<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/NCT01710774</url>
  </required_header>
  <id_info>
    <org_study_id>SUS-ID210</org_study_id>
    <nct_id>NCT01710774</nct_id>
  </id_info>
  <brief_title>Telemedicine Follow-up in Primary Health Care for Diabetes-related Foot Ulcers</brief_title>
  <acronym>DiaFOTo</acronym>
  <official_title>Effect of Telemedicine Follow-up Care in Primary Health Care Versus Traditional Follow-up in Specialist Health Care on the Healing Time for Diabetes-related Foot Ulcers - a Cluster-randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Helse Vest</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian Diabetes Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bergen University College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Research Council of Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian Nurses Organisation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helse Stavanger HF</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate whether telemedicine follow-up care for people with&#xD;
      diabetes-related foot ulcers and people with leg ulcers (without diabetes) in municipal&#xD;
      primary health care in collaboration with specialist health care is an equivalent alternative&#xD;
      to traditional outpatient clinical follow-up in specialist health care (noninferiority trial)&#xD;
      in relation to healing time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The increasing prevalence of diabetes, especially type 2 diabetes, combined with a steadily&#xD;
      increasing proportion of older people in the population, will present enormous challenges for&#xD;
      health care services and the individual with diabetes in Norway. Therefore, health care&#xD;
      services need to rapidly begin treatment for people with diabetes-related foot ulcers to&#xD;
      ensure high-quality treatment.&#xD;
&#xD;
      Telemedicine innovations for health care services have developed considerably in recent&#xD;
      decades. The National Health Plan for Norway (2007-2010) emphasizes that the use of&#xD;
      information and communication technologies is an important way of achieving health policy&#xD;
      aims in establishing more integrated diagnosis, treatment and care pathways across&#xD;
      organizational boundaries. Qualitative studies of diabetes-related foot ulcers have shown&#xD;
      that using telemedicine equipment enables follow-up care of similar quality to traditional&#xD;
      consultations while enabling more flexible organization and greater patient satisfaction. A&#xD;
      few minor quantitative studies show positive gains when telemedicine equipment is used in&#xD;
      following up diabetes-related foot ulcers, but no randomized controlled studies have been&#xD;
      performed in this field. Further, studies focusing on the more long-term effects are lacking.&#xD;
&#xD;
      The project is in accordance with national guidelines and will contribute to increasing the&#xD;
      focus on research related to integrated care. The investigators expect this project to&#xD;
      provide evidence about alternative care pathways with a holistic approach that could moderate&#xD;
      increases in the cost of health care services by delivering a larger proportion of services&#xD;
      in municipal primary care. The project will be able to provide new evidence on meeting the&#xD;
      challenges of diabetes-related care more systematically and proactively. The investigators&#xD;
      expect that the results of this study will contribute to showing the extent to which&#xD;
      treatment at the lowest effective service level will be more cost-effective and of good or&#xD;
      better quality than traditional clinical follow-up. This study can and will contribute to&#xD;
      setting priorities for the users' needs for flexible health services and enabling more&#xD;
      patients to be treated near their homes.&#xD;
&#xD;
      If the study finds evidence of positive health gains for the individual people with diabetes&#xD;
      and contributes to high quality of care, this new model can be implemented in the entire&#xD;
      Stavanger Hospital Trust. This approach will enable the multidisciplinary team in specialist&#xD;
      health care to be used more appropriately, and the team will be more accessible for health&#xD;
      care personnel in municipal primary health care. This model can be transferred to other&#xD;
      hospital trusts and contribute to improving knowledge on diabetes among nurses in municipal&#xD;
      primary health care.&#xD;
&#xD;
      The main study confirmed that TM was non-inferior in traditional treatment with regard to&#xD;
      healing time (primary outcome). The TM group had a signiﬁcantly lower proportion of&#xD;
      amputations, and there were no signiﬁcant differences in the proportion of deaths, number of&#xD;
      consultations, or patient satisfaction between groups, although the direction of the effect&#xD;
      estimates for these clinical outcomes favored the TM group.&#xD;
&#xD;
      There is a need to continue the study with additional patients to gain more knowledge about&#xD;
      the extent to which the telemedicine follow-up affects the number of consultations (secondary&#xD;
      outcome), inclusion of participants during 2019-2021. In addition, there is a need for more&#xD;
      knowledge about the effect of telemedicine follow-up for patients with leg ulcers and in&#xD;
      people without diabetes. The investigators have used qualitative interview as a process&#xD;
      evaluation in this study and will investigate process variables more systematically in the&#xD;
      further follow-up. By examining how the services are organized (organization and structure)&#xD;
      the investigators will gain knowledge how the variation in the organization of telemedicine&#xD;
      follow-up is affecting the outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 2012</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Actual">June 2022</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>healing time for leg ulcer and/or diabetes related foot ulcer</measure>
    <time_frame>one year</time_frame>
    <description>Healing time for leg ulcer and/or diabetes related foot ulcer measured from the time the person is included in the study until the foot ulcer is healed or the study ends (after 12 months). The effect will be measured in terms of hazard ratios (HR) and sub-hazard ratio (SHR) with healing as the endpoint and non-inferiority will be defined as &lt;40% increased healing time in the TM-group, i.e. the lower 95% confidence limit should not be lower than 0.60.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total number of consultations per patient</measure>
    <time_frame>one year</time_frame>
    <description>Number of consultations from baseline until the foot ulcer has healed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sequela directly related to the foot ulcer</measure>
    <time_frame>one year</time_frame>
    <description>From baseline until the foot ulcer has healed sequelae directly related to the foot ulcer: infection, hospitalization, osteomyelitis and vascular surgery during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes-related stress</measure>
    <time_frame>one year</time_frame>
    <description>Diabetes-related stress, measured by using the Problem Areas in Diabetes. Measured at baseline and when the ulcer has healed (or the end of the study)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of anxiety and depression</measure>
    <time_frame>one year</time_frame>
    <description>symptoms of anxiety and depression, measured by using the Hospital Anxiety and Depression Scale at baseline and the end of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nordic Patient Experiences Questionnaire</measure>
    <time_frame>one year</time_frame>
    <description>Patient satisfaction with health care, measured by using the Nordic Patient Experiences Questionnaire. Measured at baseline and the end of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>one year</time_frame>
    <description>Health status and cost utility, measured by using the EQ-5D from the EuroQol Group at baseline and the end of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sick leave</measure>
    <time_frame>one year</time_frame>
    <description>Sick leave (number of days with a medical certificate) measured by obtaining data from the Norwegian Sick Leave Registry measured from baseline unntil the ulcer is healed (or at the end of the study)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A new foot ulcer appears, the incidence of amputation and survival.</measure>
    <time_frame>2 and 3 years after the end of the study</time_frame>
    <description>The time elapsing before a new foot ulcer appears, the incidence of amputation and survival.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">241</enrollment>
  <condition>Diabetic Foot</condition>
  <condition>Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>Traditional follow-up</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Traditional follow-up with standard consultations at the Section of Endocrinology. For some patients, this will include follow-up from nurses in the home care or general practice office related to wound care. However, this is not the standard procedure and will not take place in combination with telemedicine follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telemedicine follow-up care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Telemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Telemedicine follow-up care</intervention_name>
    <description>Telemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care</description>
    <arm_group_label>Telemedicine follow-up care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  people with type 1 or type 2 diabetes with a new foot ulcer presenting for the first&#xD;
             time within a period of 6 months and people without diabetes presenting a venous leg&#xD;
             ulcer&#xD;
&#xD;
          -  The participants must be able to read and speak Norwegian.&#xD;
&#xD;
          -  The participants must be 20 years or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - people treated for an diabetes foot ulcer on the ipsilateral foot during the past 6&#xD;
        months in specialist health care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marjolein M. Iversen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helse Stavanger HF</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stavanger HF</name>
      <address>
        <city>Stavanger</city>
        <state>Rogaland</state>
        <zip>4068</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stord Hospital, Helse Fonna HF</name>
      <address>
        <city>Leirvik</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>April 19, 2023</last_update_submitted>
  <last_update_submitted_qc>April 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetic Foot</keyword>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Foot Ulcer</keyword>
  <keyword>Wound Healing</keyword>
  <keyword>Delivery of Health Care</keyword>
  <keyword>Depression</keyword>
  <keyword>sequela</keyword>
  <keyword>Sick Leave</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Amputation</keyword>
  <keyword>Legg ulcer</keyword>
  <keyword>Hospitalization</keyword>
  <keyword>Health Economics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Foot Ulcer</mesh_term>
    <mesh_term>Ulcer</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/NCT01710774
org study id: SUS-ID210
nct id: NCT01710774
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This study will investigate whether telemedicine follow-up care for people with
      diabetes-related foot ulcers and people with leg ulcers (without diabetes) in municipal
      primary health care in collaboration with specialist health care is an equivalent alternative
      to traditional outpatient clinical follow-up in specialist health care (noninferiority trial)
      in relation to healing time.
The increasing prevalence of diabetes, especially type 2 diabetes, combined with a steadily
      increasing proportion of older people in the population, will present enormous challenges for
      health care services and the individual with diabetes in Norway. Therefore, health care
      services need to rapidly begin treatment for people with diabetes-related foot ulcers to
      ensure high-quality treatment.

      Telemedicine innovations for health care services have developed considerably in recent
      decades. The National Health Plan for Norway (2007-2010) emphasizes that the use of
      information and communication technologies is an important way of achieving health policy
      aims in establishing more integrated diagnosis, treatment and care pathways across
      organizational boundaries. Qualitative studies of diabetes-related foot ulcers have shown
      that using telemedicine equipment enables follow-up care of similar quality to traditional
      consultations while enabling more flexible organization and greater patient satisfaction. A
      few minor quantitative studies show positive gains when telemedicine equipment is used in
      following up diabetes-related foot ulcers, but no randomized controlled studies have been
      performed in this field. Further, studies focusing on the more long-term effects are lacking.

      The project is in accordance with national guidelines and will contribute to increasing the
      focus on research related to integrated care. The investigators expect this project to
      provide evidence about alternative care pathways with a holistic approach that could moderate
      increases in the cost of health care services by delivering a larger proportion of services
      in municipal primary care. The project will be able to provide new evidence on meeting the
      challenges of diabetes-related care more systematically and proactively. The investigators
      expect that the results of this study will contribute to showing the extent to which
      treatment at the lowest effective service level will be more cost-effective and of good or
      better quality than traditional clinical follow-up. This study can and will contribute to
      setting priorities for the users' needs for flexible health services and enabling more
      patients to be treated near their homes.

      If the study finds evidence of positive health gains for the individual people with diabetes
      and contributes to high quality of care, this new model can be implemented in the entire
      Stavanger Hospital Trust. This approach will enable the multidisciplinary team in specialist
      health care to be used more appropriately, and the team will be more accessible for health
      care personnel in municipal primary health care. This model can be transferred to other
      hospital trusts and contribute to improving knowledge on diabetes among nurses in municipal
      primary health care.

      The main study confirmed that TM was non-inferior in traditional treatment with regard to
      healing time (primary outcome). The TM group had a signiﬁcantly lower proportion of
      amputations, and there were no signiﬁcant differences in the proportion of deaths, number of
      consultations, or patient satisfaction between groups, although the direction of the effect
      estimates for these clinical outcomes favored the TM group.

      There is a need to continue the study with additional patients to gain more knowledge about
      the extent to which the telemedicine follow-up affects the number of consultations (secondary
      outcome), inclusion of participants during 2019-2021. In addition, there is a need for more
      knowledge about the effect of telemedicine follow-up for patients with leg ulcers and in
      people without diabetes. The investigators have used qualitative interview as a process
      evaluation in this study and will investigate process variables more systematically in the
      further follow-up. By examining how the services are organized (organization and structure)
      the investigators will gain knowledge how the variation in the organization of telemedicine
      follow-up is affecting the outcome.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: healing time for leg ulcer and/or diabetes related foot ulcer
time frame: one year
description: Healing time for leg ulcer and/or diabetes related foot ulcer measured from the time the person is included in the study until the foot ulcer is healed or the study ends (after 12 months). The effect will be measured in terms of hazard ratios (HR) and sub-hazard ratio (SHR) with healing as the endpoint and non-inferiority will be defined as <40% increased healing time in the TM-group, i.e. the lower 95% confidence limit should not be lower than 0.60.
measure: Total number of consultations per patient
time frame: one year
description: Number of consultations from baseline until the foot ulcer has healed
measure: sequela directly related to the foot ulcer
time frame: one year
description: From baseline until the foot ulcer has healed sequelae directly related to the foot ulcer: infection, hospitalization, osteomyelitis and vascular surgery during the study
measure: Diabetes-related stress
time frame: one year
description: Diabetes-related stress, measured by using the Problem Areas in Diabetes. Measured at baseline and when the ulcer has healed (or the end of the study)
measure: Symptoms of anxiety and depression
time frame: one year
description: symptoms of anxiety and depression, measured by using the Hospital Anxiety and Depression Scale at baseline and the end of the study.
measure: Nordic Patient Experiences Questionnaire
time frame: one year
description: Patient satisfaction with health care, measured by using the Nordic Patient Experiences Questionnaire. Measured at baseline and the end of the study.
measure: EQ-5D
time frame: one year
description: Health status and cost utility, measured by using the EQ-5D from the EuroQol Group at baseline and the end of the study.
measure: Sick leave
time frame: one year
description: Sick leave (number of days with a medical certificate) measured by obtaining data from the Norwegian Sick Leave Registry measured from baseline unntil the ulcer is healed (or at the end of the study)
measure: A new foot ulcer appears, the incidence of amputation and survival.
time frame: 2 and 3 years after the end of the study
description: The time elapsing before a new foot ulcer appears, the incidence of amputation and survival.
arm group label: Traditional follow-up
arm group type: No Intervention
description: Traditional follow-up with standard consultations at the Section of Endocrinology. For some patients, this will include follow-up from nurses in the home care or general practice office related to wound care. However, this is not the standard procedure and will not take place in combination with telemedicine follow-up.
arm group label: Telemedicine follow-up care
arm group type: Active Comparator
description: Telemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care
intervention type: Procedure
intervention name: Telemedicine follow-up care
description: Telemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care
arm group label: Telemedicine follow-up care
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Marjolein M. Iversen, PhD
role: Principal Investigator
affiliation: Helse Stavanger HF
facility: 
facility: 
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer
sharing ipd: No