MultimorbidityNCT06702150
Nursing Model and Health Outcomes of Elderly People with Multimorbidity: a Quasi-experimental Study
A study testing Changing the nursing care model to the primary nursing model in people with Multimorbidity and Aged, run by Hospital da Luz, Portugal at 1 site in Portugal.
Trial summary
The goal of this quasi-experimental study is to analyze the effect of organizing nursing care according to the primary nursing model on therapeutic self-care and satisfaction with nursing care for elderly people with multimorbidity in hospital. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multimorbidity, Aged, Patient Outcome Assessment
- What is being tested?
- Changing the nursing care model to the primary nursing model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 sitePortugal
- Study dates
- 18 Apr 2022to 31 Aug 2023
- Phase
- Interventional
- 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
Who may be able to join
- Have at least two chronic diseases
- Have at least one disease classified in the International Classification of Diseases, Ninth Revision (ICD9) and belonging to one of the following groups: cardiovascular disease, cancer, chronic obstructive pulmonary disease and diabetes;
- Expect to be hospitalised for more than 48 hours;
- Have the cognitive ability to read, write and understand the information provided;
- Speak, read and write Portuguese.
Who cannot join
- Transfer to other levels of care within the organisation
- Discharged to other care units outside the organisation
- Episodes of readmission within 30 days of leaving hospital, as this made the last moment of data collection impossible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Primary Nursing Model on Health Outcomes of Elderly Person with Multimorbidity: a Quasi-experimental Study
The goal of this quasi-experimental study is to analyze the effect of organizing nursing care according to the primary nursing model on therapeutic self-care and satisfaction with nursing care for elderly people with multimorbidity in hospital. Participants were patients of both sexes aged over 65 years with at least two chronic diseases admitted to an acute hospital ward. The main questions it aims to answer are:
- Does the use of the primary nursing model increase participants' perceived ability for therapeutic self-care?
- Does the use of the primary care model increase participants' satisfaction with nursing care? The researchers are comparing whether implementing the primary nursing model with the usual care model increases patients' capacity for therapeutic self-care.
Read more
Participants:
- Complete a self-care skills questionnaire on admission to the inpatient unit;
- Complete the same self-care questionnaire on discharge from hospital;
- Complete the same self-care questionnaire by telephone one month after discharge from hospital
- Complete a nursing care satisfaction questionnaire on discharge from hospital;
Read the detailed description
The self-care skills questionnaire used was the Therapeutic Self-care Scale (TSC), translated and validated for the Portuguese population.
The questionnaire used to assess satisfaction with care was the Scale of Citizen Satisfaction with Care (ESCCE), validated for the Portuguese population.
- Conditions
- Multimorbidity, Aged, Patient Outcome Assessment
- Being tested
- Changing the nursing care model to the primary nursing model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changing the nursing care model to the primary nursing modelBehavioural
The nurses received training in primary nursing care before the start of the intervention. The model was tested and implemented in early April 2022. Since then, all patients admitted to the unit have been assigned to a primary nurse within the first 48 hours. This nurse is responsible for developing and monitoring the patient's care plan, assessing care needs, implementing the care plan and evaluating the outcomes. This nurse is also responsible for coordinating care needs and discharge planning with other healthcare professionals. When the primary nurse is not working, another nurse from his or her team continues the care plan that he or she has defined. All patients admitted to the unit who met the selection criteria were informed about the study and, if they agreed to take part, completed a self-care competence questionnaire at admission (baseline), at discharge and one month after discharge. They also completed a questionnaire on satisfaction with nursing care at discharge.
| Study group | Role | What they receive |
|---|---|---|
| Changing the nursing care model to the primary nursing model | Experimental | Inpatient unit where the primary nursing model has been implemented. Receives: Behavioral: Changing the nursing care model to the primary nursing model |
| Standard of care | No intervention | In this unit there was no change in the model of nursing care; the model used was the individualized care model. In this model, each nurse is responsible for the whole care of a group of patients on one working day and may or may not be given responsibility for the same patients on subsequent days. The patients who agreed to participate in the study completed the same questionnaires and at the same frequency as the patients in the intervention unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average global self-care score at discharge from inpatient unit
Evaluated by the difference in response to the Therapeutic Self-Care Scale on admission and discharge from the unit. It is a 12-question Likert scale with a minimum score of zero (0) and a maximum score of five (5), with higher scores corresponding to better results. Average response scores are used.
Measured: On the day of discharge from the inpatient unit, assessment up to 24 hours later.
Average global self-care score at follow-up
Evaluated by the difference between the response to the Therapeutic Self-Care Scale at discharge and at follow-up.
Also assessed by the difference between the response to the Therapeutic Self-Care Scale at admission and at follow-up.
Therapeutic Self-Care Scale is a 12-question Likert scale with a minimum score of zero (0) and a maximum score of five (5), with higher scores corresponding to better results. Average response scores are used.
Measured: At the follow-up 30 days after hospital discharge
Secondary outcomes (1)
Average score for satisfaction with nursing care at discharge from inpatient unit
Assessed by answering the Citizen Satisfaction with Nursing Care Scale at discharge from the unit. This is a 47-question Likert scale with a minimum score of one (1) and a maximum of seven (7), with higher scores corresponding to better results. Average and total response scores are used.
Measured: On the day of discharge from the inpatient unit, assessment up to 24 hours later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start18 Apr 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
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 MultimorbidityStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In the hospital where the study was carried out, each nurse is responsible for the whole care of a group of people on one working day and may or may not be given responsibility for the same people on subsequent days (individualized care model). An intervention was proposed in an inpatient unit consisting of implementing the model of organizing care by primary nursing in which a nurse is responsible for the care plan for a group of people from admission to discharge from the unit.
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital da Luz, Portugal
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Católica Portuguesa
- Responsible party
- Principal investigator, Isabel Gonçalves, Hospital da Luz, Portugal
- Investigators
- Elvio Jesus, Professor, Study director, Universidade Católica PortuguesaElisabete Nunes, Professor, Study chair, Nursing School of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702150
- Sponsor's protocol ID
- CES/01/2022/ME
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication
Publications
Goncalves I, Almeida S, Jesus E, Nunes E. Effect of the Primary Nursing Model on Self-Care Skills of Hospitalized Older Patients with Multimorbidity: A Quasi-Experimental Study. Healthcare (Basel). 2025 Sep 27;13(19):2457. doi: 10.3390/healthcare13192457.
PubMed 41095543
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Primary Nursing Model on Health Outcomes of Elderly Person with Multimorbidity: a Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT06702150
- Acronym / sponsor ID
- CES/01/2022/ME
- Conditions
- Multimorbidity, Aged, Patient Outcome Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Hospital da Luz, PortugalUniversity, hospital or other
- Collaborators
- Universidade Católica Portuguesa
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 22 Nov 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 goal of this quasi-experimental study is to analyze the effect of organizing nursing care according to the primary nursing model on therapeutic self-care and satisfaction with nursing care for elderly people with multimorbidity in hospital. Participants were patients of both sexes aged over 65 years with at least two chronic diseases admitted to an acute hospital ward. The main questions it aims to answer are:
- Does the use of the primary nursing model increase participants' perceived ability for therapeutic self-care?
- Does the use of the primary care model increase participants' satisfaction with nursing care? The researchers are comparing whether implementing the primary nursing model with the usual care model increases patients' capacity for therapeutic self-care.
Participants:
- Complete a self-care skills questionnaire on admission to the inpatient unit;
- Complete the same self-care questionnaire on discharge from hospital;
- Complete the same self-care questionnaire by telephone one month after discharge from hospital
- Complete a nursing care satisfaction questionnaire on discharge from hospital;
Detailed description
The self-care skills questionnaire used was the Therapeutic Self-care Scale (TSC), translated and validated for the Portuguese population.
The questionnaire used to assess satisfaction with care was the Scale of Citizen Satisfaction with Care (ESCCE), validated for the Portuguese population.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the hospital where the study was carried out, each nurse is responsible for the whole care of a group of people on one working day and may or may not be given responsibility for the same people on subsequent days (individualized care model). An intervention was proposed in an inpatient unit consisting of implementing the model of organizing care by primary nursing in which a nurse is responsible for the care plan for a group of people from admission to discharge from the unit.
| Arm | Type | Receives |
|---|---|---|
| Changing the nursing care model to the primary nursing model | Experimental | Behavioral: Changing the nursing care model to the primary nursing modelInpatient unit where the primary nursing model has been implemented. |
| Standard of care | No intervention | –In this unit there was no change in the model of nursing care; the model used was the individualized care model. In this model, each nurse is responsible for the whole care of a group of patients on one working day and may or may not be given responsibility for the same patients on subsequent days. The patients who agreed to participate in the study completed the same questionnaires and at the same frequency as the patients in the intervention unit. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Have at least two chronic diseases
- Have at least one disease classified in the International Classification of Diseases, Ninth Revision (ICD9) and belonging to one of the following groups: cardiovascular disease, cancer, chronic obstructive pulmonary disease and diabetes;
- Expect to be hospitalised for more than 48 hours;
- Have the cognitive ability to read, write and understand the information provided;
- Speak, read and write Portuguese.
Key exclusion criteria (3 listed)
- Transfer to other levels of care within the organisation
- Discharged to other care units outside the organisation
- Episodes of readmission within 30 days of leaving hospital, as this made the last moment of data collection impossible.
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 |
|---|---|---|
| Changing the nursing care model to the primary nursing modelThe nurses received training in primary nursing care before the start of the intervention. The model was tested and implemented in early April 2022. Since then, all patients admitted to the unit have been assigned to a primary nurse within the first 48 hours. This nurse is responsible for developing and monitoring the patient's care plan, assessing care needs, implementing the care plan and evaluating the outcomes. This nurse is also responsible for coordinating care needs and discharge planning with other healthcare professionals. When the primary nurse is not working, another nurse from his or her team continues the care plan that he or she has defined. All patients admitted to the unit who met the selection criteria were informed about the study and, if they agreed to take part, completed a self-care competence questionnaire at admission (baseline), at discharge and one month after discharge. They also completed a questionnaire on satisfaction with nursing care at discharge. | Behavioural | Changing the nursing care model to the primary nursing model |
Primary outcome
Average global self-care score at discharge from inpatient unit
Time frame: On the day of discharge from the inpatient unit, assessment up to 24 hours later.
Evaluated by the difference in response to the Therapeutic Self-Care Scale on admission and discharge from the unit. It is a 12-question Likert scale with a minimum score of zero (0) and a maximum score of five (5), with higher scores corresponding to better results. Average response scores are used.
Average global self-care score at follow-up
Time frame: At the follow-up 30 days after hospital discharge
Evaluated by the difference between the response to the Therapeutic Self-Care Scale at discharge and at follow-up. Also assessed by the difference between the response to the Therapeutic Self-Care Scale at admission and at follow-up. Therapeutic Self-Care Scale is a 12-question Likert scale with a minimum score of zero (0) and a maximum score of five (5), with higher scores corresponding to better results. Average response scores are used.
1 secondary outcome
Average score for satisfaction with nursing care at discharge from inpatient unit
Time frame: On the day of discharge from the inpatient unit, assessment up to 24 hours later.
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 22 Nov 2024.
- Derived from this study: PubMed 41095543Goncalves I, Almeida S, Jesus E, Nunes E. Effect of the Primary Nursing Model on Self-Care Skills of Hospitalized Older Patients with Multimorbidity: A Quasi-Experimental Study. Healthcare (Basel). 2025 Sep 27;13(19):2457. doi: 10.3390/healthcare13192457.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication
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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.
Elvio Jesus, Professor study director
Universidade Católica Portuguesa
Elisabete Nunes, Professor study chair
Nursing School of Lisbon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Changing the nursing care model to the primary nursing model in people with Multimorbidity and Aged, run by Hospital da Luz, Portugal at 1 site in Portugal.
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 5 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 22 Nov 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 Portugal. 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?
Average global self-care score at discharge from inpatient unit (time frame: On the day of discharge from the inpatient unit, assessment up to 24 hours later.). 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?
On the ClinicalTrials.gov record for NCT06702150, 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 22 Nov 2024.