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Effectiveness of a Structured Intervention on the Development of Self-Care Behaviors With AVF in HD Patients (SISC-AVF)

Primary Purpose

Arteriovenous Fistula, Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Structured Intervention on Self-care with AVF (SISC-AVF)
Sponsored by
Instituto Portugues de Oncologia, Francisco Gentil, Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Arteriovenous Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • clemente Sousa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Structured Intervention on Self-care with AVF

Usual-Care Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)
Self-care behaviors with Management of signs and symptoms
scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)
Self-care behaviors with prevention of complications

Full Information

First Posted
January 28, 2019
Last Updated
February 2, 2019
Sponsor
Instituto Portugues de Oncologia, Francisco Gentil, Porto
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1. Study Identification

Unique Protocol Identification Number
NCT03830658
Brief Title
Effectiveness of a Structured Intervention on the Development of Self-Care Behaviors With AVF in HD Patients
Acronym
SISC-AVF
Official Title
Effectiveness of a Structured Intervention on the Development of Self-Care Behaviors With Arteriovenous Fistula in Hemodialysis Patients: a Quasi-experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
January 14, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Portugues de Oncologia, Francisco Gentil, Porto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
This was a quasi-experimental study in dialysis units, involving patients using AVF for HD. The dialysis units are located in the north of Portugal (two units) and in the Autonomous Region of the Azores (one unit). The study started after approval by the institution ethics committee. Study Setting and Population The study was carried out in dialysis units the north of Portugal, identified as Control Group (CG), and on an island in the Autonomous Region of the Azores, identified as Intervention Group (IG). Data Collection and Instrument All data were collected from January to June 2018. Information concerning the sample demographic characteristics (age, gender, education, employment, marital status) and clinical characteristics (ESRD etiology, dialysis vintage, previous AVFs, AVF duration, information on care with the AVF) was collected with a questionnaire designed by the authors. Information concerning self-care behaviors with the AVF was collected from the Scale of Assessment of Self-Care Behaviors with Arteriovenous Fistula in Hemodialysis (ASBHD-AVF) (8). This scale has 16 items in two subscales: subscale 1 - Management of Signs and Symptoms (6 items) and subscale 2 - Prevention of Complications (10 items). Responses to each item are based on a 5-point Likert-type scale. Higher scores show patients' higher frequency of self-care with the AVF. The ASBHD-AVF scale has been applied to Portuguese patients with Cronbach's alpha of 0.797, 0.797 and 0.722 for the global scale and sub-scales 1 and 2, respectively. Memory problems were assessed by the Six-Item Cognitive Impairment Test (6CIT), Portuguese version (9).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula, Hemodialysis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Structured Intervention on Self-care with AVF
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual-Care Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Structured Intervention on Self-care with AVF (SISC-AVF)
Intervention Description
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.
Primary Outcome Measure Information:
Title
scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)
Description
self-care behaviors with arteriovenous
Time Frame
Change from baseline self-care behaviors at 12 months
Secondary Outcome Measure Information:
Title
scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)
Description
Self-care behaviors with Management of signs and symptoms
Time Frame
Change from baseline self-care behaviors at 12 months
Title
scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)
Description
Self-care behaviors with prevention of complications
Time Frame
Change from baseline self-care behaviors at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: participants should be 18 years or older; have an AVF duration on HD greater than 6 months have no memory problems be medically stable. Exclusion Criteria: patients with double vascular access (central venous catheter and AVF) or grafts as vascular access hospitalized patients at the time of data collection
Facility Information:
Facility Name
clemente Sousa
City
Porto
ZIP/Postal Code
4400
Country
Portugal

12. IPD Sharing Statement

Citations:
PubMed Identifier
33269608
Citation
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.
Results Reference
derived

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Effectiveness of a Structured Intervention on the Development of Self-Care Behaviors With AVF in HD Patients

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