Skip to main content
OpenTrials
Completed

NCT Number: NCT03830658

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Hemodialysis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

clemente Sousa

Porto, 4400, Portugal

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured Intervention on Self-care with AVF (SISC-AVF)

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Instituto Portugues de Oncologia, Francisco Gentil, Porto

Other

Registry information

Official study title

Effectiveness of a Structured Intervention on the Development of Self-Care Behaviors With Arteriovenous Fistula in Hemodialysis Patients: a Quasi-experimental Study

Acronym: SISC-AVF

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 5, 2019
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.