<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/NCT02196272</url>
  </required_header>
  <id_info>
    <org_study_id>SAPS-001</org_study_id>
    <nct_id>NCT02196272</nct_id>
  </id_info>
  <brief_title>Nurse-led Reminder Program for Therapy Adherence, Clinical Outcomes and Trust in Nurses in Diabetic Patients</brief_title>
  <official_title>The Efficacy of a Nurse-led Reminder Program on Therapy Adherence, Clinical Outcomes and Trust in Nurses in Diabetic Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti</source>
  <brief_summary>
    <textblock>
      A number of strategies have been evaluated to improve clinical outcomes in diabetics&#xD;
      patients, however no studies explored the efficacy of a nurse-led reminder program through&#xD;
      email (NRP-e) to improve medication adherence, even if it is fundamental in the management of&#xD;
      diabetics. The study aims at evaluating for the first time the efficacy of a nurse-led&#xD;
      reminder program through email (NRP-e) to improve medication adherence in diabetic patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Actual">July 2014</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>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Medication adherence</measure>
    <time_frame>6 months</time_frame>
    <description>The main outcome of the study was the improvement of medication adherence in diabetic patients between baseline and the end of follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trust in nurses</measure>
    <time_frame>6 months</time_frame>
    <description>Mean differences between groups in the average scores of trust in nurses perceived by patients between baseline and the end of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lifestyle</measure>
    <time_frame>6 months</time_frame>
    <description>Mean differences between groups in the average reduction in smoking and alcohol consumption, BMI and in the average increase of consumption of a healthy diet in diabetic patients between baseline and the end of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contacts with health services</measure>
    <time_frame>6 months</time_frame>
    <description>Mean differences between groups in the reduction of the number of contact sand admissions of diabetic patients at health care services, between baseline and the end of follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Diabetes Mellitus, Non-Insulin-Dependent</condition>
  <arm_group>
    <arm_group_label>Nurse-led email program through email</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to usual care and educational program, the intervention group will also receive email alerts and phone calls from the nurse care manager (NCM).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Management of diabetic patients</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care, educational program and usual management of Diabetic patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nurse-led reminder program through email</intervention_name>
    <description>Both groups will receive an educational program and usual care. The educational program will consist of:&#xD;
- 1-hour session, during which the NCM give advices and enphasize the importance of the correct procedure of glycemic control, report non-pharmacological strategies for a healty lifestyle and instruction on how to fill a self assessment form.</description>
    <arm_group_label>Nurse-led email program through email</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be elegible, all subjects had to be diabetics (Diabetes Mellitus, Non-Insulin-Dependent)&#xD;
&#xD;
          -  Speaking and reading italian&#xD;
&#xD;
          -  Having an active phone number and an email address&#xD;
&#xD;
          -  Providing a signed a informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mental illness&#xD;
&#xD;
          -  Hospitalized patients and who refused to partecipate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 18, 2014</last_update_submitted>
  <last_update_submitted_qc>July 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti</investigator_affiliation>
    <investigator_full_name>Giancarlo Cicolini</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT02196272
org study id: SAPS-001
nct id: NCT02196272
lead sponsor: 
A number of strategies have been evaluated to improve clinical outcomes in diabetics
      patients, however no studies explored the efficacy of a nurse-led reminder program through
      email (NRP-e) to improve medication adherence, even if it is fundamental in the management of
      diabetics. The study aims at evaluating for the first time the efficacy of a nurse-led
      reminder program through email (NRP-e) to improve medication adherence in diabetic patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Medication adherence
time frame: 6 months
description: The main outcome of the study was the improvement of medication adherence in diabetic patients between baseline and the end of follow-up.
measure: Trust in nurses
time frame: 6 months
description: Mean differences between groups in the average scores of trust in nurses perceived by patients between baseline and the end of follow-up.
measure: Lifestyle
time frame: 6 months
description: Mean differences between groups in the average reduction in smoking and alcohol consumption, BMI and in the average increase of consumption of a healthy diet in diabetic patients between baseline and the end of follow-up.
measure: Contacts with health services
time frame: 6 months
description: Mean differences between groups in the reduction of the number of contact sand admissions of diabetic patients at health care services, between baseline and the end of follow-up.
arm group label: Nurse-led email program through email
arm group type: Experimental
description: In addition to usual care and educational program, the intervention group will also receive email alerts and phone calls from the nurse care manager (NCM).
arm group label: Management of diabetic patients
arm group type: No Intervention
description: Usual care, educational program and usual management of Diabetic patients
intervention type: Behavioral
intervention name: Nurse-led reminder program through email
description: Both groups will receive an educational program and usual care. The educational program will consist of:
- 1-hour session, during which the NCM give advices and enphasize the importance of the correct procedure of glycemic control, report non-pharmacological strategies for a healty lifestyle and instruction on how to fill a self assessment form.
arm group label: Nurse-led email program through email
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
investigator full name: Giancarlo Cicolini
investigator title: PhD
mesh term: Diabetes Mellitus, Type 2