<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/NCT03841071</url>
  </required_header>
  <id_info>
    <org_study_id>2016255</org_study_id>
    <secondary_id>2016255</secondary_id>
    <nct_id>NCT03841071</nct_id>
  </id_info>
  <brief_title>A Clinical Feedback System in Ostomy Care</brief_title>
  <official_title>Use of the Ostomy Adjustment Scale (OAS) as a Routine Outcome Measure of Adaptation to Life With an Ostomy Along With a Clinical Feedback System in the Follow-up of Ostomy Patients; Does it Promote Adaptation to the Life With an Ostomy?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helse Forde</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Western Norway University of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian Nurses Organisation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helse Forde</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>
      Background: Living with an ostomy can be challenging and adapting to life with an ostomy can&#xD;
      be particularly complex, with regard to both the physical and psychosocial aspects. Follow-up&#xD;
      with a stoma care nurse is usually performed after surgery to support the adaptation process.&#xD;
      In this project, we describe a new model of ostomy care, where a clinical feedback system&#xD;
      (CFS) is implemented in order to improve the adaption process of patients with an ostomy. We&#xD;
      also present a plan for evaluating patients experience with the CFS and their clinical&#xD;
      outcomes.&#xD;
&#xD;
      Methods: We include patients who had recently performed colostomy, ileostomy, or urostomy&#xD;
      surgery. The intervention includes self-reported measures for adaptation to life with an&#xD;
      ostomy and health-related quality of life (HRQoL), as well as patient experiences and&#xD;
      satisfaction recorded by the clinical feedback system. The measures are electronically&#xD;
      assessed before each clinical consultation at 3, 6, and 12 months after surgery. The scores&#xD;
      are instantly analysed and graphically presented for use during the consultation and the&#xD;
      patient and stoma care nurse can discuss the findings. Patient experiences and satisfaction&#xD;
      with care will be measured with the Generic Short Patient Experiences Questionnaire.&#xD;
      Adaptation to the life with ostomy will be measured with the Ostomy Adjustment Scale, and&#xD;
      HRQoL with the Short Form 36.&#xD;
&#xD;
      Discussion: This study presents a novel approach that could lead to improved consultation,&#xD;
      more patient involvement, and better adaptation to life with an ostomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study protocol is avaliable on request, and will also be published in a open acsess&#xD;
      peer-reviewed journal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The patient's subjective adaptation to the physical, psychological, and social changes that occur after ostomy surgery</measure>
    <time_frame>From the 3 months follow-up after surgery to the 12 months follow-up.</time_frame>
    <description>The summary score of the Ostomy Adjustment Scale (lowest possible score is 34 and the highest 204). Higher scores represent better outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Generic health-related quality of life</measure>
    <time_frame>From the 3 months follow-up after surgery to the 12 months follow-up.</time_frame>
    <description>The two summary scores of the Short Form-36 (Physical Component Score and Mental Component Score). The lowest possible score is 0 and the highest 100. Higher scores represent better outcomes.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The patients' satisfaction with the consultation</measure>
    <time_frame>At the 12 months follow-up after surgery.</time_frame>
    <description>The Session rating scale, using the five item scores seperately (lowest possible score is 0 and the highest 10). Higher scores represent better outcomes.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Ostomy</condition>
  <condition>Quality of Life</condition>
  <condition>Adaptation, Psychological</condition>
  <arm_group>
    <arm_group_label>ROM/CFS intervention</arm_group_label>
    <description>The ROM/CFS group (N&gt;100), consists of patients who have undergone urostomy, colostomy, or ileostomy operations, and who are included in the routine follow-up program of the outpatient ostomy clinic at the Department of Surgery, Førde Central Hospital from April 2018 to June 2021.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ROM/CFS intervention</intervention_name>
    <description>The intervention (ROM/CFS) includes self-reported measures for adaptation to life with an ostomy and health-related quality of life, as well as patient satisfaction recorded by the clinical feedback system. The measures are electronically assessed before each clinical consultation at 3, 6, and 12 months after surgery, and annually thereafter. The scores are instantly analysed and graphically presented for use during the consultation and the patient and stoma care nurse can discuss the findings.</description>
    <arm_group_label>ROM/CFS intervention</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have undergone urostomy, colostomy, or ileostomy operations, and who are&#xD;
        included in the routine follow-up program at a outpatient ostomy clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  &gt;18 years of age&#xD;
&#xD;
          -  Living with a colostomy, ileostomy, or urostomy for a minimum of 3 months&#xD;
&#xD;
          -  Being able to read and write Norwegian&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  &lt; The 3 weeks follow-up after surgery are not included&#xD;
&#xD;
          -  Patients who have their ostomy removed &lt;12 months after surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John R Andersen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Førde Hospital Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kirsten L Indrebø, McS</last_name>
    <phone>4795966010</phone>
    <email>kirsten.lerum.indrebo@helse-forde.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>John R Andersen, PhD</last_name>
    <phone>4748278186</phone>
    <email>john.roger.andersen@helse-forde.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Førde Hospital Trust</name>
      <address>
        <city>Førde</city>
        <zip>6812</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kirsten L Indrebø, McS</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>https://helseforskning.etikkom.no/prosjekterirek/prosjektregister/prosjekt?_ikbLanguageCode=us</url>
    <description>Study approval from the Regional Committees for Medical and Health Research Ethics (REC)</description>
  </link>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>October 23, 2019</last_update_submitted>
  <last_update_submitted_qc>October 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The dataset generated during this study will not be publicly available as the patient consent and approval from the Regional Committee for Medical and Health Research Ethics prevents sharing of individual patient level data in public repositories. However, the data will be available from the corresponding author upon reasonable request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data will be available from the corresponding author upon reasonable request after publication.&#xD;
The study protocol is avaliable on request, and will also be published in a open acsess peer-reviewed journal.</ipd_time_frame>
    <ipd_access_criteria>Supporting information is freely available from The Central Contact Person: Kirsten L Indrebø. Email: kirsten.lerum.indrebo@helse-forde.no.</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT03841071
org study id: 2016255
secondary id: 2016255
nct id: NCT03841071
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Living with an ostomy can be challenging and adapting to life with an ostomy can
      be particularly complex, with regard to both the physical and psychosocial aspects. Follow-up
      with a stoma care nurse is usually performed after surgery to support the adaptation process.
      In this project, we describe a new model of ostomy care, where a clinical feedback system
      (CFS) is implemented in order to improve the adaption process of patients with an ostomy. We
      also present a plan for evaluating patients experience with the CFS and their clinical
      outcomes.

      Methods: We include patients who had recently performed colostomy, ileostomy, or urostomy
      surgery. The intervention includes self-reported measures for adaptation to life with an
      ostomy and health-related quality of life (HRQoL), as well as patient experiences and
      satisfaction recorded by the clinical feedback system. The measures are electronically
      assessed before each clinical consultation at 3, 6, and 12 months after surgery. The scores
      are instantly analysed and graphically presented for use during the consultation and the
      patient and stoma care nurse can discuss the findings. Patient experiences and satisfaction
      with care will be measured with the Generic Short Patient Experiences Questionnaire.
      Adaptation to the life with ostomy will be measured with the Ostomy Adjustment Scale, and
      HRQoL with the Short Form 36.

      Discussion: This study presents a novel approach that could lead to improved consultation,
      more patient involvement, and better adaptation to life with an ostomy.
The study protocol is avaliable on request, and will also be published in a open acsess
      peer-reviewed journal.
observational model: Cohort
time perspective: Prospective
measure: The patient's subjective adaptation to the physical, psychological, and social changes that occur after ostomy surgery
time frame: From the 3 months follow-up after surgery to the 12 months follow-up.
description: The summary score of the Ostomy Adjustment Scale (lowest possible score is 34 and the highest 204). Higher scores represent better outcomes.
measure: Generic health-related quality of life
time frame: From the 3 months follow-up after surgery to the 12 months follow-up.
description: The two summary scores of the Short Form-36 (Physical Component Score and Mental Component Score). The lowest possible score is 0 and the highest 100. Higher scores represent better outcomes.
measure: The patients' satisfaction with the consultation
time frame: At the 12 months follow-up after surgery.
description: The Session rating scale, using the five item scores seperately (lowest possible score is 0 and the highest 10). Higher scores represent better outcomes.
arm group label: ROM/CFS intervention
description: The ROM/CFS group (N>100), consists of patients who have undergone urostomy, colostomy, or ileostomy operations, and who are included in the routine follow-up program of the outpatient ostomy clinic at the Department of Surgery, Førde Central Hospital from April 2018 to June 2021.
intervention type: Other
intervention name: ROM/CFS intervention
description: The intervention (ROM/CFS) includes self-reported measures for adaptation to life with an ostomy and health-related quality of life, as well as patient satisfaction recorded by the clinical feedback system. The measures are electronically assessed before each clinical consultation at 3, 6, and 12 months after surgery, and annually thereafter. The scores are instantly analysed and graphically presented for use during the consultation and the patient and stoma care nurse can discuss the findings.
arm group label: ROM/CFS intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John R Andersen, PhD
role: Principal Investigator
affiliation: Førde Hospital Trust
last name: Kirsten L Indrebø, McS
phone: 4795966010
email: kirsten.lerum.indrebo@helse-forde.no
last name: John R Andersen, PhD
phone: 4748278186
email: john.roger.andersen@helse-forde.no
facility: 
status: Recruiting
contact: 
country: Norway
url: https://helseforskning.etikkom.no/prosjekterirek/prosjektregister/prosjekt?_ikbLanguageCode=us
description: Study approval from the Regional Committees for Medical and Health Research Ethics (REC)
responsible party type: Sponsor
sharing ipd: Yes
ipd description: The dataset generated during this study will not be publicly available as the patient consent and approval from the Regional Committee for Medical and Health Research Ethics prevents sharing of individual patient level data in public repositories. However, the data will be available from the corresponding author upon reasonable request.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data will be available from the corresponding author upon reasonable request after publication.
The study protocol is avaliable on request, and will also be published in a open acsess peer-reviewed journal.
ipd access criteria: Supporting information is freely available from The Central Contact Person: Kirsten L Indrebø. Email: kirsten.lerum.indrebo@helse-forde.no.