Effectiveness of a Structured Intervention on the Development of Self-Care Behaviors With AVF in HD Patients
SISC-AVF
1 other identifier
interventional
89
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
1 active site
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
January 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2018
CompletedFirst Submitted
Initial submission to the registry
January 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedFirst Posted
Study publicly available on registry
February 5, 2019
CompletedFebruary 5, 2019
February 1, 2019
12 days
January 28, 2019
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
EXPERIMENTALThe 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.
Usual-Care Control
ACTIVE COMPARATOREducational 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.
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.
Eligibility Criteria
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
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.
PMID: 33269608DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- 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