<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/NCT04491253</url>
  </required_header>
  <id_info>
    <org_study_id>2020-04</org_study_id>
    <nct_id>NCT04491253</nct_id>
  </id_info>
  <brief_title>Social Support Intervention for Self-management of Type 2 Diabetes Mellitus</brief_title>
  <official_title>Efficacy of a Social Support Intervention in Adults for Self-management of Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Antioquia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Antioquia</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 study will assess the effect of a social support intervention for self-management of&#xD;
      type 2 diabetes mellitus (DM2) in adults. This intervention is based on a medium-range&#xD;
      nursing theory of individual and family self-management. Findings will be evaluated using the&#xD;
      nursing outcomes &quot;self-management: diabetes&quot; and &quot;social support&quot; from the Nursing Outcomes&#xD;
      Classification (NOC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetes mellitus is responsible for 1.6 million deaths a year, becoming one of the world's&#xD;
      21st century health emergencies.&#xD;
&#xD;
      DM2 is the most frequent form of diabetes, accounting for 90% of all cases of this chronic&#xD;
      condition. If this trend continues, by 2045 about 693 million people will have diabetes.&#xD;
&#xD;
      People with chronic diseases have changing perspectives, in addition to suffering physical&#xD;
      alterations, their psychological, emotional and social state is also compromised, presenting&#xD;
      themselves as a need to modify lifestyle to improve prognosis, facing alterations in the&#xD;
      ability to socialize and with death or a great loss. Few studies comprehensively address&#xD;
      these dimensions.&#xD;
&#xD;
      The literature reports that DM2 self-control has a direct effect in improving clinical&#xD;
      results, reducing complications and quality of life. Therefore, the patient must make&#xD;
      multiple decisions every day regarding diet, physical activity, glucose control, and&#xD;
      medication compliance.&#xD;
&#xD;
      However, intervention studies that seek to improve self-management behaviors in people with&#xD;
      DM2 are characterized by emphasizing the transmission of knowledge and establishing&#xD;
      compliance with prescribed treatments, but they do not address social and emotional elements&#xD;
      such as social support. Additionally, most of these interventions do not show the use of&#xD;
      theoretical models that provide explanations of human responses to disease and other&#xD;
      phenomena important to practice.&#xD;
&#xD;
      Studies using the Nursing Outcomes Classification to assess the effect of social support&#xD;
      interventions are scarce.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2021</start_date>
  <completion_date type="Actual">February 18, 2022</completion_date>
  <primary_completion_date type="Actual">February 18, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-management: diabetes</measure>
    <time_frame>2 months</time_frame>
    <description>NOC outcome. Personal actions to manage diabetes, its treatment, and to prevent complications. Indicators of participation in self-management behaviors, specifically healthy eating, physical exercise, glucose monitoring and symptom management. This outcome will be evaluated by a Likert scale, being 1 the worst score and 5 best score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Social support</measure>
    <time_frame>2 months</time_frame>
    <description>NOC outcome. Reliable assistance from others. Indicators of emotions, stress, communication, decision-making, empowerment, trust, support groups and networks. This outcome will be evaluated by a Likert scale, being 1 the worst score and 5 best score.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention is defined as informational support (transmission of information for health care, knowledge of DM2, nutrition, physical activity), instrumental (physical care) and emotional (management of anxiety, empowerment and decision-making).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group will receive usual care treatment at the diabetes mellitus nursing consultation in primary care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social support for diabetes self-management</intervention_name>
    <description>Four individualized intervention sessions, every two weeks with a duration of 40 minutes.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults over 18 years with a diagnosis of DM2, attending the outpatient diabetes&#xD;
             consultation at the health care institution.&#xD;
&#xD;
          -  Initial score less than or equal to 3 on the NOC outcomes: self-management: diabetes&#xD;
             and social support.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People with a score &lt;30 on the cognitive mini mental test.&#xD;
&#xD;
          -  Other comorbidities reported by the patient or in the medical history that limit&#xD;
             receiving the intervention (example: hearing loss, deafness, Alzheimer's disease).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wilson Canon Montanez, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidad de Antioquia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidad de Antioquia</name>
      <address>
        <city>Medellín</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <reference>
    <citation>Garizábalo-Dávila CM, Rodríguez-Acelas AL, Cañon-Montañez W. Soporte social enfocado a personas con diabetes: una necesidad desde enfermería. Rev Cuid. 2019; 10(1): e697. http://dx.doi.org/10.15649/cuidarte.v10i1.697</citation>
  </reference>
  <reference>
    <citation>Garizábalo-Dávila CM, Rodríguez-Acelas AL, Mattiello R, Cañon-Montañez W. Social Support Intervention for Self-Management of Type 2 Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial. Open Access Journal of Clinical Trials. 2021;13:37-43 https://doi.org/10.2147/OAJCT.S314030</citation>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>February 23, 2022</last_update_submitted>
  <last_update_submitted_qc>February 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nursing Outcomes Classification Terminology</keyword>
  <keyword>Self-management</keyword>
  <keyword>Social support</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>
  <!-- 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/NCT04491253
org study id: 2020-04
nct id: NCT04491253
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will assess the effect of a social support intervention for self-management of
      type 2 diabetes mellitus (DM2) in adults. This intervention is based on a medium-range
      nursing theory of individual and family self-management. Findings will be evaluated using the
      nursing outcomes "self-management: diabetes" and "social support" from the Nursing Outcomes
      Classification (NOC).
Diabetes mellitus is responsible for 1.6 million deaths a year, becoming one of the world's
      21st century health emergencies.

      DM2 is the most frequent form of diabetes, accounting for 90% of all cases of this chronic
      condition. If this trend continues, by 2045 about 693 million people will have diabetes.

      People with chronic diseases have changing perspectives, in addition to suffering physical
      alterations, their psychological, emotional and social state is also compromised, presenting
      themselves as a need to modify lifestyle to improve prognosis, facing alterations in the
      ability to socialize and with death or a great loss. Few studies comprehensively address
      these dimensions.

      The literature reports that DM2 self-control has a direct effect in improving clinical
      results, reducing complications and quality of life. Therefore, the patient must make
      multiple decisions every day regarding diet, physical activity, glucose control, and
      medication compliance.

      However, intervention studies that seek to improve self-management behaviors in people with
      DM2 are characterized by emphasizing the transmission of knowledge and establishing
      compliance with prescribed treatments, but they do not address social and emotional elements
      such as social support. Additionally, most of these interventions do not show the use of
      theoretical models that provide explanations of human responses to disease and other
      phenomena important to practice.

      Studies using the Nursing Outcomes Classification to assess the effect of social support
      interventions are scarce.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Self-management: diabetes
time frame: 2 months
description: NOC outcome. Personal actions to manage diabetes, its treatment, and to prevent complications. Indicators of participation in self-management behaviors, specifically healthy eating, physical exercise, glucose monitoring and symptom management. This outcome will be evaluated by a Likert scale, being 1 the worst score and 5 best score.
measure: Social support
time frame: 2 months
description: NOC outcome. Reliable assistance from others. Indicators of emotions, stress, communication, decision-making, empowerment, trust, support groups and networks. This outcome will be evaluated by a Likert scale, being 1 the worst score and 5 best score.
arm group label: Intervention
arm group type: Experimental
description: The intervention is defined as informational support (transmission of information for health care, knowledge of DM2, nutrition, physical activity), instrumental (physical care) and emotional (management of anxiety, empowerment and decision-making).
arm group label: Control
arm group type: No Intervention
description: Control group will receive usual care treatment at the diabetes mellitus nursing consultation in primary care.
intervention type: Behavioral
intervention name: Social support for diabetes self-management
description: Four individualized intervention sessions, every two weeks with a duration of 40 minutes.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Wilson Canon Montanez, PhD
role: Study Director
affiliation: Universidad de Antioquia
facility: 
country: Colombia
citation: Garizábalo-Dávila CM, Rodríguez-Acelas AL, Cañon-Montañez W. Soporte social enfocado a personas con diabetes: una necesidad desde enfermería. Rev Cuid. 2019; 10(1): e697. http://dx.doi.org/10.15649/cuidarte.v10i1.697
citation: Garizábalo-Dávila CM, Rodríguez-Acelas AL, Mattiello R, Cañon-Montañez W. Social Support Intervention for Self-Management of Type 2 Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial. Open Access Journal of Clinical Trials. 2021;13:37-43 https://doi.org/10.2147/OAJCT.S314030
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No