<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/NCT02994706</url>
  </required_header>
  <id_info>
    <org_study_id>2012135RM</org_study_id>
    <nct_id>NCT02994706</nct_id>
  </id_info>
  <brief_title>A Study of Home Monitoring in Adults With Cystic Fibrosis (HOMECF)</brief_title>
  <acronym>HOME-CF</acronym>
  <official_title>A Prospective Pilot Study of Home Monitoring in Adults With Cystic Fibrosis (HOMECF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heart of England NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Heart of England NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cystic fibrosis (CF) is the most common fatal inherited condition in Caucasians, causing&#xD;
      recurrent chest infections and premature death due to lung failure. When patients develop&#xD;
      chest infections their symptoms usually slowly worsen over the course of several days to&#xD;
      weeks. Due to this gradual onset, patients often seek medical attention several days or weeks&#xD;
      after symptoms start to worsen. The Investigators believe that if they were able to monitor&#xD;
      patients more closely they could diagnose and treat chest infections earlier and consequently&#xD;
      improve health outcomes.&#xD;
&#xD;
      The HOMECF study aims to investigate whether home monitoring is beneficial for adults with&#xD;
      CF. 100 subjects will be randomly allocated, 50 to receive home monitoring and 50 to receive&#xD;
      routine clinical care for 12 months. Subjects receiving home monitoring will measure their&#xD;
      lung function and symptoms twice weekly and this data will be transmitted to the medical team&#xD;
      by means of a modified mobile phone.&#xD;
&#xD;
      the Investigators hypothesize that home monitoring will allow them to diagnose chest&#xD;
      infections at an earlier stage and reduce hospital inpatient days. They will also assess the&#xD;
      subjects' experience of receiving home monitoring, the impact on body weight and lung&#xD;
      function and and conduct a full health economic analysis to assess value for money. They will&#xD;
      also ask subjects to collect a urine sample once weekly to allow us to measure urinary levels&#xD;
      of inflammatory markers.&#xD;
&#xD;
      Subjects will be recruited at the West Midlands Adult CF Centre in Birmingham. The research&#xD;
      team are well placed to carry out the study because it is a large regional adult CF centre&#xD;
      with an excellent record of conducting clinical research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The principal question being answered by this research study is:&#xD;
&#xD;
      1. Does home monitoring reduce the total number of inpatient hospital days in adults with&#xD;
      cystic fibrosis (CF) compared to routine clinical care?&#xD;
&#xD;
      The secondary objectives of this research study are to assess:&#xD;
&#xD;
        1. The effect of home monitoring on lung function in adults with cystic fibrosis (CF)&#xD;
&#xD;
        2. The effect of home monitoring on requirement for antibiotics in adults with CF&#xD;
&#xD;
        3. The effect of home monitoring on nutritional status in adults with CF&#xD;
&#xD;
        4. The effect of home monitoring on health related quality of life in adults with CF&#xD;
&#xD;
        5. Costeffectiveness analysis comparing the home monitoring period with the routine&#xD;
           clinical care period&#xD;
&#xD;
        6. The patient experience of receiving home monitoring in adults with CF&#xD;
&#xD;
        7. Whether urine levels of inflammatory markers correlate with symptoms and lung function&#xD;
           in adults with CF&#xD;
&#xD;
      The aim of this study is assess whether home monitoring is beneficial for adults with cystic&#xD;
      fibrosis. Overall, 100 subjects will be recruited at the West Midlands Adult Centre and&#xD;
      randomly allocated in a 1:1 ratio to receive home monitoring or routine clinical care for 12&#xD;
      months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2006</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">September 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of inpatient hospital days in the home monitoring group compared to the routine clinical care group</measure>
    <time_frame>up to 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in FEV1 in the home monitoring group compared to the routine clinical care group</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FVC in the home monitoring group compared to the routine</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days on oral and intravenous antibiotics in the home monitoring group compared to the routine clinical care group</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight in the home monitoring group compared to the routine clinical care group</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in BMI in the home monitoring group compared to the routine clinical care group</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CFQ-R scores in the home monitoring group compared to the routine clinical care group</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>The Cystic Fibrosis Questionnaire Revised version (CFQ-R) is a multiple choice and likert questionnaire split into two sections: Demographics and Quality of Life. Answers of 'Always' or similar are deemed a higher value than 'Never' or similar. The total score is gathered by calculating the amount of 'positive' and 'negative' answers - 'positive' answers are those that are lower values (e.g. never) than those that are higher values (e.g. 'always)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health economic analysis measured by EQ-5D-5L</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>The Euro Quality of Life (EQ5D) is a multiple choice questionnaire split onto sections including Mobility, Self-Care, Usual activities, Pain/Discomfort, and Anxiety/Depression. For each of these sections, it asks if a person always have issues, some issues or no issues (e.g. Mobility - I have no problems / I have some problems / I am confined to bed). The total score is gathered by calculating the amount of 'positive' and 'negative' answers - 'positive' answers are those that are lower values (e.g. I have no issues) than those that are higher values (e.g. I am confined to bed). There is also a scale, ranging from 0 (worst imaginable health) to 100 (best imaginable health) with 99 intervals in between whereby the patient marks where they feel their current health lays.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health economic analysis measured by ICECAP-A</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>The ICEpop CAPability measure for Adults (ICECAP-A) is a multiple choice questionnaire split onto sections including 'Feeling Settled and Secure, Love, Friendship and Support, Being Independent, Achievement and progress, and Enjoyment and pleasure. For each of these sections, it asks whether a person has no problem, some problems, many problems or total problem with a certain area (e.g. Being Independent - I can achieve in all aspects of my life / I can achieve in many aspects of my life / I can achieve in some aspects of my life / I am unable to be at all independent). The total score is gathered by calculating the amount of 'positive' and 'negative' answers - 'positive' answers are those that are lower values (e.g. I can achieve in all aspects of my life) than those that are higher values (e.g. I am unable to be at all independent).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs associated with caring for each participant and the cost of conducting the study in the home monitoring group compared to the routine clinical care group</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient experience assessed by a semi-structured qualitative interview in the home monitoring group compared to the routine clinical care group</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of relevant urine biomarkers in the home monitoring group associated with pulmonary exacerbations</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Home monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Home monitoring will involve participants recording their symptoms twice weekly on a modified mobile phone and recording their lung function twice weekly using a digital spirometer. This data will be automatically transmitted to the CF team and we will contact patients on the mobile phone if symptoms and/or lung function decline below a set threshold, suggesting the onset of a pulmonary exacerbation. We will contact patients within 24 hours of symptoms and/or lung function falling below this set threshold.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinical Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Throughout the study period, participants will attend outpatient clinic visits as usual and treatment with antibiotics as clinically indicated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Home Monitoring</intervention_name>
    <description>Participants selected to receive home monitoring, in addition to routine CF care, will be given a digital lung function monitor (spirometer) and a modified mobile phone.</description>
    <arm_group_label>Home monitoring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical Care</intervention_name>
    <description>Participants selected for this arm will continue to receive routine clinical care.</description>
    <arm_group_label>Clinical Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  confirmed diagnosis of CF&#xD;
&#xD;
          -  age over 18 years&#xD;
&#xD;
          -  the requirement for 1 or more admission to hospital to receive intravenous antibiotics&#xD;
             over the preceding 24 months&#xD;
&#xD;
          -  clinically stable at the time of recruitment&#xD;
&#xD;
          -  Patients who give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who are currently participating in another clinical trial (excluding&#xD;
             observational studies)&#xD;
&#xD;
          -  pneumothorax or lung surgery within the previous 3 months, eye surgery (e.g. cataract&#xD;
             operation) in the previous 4 weeks (since these factors prevent measurement of&#xD;
             spirometry)&#xD;
&#xD;
          -  Sputum infection with Burkholderia cenocepacia or Mycobacterium abscessus&#xD;
&#xD;
          -  Current diagnosis of active allergic bronchopulmonary aspergillosis (ABPA)&#xD;
&#xD;
          -  Previous lung transplantation procedure.&#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>Edward F Nash, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heart of England NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Birmingham Heartlands Hospital</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>February 21, 2019</last_update_submitted>
  <last_update_submitted_qc>February 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02994706
org study id: 2012135RM
nct id: NCT02994706
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Cystic fibrosis (CF) is the most common fatal inherited condition in Caucasians, causing
      recurrent chest infections and premature death due to lung failure. When patients develop
      chest infections their symptoms usually slowly worsen over the course of several days to
      weeks. Due to this gradual onset, patients often seek medical attention several days or weeks
      after symptoms start to worsen. The Investigators believe that if they were able to monitor
      patients more closely they could diagnose and treat chest infections earlier and consequently
      improve health outcomes.

      The HOMECF study aims to investigate whether home monitoring is beneficial for adults with
      CF. 100 subjects will be randomly allocated, 50 to receive home monitoring and 50 to receive
      routine clinical care for 12 months. Subjects receiving home monitoring will measure their
      lung function and symptoms twice weekly and this data will be transmitted to the medical team
      by means of a modified mobile phone.

      the Investigators hypothesize that home monitoring will allow them to diagnose chest
      infections at an earlier stage and reduce hospital inpatient days. They will also assess the
      subjects' experience of receiving home monitoring, the impact on body weight and lung
      function and and conduct a full health economic analysis to assess value for money. They will
      also ask subjects to collect a urine sample once weekly to allow us to measure urinary levels
      of inflammatory markers.

      Subjects will be recruited at the West Midlands Adult CF Centre in Birmingham. The research
      team are well placed to carry out the study because it is a large regional adult CF centre
      with an excellent record of conducting clinical research.
The principal question being answered by this research study is:

      1. Does home monitoring reduce the total number of inpatient hospital days in adults with
      cystic fibrosis (CF) compared to routine clinical care?

      The secondary objectives of this research study are to assess:

        1. The effect of home monitoring on lung function in adults with cystic fibrosis (CF)

        2. The effect of home monitoring on requirement for antibiotics in adults with CF

        3. The effect of home monitoring on nutritional status in adults with CF

        4. The effect of home monitoring on health related quality of life in adults with CF

        5. Costeffectiveness analysis comparing the home monitoring period with the routine
           clinical care period

        6. The patient experience of receiving home monitoring in adults with CF

        7. Whether urine levels of inflammatory markers correlate with symptoms and lung function
           in adults with CF

      The aim of this study is assess whether home monitoring is beneficial for adults with cystic
      fibrosis. Overall, 100 subjects will be recruited at the West Midlands Adult Centre and
      randomly allocated in a 1:1 ratio to receive home monitoring or routine clinical care for 12
      months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of inpatient hospital days in the home monitoring group compared to the routine clinical care group
time frame: up to 12 months
measure: Change in FEV1 in the home monitoring group compared to the routine clinical care group
time frame: up to 12 months
measure: Change in FVC in the home monitoring group compared to the routine
time frame: up to 12 months
measure: Days on oral and intravenous antibiotics in the home monitoring group compared to the routine clinical care group
time frame: Up to 12 months
measure: Change in body weight in the home monitoring group compared to the routine clinical care group
time frame: Up to 12 months
measure: Change in BMI in the home monitoring group compared to the routine clinical care group
time frame: Up to 12 months
measure: Change in CFQ-R scores in the home monitoring group compared to the routine clinical care group
time frame: Up to 12 months
description: The Cystic Fibrosis Questionnaire Revised version (CFQ-R) is a multiple choice and likert questionnaire split into two sections: Demographics and Quality of Life. Answers of 'Always' or similar are deemed a higher value than 'Never' or similar. The total score is gathered by calculating the amount of 'positive' and 'negative' answers - 'positive' answers are those that are lower values (e.g. never) than those that are higher values (e.g. 'always)
measure: Health economic analysis measured by EQ-5D-5L
time frame: Up to 12 months
description: The Euro Quality of Life (EQ5D) is a multiple choice questionnaire split onto sections including Mobility, Self-Care, Usual activities, Pain/Discomfort, and Anxiety/Depression. For each of these sections, it asks if a person always have issues, some issues or no issues (e.g. Mobility - I have no problems / I have some problems / I am confined to bed). The total score is gathered by calculating the amount of 'positive' and 'negative' answers - 'positive' answers are those that are lower values (e.g. I have no issues) than those that are higher values (e.g. I am confined to bed). There is also a scale, ranging from 0 (worst imaginable health) to 100 (best imaginable health) with 99 intervals in between whereby the patient marks where they feel their current health lays.
measure: Health economic analysis measured by ICECAP-A
time frame: Up to 12 months
description: The ICEpop CAPability measure for Adults (ICECAP-A) is a multiple choice questionnaire split onto sections including 'Feeling Settled and Secure, Love, Friendship and Support, Being Independent, Achievement and progress, and Enjoyment and pleasure. For each of these sections, it asks whether a person has no problem, some problems, many problems or total problem with a certain area (e.g. Being Independent - I can achieve in all aspects of my life / I can achieve in many aspects of my life / I can achieve in some aspects of my life / I am unable to be at all independent). The total score is gathered by calculating the amount of 'positive' and 'negative' answers - 'positive' answers are those that are lower values (e.g. I can achieve in all aspects of my life) than those that are higher values (e.g. I am unable to be at all independent).
measure: Costs associated with caring for each participant and the cost of conducting the study in the home monitoring group compared to the routine clinical care group
time frame: Up to 12 months
measure: Patient experience assessed by a semi-structured qualitative interview in the home monitoring group compared to the routine clinical care group
time frame: Up to 12 months
measure: Levels of relevant urine biomarkers in the home monitoring group associated with pulmonary exacerbations
time frame: Up to 12 months
arm group label: Home monitoring
arm group type: Experimental
description: Home monitoring will involve participants recording their symptoms twice weekly on a modified mobile phone and recording their lung function twice weekly using a digital spirometer. This data will be automatically transmitted to the CF team and we will contact patients on the mobile phone if symptoms and/or lung function decline below a set threshold, suggesting the onset of a pulmonary exacerbation. We will contact patients within 24 hours of symptoms and/or lung function falling below this set threshold.
arm group label: Clinical Care
arm group type: Active Comparator
description: Throughout the study period, participants will attend outpatient clinic visits as usual and treatment with antibiotics as clinically indicated.
intervention type: Procedure
intervention name: Home Monitoring
description: Participants selected to receive home monitoring, in addition to routine CF care, will be given a digital lung function monitor (spirometer) and a modified mobile phone.
arm group label: Home monitoring
intervention type: Other
intervention name: Clinical Care
description: Participants selected for this arm will continue to receive routine clinical care.
arm group label: Clinical Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Edward F Nash, MD
role: Principal Investigator
affiliation: Heart of England NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis
sharing ipd: No