<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/NCT02993887</url>
  </required_header>
  <id_info>
    <org_study_id>10-16-10</org_study_id>
    <nct_id>NCT02993887</nct_id>
  </id_info>
  <brief_title>Resourcefulness Training and Decentering on Self-Management in Caregivers of Technology Dependent Children</brief_title>
  <official_title>The Effects of Resourcefulness Training Intervention and Decentering on Self-Management of Stress in Caregivers of Children With Complex Chronic Conditions Dependent on Lifesaving Medical Technology: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospitals Cleveland Medical Center</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>
      The investigators will conduct a randomized clinical trial pilot study to examine the&#xD;
      effectiveness of a theoretically based intervention (called ReMind) encompassing two key&#xD;
      components: (a) Resourcefulness Training for parent caregivers, and (b) daily mindfulness&#xD;
      meditation delivered using a smart phone application (Stop, Breathe &amp; Think™) with an&#xD;
      intervention (Mind Only) that consists only of daily mindfulness meditation. Both components&#xD;
      of the intervention have been tested separately (but not combined) and both interventions can&#xD;
      be self-tailored, which meets the vital need for these caregivers to engage in&#xD;
      self-management activities when it is convenient for them. The investigators will test the&#xD;
      two arms of the intervention in 30 parents of technology-dependent children, 15 parents in&#xD;
      each group. The investigators will collect mixed data at baseline, 3 months and 6 months&#xD;
      after subject enrollment to describe changes in proximal and distal outcomes. The&#xD;
      investigators aim to:&#xD;
&#xD;
        1. Evaluate the intermediate (3 month) and long-term (6 month) effects of the ReMind and&#xD;
           Mind Only interventions on study mediators (HPA Axis Function and stress, cognitive&#xD;
           factors, resourcefulness) and determine if there are different effects between ReMind&#xD;
           and Mind Only interventions.&#xD;
&#xD;
        2. Evaluate the differences in distal psychological (Mental Health Related Quality of Life,&#xD;
           Depressive Cognitions, Depressive Symptoms, Anxiety, Caregiver Burden), physical&#xD;
           (Physical Health Related Quality of Life), and cost outcomes between subjects in the&#xD;
           ReMind and Mind Only arms over time.&#xD;
&#xD;
        3. Determine the moderating effects of parents' social support, demographics (age, gender,&#xD;
           family income) and children's functional status on (a) proximal outcomes and the&#xD;
           relationship between (a) the intervention arm and distal outcomes, and (b) HPA Axis&#xD;
           Function, stress, cognitive factors and distal outcomes.&#xD;
&#xD;
        4. Evaluate the impact of decentering on the association between the interventions and the&#xD;
           proximal and distal outcomes.&#xD;
&#xD;
        5. Explore differences in neurological processing (DMN and TPN) and decentering in proximal&#xD;
           and distal outcomes associated with each intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design Overview. The investigators will conduct a two-arm Randomized Clinical Trial to&#xD;
      compare the effects of the ReMind with the Mind interventions on psychological and physical&#xD;
      health outcomes and cognitive task switching between the DMN and TPN neural networks in&#xD;
      Functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI). The full&#xD;
      ReMind intervention involves daily self-tailored mindful meditation application focused on&#xD;
      kindness and compassion for 4 weeks with self-selected frequency of use thereafter. The&#xD;
      application that is being used is theoretically constructed and tested and can be delivered&#xD;
      on a smart phone app for free (iPad, computer as well). ReMind also includes five&#xD;
      resourcefulness training aspects: 1) one face-to-face session for teaching social&#xD;
      (help-seeking) and personal (self-help) resourcefulness skills, 2) ongoing web access to&#xD;
      video vignettes of parents of technology-dependent children describing the application of&#xD;
      resourcefulness skills in daily life, 3) 4 weeks of skills' reinforcement using daily journal&#xD;
      writing by the parents, 4) weekly phone calls from the intervention nurse over 4 weeks after&#xD;
      face-to-face intervention training. The Mind Only intervention includes only the meditation&#xD;
      component. Thus, the investigators will be able to see if the addition of Resourcefulness&#xD;
      Training will significantly impact proximal outcomes (self management behaviors) such as&#xD;
      appraised sleep quality, positive health practices and distal outcomes such as psychological&#xD;
      health (Mental Health Related Quality of Life, depressive cognitions, anxiety, caregiver&#xD;
      burden), physical health (Physical Health Related Quality of Life), and economic costs.&#xD;
&#xD;
      Sample. A purposive sample of 30 parent caregivers of technology-dependent children (n=15&#xD;
      ReMind, n=15 Mind Only) seen at outpatient clinics (Pulmonology, Gastroenterology,&#xD;
      Trach/Vent). The investigators have used this patient population in prior work. Given the&#xD;
      availability of potential subjects and the investigator's experience with this population,&#xD;
      the investigators anticipate little difficulty in recruiting 30 subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2017</start_date>
  <completion_date type="Actual">March 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 30, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Mental &amp; Physical Health Related Quality of Life at 3 Months &amp; 6 Months</measure>
    <time_frame>Measured at baseline with follow up at 3 months, 6 months</time_frame>
    <description>Measure using the Patient Reported Outcomes Measurement Information System (PROMIS)-29</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Appraised Sleep Quality at 3 months and 6 months</measure>
    <time_frame>Measured at baseline with follow up at 3 months, 6 months</time_frame>
    <description>Measure using Pittsburgh Sleep Quality Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Positive Health Practices at 3 months and 6 months</measure>
    <time_frame>Measured at baseline with follow up at 3 months, 6 months</time_frame>
    <description>Measure using Personal Lifestyle Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Caregiver</condition>
  <condition>Mindfulness</condition>
  <condition>Mechanical Ventilation Pressure High</condition>
  <condition>Gastrostomy</condition>
  <condition>Chronic Illness</condition>
  <arm_group>
    <arm_group_label>Mindfulness</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Mindfulness (Decentering) only using the Stop, Breathe, Think Smart Phone application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resourcefulness and Mindfulness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Resourcefulness Training (a cognitive behavioral intervention that teaches self-help and help-seeking skills) and Mindfulness using the Stop, Think, Breathe app.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resourcefulness Training</intervention_name>
    <description>This intervention will include a one time face to face instruction on Resourcefulness Training that entails 8 self-help and help-seeking skills plus viewing short video vignettes of caregivers describing application of the resourcefulness skills. In addition, participants will use daily journaling to describe application of the resourcefulness skills in their daily caregiving with their technology-dependent child.</description>
    <arm_group_label>Resourcefulness and Mindfulness</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness</intervention_name>
    <description>The mindfulness intervention will include the use of an app daily via Stop, Think, Breathe.</description>
    <arm_group_label>Mindfulness</arm_group_label>
    <arm_group_label>Resourcefulness and Mindfulness</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. parent (biological, adoptive, or foster mother, father, grandmother, or grandfather)&#xD;
             caregiver for a child aged ≤17 years dependent on medical technology (mechanical&#xD;
             ventilators, intravenous nutrition/medication, respiratory or nutritional support) at&#xD;
             home;&#xD;
&#xD;
          2. aged ≥18 years;&#xD;
&#xD;
          3. able to speak and understand English.&#xD;
&#xD;
             Exclusion Criteria:&#xD;
&#xD;
             1. currently practicing mindfulness-based interventions (yoga, meditation, deep&#xD;
             breathing)&#xD;
&#xD;
             2 history of a medical condition or procedure that is contraindicated for imaging&#xD;
             (i.e. cardiac pacemaker, sternal wires, or metal implants);&#xD;
&#xD;
             3 claustrophobia requiring anxiolytics or sedation&#xD;
&#xD;
             4 Pregnancy at time of recruitment.&#xD;
&#xD;
             5 If participant becomes pregnant during the follow up period the participant will be&#xD;
             excluded from all imaging studies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Valerie A Toly, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Case Western Reserve University, Frances Payne Bolton School of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106-5065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>September 24, 2019</last_update_submitted>
  <last_update_submitted_qc>September 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospitals Cleveland Medical Center</investigator_affiliation>
    <investigator_full_name>Valerie Toly</investigator_full_name>
    <investigator_title>Assistant Professor of Nursing</investigator_title>
  </responsible_party>
  <keyword>Caregiver</keyword>
  <keyword>Technology Dependent Children</keyword>
  <keyword>Resourcefulness</keyword>
  <keyword>Mindfulness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</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/NCT02993887
org study id: 10-16-10
nct id: NCT02993887
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators will conduct a randomized clinical trial pilot study to examine the
      effectiveness of a theoretically based intervention (called ReMind) encompassing two key
      components: (a) Resourcefulness Training for parent caregivers, and (b) daily mindfulness
      meditation delivered using a smart phone application (Stop, Breathe & Think™) with an
      intervention (Mind Only) that consists only of daily mindfulness meditation. Both components
      of the intervention have been tested separately (but not combined) and both interventions can
      be self-tailored, which meets the vital need for these caregivers to engage in
      self-management activities when it is convenient for them. The investigators will test the
      two arms of the intervention in 30 parents of technology-dependent children, 15 parents in
      each group. The investigators will collect mixed data at baseline, 3 months and 6 months
      after subject enrollment to describe changes in proximal and distal outcomes. The
      investigators aim to:

        1. Evaluate the intermediate (3 month) and long-term (6 month) effects of the ReMind and
           Mind Only interventions on study mediators (HPA Axis Function and stress, cognitive
           factors, resourcefulness) and determine if there are different effects between ReMind
           and Mind Only interventions.

        2. Evaluate the differences in distal psychological (Mental Health Related Quality of Life,
           Depressive Cognitions, Depressive Symptoms, Anxiety, Caregiver Burden), physical
           (Physical Health Related Quality of Life), and cost outcomes between subjects in the
           ReMind and Mind Only arms over time.

        3. Determine the moderating effects of parents' social support, demographics (age, gender,
           family income) and children's functional status on (a) proximal outcomes and the
           relationship between (a) the intervention arm and distal outcomes, and (b) HPA Axis
           Function, stress, cognitive factors and distal outcomes.

        4. Evaluate the impact of decentering on the association between the interventions and the
           proximal and distal outcomes.

        5. Explore differences in neurological processing (DMN and TPN) and decentering in proximal
           and distal outcomes associated with each intervention.
Design Overview. The investigators will conduct a two-arm Randomized Clinical Trial to
      compare the effects of the ReMind with the Mind interventions on psychological and physical
      health outcomes and cognitive task switching between the DMN and TPN neural networks in
      Functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI). The full
      ReMind intervention involves daily self-tailored mindful meditation application focused on
      kindness and compassion for 4 weeks with self-selected frequency of use thereafter. The
      application that is being used is theoretically constructed and tested and can be delivered
      on a smart phone app for free (iPad, computer as well). ReMind also includes five
      resourcefulness training aspects: 1) one face-to-face session for teaching social
      (help-seeking) and personal (self-help) resourcefulness skills, 2) ongoing web access to
      video vignettes of parents of technology-dependent children describing the application of
      resourcefulness skills in daily life, 3) 4 weeks of skills' reinforcement using daily journal
      writing by the parents, 4) weekly phone calls from the intervention nurse over 4 weeks after
      face-to-face intervention training. The Mind Only intervention includes only the meditation
      component. Thus, the investigators will be able to see if the addition of Resourcefulness
      Training will significantly impact proximal outcomes (self management behaviors) such as
      appraised sleep quality, positive health practices and distal outcomes such as psychological
      health (Mental Health Related Quality of Life, depressive cognitions, anxiety, caregiver
      burden), physical health (Physical Health Related Quality of Life), and economic costs.

      Sample. A purposive sample of 30 parent caregivers of technology-dependent children (n=15
      ReMind, n=15 Mind Only) seen at outpatient clinics (Pulmonology, Gastroenterology,
      Trach/Vent). The investigators have used this patient population in prior work. Given the
      availability of potential subjects and the investigator's experience with this population,
      the investigators anticipate little difficulty in recruiting 30 subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Change from Baseline Mental & Physical Health Related Quality of Life at 3 Months & 6 Months
time frame: Measured at baseline with follow up at 3 months, 6 months
description: Measure using the Patient Reported Outcomes Measurement Information System (PROMIS)-29
measure: Change from Baseline Appraised Sleep Quality at 3 months and 6 months
time frame: Measured at baseline with follow up at 3 months, 6 months
description: Measure using Pittsburgh Sleep Quality Index
measure: Change from Baseline Positive Health Practices at 3 months and 6 months
time frame: Measured at baseline with follow up at 3 months, 6 months
description: Measure using Personal Lifestyle Questionnaire
arm group label: Mindfulness
arm group type: Placebo Comparator
description: Mindfulness (Decentering) only using the Stop, Breathe, Think Smart Phone application
arm group label: Resourcefulness and Mindfulness
arm group type: Experimental
description: Resourcefulness Training (a cognitive behavioral intervention that teaches self-help and help-seeking skills) and Mindfulness using the Stop, Think, Breathe app.
intervention type: Behavioral
intervention name: Resourcefulness Training
description: This intervention will include a one time face to face instruction on Resourcefulness Training that entails 8 self-help and help-seeking skills plus viewing short video vignettes of caregivers describing application of the resourcefulness skills. In addition, participants will use daily journaling to describe application of the resourcefulness skills in their daily caregiving with their technology-dependent child.
arm group label: Resourcefulness and Mindfulness
intervention type: Behavioral
intervention name: Mindfulness
description: The mindfulness intervention will include the use of an app daily via Stop, Think, Breathe.
arm group label: Mindfulness
arm group label: Resourcefulness and Mindfulness
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Valerie A Toly, PhD
role: Principal Investigator
affiliation: Case Western Reserve University, Frances Payne Bolton School of Nursing
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University Hospitals Cleveland Medical Center
investigator full name: Valerie Toly
investigator title: Assistant Professor of Nursing
mesh term: Chronic Disease
sharing ipd: Undecided