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Clinical Trials/NCT03830658
NCT03830658
Completed
Not Applicable

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

Instituto Portugues de Oncologia, Francisco Gentil, Porto1 site in 1 country89 target enrollmentJanuary 2, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arteriovenous Fistula
Sponsor
Instituto Portugues de Oncologia, Francisco Gentil, Porto
Enrollment
89
Locations
1
Primary Endpoint
scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)
Status
Completed
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 2, 2018
End Date
January 31, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Instituto Portugues de Oncologia, Francisco Gentil, Porto
Responsible Party
Principal Investigator
Principal Investigator

Clemente Neves Sousa

Clinical Professor

Instituto Portugues de Oncologia, Francisco Gentil, Porto

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

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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