FrailtyNCT06525038
PRISMA 7 and SARC-F in Predicting Emergency Department Readmission and Mortality
An observational study of Frailty and Sarcopenia, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
Frailty scores can predict hospitalization and other related adversities. Thus, the frailty status determination is useful in clinical decisions regarding elderly patients. This study aimed to evaluate the potential of PRISMA-7 and SARC-F scores in predicting hospitalization following emergency department (ED)… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Sarcopenia, Morality
- What is being tested?
- All groups were observed for clinical end-points described in the study protocol
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 Sep 2023
- 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: Patients aged over 65 years and admitted to the emergency department
Who may be able to join
- Patients aged over 65 years
Who cannot join
- Patients with no spontaneous heartbeat or breathing at the time of ED arrival
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Firat University School of Medicine
Elâzığ, 23119
About this study
Official title: PRISMA 7 (for Frailty Assessment) and SARC-F (for Evaluation of Sarcopenia Risk) in Predicting Emergency Department Readmission and Mortality
Frailty scores can predict hospitalization and other related adversities. Thus, the frailty status determination is useful in clinical decisions regarding elderly patients. This study aimed to evaluate the potential of PRISMA-7 and SARC-F scores in predicting hospitalization following emergency department (ED) admission, readmission at 1, 3, and 6 months, and mortality within a 6-month follow-up period.
Read the detailed description
- Aim Most screening tools for frailty and sarcopenia are complex and thus impractical for emergency physicians. They require more time. Administering them to patients in limited time and in emergencies is difficult as it requires most equipment. Among these methods, PRISMA-7 and SARC-F can be applied in the ED as they are practical, fast, and convenient. This prospective study evaluates the ability of PRISMA-7 and SARC-F to predict hospitalization after ED admission, readmission to the hospital ED at 1, 3, and 6 months, and mortality at 6-month follow-up.
- Materials and Methods 2.1 Study Design and Compliance Criteria This study was approved by the Non-Interventional Research Ethics Committee of Firat University and conducted by the Faculty of Medicine, Department of Emergency Medicine. 150 patients aged ≥65 who presented to the emergency department (ED) in a 6-month period from January 2023 to July 2023 were included in this study. The patient's gender, comorbidities, and reasons for admission were examined. The admission dates to the ED were recorded. Patients and their relatives were informed about the study to obtain written informed consent.
Patients meeting the inclusion criteria and providing written consent to participate in this study were included. The patients were consecutively included in the study. Patients with no spontaneous heartbeat or breathing at the time of ED arrival, the ones refusing to participate in the study, and whose information could not be retrieved were excluded. The patients' SARC-F and PRISMA-7 scores were calculated at the first ED presentation. Later, the same patients were evaluated via the electronic hospital system and called by phone. Their status was assessed regarding the recurrent ED visits, hospitalization, and mortality at 1, 3, and 6 months. Patients were divided into four groups. Group 1: risk of sarcopenia (-) and risk of frailty (-), Group 2: risk of sarcopenia (+) and risk of frailty (-), Group 3: risk of sarcopenia (-) and risk of frailty (+), and Group 4: risk of sarcopenia (+) and risk of frailty (+).
2.2 Frailty and Sarcopenia Assessment PRISMA-7 assessment included seven yes/no questions. The questionnaire interrogated patients' demographic characteristics (age and gender), physical ability, limiting medical problems, and dependency on others. The questionnaire was scored between 0 and 7 points, where higher scores indicated higher severity of frailty. A score of ≥3 suggested further assessment and that the patient had a frailty risk. Turkish validity and reliability studies of this questionnaire were conducted.
The SARC-F for sarcopenia assessment had five questions. Each question was scored between 0 and 2. The questionnaire interrogated patients' strength, assistance in walking, climbing stairs, rising from chairs, and falling status. The questionnaire was scored between 0 and 10 points. A score of ≥4 demonstrated possible sarcopenia risk and indicated the need for the patient's further examination. It was susceptible for detecting sarcopenia risk in older adults.
2.3 Follow-up Evaluation and Outcome Criteria Patients or their immediate relatives were contacted at 1, 3, and 6 months for the follow-up interviews. The information included hospitalization, readmission to ED, and mortality status. The mortality and ED readmissions of patients with and without frailty and sarcopenia were compared.
2.4 Statistical Analysis The data analysis was carried out using SPSS version 22. Kolmogorov-Smirnov test determined whether the numerical data were normally distributed. The numerical parameters exhibiting normal distributions were presented as mean (standard deviation), while those without normal distribution were shown as median (minimum-maximum). Non-quantitative parameters were analyzed using the Chi-square test and expressed as numbers and percentages. Student's t-test compared the numerical parameters with normal distribution between the groups, while the Mann-Whitney U test compared the non-parametric groups. Kruskal-Wallis and Bonferroni-adjusted Mann-Whitney U tests were conducted for the post hoc analysis. ANOVA and Tukey or Tamhane tests compared the means in more than two groups (according to the sarcopenia risk and frailty status). Spearman correlation test examined the relationship between numerical parameters. According to the Spearman test, the rho coefficient <0.4 was considered a weak correlation, 0.4 and 0.59 a moderate correlation, 0.6 and 0.79 a strong correlation, and 0.80 and above a very strong correlation. ROC analyses examined the potential of PRISMA-7 and SARC-F scores in predicting long-term mortality. The cut-off points were assessed using the ROC curve analysis. The best points for both scores (PRISMA-7 and SARC-F) were calculated using the Youden index. The significance level was considered as 0.05.
- Conditions
- Frailty, Sarcopenia, Morality
- Being tested
- All groups were observed for clinical end-points described in the study protocol
- Keywords
- Emergency Service, Mortality, Sarcopenia, Frailty
- Medical subject headings
- Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All groups were observed for clinical end-points described in the study protocolOther
All groups were observed for clinical end-points (mortality, readmission to emergency service) described in the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Risk of sarcopenia (-) and risk of frailty (-) | Not described Receives: Other: All groups were observed for clinical end-points described in the study protocol | |
| Risk of sarcopenia (+) and risk of frailty (-) | Not described Receives: Other: All groups were observed for clinical end-points described in the study protocol | |
| Risk of sarcopenia (-) and risk of frailty (+) | Not described Receives: Other: All groups were observed for clinical end-points described in the study protocol | |
| Risk of sarcopenia (+) and risk of frailty (+) | Not described Receives: Other: All groups were observed for clinical end-points described in the study protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: up to 6 months
Readmission to the Emergency Department
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Jan 2023
- Primary completion31 Jul 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Cagri Goktekin, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525038
- Sponsor's protocol ID
- FiratU-EM-MCG-01
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be available to the researchers, and they will be shared if wanted.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRISMA 7 (for Frailty Assessment) and SARC-F (for Evaluation of Sarcopenia Risk) in Predicting Emergency Department Readmission and Mortality
- ClinicalTrials.gov ID
- NCT06525038
- Acronym / sponsor ID
- FiratU-EM-MCG-01
- Conditions
- Frailty, Sarcopenia, Morality
- Keywords
- Emergency Service, Mortality, Sarcopenia, Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 29 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.
Frailty scores can predict hospitalization and other related adversities. Thus, the frailty status determination is useful in clinical decisions regarding elderly patients. This study aimed to evaluate the potential of PRISMA-7 and SARC-F scores in predicting hospitalization following emergency department (ED) admission, readmission at 1, 3, and 6 months, and mortality within a 6-month follow-up period.
Detailed description
- Aim Most screening tools for frailty and sarcopenia are complex and thus impractical for emergency physicians. They require more time. Administering them to patients in limited time and in emergencies is difficult as it requires most equipment. Among these methods, PRISMA-7 and SARC-F can be applied in the ED as they are practical, fast, and convenient. This prospective study evaluates the ability of PRISMA-7 and SARC-F to predict hospitalization after ED admission, readmission to the hospital ED at 1, 3, and 6 months, and mortality at 6-month follow-up.
- Materials and Methods 2.1 Study Design and Compliance Criteria This study was approved by the Non-Interventional Research Ethics Committee of Firat University and conducted by the Faculty of Medicine, Department of Emergency Medicine. 150 patients aged ≥65 who presented to the emergency department (ED) in a 6-month period from January 2023 to July 2023 were included in this study. The patient's gender, comorbidities, and reasons for admission were examined. The admission dates to the ED were recorded. Patients and their relatives were informed about the study to obtain written informed consent.
Patients meeting the inclusion criteria and providing written consent to participate in this study were included. The patients were consecutively included in the study. Patients with no spontaneous heartbeat or breathing at the time of ED arrival, the ones refusing to participate in the study, and whose information could not be retrieved were excluded. The patients' SARC-F and PRISMA-7 scores were calculated at the first ED presentation. Later, the same patients were evaluated via the electronic hospital system and called by phone. Their status was assessed regarding the recurrent ED visits, hospitalization, and mortality at 1, 3, and 6 months. Patients were divided into four groups. Group 1: risk of sarcopenia (-) and risk of frailty (-), Group 2: risk of sarcopenia (+) and risk of frailty (-), Group 3: risk of sarcopenia (-) and risk of frailty (+), and Group 4: risk of sarcopenia (+) and risk of frailty (+).
2.2 Frailty and Sarcopenia Assessment PRISMA-7 assessment included seven yes/no questions. The questionnaire interrogated patients' demographic characteristics (age and gender), physical ability, limiting medical problems, and dependency on others. The questionnaire was scored between 0 and 7 points, where higher scores indicated higher severity of frailty. A score of ≥3 suggested further assessment and that the patient had a frailty risk. Turkish validity and reliability studies of this questionnaire were conducted.
The SARC-F for sarcopenia assessment had five questions. Each question was scored between 0 and 2. The questionnaire interrogated patients' strength, assistance in walking, climbing stairs, rising from chairs, and falling status. The questionnaire was scored between 0 and 10 points. A score of ≥4 demonstrated possible sarcopenia risk and indicated the need for the patient's further examination. It was susceptible for detecting sarcopenia risk in older adults.
2.3 Follow-up Evaluation and Outcome Criteria Patients or their immediate relatives were contacted at 1, 3, and 6 months for the follow-up interviews. The information included hospitalization, readmission to ED, and mortality status. The mortality and ED readmissions of patients with and without frailty and sarcopenia were compared.
2.4 Statistical Analysis The data analysis was carried out using SPSS version 22. Kolmogorov-Smirnov test determined whether the numerical data were normally distributed. The numerical parameters exhibiting normal distributions were presented as mean (standard deviation), while those without normal distribution were shown as median (minimum-maximum). Non-quantitative parameters were analyzed using the Chi-square test and expressed as numbers and percentages. Student's t-test compared the numerical parameters with normal distribution between the groups, while the Mann-Whitney U test compared the non-parametric groups. Kruskal-Wallis and Bonferroni-adjusted Mann-Whitney U tests were conducted for the post hoc analysis. ANOVA and Tukey or Tamhane tests compared the means in more than two groups (according to the sarcopenia risk and frailty status). Spearman correlation test examined the relationship between numerical parameters. According to the Spearman test, the rho coefficient <0.4 was considered a weak correlation, 0.4 and 0.59 a moderate correlation, 0.6 and 0.79 a strong correlation, and 0.80 and above a very strong correlation. ROC analyses examined the potential of PRISMA-7 and SARC-F scores in predicting long-term mortality. The cut-off points were assessed using the ROC curve analysis. The best points for both scores (PRISMA-7 and SARC-F) were calculated using the Youden index. The significance level was considered as 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Risk of sarcopenia (-) and risk of frailty (-) | – | Other: All groups were observed for clinical end-points described in the study protocol |
| Risk of sarcopenia (+) and risk of frailty (-) | – | Other: All groups were observed for clinical end-points described in the study protocol |
| Risk of sarcopenia (-) and risk of frailty (+) | – | Other: All groups were observed for clinical end-points described in the study protocol |
| Risk of sarcopenia (+) and risk of frailty (+) | – | Other: All groups were observed for clinical end-points described in the study protocol |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged over 65 years and admitted to the emergency department
Key inclusion criteria (1 listed)
- Patients aged over 65 years
Key exclusion criteria (1 listed)
- Patients with no spontaneous heartbeat or breathing at the time of ED arrival
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 |
|---|---|---|
| All groups were observed for clinical end-points described in the study protocolAll groups were observed for clinical end-points (mortality, readmission to emergency service) described in the study protocol. | Other | Risk of sarcopenia (+) and risk of frailty (+), Risk of sarcopenia (+) and risk of frailty (-), Risk of sarcopenia (-) and risk of frailty (+), Risk of sarcopenia (-) and risk of frailty (-) |
Primary outcome
Mortality
Time frame: up to 6 months
Readmission to the Emergency Department
Time frame: up to 6 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 29 Jul 2024.
- Individual participant dataSharing planned: No. The data will be available to the researchers, and they will be shared if wanted.
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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.
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 Sarcopenia, run by Firat University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 29 Jul 2024. 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 Turkey (Türkiye). 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?
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?
Mortality (time frame: up to 6 months). The study lists 2 primary outcomes in all. 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 29 Jul 2024.