Skill Building Education of Arteriovenous-Fistula Self-Care Behaviors and Quality of Life of Patients on Hemodialysis

NCT06947772 | Not Yet Recruiting DMC

• 1 other identifier: 057-25
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effectiveness of skill building educational interventions in improving the self-care behaviors and quality of life of AVF in hemodialysis patients. This study will address questions. What is the effect of skill building education on the self-care behaviors of AVF care and quality of life in patients in patients undergoing hemodialysis treatment? A total 274 participants will be recruited from dialysis units of the study hospitals. Using random allocation 137 participants will be assigned to the control group and 137 to the intervention group. The intervention group will additionally receive a skill building education for improving their self-care behaviors and quality of life of AVF. Researcher will implement skill building educational intervention in interventional group to enhance the self-care behaviors and quality of life. This intervention have two session, first is theoretical and another one is practical. The primary outcome of this study is AVF self-care behaviors and secondary outcome is quality of life related to AVF. This outcome will be assessed using the Self-care Behaviors Scale with Arteriovenous Fistula in Hemodialysis patients (ASBHD-AVF). The secondary outcome will be assessed using the Hemodialysis Access-related Quality of Life (HARQ) which is a self-administered tool develop by Nordyke. The primary and secondary outcomes will be assessed at: baseline, after the completion of the intervention, and follow-up data will be collected at the second and sixth weeks after intervention is completed. Data will be analyzed using the Statistical Package of Social Science (SPSS) version 25. Descriptive statistics, means and standard deviations will be used for the continuous variables, while frequencies and percentages will be utilized for categorical demographic data (gender, educational level, hemodialysis frequency, items of self-care behavior scale, QOL). Normality of data will be check and applied test accordingly.

Conditions

Chronic Kidney Disease; Hemodialysis; Hemodialysis Access Failure

Keywords

Slef-care behaviors; hemodialysis; quality of life; arteriovenous fistula; Kidney disease

Outcome Measures

Primary Outcomes (1)

• Assessment of Self-Care Behaviors with AVF in Hemodialysis Patients (ASBHD-AVF)

  Primary outcome of this study will be the assessment of self-care behaviors related to AVF in hemodialysis patients. The ASBHD-AVF is a 16 itme self-assessment scale develop by Sousa et al (2015) to assess self-care behaviors of AVF of hemodialysis patients. This scale consists of two sub scale: 1) Management of sign and symptom and 2) Prevention from complication. Response option consists of five point Likert scale ranging from 1(nevern develop the self-care)-5 (always develop the self-care). The minimum scores is 16 and maximum is 80.A higher scores reflect higher frequency of self-care behaviors. Permission of this tool is taken. The overall reported reliability is 0.72 and CVI is1.

  4 months

Secondary Outcomes (1)

• Hemodialysis Access-Related Quality of Life (HARQ)

  4 months

Study Arms (2)

Interventional

ACTIVE COMPARATOR

Skill building educational intervention will be implemented into two session. First is theoretical and other is practical. In theoretical session patients will be teach about the AVF self-care behavior. In practical session patient will be teach about how to monitor their AVF. Monitoring of AVF include the assessment of AVF. Assessment have three steps. Inspection, palpation and auscultation.

Behavioral: Skill building education

usual care

NO INTERVENTION

Control group will receive usual care in the dialysis units.

Interventions

Skill building education BEHAVIORAL

This intervention includes two session. theoretical and practical. In theroretical patient will be teahc about self-care of AVF and in oracticla session they learn how to monitor their AVF. monitoring have three part. inspection, palpation and auscultation

Also known as: education

Interventional

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The study will include patients:
• diagnosed with end-stage renal disease on hemodialysis through an arteriovenous fistula
• aged 18 years or above.
• who can read and understand the Urdu language.

You may not qualify if:

• The study will exclude patients:
• having any physical or mental disabilities that can interfere with their capacity to perform daily life activities.
• with any visual and hearing impairment. -

Sponsors & Collaborators

• Shifa Tameer-e-Millat University: lead

Study Sites (1)

Shifa College of Nursing

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Arteriovenous Fistula; Kidney Diseases

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Bushra Sultan, PhD

  Shifa College of Nursing (STMU)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bushra Sultan, PhD

CONTACT

+923315116190; bushra.scn@stmu.edu.pk

Khairunnisa Dhamani, PhD

CONTACT

+1409308975; khairunnisa.scn@stmu.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data analyst will assist with permuted block randomization procedure will be used to separate random scheme in both setting (A) and (B). The sealed envelopes will be prepared by data analyst, shuffled, numbered serial, and placed in a locked drawer in both units (A and B), and only research assistant can access it. After consenting and completing baseline assessment, the research assistant will open a sealed envelope to reveal the patient's group assignment. The patient will then be assigned to specific group accordingly. Research assistant will ensure that intervention and control groups' patients will have dialysis in separate rooms or wards to prevent contamination in intervention. The sealed envelop will be coded with numbers the research assistant will not know what these numbers mean.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The randomize control trial (RCT) parallel design with the allocation ratio 1:1 will be employed to assess the effectiveness of a skill-building educational intervention on the self-care behaviors and quality of life of AVF in hemodialysis patients

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 27, 2025
• Study Start: May 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 30, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

PA (1)