care for frail patients in order to increase the effectiveness and safety of medical treatments and procedures. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Frailty, Comorbidities and Coexisting Conditions, Complication
- What is being tested?
- Collection of variables
- How many people
- 1,474 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2024to Feb 2027
- How long will I take part?
- 16 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Outpatients may be referred from hospital consultations or from out-of-hospital medical centers. Age is the inclusion criterion so that frailty can be assessed in patients over 70 years of age, who are the patients with the highest risk of presenting a frailty condition.
Who may be able to join
- It will include all patients over 70 years of age who are indicated to undergo an ambulatory upper or lower endoscopy.
Who cannot join
- Age below 70 years
- Non-ambulatory endoscopies
- Assessment of test contraindications by the endoscopist
- Non-acceptance to enter the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Parc de Salut Mar. Hospital del Mar
Barcelona, 08003
Agustín Seoane Urgorri, MD, 932483000 ext. 3057, 92847@parcdesalutmar.cat
Agustín Seoane Urgorri, MD
About this study
Official title: ASSESSMENT OF THE ADEQUACY IN CARE OF THE FRAGILE PATIENT IN A DIGESTIVE ENDOSCOPY UNIT FRIEND Study (FRailty In ENDoscopy) Estudi FRIEND (FRailty In ENDoscopy)
The increase in our society of the proportion of frail people who suffer from disability and dependency forces us to detect modifiable factors and therefore subject to intervention that can adapt health care for frail patients in order to increase the effectiveness and safety of medical treatments and procedures.
A geriatric assessment should be performed on all patients likely to present frailty prior to a digestive endoscopy to assess the risk-benefit of the indication and to improve patient preparation by avoiding adverse effects of endoscopic examinations, increasing the safety and profitability of the tests There are no data in our medium on the prevalence of frailty in patients referred for endoscopy, nor on the incidence in these patients of adverse effects, inadequate preparations, or incomplete examinations, so a frailty study is needed to elaborate multidisciplinary protocols that improve circuits and care in these patients and prevent complications.
Read more
The questions we want to try to answer are:
- Prevalence and severity of fragility in digestive endoscopy.
- Specific problems related to fragility in digestive endoscopy, mainly the profitability of the examination and the incidence of adverse effects, in order to create protocols for improving care in this group of patients.
Read the detailed description
This is a prospective observational study.
In all patients older than 70 years referred for an ambulatory endoscopy, the presence of frailty and its degree will be assessed through validated questionnaires commonly used in the preparation of the patient for digestive endoscopy. A nurse trained by the Geriatrics Service of our hospital carries out a telephone contact with the patient or the patient's caregiver to fill out the questionnaires.
The formation of subgroups of patients will be assessed for the statistical analysis in relation to the degree of frailty and the type of endoscopy (upper or lower digestive endoscopy)
A random sample of 1474 individuals is sufficient to estimate, with 95% confidence and an accuracy of +/- 2.5 percentage units, a prevalence of frailty in the study population that is expected to be around 40%. Given that at this stage it is a cross-sectional study, no follow-up losses are expected.
Since the main aim of the study is cross-sectional, it is necessary to estimate the prevalence of frailty and a 95% confidence interval calculated using an exact method (Clopper-Pearson method).
The analysis of the profitability of the indication and of the adverse effects, as outcomes of interest in the achievement of the secondary objectives, will be analyzed according to the degree of frailty (main factor of the study). Likewise, the effect of potentially confounding variables will be studied, on the degree of fragility, and also on each of the outcomes taken into consideration. Finally, a multivariate analysis for each outcome will be used to evaluate the possible causal association with the degree of frailty, adjusting in each analysis for potentially confounding variables.
For the analyzes the statistical package STATA 15.1 and R will be used in the version that is updated at the time of the statistical analysis.
Basic patient demographic data (age, sex) will be collected. The presence of multipathology will be assessed using the CIRS(G)-Charlson questionnaire. Data related to the patient's frailty will be collected using the CFS and FRAGIL-VIG questionnaires.
Information about the endoscopic procedure will be collected with data recorded in the medical history. The cleaning agent and the degree of compliance with the colon cleaning protocol (diet, fasting, volume ingested, fractionation of the cleaning agent) will be noted in the clinical history, as well as the incidents that occurred in relation to the preparation for endoscopy.
In the endoscopic report, data on the preparation of the colon and intra-trial complications will be recorded.
Information on post-test complications will be collected with the data recorded in the clinical record. Only relevant adverse effects that require medical attention will be recorded, not considering minor adverse effects because they are not relevant to our study, since they do not provide information that helps to improve the care of the fragile patient in the field of endoscopy.
Frailty is defined as a CFS rating greater than 4 or a FRAGIL-VIG value greater than 0.
Adequate preparation is defined as a Boston Cleansing Classification rating of 2 or 3 in each and every segment of the colon.
The endoscopy indication is defined as unprofitable in the following cases:
- The patient does not show up or reschedules the examination
- The patient appears but it is not possible to perform the examination due to decompensation of the underlying pathology or for not having been able to comply with the test preparation protocols.
- The patient appears and the endoscopic examination is carried out, but it is not possible to give an adequate diagnosis or to carry out a therapeutic under safe conditions.
The cost-effectiveness calculation will be done by calculating the overall percentage of patients in which there are no situations that prevent an adequate diagnosis and/or therapy, and the causes of lack of cost-effectiveness will be calculated based on the assumptions explained in the text.The calculation of the cost of the endoscopy indication is closely related to the concept of profitability. All cases with a lack of profitability conceptually maintain the indication of the test and therefore need repetition of their request, given that the diagnostic-therapeutic objective of the initial indication has not been achieved. The cost of the hypothetical repetition of these scans will be calculated based on the prices established for each type of endoscopy and a cost comparison will be made between the different degrees of fragility.
A relevant adverse effect is defined in the following cases:
- Decompensation of underlying pathology that requires hospital care
- Complications related to sedation
- Post-colonoscopy bleeding
- Post-colonoscopy perforation
- Being tested
- Collection of variables
- Keywords
- Endoscopy, Indication, Bowell Preparation, Adverse effects
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of variablesOther
This is an observational study, so no interventions that are not routine clinical practice are performed. It is only about collecting information on variables that are already collected in normal clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Outpatients over 70 years of age referred to the Digestive Endoscopy Unit | Collection of variables: demographic variables, comorbidity, frailty (specific questionnaires), digestive endoscopy (upper and/or lower), possible complications related to the endoscopic process and the profitability and impact of the endoscopy. Receives: Other: Collection of variables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of frailty
Valuated frailty questionnaires (CFS and FRAGIL-VIG). Frailty is defined as a CFS rating greater than 4 or a FRAGIL-VIG value greater than 0. The degree of frailty is determined by FRAGIL-VIG score. The frailty questionnaires are completed during nurse telephone contact with the patient, prior to the digestive endoscopy.
Measured: At the moment of telephone contact with the patient
Secondary outcomes (5)
Profitability of the endoscopy indication.
The endoscopy indication is defined as unprofitable in the following cases:
- The patient does not show up or reschedules the examination
- The patient appears but it is not possible to perform the examination due to decompensation of the underlying pathology or for not having been able to comply with the test preparation protocols.
- The patient appears and the endoscopic examination is carried out, but it is not possible to give an adequate diagnosis or to carry out a therapeutic under safe conditions.
The profitability calculation will be done by calculating the overall percentage of patients in which there are no situations that prevent a diagnosis and/or adequate therapy
Measured: At the moment of endoscopy.
Cost of the endoscopy indication
The calculation of the cost of the endoscopy indication is closely related to the concept of profitability. All cases with a lack of profitability conceptually maintain the indication of the test and therefore need repetition of their request, given that the diagnostic-therapeutic objective of the initial indication has not been achieved. The cost of the hypothetical repetition of these scans will be calculated based on the prices established for each type of endoscopy and a cost comparison will be made between the different degrees of fragility.
Measured: At the moment of endoscopy
Incidence of relevant complications during the endoscopy process.
A relevant adverse effect is defined in the following cases:
- Decompensation of underlying pathology that requires hospital care
- Complications related to sedation
- Post-colonoscopy bleeding
- Post-colonoscopy perforation
The patient's medical history will be reviewed 30 days after the endoscopy to collect data on possible relevant complications.
Measured: 30 days after digestive endoscopy.
Clinical impact of the endoscopy indication
The clinical impact will be measured based on whether the endoscopy performed leads to:
- Absence of information in relation to the medical process investigated
- A clinical diagnosis in relation to the medical process investigated
- A clinical diagnosis not related to the medical process investigated
- A therapeutic intervention After the clinical evaluation and medical decision on the result of the endoscopy by the requesting doctor or the endoscopist
Measured: Up to 2 months after endoscopy
Degree of frailty
The degree of frailty is determined by FRAGIL-VIG score (<0,20 absence of frailty or pre-frailty, 0,20-0,35 initial, 0,36-0,50 intermediate, >0,50 advanced)
Measured: At the moment of telephone contact with the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start10 Jun 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,474 participants (estimated)
- Target duration
- 16 Months
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AGUSTIN SEOANE URGORRI, MD, Principal investigator, Parc de Salut Mar. Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507527
- Sponsor's protocol ID
- FRIEND
- Acronym
- FRIEND
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected will be entered into a database so that statistical analysis can later be carried out. This database must subsequently be shared with the statistics service of our hospital in order to perform an appropriate statistical analysis.
Publications
Machlab S, Francia E, Mascort J, Garcia-Iglesias P, Mendive JM, Riba F, Guarner-Argente C, Solanes M, Ortiz J, Calvet X. Risks, indications and technical aspects of colonoscopy in elderly or frail patients. Position paper of the Societat Catalana de Digestologia, the Societat Catalana de Geriatria i Gerontologia and the Societat Catalana de Medicina de Familia i Comunitaria. Gastroenterol Hepatol. 2024 Jan;47(1):107-117. doi: 10.1016/j.gastrohep.2023.05.004. Epub 2023 May 18. English, Spanish.
PubMed 37209916Oberndorfer T, Jurawan R. Frailty should be assessed in older patients considered for colonoscopy. N Z Med J. 2021 Jul 30;134(1539):74-76. No abstract available.
PubMed 34320617Cha JM, Kozarek RA, La Selva D, Gluck M, Ross A, Chiorean M, Koch J, Lin OS. Risks and Benefits of Colonoscopy in Patients 90 Years or Older, Compared With Younger Patients. Clin Gastroenterol Hepatol. 2016 Jan;14(1):80-6.e1. doi: 10.1016/j.cgh.2015.06.036. Epub 2015 Jul 9.
PubMed 26164224Taleban S, Toosizadeh N, Junna S, Golden T, Ghazala S, Wadeea R, Tirambulo C, Mohler J. Frailty Assessment Predicts Acute Outcomes in Patients Undergoing Screening Colonoscopy. Dig Dis Sci. 2018 Dec;63(12):3272-3280. doi: 10.1007/s10620-018-5129-x. Epub 2018 May 24.
PubMed 29796910
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSMENT OF THE ADEQUACY IN CARE OF THE FRAGILE PATIENT IN A DIGESTIVE ENDOSCOPY UNIT FRIEND Study (FRailty In ENDoscopy) Estudi FRIEND (FRailty In ENDoscopy)
- ClinicalTrials.gov ID
- NCT06507527
- Acronym / sponsor ID
- FRIEND / FRIEND
- Keywords
- Endoscopy, Indication, Bowell Preparation, Adverse effects
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,474 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 18 Jul 2024 (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.
The increase in our society of the proportion of frail people who suffer from disability and dependency forces us to detect modifiable factors and therefore subject to intervention that can adapt health care for frail patients in order to increase the effectiveness and safety of medical treatments and procedures.
A geriatric assessment should be performed on all patients likely to present frailty prior to a digestive endoscopy to assess the risk-benefit of the indication and to improve patient preparation by avoiding adverse effects of endoscopic examinations, increasing the safety and profitability of the tests There are no data in our medium on the prevalence of frailty in patients referred for endoscopy, nor on the incidence in these patients of adverse effects, inadequate preparations, or incomplete examinations, so a frailty study is needed to elaborate multidisciplinary protocols that improve circuits and care in these patients and prevent complications.
The questions we want to try to answer are:
- Prevalence and severity of fragility in digestive endoscopy.
- Specific problems related to fragility in digestive endoscopy, mainly the profitability of the examination and the incidence of adverse effects, in order to create protocols for improving care in this group of patients.
Detailed description
This is a prospective observational study.
In all patients older than 70 years referred for an ambulatory endoscopy, the presence of frailty and its degree will be assessed through validated questionnaires commonly used in the preparation of the patient for digestive endoscopy. A nurse trained by the Geriatrics Service of our hospital carries out a telephone contact with the patient or the patient's caregiver to fill out the questionnaires.
The formation of subgroups of patients will be assessed for the statistical analysis in relation to the degree of frailty and the type of endoscopy (upper or lower digestive endoscopy)
A random sample of 1474 individuals is sufficient to estimate, with 95% confidence and an accuracy of +/- 2.5 percentage units, a prevalence of frailty in the study population that is expected to be around 40%. Given that at this stage it is a cross-sectional study, no follow-up losses are expected.
Since the main aim of the study is cross-sectional, it is necessary to estimate the prevalence of frailty and a 95% confidence interval calculated using an exact method (Clopper-Pearson method).
The analysis of the profitability of the indication and of the adverse effects, as outcomes of interest in the achievement of the secondary objectives, will be analyzed according to the degree of frailty (main factor of the study). Likewise, the effect of potentially confounding variables will be studied, on the degree of fragility, and also on each of the outcomes taken into consideration. Finally, a multivariate analysis for each outcome will be used to evaluate the possible causal association with the degree of frailty, adjusting in each analysis for potentially confounding variables.
For the analyzes the statistical package STATA 15.1 and R will be used in the version that is updated at the time of the statistical analysis.
Basic patient demographic data (age, sex) will be collected. The presence of multipathology will be assessed using the CIRS(G)-Charlson questionnaire. Data related to the patient's frailty will be collected using the CFS and FRAGIL-VIG questionnaires.
Information about the endoscopic procedure will be collected with data recorded in the medical history. The cleaning agent and the degree of compliance with the colon cleaning protocol (diet, fasting, volume ingested, fractionation of the cleaning agent) will be noted in the clinical history, as well as the incidents that occurred in relation to the preparation for endoscopy.
In the endoscopic report, data on the preparation of the colon and intra-trial complications will be recorded.
Information on post-test complications will be collected with the data recorded in the clinical record. Only relevant adverse effects that require medical attention will be recorded, not considering minor adverse effects because they are not relevant to our study, since they do not provide information that helps to improve the care of the fragile patient in the field of endoscopy.
Frailty is defined as a CFS rating greater than 4 or a FRAGIL-VIG value greater than 0.
Adequate preparation is defined as a Boston Cleansing Classification rating of 2 or 3 in each and every segment of the colon.
The endoscopy indication is defined as unprofitable in the following cases:
- The patient does not show up or reschedules the examination
- The patient appears but it is not possible to perform the examination due to decompensation of the underlying pathology or for not having been able to comply with the test preparation protocols.
- The patient appears and the endoscopic examination is carried out, but it is not possible to give an adequate diagnosis or to carry out a therapeutic under safe conditions.
The cost-effectiveness calculation will be done by calculating the overall percentage of patients in which there are no situations that prevent an adequate diagnosis and/or therapy, and the causes of lack of cost-effectiveness will be calculated based on the assumptions explained in the text.The calculation of the cost of the endoscopy indication is closely related to the concept of profitability. All cases with a lack of profitability conceptually maintain the indication of the test and therefore need repetition of their request, given that the diagnostic-therapeutic objective of the initial indication has not been achieved. The cost of the hypothetical repetition of these scans will be calculated based on the prices established for each type of endoscopy and a cost comparison will be made between the different degrees of fragility.
A relevant adverse effect is defined in the following cases:
- Decompensation of underlying pathology that requires hospital care
- Complications related to sedation
- Post-colonoscopy bleeding
- Post-colonoscopy perforation
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 16 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatients over 70 years of age referred to the Digestive Endoscopy Unit | – | Other: Collection of variablesCollection of variables: demographic variables, comorbidity, frailty (specific questionnaires), digestive endoscopy (upper and/or lower), possible complications related to the endoscopic process and the profitability and impact of the endoscopy. |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Outpatients may be referred from hospital consultations or from out-of-hospital medical centers. Age is the inclusion criterion so that frailty can be assessed in patients over 70 years of age, who are the patients with the highest risk of presenting a frailty condition.
Key inclusion criteria (1 listed)
- It will include all patients over 70 years of age who are indicated to undergo an ambulatory upper or lower endoscopy.
Key exclusion criteria (4 listed)
- Age below 70 years
- Non-ambulatory endoscopies
- Assessment of test contraindications by the endoscopist
- Non-acceptance to enter the study
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 |
|---|---|---|
| Collection of variablesThis is an observational study, so no interventions that are not routine clinical practice are performed. It is only about collecting information on variables that are already collected in normal clinical practice. | Other | Outpatients over 70 years of age referred to the Digestive Endoscopy Unit |
Primary outcome
Prevalence of frailty
Time frame: At the moment of telephone contact with the patient
Valuated frailty questionnaires (CFS and FRAGIL-VIG). Frailty is defined as a CFS rating greater than 4 or a FRAGIL-VIG value greater than 0. The degree of frailty is determined by FRAGIL-VIG score. The frailty questionnaires are completed during nurse telephone contact with the patient, prior to the digestive endoscopy.
5 secondary outcomes
Profitability of the endoscopy indication.
Time frame: At the moment of endoscopy.
Cost of the endoscopy indication
Time frame: At the moment of endoscopy
Incidence of relevant complications during the endoscopy process.
Time frame: 30 days after digestive endoscopy.
Clinical impact of the endoscopy indication
Time frame: Up to 2 months after endoscopy
Degree of frailty
Time frame: At the moment of telephone contact with the patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 37209916Machlab S, Francia E, Mascort J, Garcia-Iglesias P, Mendive JM, Riba F, Guarner-Argente C, Solanes M, Ortiz J, Calvet X. Risks, indications and technical aspects of colonoscopy in elderly or frail patients. Position paper of the Societat Catalana de Digestologia, the Societat Catalana de Geriatria i Gerontologia and the Societat Catalana de Medicina de Familia i Comunitaria. Gastroenterol Hepatol. 2024 Jan;47(1):107-117. doi: 10.1016/j.gastrohep.2023.05.004. Epub 2023 May 18. English, Spanish.
- Background: PubMed 34320617Oberndorfer T, Jurawan R. Frailty should be assessed in older patients considered for colonoscopy. N Z Med J. 2021 Jul 30;134(1539):74-76. No abstract available.
- Background: PubMed 26164224Cha JM, Kozarek RA, La Selva D, Gluck M, Ross A, Chiorean M, Koch J, Lin OS. Risks and Benefits of Colonoscopy in Patients 90 Years or Older, Compared With Younger Patients. Clin Gastroenterol Hepatol. 2016 Jan;14(1):80-6.e1. doi: 10.1016/j.cgh.2015.06.036. Epub 2015 Jul 9.
- Background: PubMed 29796910Taleban S, Toosizadeh N, Junna S, Golden T, Ghazala S, Wadeea R, Tirambulo C, Mohler J. Frailty Assessment Predicts Acute Outcomes in Patients Undergoing Screening Colonoscopy. Dig Dis Sci. 2018 Dec;63(12):3272-3280. doi: 10.1007/s10620-018-5129-x. Epub 2018 May 24.
- World report on aging and health. \[Internet\]. Geneva: World Health Organization.2015Link provided by the sponsor.
- Population Projections 2018 \[Internet\]. Statistics National Institute; 2018Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All data collected will be entered into a database so that statistical analysis can later be carried out. This database must subsequently be shared with the statistics service of our hospital in order to perform an appropriate statistical analysis.
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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.
AGUSTIN SEOANE URGORRI, MD principal investigator
Parc de Salut Mar. Hospital del Mar
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 Frailty and Comorbidities and Coexisting Conditions, run by Parc de Salut Mar at 1 site in Spain.
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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AGUSTIN SEOANE URGORRI, MD (932403057 ext. 0034, aseoane@psmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of frailty (time frame: At the moment of telephone contact with the patient). 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 NCT06507527, which also lists 4 linked publications.
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 Sep 2026.