<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/NCT03753997</url>
  </required_header>
  <id_info>
    <org_study_id>Psychologystudy</org_study_id>
    <nct_id>NCT03753997</nct_id>
  </id_info>
  <brief_title>A Trial of Diabetes-educated Psychologist to Improve HbA1c and Reduce Diabetes-related Distress</brief_title>
  <official_title>A Randomized Trial of Diabetes-educated Psychologist to Improve HbA1c and Reduce Diabetes-related Distress</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vastra Gotaland Region</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vastra Gotaland Region</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Type 1 diabetes is associated with a significant increase in mortality, cardiovascular&#xD;
      disease, injuries on eyes and kidneys. These risks are largely dependent on glycemic control.&#xD;
      Multiple strategies of achieving good glycemic control exist. Despite this, only about 20 %&#xD;
      of patients in Sweden reach the target HbA1c of ≤ 52 mmol/mol.&#xD;
&#xD;
      It is well-known that when the motivation is high, a large proportion of patients reach good&#xD;
      glycaemic control with current treatments, e.g. most pregnant women reach a much better&#xD;
      glycaemic control. The patient is then motivated to a greater extent in managing the disease,&#xD;
      e.g. by carefully dosing insulin and more closely monitoring blood glucose levels.&#xD;
&#xD;
      Moreover, besides lack of motivation, specific psychiatric conditions are well-known barriers&#xD;
      in being compliant with treatments such as depression, eating disorders and attention deficit&#xD;
      disorders (ADHD). Further, identified specific diabetes-related psychosocial factors include&#xD;
      severe fear of hypoglycaemia, diabetes-burnout, unrealistic treatment goals, poor&#xD;
      relationship with physician, feelings of powerlessness and treatment skepticism. These&#xD;
      parameters can be measured via a diabetes distress scale where a high score is correlated to&#xD;
      higher HbA1c.&#xD;
&#xD;
      The majority of outpatient diabetes clinics in Sweden today request the resource of a&#xD;
      diabetes-educated psychologist. However, more evidence is needed from randomized multicentre&#xD;
      trials whether such a resource would help to improve HbA1c, reduce diabetes-related distress&#xD;
      and improve quality of life.&#xD;
&#xD;
      The primary aim of the current study is to evaluate whether the assistance of a&#xD;
      diabetes-educated psychologist in the diabetes care of patients with type 1 diabetes improves&#xD;
      HbA1c. Secondary endpoints include studying its influence on diabetes-related distress and&#xD;
      quality of life. The study is a 1 year randomized trial where the intervention group will&#xD;
      meet with a diabetes-educated psychologist in addition to conventional care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c from baseline to 52 weeks follow-up</measure>
    <time_frame>52 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Diabetes distress scale score from baseline to week 52</measure>
    <time_frame>52 weeks</time_frame>
    <description>Diabetes Distress scale is a questionnaire with 28 questions where patients answer on a scale between 1-6.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life score (ADDQoL) from baseline to week 52</measure>
    <time_frame>52 weeks</time_frame>
    <description>ADDQoL (actual name for questionnaire) is a quality of life questionnaire with 19 questions. Answers are on a scale of 1-4,1-5,1-6 and 1-7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>score of Diabetes Treatment satisfaction questionnaire - change (DTSQc) at week 52</measure>
    <time_frame>52 weeks</time_frame>
    <description>8 questions which patients answer on a scale of -3 to 3</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in the Diabetes Treatment satisfaction questionnaire - status (DTSQs) score from baseline to week 52</measure>
    <time_frame>52 weeks</time_frame>
    <description>8 questions which patients answer on a scale of 6 to 0</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the score of the hypoglycaemia confidence questionnaire from baseline to week 52</measure>
    <time_frame>52 weeks</time_frame>
    <description>9 questions with 4 answer possibilities. Not confident at all, to very confident</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of patients with HbA1c less than 59 mmol/mol at week 52</measure>
    <time_frame>52 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of patients with HbA1c less than 53 mmol/mol at week 52</measure>
    <time_frame>52 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of patients lowering HbA1c 5 mmol/mol or more from baseline to week 52</measure>
    <time_frame>52 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in total insulin dose from baseline to week 52</measure>
    <time_frame>52 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>change weight from baseline to week 52</measure>
    <time_frame>52 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in systolic and diastolic blood pressure from baseline to week 52</measure>
    <time_frame>52 week</time_frame>
    <description>Change in systolic and diastolic blood pressure.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">142</enrollment>
  <condition>Type1diabetes</condition>
  <condition>Psychology Functional Behavior</condition>
  <arm_group>
    <arm_group_label>Conventional therapy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patiens´s will come to the clinic for regular contact with a diabetes nurse.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment by a Psychologist</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will meet with a diabetes educated psychologist over 9 months and will come to the clinic for regular contact with a diabetes nurse</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment by a diabetes educated psychologist</intervention_name>
    <description>Patients will meet a diabetes educated psychologist. There will be a minimum of 5 meetings during the first 3 months and then in the following 6 months there will be a minimum of 2 meetings. More meetings will be scheduled if needed.</description>
    <arm_group_label>Treatment by a Psychologist</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent obtained before trial-related activities (i.e., any activity that&#xD;
             would not have been performed during routine patient management)&#xD;
&#xD;
          -  Clinical diagnosis of Type 1 diabetes&#xD;
&#xD;
          -  Adult patients over 18 years of age&#xD;
&#xD;
          -  HbA1c &gt; 62 mmol/mol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes&#xD;
&#xD;
          -  Diabetes duration &lt;1 year&#xD;
&#xD;
          -  Long-term Systemic glucocorticoid treatment during the last 3 months&#xD;
&#xD;
          -  Changed treatment the last 3 months regarding MDI vs. Insulin pump or added or stopped&#xD;
             CGM or FGM therapy&#xD;
&#xD;
          -  Current or planned pregnancy or breastfeeding during the next 12 months&#xD;
&#xD;
          -  Planned move during the next 12 months making it not possible to participate in study&#xD;
             activities&#xD;
&#xD;
          -  Other reason determined by the investigator not being appropriate for participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcus Lind, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NU-Hospital Organization, Sweden</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marie Ekström, BSc nursing</last_name>
    <phone>+46104350000</phone>
    <email>marie.el.ekstrom@vgregion.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Arndís Ólafsdóttir, PgD</last_name>
    <phone>+46104350000</phone>
    <email>finna.olafdottir@vgregion.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>NU Hospital Group</name>
      <address>
        <city>Uddevalla</city>
        <zip>45180</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie Ekström</last_name>
      <phone>+4673-063 23 72</phone>
      <email>marie.el.ekstrom@vgregion.se</email>
    </contact>
    <contact_backup>
      <last_name>Arndís F Òlafsdóttir</last_name>
      <phone>+46700 82 22 55</phone>
      <email>finna.olafsdottir@vgregion.se</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>May 2, 2022</last_update_submitted>
  <last_update_submitted_qc>May 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2022</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>Diabetes Mellitus</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/NCT03753997
org study id: Psychologystudy
nct id: NCT03753997
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Type 1 diabetes is associated with a significant increase in mortality, cardiovascular
      disease, injuries on eyes and kidneys. These risks are largely dependent on glycemic control.
      Multiple strategies of achieving good glycemic control exist. Despite this, only about 20 %
      of patients in Sweden reach the target HbA1c of ≤ 52 mmol/mol.

      It is well-known that when the motivation is high, a large proportion of patients reach good
      glycaemic control with current treatments, e.g. most pregnant women reach a much better
      glycaemic control. The patient is then motivated to a greater extent in managing the disease,
      e.g. by carefully dosing insulin and more closely monitoring blood glucose levels.

      Moreover, besides lack of motivation, specific psychiatric conditions are well-known barriers
      in being compliant with treatments such as depression, eating disorders and attention deficit
      disorders (ADHD). Further, identified specific diabetes-related psychosocial factors include
      severe fear of hypoglycaemia, diabetes-burnout, unrealistic treatment goals, poor
      relationship with physician, feelings of powerlessness and treatment skepticism. These
      parameters can be measured via a diabetes distress scale where a high score is correlated to
      higher HbA1c.

      The majority of outpatient diabetes clinics in Sweden today request the resource of a
      diabetes-educated psychologist. However, more evidence is needed from randomized multicentre
      trials whether such a resource would help to improve HbA1c, reduce diabetes-related distress
      and improve quality of life.

      The primary aim of the current study is to evaluate whether the assistance of a
      diabetes-educated psychologist in the diabetes care of patients with type 1 diabetes improves
      HbA1c. Secondary endpoints include studying its influence on diabetes-related distress and
      quality of life. The study is a 1 year randomized trial where the intervention group will
      meet with a diabetes-educated psychologist in addition to conventional care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in HbA1c from baseline to 52 weeks follow-up
time frame: 52 weeks
measure: Change in Diabetes distress scale score from baseline to week 52
time frame: 52 weeks
description: Diabetes Distress scale is a questionnaire with 28 questions where patients answer on a scale between 1-6.
measure: Change in quality of life score (ADDQoL) from baseline to week 52
time frame: 52 weeks
description: ADDQoL (actual name for questionnaire) is a quality of life questionnaire with 19 questions. Answers are on a scale of 1-4,1-5,1-6 and 1-7
measure: score of Diabetes Treatment satisfaction questionnaire - change (DTSQc) at week 52
time frame: 52 weeks
description: 8 questions which patients answer on a scale of -3 to 3
measure: Change in the Diabetes Treatment satisfaction questionnaire - status (DTSQs) score from baseline to week 52
time frame: 52 weeks
description: 8 questions which patients answer on a scale of 6 to 0
measure: Change in the score of the hypoglycaemia confidence questionnaire from baseline to week 52
time frame: 52 weeks
description: 9 questions with 4 answer possibilities. Not confident at all, to very confident
measure: Proportion of patients with HbA1c less than 59 mmol/mol at week 52
time frame: 52 weeks
measure: Proportion of patients with HbA1c less than 53 mmol/mol at week 52
time frame: 52 weeks
measure: Proportion of patients lowering HbA1c 5 mmol/mol or more from baseline to week 52
time frame: 52 weeks
measure: Change in total insulin dose from baseline to week 52
time frame: 52 weeks
measure: change weight from baseline to week 52
time frame: 52 weeks
measure: Change in systolic and diastolic blood pressure from baseline to week 52
time frame: 52 week
description: Change in systolic and diastolic blood pressure.
arm group label: Conventional therapy
arm group type: No Intervention
description: Patiens´s will come to the clinic for regular contact with a diabetes nurse.
arm group label: Treatment by a Psychologist
arm group type: Experimental
description: Patients will meet with a diabetes educated psychologist over 9 months and will come to the clinic for regular contact with a diabetes nurse
intervention type: Behavioral
intervention name: Treatment by a diabetes educated psychologist
description: Patients will meet a diabetes educated psychologist. There will be a minimum of 5 meetings during the first 3 months and then in the following 6 months there will be a minimum of 2 meetings. More meetings will be scheduled if needed.
arm group label: Treatment by a Psychologist
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Marcus Lind, PhD
role: Principal Investigator
affiliation: NU-Hospital Organization, Sweden
last name: Marie Ekström, BSc nursing
phone: +46104350000
email: marie.el.ekstrom@vgregion.se
last name: Arndís Ólafsdóttir, PgD
phone: +46104350000
email: finna.olafdottir@vgregion.se
facility: 
status: Recruiting
contact: 
contact backup: 
country: Sweden
responsible party type: Sponsor
mesh term: Diabetes Mellitus