Clinical trial NCT03830658: Effectiveness of a Structured Intervention on the Development of Self-Care Behaviors With AVF in HD Patients
Official title: Effectiveness of a Structured Intervention on the Development of Self-Care Behaviors With Arteriovenous Fistula in Hemodialysis Patients: a Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arteriovenous Fistula
Hemodialysis
Lead sponsor: Instituto Portugues de Oncologia, Francisco Gentil, Porto
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)
timeFrame: Change from baseline self-care behaviors at 12 months
Secondary outcomes:
measure: scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)
timeFrame: Change from baseline self-care behaviors at 12 months
measure: scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)
timeFrame: Change from baseline self-care behaviors at 12 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: clemente Sousa
Study officials:
References:
citation: 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.