Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-02 @ 8:09 AM
Study NCT ID:
NCT03830658
Status:
COMPLETED
Last Update Posted:
2019-02-05
First Post:
2019-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Structured Intervention on the Development of Self-Care Behaviors With AVF in HD Patients
Sponsor:
Instituto Portugues de Oncologia, Francisco Gentil, Porto
Organization:
Study Overview
Official Title:
Effectiveness of a Structured Intervention on the Development of Self-Care Behaviors With Arteriovenous Fistula in Hemodialysis Patients: a Quasi-experimental Study
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SISC-AVF
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 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: