NCT07168239

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

August 13, 2025

Last Update Submit

September 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (1)

  • Self-care behaviours with the AVF

    1 month

Study Arms (1)

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.

Behavioral: ENHANCING VASCULAR ACCESS SELF-CARE IN HEMODIALYSIS PATIENTS

Interventions

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

Patients from two Hemodialysis units with AVF as Vascular Access

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CKD patients on outpatient HD
  • Independent in self-care
  • With AVF as Vascular Access

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de Aveiro

Aveiro, 3810, Portugal

Location

Study Officials

  • Ana Catarina Brito Silva, Master

    Student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: INTERVENTIONAL STUDY
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Nurse

Study Record Dates

First Submitted

August 13, 2025

First Posted

September 11, 2025

Study Start

August 1, 2024

Primary Completion

September 30, 2024

Study Completion

December 31, 2024

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations