<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/NCT03840850</url>
  </required_header>
  <id_info>
    <org_study_id>17/NW/0267</org_study_id>
    <nct_id>NCT03840850</nct_id>
  </id_info>
  <brief_title>Type 2 Diabetes: Risk Perceptions and Self-management Behaviour</brief_title>
  <official_title>Type 2 Diabetes: Risk Perceptions and Self-management Behaviour</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NIHR Collaboration for Leadership in Applied Health Research and Care (Oxford)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oxford</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>
      This pilot randomised controlled trial (RCT) aims to assess the feasibility of using a new&#xD;
      type of risk communication intervention for people with Type 2 diabetes mellitus (T2DM) in&#xD;
      primary care and to evaluate its potential impact on risk perceptions and self-management&#xD;
      behaviour.&#xD;
&#xD;
      The study comprises 40 participants with T2DM randomly allocated to usual care supported by&#xD;
      the risk communication intervention or usual care only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetes self-management, which includes self-care behaviours such as healthy eating and&#xD;
      physical exercise, has become the cornerstone for treating type-2 diabetes mellitus (T2DM).&#xD;
      However, although self-management education (SME) is necessary to equip patients with the&#xD;
      knowledge, skills and attitudes required to manage their diabetes care, the most effective&#xD;
      method to do so is still unclear.&#xD;
&#xD;
      Recent studies have shown that people with T2DM underestimated their risks of developing&#xD;
      complications. Although behavioural processes are complex, wrong risk perceptions are a major&#xD;
      impediment to the adoption of self-care behaviours and, as a result, an additional risk for&#xD;
      the occurrence of adverse outcomes.&#xD;
&#xD;
      Existing risk communication interventions have shown mixed results, with many participants&#xD;
      barely understanding the explanations of health professionals about risks and having poor&#xD;
      recall of risk information. In this context, there is a need for better risk communication&#xD;
      interventions.&#xD;
&#xD;
      Based on the results of recent studies investigating the risk perceptions and risk attitudes&#xD;
      of people with T2DM, we have developed a new, tailored risk communication intervention. The&#xD;
      objectives of this intervention are:&#xD;
&#xD;
        -  To increase the awareness of risks for complications associated with type 2 diabetes.&#xD;
&#xD;
        -  To encourage the adoption of recommended self-care behaviours.&#xD;
&#xD;
      The intervention has been developed in collaboration with both health professionals and&#xD;
      patients. We have designed a pilot study to assess the feasibility of using the intervention&#xD;
      in primary care and to evaluate its potential impact on patients' risk perceptions and&#xD;
      self-management behaviour, in order to inform the design of a largest study (RCT to be&#xD;
      conducted in the future)&#xD;
&#xD;
      The intervention lasts 5 minutes on average, conducted by the general practitioner (GP)&#xD;
      during patients' routine primary care consultation. The study involves 40 participants with&#xD;
      T2DM randomly allocated to usual care supported by the risk communication intervention or&#xD;
      usual care only.&#xD;
&#xD;
      The research is supported by the National Institute for Health Research (NIHR) Collaboration&#xD;
      for Leadership in Applied Health Research and Care Oxford at Oxford Health NHS Foundation&#xD;
      Trust.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">February 9, 2018</completion_date>
  <primary_completion_date type="Actual">February 9, 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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of implementing the intervention in primary care: Binary outcome (feasible / not feasible), as judged by the investigators</measure>
    <time_frame>3 months</time_frame>
    <description>Binary outcome (feasible / not feasible), as judged by the investigators following analysis of study pre-specified outcome measures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recall of personalised risk information</measure>
    <time_frame>3 months</time_frame>
    <description>Recall of personalised risk information is measured immediately and 3 months after the intervention.&#xD;
Type of question used: &quot;The doctor has recently calculated your personalised risk information on his computer. Do you remember these numbers?&#xD;
Binary outcome: information recalled or information not recalled. Recall of information represents a better outcome. Rates of information recall (%) are compared between the two groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intentions to make lifestyle changes</measure>
    <time_frame>3 months</time_frame>
    <description>Intentions to make lifestyle changes are measured immediately before and after the intervention using the validated Determinants of Lifestyle Behaviour Questionnaire (DLBQ). The DLBQ consists of three parts: intentions to eat healthier, to increase physical activity, and to reduce smoking consumption. Intentions are assessed by a 5-point Likert scale ranging from 0 (strongly disagree) to 5 (strongly agree). Each dimension score is assessed individually. Higher scores represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-management behaviour</measure>
    <time_frame>3 months</time_frame>
    <description>Change in self-management behaviour from baseline to 3 months is measured using the validated Summary of Diabetes Self-Care Activities (SDSCA) questionnaire. This instrument explores six dimensions of self-management (healthy eating, physical activity, medication adherence, self-monitoring of blood glucose, foot checks and smoking behaviour), using the self-reported frequency of completing recommended activities during the past seven days as an outcome (SDSCA score ranging from 0 to 7 for each dimension). Each dimension score is assessed individually. Higher scores represent a better outcome.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Consent rate</measure>
    <time_frame>3 months</time_frame>
    <description>Rate of eligible subjects consenting to participate in the study (%)</description>
  </other_outcome>
  <other_outcome>
    <measure>Acceptability of the intervention</measure>
    <time_frame>Immediately after the intervention</time_frame>
    <description>Participants' acceptability of the intervention is measured using adapted questions from the COMRADE (Combined Outcome Measure for Risk communication And treatment Decision-making Effectiveness) scale, which was validated for use in the UK. This scale consists of 10 questions on a 5-point scale ranging from 0 (strongly disagree) to 5 (strongly agree) and is used immediately after the intervention. The scores of each question are combined to compute an average score. Higher average scores represent a better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Anxiety due to the intervention</measure>
    <time_frame>Immediately after the inervention</time_frame>
    <description>Following Welschen et al. (2012), a question adapted from Claassen et al. (2010) is used to assess how anxious participants are about their personalised risk information (7-point Likert scale ranging from 0 (not anxious at all) to 7 (very much anxious). Higher scores represent a worse outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Worry due to the intervention</measure>
    <time_frame>Immediately after the intervention</time_frame>
    <description>Following Welschen et al. (2012), a question adapted from Claassen et al. (2010) is used to assess how worried participants are about their personalised risk information (7-point Likert scale ranging from 0 (not worried at all) to 7 (very much worried). Higher scores represent a worse outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Retention rate</measure>
    <time_frame>3 months</time_frame>
    <description>Rate of participants who stay enrolled in the study until it ends (%)</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of missing data</measure>
    <time_frame>3 months</time_frame>
    <description>Rate of missing data in participants' self-reported questionnaires (%)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Intervention and usual care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Risk communication intervention and usual care including personalized lifestyle advice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care including personalized lifestyle advice</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Personalized Risk Communication for People with Type 2 Diabetes</intervention_name>
    <description>The risk communication intervention consists of communicating the impact of being poorly controlled on two types of outcome: (1) absolute 10-year risk of experiencing a cardiovascular event, i.e. heart attack or stroke (10-year CV risk); (2) life expectancy. These personalized risk estimates are calculated based on the UKPDS outcomes model (version 2), which is a prognostic model of reference in the area of Type 2 diabetes.</description>
    <arm_group_label>Intervention and usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
          -  Diagnosed with type-2 diabetes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent.&#xD;
&#xD;
          -  Non-English speaker.&#xD;
&#xD;
          -  Not suitable for the study according to GP.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>27 Beaumont Street Surgery Practice</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX1 2NR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 18, 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>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 2 diabetes mellitus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 7, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03840850/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 7, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03840850/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03840850
org study id: 17/NW/0267
nct id: NCT03840850
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot randomised controlled trial (RCT) aims to assess the feasibility of using a new
      type of risk communication intervention for people with Type 2 diabetes mellitus (T2DM) in
      primary care and to evaluate its potential impact on risk perceptions and self-management
      behaviour.

      The study comprises 40 participants with T2DM randomly allocated to usual care supported by
      the risk communication intervention or usual care only.
Diabetes self-management, which includes self-care behaviours such as healthy eating and
      physical exercise, has become the cornerstone for treating type-2 diabetes mellitus (T2DM).
      However, although self-management education (SME) is necessary to equip patients with the
      knowledge, skills and attitudes required to manage their diabetes care, the most effective
      method to do so is still unclear.

      Recent studies have shown that people with T2DM underestimated their risks of developing
      complications. Although behavioural processes are complex, wrong risk perceptions are a major
      impediment to the adoption of self-care behaviours and, as a result, an additional risk for
      the occurrence of adverse outcomes.

      Existing risk communication interventions have shown mixed results, with many participants
      barely understanding the explanations of health professionals about risks and having poor
      recall of risk information. In this context, there is a need for better risk communication
      interventions.

      Based on the results of recent studies investigating the risk perceptions and risk attitudes
      of people with T2DM, we have developed a new, tailored risk communication intervention. The
      objectives of this intervention are:

        -  To increase the awareness of risks for complications associated with type 2 diabetes.

        -  To encourage the adoption of recommended self-care behaviours.

      The intervention has been developed in collaboration with both health professionals and
      patients. We have designed a pilot study to assess the feasibility of using the intervention
      in primary care and to evaluate its potential impact on patients' risk perceptions and
      self-management behaviour, in order to inform the design of a largest study (RCT to be
      conducted in the future)

      The intervention lasts 5 minutes on average, conducted by the general practitioner (GP)
      during patients' routine primary care consultation. The study involves 40 participants with
      T2DM randomly allocated to usual care supported by the risk communication intervention or
      usual care only.

      The research is supported by the National Institute for Health Research (NIHR) Collaboration
      for Leadership in Applied Health Research and Care Oxford at Oxford Health NHS Foundation
      Trust.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Feasibility of implementing the intervention in primary care: Binary outcome (feasible / not feasible), as judged by the investigators
time frame: 3 months
description: Binary outcome (feasible / not feasible), as judged by the investigators following analysis of study pre-specified outcome measures.
measure: Recall of personalised risk information
time frame: 3 months
description: Recall of personalised risk information is measured immediately and 3 months after the intervention.
Type of question used: "The doctor has recently calculated your personalised risk information on his computer. Do you remember these numbers?
Binary outcome: information recalled or information not recalled. Recall of information represents a better outcome. Rates of information recall (%) are compared between the two groups.
measure: Intentions to make lifestyle changes
time frame: 3 months
description: Intentions to make lifestyle changes are measured immediately before and after the intervention using the validated Determinants of Lifestyle Behaviour Questionnaire (DLBQ). The DLBQ consists of three parts: intentions to eat healthier, to increase physical activity, and to reduce smoking consumption. Intentions are assessed by a 5-point Likert scale ranging from 0 (strongly disagree) to 5 (strongly agree). Each dimension score is assessed individually. Higher scores represent a better outcome.
measure: Change in self-management behaviour
time frame: 3 months
description: Change in self-management behaviour from baseline to 3 months is measured using the validated Summary of Diabetes Self-Care Activities (SDSCA) questionnaire. This instrument explores six dimensions of self-management (healthy eating, physical activity, medication adherence, self-monitoring of blood glucose, foot checks and smoking behaviour), using the self-reported frequency of completing recommended activities during the past seven days as an outcome (SDSCA score ranging from 0 to 7 for each dimension). Each dimension score is assessed individually. Higher scores represent a better outcome.
measure: Consent rate
time frame: 3 months
description: Rate of eligible subjects consenting to participate in the study (%)
measure: Acceptability of the intervention
time frame: Immediately after the intervention
description: Participants' acceptability of the intervention is measured using adapted questions from the COMRADE (Combined Outcome Measure for Risk communication And treatment Decision-making Effectiveness) scale, which was validated for use in the UK. This scale consists of 10 questions on a 5-point scale ranging from 0 (strongly disagree) to 5 (strongly agree) and is used immediately after the intervention. The scores of each question are combined to compute an average score. Higher average scores represent a better outcome.
measure: Anxiety due to the intervention
time frame: Immediately after the inervention
description: Following Welschen et al. (2012), a question adapted from Claassen et al. (2010) is used to assess how anxious participants are about their personalised risk information (7-point Likert scale ranging from 0 (not anxious at all) to 7 (very much anxious). Higher scores represent a worse outcome.
measure: Worry due to the intervention
time frame: Immediately after the intervention
description: Following Welschen et al. (2012), a question adapted from Claassen et al. (2010) is used to assess how worried participants are about their personalised risk information (7-point Likert scale ranging from 0 (not worried at all) to 7 (very much worried). Higher scores represent a worse outcome.
measure: Retention rate
time frame: 3 months
description: Rate of participants who stay enrolled in the study until it ends (%)
measure: Rate of missing data
time frame: 3 months
description: Rate of missing data in participants' self-reported questionnaires (%)
arm group label: Intervention and usual care
arm group type: Experimental
description: Risk communication intervention and usual care including personalized lifestyle advice
arm group label: Usual care only
arm group type: No Intervention
description: Usual care including personalized lifestyle advice
intervention type: Other
intervention name: Personalized Risk Communication for People with Type 2 Diabetes
description: The risk communication intervention consists of communicating the impact of being poorly controlled on two types of outcome: (1) absolute 10-year risk of experiencing a cardiovascular event, i.e. heart attack or stroke (10-year CV risk); (2) life expectancy. These personalized risk estimates are calculated based on the UKPDS outcomes model (version 2), which is a prognostic model of reference in the area of Type 2 diabetes.
arm group label: Intervention and usual care
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
provided document: 
provided document: 