NCT03830658

Brief Summary

End stage renal disease patients (ESRD) should be educated to take care of their arteriovenous fistula (AVF). Educational programs should have clear objectives and the interventions should be well defined. Therefore, assessing the interventions that can have the strongest impact on the patient's acquisition of self-care behaviors with AVF is extremely important. The aim is to assess the effectiveness of a structured intervention on the frequency of self-care behaviors with AVF by patients with ESRD on hemodialysis (HD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2018

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 28, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

12 days

First QC Date

January 28, 2019

Last Update Submit

February 2, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)

    self-care behaviors with arteriovenous

    Change from baseline self-care behaviors at 12 months

Secondary Outcomes (2)

  • scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)

    Change from baseline self-care behaviors at 12 months

  • scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)

    Change from baseline self-care behaviors at 12 months

Study Arms (2)

Structured Intervention on Self-care with AVF

EXPERIMENTAL

The structured intervention designed for this study was a multimethod approach with the purpose of capturing the learning styles of most patients through the use of written, listening and visual learning (10). Structured Intervention on Self-care with AVF (SISC-AVF) has been designed taking into account the structure of care to the person with AVF developed by Sousa (11). The SISC-AVF had the purpose of identifying the signs/symptoms or situations jeopardizing AVF working and includes both a theoretical and a practical part.

Behavioral: Structured Intervention on Self-care with AVF (SISC-AVF)

Usual-Care Control

ACTIVE COMPARATOR

Educational training was given during HD sessions. The dialysis nurse provided information about arteriovenous fistula care and trained the patient when he/she felt it was required. The dialysis units had no documentation concerning the educational training given to patients and the moment to provide such information was not defined, either.

Behavioral: Structured Intervention on Self-care with AVF (SISC-AVF)

Interventions

Theoretical Part: structured intervention involved an educational group session with the purpose of teaching patients how to identify situations that can compromise AVF working. Each presentation allowed a maximum of eight patients and took 30 minutes. Each presentation was assessed in the end by asking participants to identify the signs and symptoms of infection, thrombosis and steal syndrome and to describe the care to be taken during dialysis and in the period outside dialysis. Practical Part: started a week after the theoretical part, lasting for two weeks, and was given to each participant in an appropriate room at the beginning of the HD treatment. Interactive training sessions were conducted using an informal approach with the objective of developing skills of inspection and palpation of the AVF arm. Inspection had the purpose of enabling participants to identify situations that could compromise the working of the AVF. Each patient was given two 15-minute sessions.

Structured Intervention on Self-care with AVFUsual-Care Control

Eligibility Criteria

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

You may qualify if:

  • participants should be 18 years or older;
  • have an AVF duration on HD greater than 6 months
  • have no memory problems
  • be medically stable.

You may not qualify if:

  • patients with double vascular access (central venous catheter and AVF) or grafts as vascular access
  • hospitalized patients at the time of data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

clemente Sousa

Porto, 4400, Portugal

Location

Related Publications (1)

  • Sousa CN, Paquete ARC, Teles P, Pinto CMCB, Dias VFF, Ribeiro OMPL, Manzini CSS, Nicole AG, Souza LH, Ozen N. Investigating the Effect of a Structured Intervention on the Development of Self-Care Behaviors With Arteriovenous Fistula in Hemodialysis Patients. Clin Nurs Res. 2021 Jul;30(6):866-874. doi: 10.1177/1054773820974834. Epub 2020 Dec 3.

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The structured intervention designed for this study was a multimethod approach with the purpose of capturing the learning styles of most patients through the use of written, listening and visual learning (10). Structured Intervention on Self-care with AVF (SISC-AVF) has been designed taking into account the structure of care to the person with AVF developed by Sousa (11). The SISC-AVF had the purpose of identifying the signs/symptoms or situations jeopardizing AVF working and includes both a theoretical and a practical part.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 28, 2019

First Posted

February 5, 2019

Study Start

January 2, 2018

Primary Completion

January 14, 2018

Study Completion

January 31, 2019

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations