Frail PatientNCT07471945
Individualized Nursing Care and Frailty Outcomes in Cardiac Surgery
A study testing Experimental in people with Frail Patient and Cardiac Surgical Procedures (Postoperative Population), run by SELDA MERT at 1 site in Turkey (Türkiye).
Trial summary
This study is a randomized controlled trial aiming to compare targeted individualized nursing care with standard care in frail elderly patients undergoing cardiac surgery. The hypotheses of the study are: H1: Targeted individualized nursing care has an effect on the frailty level of frail elderly patients undergoing… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Patient, Cardiac Surgical Procedures (Postoperative Population), Patient-centered Care
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 30 Jun 2026
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years and older
- Scheduled for elective surgery
- Edmonton Frail Scale score ≥ 7
- Able to speak Turkish and communicate effectively
- Can be transferred from the postoperative intensive care unit to the ward
- Patients who agree to participate in the study
Who cannot join
- Patients with neurological or psychological disorders
- Patients who cannot be transferred from the postoperative intensive care unit to the ward
- Emergency and unplanned cases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskişehir Osmangazi University Health, Practice, and Research Hospital
Eskişehir
About this study
Official title: The Effect of Targeted Individualized Nursing Care Interventions on Frailty Levels and Clinical Outcomes in Frail Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
This study is a randomized controlled trial aiming to compare targeted individualized nursing care with standard care in frail elderly patients undergoing cardiac surgery.
The hypotheses of the study are:
H1: Targeted individualized nursing care has an effect on the frailty level of frail elderly patients undergoing cardiac surgery.
H2: Targeted individualized nursing care affects the factors influencing frailty in frail elderly patients undergoing cardiac surgery.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Targeted Individualized Nursing Care
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Standard nursing care was provided to patients in this group |
| Targeted Individualized Nursing Care Group | Experimental | An individualized nursing intervention targeting risk factors associated with frailty was planned for patients in this group Receives: Other: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function - Standardized Mini-Mental State Examination (MMSE)
Cognitive status will be assessed using the Standardized Mini-Mental State Examination (MMSE). The MMSE evaluates orientation, memory, attention, recall, language, and visuospatial skills. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. Scores of 23 or below are generally considered indicative of cognitive impairment.
Measured: Postoperative day 1 and the day of discharge
Cognitive Function - Delirium Risk - Nursing Delirium Screening Scale (Nu-DESC)
Delirium risk will be evaluated using the Nursing Delirium Screening Scale (Nu-DESC). The scale assesses five domains: disorientation, inappropriate behavior, inappropriate communication, hallucinations, and psychomotor retardation.
Each symptom is scored per shift as follows:
0 points: Symptom absent, 1 point: Symptom present/mild, 2 points: Symptom present and pronounced/severe A total score of 2 points or higher is considered indicative of delirium.
Measured: Postoperative day 1 and the day of discharge
Physical Status Assessment - Pain Level - Numeric Rating Scale (NRS)
Pain Level - Numeric Rating Scale (NRS): Pain intensity will be assessed using the Numeric Rating Scale (NRS). Patients rate their pain from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: Postoperative day 1 and the day of discharge
Physical Status Assessment - Katz Activities of Daily Living (ADL) Scale
Katz Activities of Daily Living (ADL) Scale: Functional status will be evaluated using the Katz Activities of Daily Living (ADL) Scale, which assesses independence in six activities: bathing, dressing, toileting, transferring, continence, and feeding. Higher scores indicate greater independence in daily activities.
Evaluation of the scale is based on the total score obtained from these items:
0-6 points: Dependent, 7-12 points: Partially dependent, 13-18 points: Independent.
Measured: Postoperative day 1 and the day of discharge
Physical Status Assessment - Itaki Fall Risk Scale
Itaki Fall Risk Scale: The Itaki Fall Risk Scale will be used to evaluate patients' risk of falling. The scale assesses various risk factors related to falls in hospitalized patients. The scale consists of 19 risk factors that may contribute to patient falls. The risk factors are categorized as major and minor, with 1 point assigned for each minor risk factor and 5 points for each major risk factor. Based on the total score obtained from evaluating all risk factors, two risk levels are defined: 0-4 points: Low risk, 5 points and above: High risk.
Measured: Postoperative day 1 and the day of discharge
Nutritional Status - Mini Nutritional Assessment Short Form (MNA-SF)
Mini Nutritional Assessment Short Form (MNA-SF): Nutritional status will be assessed using the Mini Nutritional Assessment-Short Form (MNA-SF). The total score ranges from 0 to 14, with higher scores indicating better nutritional status.
Measured: Postoperative day 1 and the day of discharge
Psychological Status Assessment - Geriatric Depression Scale (GDS)
Geriatric Depression Scale-15 (Short Form): It is a scale used to screen for depression in older adults. The total score ranges from 0 to 15. Scores of 0-4 indicate no depression, 5-8 indicate mild depression, 9-11 indicate moderate depression, and 12-15 indicate severe depression.
Measured: Postoperative day 1 and the day of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Mar 2026
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail PatientStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Targeted Individualized Nursing Care Group (Intervention Group) Standard Care Group (Control Group)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SELDA MERT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SELDA MERT, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471945
- Sponsor's protocol ID
- Decision Number: 33
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Targeted Individualized Nursing Care Interventions on Frailty Levels and Clinical Outcomes in Frail Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07471945
- Acronym / sponsor ID
- Decision Number: 33
- Conditions
- Frail Patient, Cardiac Surgical Procedures (Postoperative Population), Patient-centered Care, Clinical Outcomes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- SELDA MERTUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 Mar 2026 (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.
This study is a randomized controlled trial aiming to compare targeted individualized nursing care with standard care in frail elderly patients undergoing cardiac surgery.
The hypotheses of the study are:
H1: Targeted individualized nursing care has an effect on the frailty level of frail elderly patients undergoing cardiac surgery.
H2: Targeted individualized nursing care affects the factors influencing frailty in frail elderly patients undergoing cardiac surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Targeted Individualized Nursing Care Group (Intervention Group) Standard Care Group (Control Group)
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Standard nursing care was provided to patients in this group |
| Targeted Individualized Nursing Care Group | Experimental | Other: ExperimentalAn individualized nursing intervention targeting risk factors associated with frailty was planned for patients in this group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Aged 65 years and older
- Scheduled for elective surgery
- Edmonton Frail Scale score ≥ 7
- Able to speak Turkish and communicate effectively
- Can be transferred from the postoperative intensive care unit to the ward
Key exclusion criteria (3 listed)
- Patients with neurological or psychological disorders
- Patients who cannot be transferred from the postoperative intensive care unit to the ward
- Emergency and unplanned cases
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 |
|---|---|---|
| ExperimentalTargeted Individualized Nursing Care | Other | Targeted Individualized Nursing Care Group |
Primary outcome
Cognitive Function - Standardized Mini-Mental State Examination (MMSE)
Time frame: Postoperative day 1 and the day of discharge
Cognitive status will be assessed using the Standardized Mini-Mental State Examination (MMSE). The MMSE evaluates orientation, memory, attention, recall, language, and visuospatial skills. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. Scores of 23 or below are generally considered indicative of cognitive impairment.
Cognitive Function - Delirium Risk - Nursing Delirium Screening Scale (Nu-DESC)
Time frame: Postoperative day 1 and the day of discharge
Delirium risk will be evaluated using the Nursing Delirium Screening Scale (Nu-DESC). The scale assesses five domains: disorientation, inappropriate behavior, inappropriate communication, hallucinations, and psychomotor retardation. Each symptom is scored per shift as follows: 0 points: Symptom absent, 1 point: Symptom present/mild, 2 points: Symptom present and pronounced/severe A total score of 2 points or higher is considered indicative of delirium.
Physical Status Assessment - Pain Level - Numeric Rating Scale (NRS)
Time frame: Postoperative day 1 and the day of discharge
Pain Level - Numeric Rating Scale (NRS): Pain intensity will be assessed using the Numeric Rating Scale (NRS). Patients rate their pain from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Physical Status Assessment - Katz Activities of Daily Living (ADL) Scale
Time frame: Postoperative day 1 and the day of discharge
Katz Activities of Daily Living (ADL) Scale: Functional status will be evaluated using the Katz Activities of Daily Living (ADL) Scale, which assesses independence in six activities: bathing, dressing, toileting, transferring, continence, and feeding. Higher scores indicate greater independence in daily activities. Evaluation of the scale is based on the total score obtained from these items: 0-6 points: Dependent, 7-12 points: Partially dependent, 13-18 points: Independent.
Physical Status Assessment - Itaki Fall Risk Scale
Time frame: Postoperative day 1 and the day of discharge
Itaki Fall Risk Scale: The Itaki Fall Risk Scale will be used to evaluate patients' risk of falling. The scale assesses various risk factors related to falls in hospitalized patients. The scale consists of 19 risk factors that may contribute to patient falls. The risk factors are categorized as major and minor, with 1 point assigned for each minor risk factor and 5 points for each major risk factor. Based on the total score obtained from evaluating all risk factors, two risk levels are defined: 0-4 points: Low risk, 5 points and above: High risk.
Nutritional Status - Mini Nutritional Assessment Short Form (MNA-SF)
Time frame: Postoperative day 1 and the day of discharge
Mini Nutritional Assessment Short Form (MNA-SF): Nutritional status will be assessed using the Mini Nutritional Assessment-Short Form (MNA-SF). The total score ranges from 0 to 14, with higher scores indicating better nutritional status.
Psychological Status Assessment - Geriatric Depression Scale (GDS)
Time frame: Postoperative day 1 and the day of discharge
Geriatric Depression Scale-15 (Short Form): It is a scale used to screen for depression in older adults. The total score ranges from 0 to 15. Scores of 0-4 indicate no depression, 5-8 indicate mild depression, 9-11 indicate moderate depression, and 12-15 indicate severe depression.
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 22 Apr 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Experimental in people with Frail Patient and Cardiac Surgical Procedures (Postoperative Population), run by SELDA MERT 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 6 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 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 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?
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?
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?
Cognitive Function - Standardized Mini-Mental State Examination (MMSE) (time frame: Postoperative day 1 and the day of discharge). The study lists 7 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 22 Apr 2026.