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

Hemodialysis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830658
• Other study ID #: 0012
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: February 2019
• Source: Instituto Portugues de Oncologia, Francisco Gentil, Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: January 31, 2019
• Est. primary completion date: January 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula
• Hemodialysis

Intervention

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.

Locations

Country	Name	City	State
Portugal	clemente Sousa	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Portugues de Oncologia, Francisco Gentil, Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)	Self-care behaviors with Management of signs and symptoms	Change from baseline self-care behaviors at 12 months
Secondary	scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)	Self-care behaviors with prevention of complications	Change from baseline self-care behaviors at 12 months