Chronic Kidney Disease Patients on HemodialysisNCT07168239
Effectiveness of Nursing Educational Intervention on Vascular Access Self-Care in Hemodialysis
A study testing ENHANCING VASCULAR ACCESS SELF-CARE IN HEMODIALYSIS PATIENTS in people with Chronic Kidney Disease Patients on Hemodialysis, run by Aveiro University at 1 site in Portugal.
Trial summary
Background: Hemodialysis patients experience health-illness transitions, which are prompted by changes in social and personal roles as they adapt to chronic kidney disease and its treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Patients on Hemodialysis
- What is being tested?
- ENHANCING VASCULAR ACCESS SELF-CARE IN HEMODIALYSIS PATIENTS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Aug 2024to 31 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD patients on outpatient HD
- Independent in self-care
- With AVF as Vascular Access
Who cannot join
- Usage of CVC or AVP as Vascular Access
- Cognitive impairment (assessed through the Mini-Mental State Examination developed by Folstein et al., 1975)
- non-fluent in Portuguese language
Trial locations and contacts
1 site in 1 country.
About this study
Background: Hemodialysis patients experience health-illness transitions, which are prompted by changes in social and personal roles as they adapt to chronic kidney disease and its treatments. In this context, nurses play a facilitative role in supporting these transitions, aiming to enhance the patients' sense of well-being.
There is an increasing need to provide care that positively impacts clinical and health outcomes, including the empowerment of these patients to be as independent as possible including promoting self-care for their vascular access.
Read more
The present study aims to assess the self-care profile regarding vascular access in a population of patients with chronic kidney disease undergoing outpatient hemodialysis and to evaluate the impact of educational nursing interventions on the transition process to self-care with vascular access in this population.
Methods: The investigators conducted a prospective, quantitative, and cross-sectional study with an interventional methodology, which involved an initial diagnostic assessment about self-care behaviours with the arteriovenous fistula, followed by an educational intervention to promote adherence to self-care, and a subsequent re-evaluation of the outcomes after the intervention. The assessment of self-care behaviours with the arteriovenous fistula was carried out by the Self-Care Behaviour Assessment Scale with arteriovenous fistula in Hemodialysis.
Data collection was split in three parts: sociodemographic characterization, clinical characterization of participants, and assessment of self-care behaviours with the AVF.
- Being tested
- ENHANCING VASCULAR ACCESS SELF-CARE IN HEMODIALYSIS PATIENTS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENHANCING VASCULAR ACCESS SELF-CARE IN HEMODIALYSIS PATIENTSBehavioural
A set of health education sessions were developed for patients who did not exhibit fully adequate behaviour in the first assessment of the Scale of Assessment of Self-Care with AVF in HD. The sessions were conducted individually through an expository method and providing an informative leaflet. The sessions focused on the areas presented by the scale, i.e. prevention of thrombosis and infection, signs and symptoms of intra/interdialytic complications, haemostasis care, protection of the AV limb and correct assessment of signs and symptoms suggestive of complications with the AVF, evaluation of AVF functionality and detection of thrombosis, changes in colour and sensitivity of the hand corresponding to the AV, pain in the AV limb
| Study group | Role | What they receive |
|---|---|---|
| Patients from two Hemodialysis units with AVF as Vascular Access | Experimental | Population of CKD patients undergoing HD from two portuguese HD units. The sample was non-probabilistic and convenience-based, including patients with an AVF in use. A set of health education sessions were developed for patients who did not exhibit fully adequate behaviour in the first assessment of the Scale of Assessment of Self-Care with AVF in HD. Receives: Behavioral: ENHANCING VASCULAR ACCESS SELF-CARE IN HEMODIALYSIS PATIENTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-care behaviours with the arteriovenous fistula after a nursing intervention
Data collection of self-care behaviours with the AVF, as described for the primary outcomes, after a nursing intervention.
Inferential statistical analyses were performed. A paired t-test was used to compare participants' knowledge levels ie. overall score, score on signs and symptoms, and score on complication prevention, at two distinct points.
Measured: 3 months
Secondary outcomes (1)
Self-care behaviours with the AVF
Carried out with the Scale of Assessment of Self-Care with AVF in HD. This scale consists of 16 items, with a two-dimensional structure with a total value of Cronbach's alpha of 0.797. The two subscales are management of signs and symptoms and prevention of complications.
The scale comprises 31 items scored on a five-point Likert scale, ranging from 31 to 155 points overall. Lower scores reflect insufficient or inconsistent self-care behaviors, while higher scores indicate greater adequacy and consistency in knowledge, attitudes, and practices The application of the scale can be segmented by domain to identify areas with potential for intervention, while the overall score provides an overview of the patient's autonomy in these behaviors.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Aug 2024
- Primary completion30 Sep 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Patients on HemodialysisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- INTERVENTIONAL STUDY
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Catarina Silva, Aveiro University
- Investigators
- Ana Catarina Brito Silva, Master, Principal investigator, Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168239
- Sponsor's protocol ID
- Diaverum08072024
- Status last verified
- Sep 2025
- First submitted
- 13 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nursing Educational Intervention on Vascular Access Self-Care in Hemodialysis
- ClinicalTrials.gov ID
- NCT07168239
- Acronym / sponsor ID
- Diaverum08072024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 11 Sep 2025 (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.
Background: Hemodialysis patients experience health-illness transitions, which are prompted by changes in social and personal roles as they adapt to chronic kidney disease and its treatments. In this context, nurses play a facilitative role in supporting these transitions, aiming to enhance the patients' sense of well-being.
There is an increasing need to provide care that positively impacts clinical and health outcomes, including the empowerment of these patients to be as independent as possible including promoting self-care for their vascular access.
The present study aims to assess the self-care profile regarding vascular access in a population of patients with chronic kidney disease undergoing outpatient hemodialysis and to evaluate the impact of educational nursing interventions on the transition process to self-care with vascular access in this population.
Methods: The investigators conducted a prospective, quantitative, and cross-sectional study with an interventional methodology, which involved an initial diagnostic assessment about self-care behaviours with the arteriovenous fistula, followed by an educational intervention to promote adherence to self-care, and a subsequent re-evaluation of the outcomes after the intervention. The assessment of self-care behaviours with the arteriovenous fistula was carried out by the Self-Care Behaviour Assessment Scale with arteriovenous fistula in Hemodialysis.
Data collection was split in three parts: sociodemographic characterization, clinical characterization of participants, and assessment of self-care behaviours with the AVF.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- INTERVENTIONAL STUDY
| Arm | Type | Receives |
|---|---|---|
| Patients from two Hemodialysis units with AVF as Vascular Access | Experimental | Behavioral: ENHANCING VASCULAR ACCESS SELF-CARE IN HEMODIALYSIS PATIENTSPopulation of CKD patients undergoing HD from two portuguese HD units. The sample was non-probabilistic and convenience-based, including patients with an AVF in use. A set of health education sessions were developed for patients who did not exhibit fully adequate behaviour in the first assessment of the Scale of Assessment of Self-Care with AVF in HD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CKD patients on outpatient HD
- Independent in self-care
- With AVF as Vascular Access
Key exclusion criteria (3 listed)
- Usage of CVC or AVP as Vascular Access
- Cognitive impairment (assessed through the Mini-Mental State Examination developed by Folstein et al., 1975)
- non-fluent in Portuguese language
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 |
|---|---|---|
| ENHANCING VASCULAR ACCESS SELF-CARE IN HEMODIALYSIS PATIENTSA set of health education sessions were developed for patients who did not exhibit fully adequate behaviour in the first assessment of the Scale of Assessment of Self-Care with AVF in HD. The sessions were conducted individually through an expository method and providing an informative leaflet. The sessions focused on the areas presented by the scale, i.e. prevention of thrombosis and infection, signs and symptoms of intra/interdialytic complications, haemostasis care, protection of the AV limb and correct assessment of signs and symptoms suggestive of complications with the AVF, evaluation of AVF functionality and detection of thrombosis, changes in colour and sensitivity of the hand corresponding to the AV, pain in the AV limb | Behavioural | Patients from two Hemodialysis units with AVF as Vascular Access |
Primary outcome
Self-care behaviours with the arteriovenous fistula after a nursing intervention
Time frame: 3 months
Data collection of self-care behaviours with the AVF, as described for the primary outcomes, after a nursing intervention. Inferential statistical analyses were performed. A paired t-test was used to compare participants' knowledge levels ie. overall score, score on signs and symptoms, and score on complication prevention, at two distinct points.
1 secondary outcome
Self-care behaviours with the AVF
Time frame: 1 month
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 11 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Ana Catarina Brito Silva, Master principal investigator
Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENHANCING VASCULAR ACCESS SELF-CARE IN HEMODIALYSIS PATIENTS in people with Chronic Kidney Disease Patients on Hemodialysis, run by Aveiro University 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 3 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 11 Sep 2025. 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?
Self-care behaviours with the arteriovenous fistula after a nursing intervention (time frame: 3 months). 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 11 Sep 2025.