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

• ClinicalTrials.gov Identifier: NCT03830658
• Recruitment Status: Completed
• First Posted: February 5, 2019
• Last Update Posted: February 5, 2019
• Sponsor: Instituto Portugues de Oncologia, Francisco Gentil, Porto
• Information provided by (Responsible Party): Clemente Neves Sousa, Instituto Portugues de Oncologia, Francisco Gentil, Porto

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).

Condition or disease	Intervention/treatment	Phase
Arteriovenous Fistula; Hemodialysis	Behavioral: Structured Intervention on Self-care with AVF (SISC-AVF)	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 89 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Other
• Official Title: Effectiveness of a Structured Intervention on the Development of Self-Care Behaviors With Arteriovenous Fistula in Hemodialysis Patients: a Quasi-experimental Study
• Actual Study Start Date: January 2, 2018
• Actual Primary Completion Date: January 14, 2018
• Actual Study Completion Date: January 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Structured Intervention on Self-care with AVF; 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); 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.
Active Comparator: Usual-Care Control; 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); 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.

Outcome Measures

Primary Outcome Measures :

1. scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF) [ Time Frame: Change from baseline self-care behaviors at 12 months ]
   self-care behaviors with arteriovenous

Secondary Outcome Measures :

1. scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF) [ Time Frame: Change from baseline self-care behaviors at 12 months ]
   Self-care behaviors with Management of signs and symptoms
2. scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF) [ Time Frame: Change from baseline self-care behaviors at 12 months ]
   Self-care behaviors with prevention of complications

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Portugal

clemente Sousa

Porto, Portugal, 4400

Sponsors and Collaborators

Instituto Portugues de Oncologia, Francisco Gentil, Porto

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Clemente Neves Sousa, Clinical Professor, Instituto Portugues de Oncologia, Francisco Gentil, Porto
• ClinicalTrials.gov Identifier: NCT03830658
• Other Study ID Numbers: 0012
• First Posted: February 5, 2019
• Last Update Posted: February 5, 2019
• Last Verified: February 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Arteriovenous Fistula; Fistula; Pathological Conditions, Anatomical; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities