<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03830658</url>
  </required_header>
  <id_info>
    <org_study_id>0012</org_study_id>
    <nct_id>NCT03830658</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Structured Intervention on the Development of Self-Care Behaviors With AVF in HD Patients</brief_title>
  <acronym>SISC-AVF</acronym>
  <official_title>Effectiveness of a Structured Intervention on the Development of Self-Care Behaviors With Arteriovenous Fistula in Hemodialysis Patients: a Quasi-experimental Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Portugues de Oncologia, Francisco Gentil, Porto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Portugues de Oncologia, Francisco Gentil, Porto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      End stage renal disease patients (ESRD) should be educated to take care of their&#xD;
      arteriovenous fistula (AVF). Educational programs should have clear objectives and the&#xD;
      interventions should be well defined. Therefore, assessing the interventions that can have&#xD;
      the strongest impact on the patient's acquisition of self-care behaviors with AVF is&#xD;
      extremely important. The aim is to assess the effectiveness of a structured intervention on&#xD;
      the frequency of self-care behaviors with AVF by patients with ESRD on hemodialysis (HD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a quasi-experimental study in dialysis units, involving patients using AVF for HD.&#xD;
      The dialysis units are located in the north of Portugal (two units) and in the Autonomous&#xD;
      Region of the Azores (one unit). The study started after approval by the institution ethics&#xD;
      committee.&#xD;
&#xD;
      Study Setting and Population The study was carried out in dialysis units the north of&#xD;
      Portugal, identified as Control Group (CG), and on an island in the Autonomous Region of the&#xD;
      Azores, identified as Intervention Group (IG).&#xD;
&#xD;
      Data Collection and Instrument All data were collected from January to June 2018. Information&#xD;
      concerning the sample demographic characteristics (age, gender, education, employment,&#xD;
      marital status) and clinical characteristics (ESRD etiology, dialysis vintage, previous AVFs,&#xD;
      AVF duration, information on care with the AVF) was collected with a questionnaire designed&#xD;
      by the authors.&#xD;
&#xD;
      Information concerning self-care behaviors with the AVF was collected from the Scale of&#xD;
      Assessment of Self-Care Behaviors with Arteriovenous Fistula in Hemodialysis (ASBHD-AVF) (8).&#xD;
      This scale has 16 items in two subscales: subscale 1 - Management of Signs and Symptoms (6&#xD;
      items) and subscale 2 - Prevention of Complications (10 items). Responses to each item are&#xD;
      based on a 5-point Likert-type scale. Higher scores show patients' higher frequency of&#xD;
      self-care with the AVF. The ASBHD-AVF scale has been applied to Portuguese patients with&#xD;
      Cronbach's alpha of 0.797, 0.797 and 0.722 for the global scale and sub-scales 1 and 2,&#xD;
      respectively.&#xD;
&#xD;
      Memory problems were assessed by the Six-Item Cognitive Impairment Test (6CIT), Portuguese&#xD;
      version (9).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2018</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">January 14, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)</measure>
    <time_frame>Change from baseline self-care behaviors at 12 months</time_frame>
    <description>self-care behaviors with arteriovenous</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)</measure>
    <time_frame>Change from baseline self-care behaviors at 12 months</time_frame>
    <description>Self-care behaviors with Management of signs and symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)</measure>
    <time_frame>Change from baseline self-care behaviors at 12 months</time_frame>
    <description>Self-care behaviors with prevention of complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Arteriovenous Fistula</condition>
  <condition>Hemodialysis</condition>
  <arm_group>
    <arm_group_label>Structured Intervention on Self-care with AVF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual-Care Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Educational training was given during HD sessions. The dialysis nurse provided information about arteriovenous fistula care and trained the patient when he/she felt it was required. The dialysis units had no documentation concerning the educational training given to patients and the moment to provide such information was not defined, either.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Structured Intervention on Self-care with AVF (SISC-AVF)</intervention_name>
    <description>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.&#xD;
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.</description>
    <arm_group_label>Structured Intervention on Self-care with AVF</arm_group_label>
    <arm_group_label>Usual-Care Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  participants should be 18 years or older;&#xD;
&#xD;
          -  have an AVF duration on HD greater than 6 months&#xD;
&#xD;
          -  have no memory problems&#xD;
&#xD;
          -  be medically stable.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with double vascular access (central venous catheter and AVF) or grafts as&#xD;
             vascular access&#xD;
&#xD;
          -  hospitalized patients at the time of data collection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>clemente Sousa</name>
      <address>
        <city>Porto</city>
        <zip>4400</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 2, 2019</last_update_submitted>
  <last_update_submitted_qc>February 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Portugues de Oncologia, Francisco Gentil, Porto</investigator_affiliation>
    <investigator_full_name>Clemente Neves Sousa</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arteriovenous Fistula</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03830658
org study id: 0012
nct id: NCT03830658
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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).
allocation: Non-Randomized
intervention model: Parallel Assignment
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
masking: None (Open Label)
measure: 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
description: self-care behaviors with arteriovenous
measure: 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
description: Self-care behaviors with Management of signs and symptoms
measure: 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
description: Self-care behaviors with prevention of complications
arm group label: Structured Intervention on Self-care with AVF
arm group type: Experimental
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.
arm group label: Usual-Care Control
arm group type: Active Comparator
description: Educational training was given during HD sessions. The dialysis nurse provided information about arteriovenous fistula care and trained the patient when he/she felt it was required. The dialysis units had no documentation concerning the educational training given to patients and the moment to provide such information was not defined, either.
intervention type: Behavioral
intervention name: Structured Intervention on Self-care with AVF (SISC-AVF)
description: 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.
arm group label: Structured Intervention on Self-care with AVF
arm group label: Usual-Care Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: Instituto Portugues de Oncologia, Francisco Gentil, Porto
investigator full name: Clemente Neves Sousa
investigator title: Clinical Professor
mesh term: Arteriovenous Fistula
mesh term: Fistula