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

Not Applicable

Completed

• Conditions: Arteriovenous Fistula; Hemodialysis

• Registration Number: NCT03830658
• Lead Sponsor: Instituto Portugues de Oncologia, Francisco Gentil, Porto

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).

Study Timeline

• Study Start: 2018-01-02
• Primary Completion: 2018-01-14
• Study First Submitted: 2019-01-28
• Study Completion: 2019-01-31
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-02
• Last Update Submitted: 2019-02-02
• Study First Posted: 2019-02-05
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)	Change from baseline self-care behaviors at 12 months	self-care behaviors with arteriovenous

Secondary Outcome Measures

Name	Time	Method
scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)	Change from baseline self-care behaviors at 12 months	Self-care behaviors with prevention of complications

Trial Locations

Locations (1)

clemente Sousa; 🇵🇹 Porto, Portugal