<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/NCT03788096</url>
  </required_header>
  <id_info>
    <org_study_id>2018-08-0097</org_study_id>
    <nct_id>NCT03788096</nct_id>
  </id_info>
  <brief_title>Peer Support for Post Intensive Care Syndrome Self-Management</brief_title>
  <acronym>PS-PICS</acronym>
  <official_title>Peer Support for Post Intensive Care Syndrome Self-Management (PS-PICS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas at Austin</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>
      A prospective, 2-arm, single-blind, randomized controlled clinical feasibility trial design&#xD;
      is planned. Forty CCI survivors will be randomized (1:1) to either the PS-PICS (peer support)&#xD;
      intervention or usual care (control) group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized participants will complete 4 study assessments: 1) baseline data at hospital&#xD;
      discharge; 2) baseline data post-hospital discharge and before the start of the weekly peer&#xD;
      support intervention; 3) post-intervention at the conclusion of the 90-day weekly peer&#xD;
      support intervention; and 4) follow-up at 6-months post-hospital discharge. The weekly peer&#xD;
      support intervention will be delivered by a small pool of critical illness survivor peers&#xD;
      (mentors) recruited from the study site from previous research. Peer support mentors will be&#xD;
      trained in peer support and MI, and will deliver 3 months of weekly MI interventions&#xD;
      (phone-based) to CCI survivors randomized to the intervention group. Participants randomized&#xD;
      to the usual care group will not receive the weekly peer support/MI intervention but will&#xD;
      receive the usual discharge planning services currently provided at hospital discharge.&#xD;
      Participants in both groups will be contacted by the research team for 4 telephone-based&#xD;
      assessments. The design will allow us to test the feasibility and potential impact of the&#xD;
      PS-PICS intervention on social relationship measures, depression and self-management. Data&#xD;
      collection and analyses are guided by the Individual and Family Self-Management Theory. The&#xD;
      Individual and Family Self-Management Theory illustrates the interaction of the process of&#xD;
      self-management with risk and protective factors, and short-term and long-term outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 20, 2020</start_date>
  <completion_date type="Anticipated">January 27, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 27, 2020</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>
    <intervention_model_description>A prospective, 2-arm, single-blind, randomized controlled clinical feasibility trial design.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Social Network Index</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>Social Network Index (SNI) to measure social relationships. The scale range is 0-12. The total score will be reported. The maximum total score is 12. Higher values represent a broader diversity of social networks and are classified as a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiologic Studies Depression Scale (CES-D)</measure>
    <time_frame>1-week Post-intervention</time_frame>
    <description>Center for Epidemiologic Studies Depression Scale (CES-D) to measure self-reported symptoms of depression The scale range is 0-60. The total score will be reported. The maximum total score is 60. Higher values represent self-reported symptoms of depression. Higher values represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiologic Studies Depression Scale (CES-D)</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>Center for Epidemiologic Studies Depression Scale (CES-D) to measure self-reported symptoms of depression The scale range is 0-60. The total score will be reported. The maximum total score is 60. Higher values represent self-reported symptoms of depression. Higher values represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Network Index</measure>
    <time_frame>1-week Post-intervention</time_frame>
    <description>Social Network Index (SNI) to measure social relationships. The scale range is 0-12. The total score will be reported. The maximum total score is 12. Higher values represent a broader diversity of social networks and are classified as a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Activation Measure</measure>
    <time_frame>1-week Post-intervention</time_frame>
    <description>Patient Activation Measure (PAM) Survey to measure self-reported active behavior in the self-management of chronic illness.&#xD;
The scale range is 0-100. The total score will be reported. The maximum total score is 100. Higher values represent high levels of activation in self-management. Higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Activation Measure</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>Patient Activation Measure (PAM) Survey to measure self-reported active behavior in the self-management of chronic illness.&#xD;
The scale range is 0-100. The total score will be reported. The maximum total score is 100. Higher values represent high levels of activation in self-management. Higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale</measure>
    <time_frame>1-week Post-intervention</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale The scale range is 0-65. The total score will be reported. For each scale range provided, specify which values are considered to be a better or worse outcome (e.g., Do higher values represent a better or worse outcome?).&#xD;
The maximum total score is 65. Higher values represent higher levels of fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>The Measure includes a scale. Please provide the following scale information:&#xD;
Specify the full (unabbreviated) scale name and construct (i.e., indicate what the scale measures if not clear from name).&#xD;
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values. For example, if the *total* score is reported, the *total* range should be provided. If *subscale* scores are reported, the range for each *subscale* should be provided.&#xD;
The scale range is 0-65. The total score will be reported. For each scale range provided, specify which values are considered to be a better or worse outcome (e.g., Do higher values represent a better or worse outcome?).&#xD;
The maximum total score is 65. Higher values represent higher levels of fatigue.&#xD;
If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.).&#xD;
N/A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form-36 (SF-36)</measure>
    <time_frame>1-week Post-intervention</time_frame>
    <description>Short Form-36 (SF-36) or 36-Item Short Form Health Survey Instrument The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100.&#xD;
Lower scores = more disability, higher scores = less disability Sections: ∙ Vitality ∙ Physical functioning ∙ Bodily pain ∙ General health perceptions ∙ Physical role functi</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form-36 (SF-36)</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>Short Form-36 (SF-36) or 36-Item Short Form Health Survey Instrument The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100.&#xD;
Lower scores = more disability, higher scores = less disability Sections: ∙ Vitality ∙ Physical functioning ∙ Bodily pain ∙ General health perceptions ∙ Physical role functi</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Health services utilization</measure>
    <time_frame>1-week Post-intervention</time_frame>
    <description>Utilization of health services</description>
  </other_outcome>
  <other_outcome>
    <measure>Health services utilization</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Utilization of health services</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Critical Illness</condition>
  <condition>Sepsis</condition>
  <condition>Shock, Septic</condition>
  <condition>Shock</condition>
  <condition>Respiratory Failure</condition>
  <condition>Respiratory Distress Syndrome, Adult</condition>
  <condition>Shock, Hypovolemic</condition>
  <condition>Chronic Disease</condition>
  <arm_group>
    <arm_group_label>PS-PICS Peer Support Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ICU mentors will be responsible for providing support to survivor participants randomized to the PS-PICS peer support intervention. Mentors will be trained in motivational interviewing techniques to engage mentees in goal setting and emotional management that is not readily accessible as part of discharge planning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A control intervention will be used to provide comparison data consistent with usual care (absence of structured peer support telephone intervention) to evaluate the impact of the PS-PICS peer support intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peer Support with Motivational Interviewing</intervention_name>
    <description>Mentors will trained in motivational interviewing and will conduct weekly telephone calls with participants randomized to the PS-PICS peer support intervention arm.</description>
    <arm_group_label>PS-PICS Peer Support Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care Group</intervention_name>
    <description>Usual care.</description>
    <arm_group_label>Usual Care Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age18 years or older&#xD;
&#xD;
          -  ICU length of stay 8 days or longer&#xD;
&#xD;
          -  expected to survive hospitalization with a discharge destination to home within 28&#xD;
             days of hospital discharge&#xD;
&#xD;
          -  diagnosed with 2 or more chronic conditions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  death prior to hospital discharge&#xD;
&#xD;
          -  enrollment in Hospice services at the time of hospital discharge&#xD;
&#xD;
          -  non-communicative&#xD;
&#xD;
          -  no access to telephone&#xD;
&#xD;
          -  incarcerated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Baylor Scott &amp; White Health</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Richard Hao</last_name>
      <phone>214-265-3683</phone>
      <email>Richard.Hao@BSWHealth.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>October 30, 2020</last_update_submitted>
  <last_update_submitted_qc>October 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas at Austin</investigator_affiliation>
    <investigator_full_name>Valerie Danesh</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Post-Intensive Care Syndrome (PICS)</keyword>
  <keyword>Chronic Critical Illness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Shock</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
    <mesh_term>Hypovolemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03788096
org study id: 2018-08-0097
nct id: NCT03788096
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A prospective, 2-arm, single-blind, randomized controlled clinical feasibility trial design
      is planned. Forty CCI survivors will be randomized (1:1) to either the PS-PICS (peer support)
      intervention or usual care (control) group.
Randomized participants will complete 4 study assessments: 1) baseline data at hospital
      discharge; 2) baseline data post-hospital discharge and before the start of the weekly peer
      support intervention; 3) post-intervention at the conclusion of the 90-day weekly peer
      support intervention; and 4) follow-up at 6-months post-hospital discharge. The weekly peer
      support intervention will be delivered by a small pool of critical illness survivor peers
      (mentors) recruited from the study site from previous research. Peer support mentors will be
      trained in peer support and MI, and will deliver 3 months of weekly MI interventions
      (phone-based) to CCI survivors randomized to the intervention group. Participants randomized
      to the usual care group will not receive the weekly peer support/MI intervention but will
      receive the usual discharge planning services currently provided at hospital discharge.
      Participants in both groups will be contacted by the research team for 4 telephone-based
      assessments. The design will allow us to test the feasibility and potential impact of the
      PS-PICS intervention on social relationship measures, depression and self-management. Data
      collection and analyses are guided by the Individual and Family Self-Management Theory. The
      Individual and Family Self-Management Theory illustrates the interaction of the process of
      self-management with risk and protective factors, and short-term and long-term outcomes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A prospective, 2-arm, single-blind, randomized controlled clinical feasibility trial design.
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Social Network Index
time frame: 3 months post-intervention
description: Social Network Index (SNI) to measure social relationships. The scale range is 0-12. The total score will be reported. The maximum total score is 12. Higher values represent a broader diversity of social networks and are classified as a better outcome.
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
time frame: 1-week Post-intervention
description: Center for Epidemiologic Studies Depression Scale (CES-D) to measure self-reported symptoms of depression The scale range is 0-60. The total score will be reported. The maximum total score is 60. Higher values represent self-reported symptoms of depression. Higher values represent a worse outcome.
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
time frame: 3 months post-intervention
description: Center for Epidemiologic Studies Depression Scale (CES-D) to measure self-reported symptoms of depression The scale range is 0-60. The total score will be reported. The maximum total score is 60. Higher values represent self-reported symptoms of depression. Higher values represent a worse outcome.
measure: Social Network Index
time frame: 1-week Post-intervention
description: Social Network Index (SNI) to measure social relationships. The scale range is 0-12. The total score will be reported. The maximum total score is 12. Higher values represent a broader diversity of social networks and are classified as a better outcome.
measure: Patient Activation Measure
time frame: 1-week Post-intervention
description: Patient Activation Measure (PAM) Survey to measure self-reported active behavior in the self-management of chronic illness.
The scale range is 0-100. The total score will be reported. The maximum total score is 100. Higher values represent high levels of activation in self-management. Higher values represent a better outcome.
measure: Patient Activation Measure
time frame: 3 months post-intervention
description: Patient Activation Measure (PAM) Survey to measure self-reported active behavior in the self-management of chronic illness.
The scale range is 0-100. The total score will be reported. The maximum total score is 100. Higher values represent high levels of activation in self-management. Higher values represent a better outcome.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
time frame: 1-week Post-intervention
description: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale The scale range is 0-65. The total score will be reported. For each scale range provided, specify which values are considered to be a better or worse outcome (e.g., Do higher values represent a better or worse outcome?).
The maximum total score is 65. Higher values represent higher levels of fatigue.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
time frame: 3 months post-intervention
description: The Measure includes a scale. Please provide the following scale information:
Specify the full (unabbreviated) scale name and construct (i.e., indicate what the scale measures if not clear from name).
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values. For example, if the *total* score is reported, the *total* range should be provided. If *subscale* scores are reported, the range for each *subscale* should be provided.
The scale range is 0-65. The total score will be reported. For each scale range provided, specify which values are considered to be a better or worse outcome (e.g., Do higher values represent a better or worse outcome?).
The maximum total score is 65. Higher values represent higher levels of fatigue.
If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.).
N/A
measure: Short Form-36 (SF-36)
time frame: 1-week Post-intervention
description: Short Form-36 (SF-36) or 36-Item Short Form Health Survey Instrument The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100.
Lower scores = more disability, higher scores = less disability Sections: ∙ Vitality ∙ Physical functioning ∙ Bodily pain ∙ General health perceptions ∙ Physical role functi
measure: Short Form-36 (SF-36)
time frame: 3 months post-intervention
description: Short Form-36 (SF-36) or 36-Item Short Form Health Survey Instrument The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100.
Lower scores = more disability, higher scores = less disability Sections: ∙ Vitality ∙ Physical functioning ∙ Bodily pain ∙ General health perceptions ∙ Physical role functi
measure: Health services utilization
time frame: 1-week Post-intervention
description: Utilization of health services
measure: Health services utilization
time frame: 3 months post intervention
description: Utilization of health services
arm group label: PS-PICS Peer Support Intervention
arm group type: Experimental
description: ICU mentors will be responsible for providing support to survivor participants randomized to the PS-PICS peer support intervention. Mentors will be trained in motivational interviewing techniques to engage mentees in goal setting and emotional management that is not readily accessible as part of discharge planning.
arm group label: Usual Care Group
arm group type: Placebo Comparator
description: A control intervention will be used to provide comparison data consistent with usual care (absence of structured peer support telephone intervention) to evaluate the impact of the PS-PICS peer support intervention.
intervention type: Behavioral
intervention name: Peer Support with Motivational Interviewing
description: Mentors will trained in motivational interviewing and will conduct weekly telephone calls with participants randomized to the PS-PICS peer support intervention arm.
arm group label: PS-PICS Peer Support Intervention
intervention type: Behavioral
intervention name: Usual Care Group
description: Usual care.
arm group label: Usual Care Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas at Austin
investigator full name: Valerie Danesh
investigator title: Assistant Professor
mesh term: Shock, Septic
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Respiratory Insufficiency
mesh term: Acute Lung Injury
mesh term: Syndrome
mesh term: Shock
mesh term: Critical Illness
mesh term: Chronic Disease
mesh term: Hypovolemia
sharing ipd: Undecided