<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/NCT03820674</url>
  </required_header>
  <id_info>
    <org_study_id>UMCIRB 16-000078</org_study_id>
    <nct_id>NCT03820674</nct_id>
  </id_info>
  <brief_title>A Telerehabilitation Intervention for People With Heart Failure and Chronic Fatigue</brief_title>
  <official_title>A Telerehabilitation Intervention to Reduce the Impact of Fatigue in People With Congestive Heart Failure and Chronic Fatigue</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>East Carolina University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>East Carolina University</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 compares the effectiveness of a 6-week Energy Conservation + Problem Solving&#xD;
      Therapy Intervention to Health Education Intervention for reducing the fatigue impact and&#xD;
      fatigue level and improving the level of participation in instrumental, leisure, and social&#xD;
      activities in people with heart failure associated fatigue. Half of the participants received&#xD;
      Energy Conservation + Problem Solving Therapy Intervention, and the other half received&#xD;
      Health Education Intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Energy Conservation+Problem Solving Therapy (EC+PST) Intervention: In this study, the EC+PST&#xD;
      Intervention will ideally occur twice a week for 6 weeks with each session lasting&#xD;
      approximately 30 minutes. The intervention will be individually delivered via telehealth;&#xD;
      therefore, participants will receive the intervention in their home to minimize fatigue from&#xD;
      the intervention.&#xD;
&#xD;
      Health Education Intervention: The Health Education Intervention will occur once a week for 6&#xD;
      weeks with each session lasting approximately 30 minutes. The Health Education Intervention&#xD;
      will be delivered via telehealth; therefore, participants will receive the intervention at&#xD;
      their convenient quiet place to minimize fatigue from the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 17, 2016</start_date>
  <completion_date type="Actual">May 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 2, 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>
    <intervention_model_description>Both groups received 6-week interventions.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants are blinded to their group assignment. Assessors and interventionists were not blinded to the group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Fatigue Impact Scale (FIS)</measure>
    <time_frame>Pretest (Week 0), Posttest (Week 7)</time_frame>
    <description>The FIS is a 40-item measure that assesses the impact of fatigue on daily life in three different dimensions: Cognitive (10 items), Physical (10 items), and Psychosocial functioning (20 items). Each item is rated on a 5-point scale ranging from 0 (no problem) to 4 (extreme problem), and the global score is the sum of 40 items, ranging from 0 to 160.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form Ver 1.0 Fatigue 8a</measure>
    <time_frame>Pretest (Week 0), Posttest (Week 7)</time_frame>
    <description>The PROMIS Fatigue 8a is a test measuring the experience and impact of fatigue. This assessment consists of 8 questions on fatigue experience and impact, and the raw score is converted to T-score (50% is the mean of the population). Higher the T-score, worse the fatigue.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Activity Card Sort (ACS)</measure>
    <time_frame>Pretest (Week 0), Posttest (Week 7)</time_frame>
    <description>The ACS is a measure of the participation level in instrumental, leisure, and social activities. The ACS uses 89 photographs to calculate the percentage of retained activities since their diagnosis</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Energy Conservation plus Problem Solving Therapy Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receiving experimental intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health Education Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receiving control intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Energy Conservation plus Problem Solving Therapy</intervention_name>
    <description>EC-PST is a client-centered intervention aiming to guide people with chronic fatigue to create their own solutions so that they can generalize those learned solutions and strategies to other fatigue-related problems even after completing the study participation. Some of the topics covered during the first two introductory sessions are facts regarding fatigue, budgeting and banking energy, and the introduction of EC+PST Intervention.</description>
    <arm_group_label>Energy Conservation plus Problem Solving Therapy Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Health Education Intervention</intervention_name>
    <description>The interventionist will be the PI, an occupational therapist (co-I), or OT graduate student who will be trained in the health education topics. During the Health Education sessions, participants will be educated on health-related topics relevant to CHF and EC strategies, although they will not learn how to apply the information to their daily life. Health Education Workbook containing information on the topics taught during the sessions will be provided during the Pretest visit and used throughout the Health Education sessions.</description>
    <arm_group_label>Health Education Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (a) a minimum 6 months since diagnosed with HF and 3 months post-hospitalization, (b)&#xD;
        reporting of moderate to severe fatigue by scoring ≥4 according to Fatigue Severity Scale,&#xD;
        (c) living in the community, (d) having access to the internet or telephone in the place of&#xD;
        residence, (e) having functional English fluency, and (f) having functional vision to&#xD;
        operate the tablet computer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. had a score of ≥9 in Short Blessed Test indicating cognitive impairment&#xD;
&#xD;
          2. were classified as having New York Heart Association (NYHA) Functional Classification&#xD;
             level IV on their medical record&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 27, 2020</last_update_submitted>
  <last_update_submitted_qc>January 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>East Carolina University</investigator_affiliation>
    <investigator_full_name>Young Joo Kim</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Heart Failure</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Occupational Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Fatigue</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/NCT03820674
org study id: UMCIRB 16-000078
nct id: NCT03820674
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study compares the effectiveness of a 6-week Energy Conservation + Problem Solving
      Therapy Intervention to Health Education Intervention for reducing the fatigue impact and
      fatigue level and improving the level of participation in instrumental, leisure, and social
      activities in people with heart failure associated fatigue. Half of the participants received
      Energy Conservation + Problem Solving Therapy Intervention, and the other half received
      Health Education Intervention.
Energy Conservation+Problem Solving Therapy (EC+PST) Intervention: In this study, the EC+PST
      Intervention will ideally occur twice a week for 6 weeks with each session lasting
      approximately 30 minutes. The intervention will be individually delivered via telehealth;
      therefore, participants will receive the intervention in their home to minimize fatigue from
      the intervention.

      Health Education Intervention: The Health Education Intervention will occur once a week for 6
      weeks with each session lasting approximately 30 minutes. The Health Education Intervention
      will be delivered via telehealth; therefore, participants will receive the intervention at
      their convenient quiet place to minimize fatigue from the intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Both groups received 6-week interventions.
primary purpose: Treatment
masking: Single (Participant)
masking description: Participants are blinded to their group assignment. Assessors and interventionists were not blinded to the group assignment.
measure: Changes in Fatigue Impact Scale (FIS)
time frame: Pretest (Week 0), Posttest (Week 7)
description: The FIS is a 40-item measure that assesses the impact of fatigue on daily life in three different dimensions: Cognitive (10 items), Physical (10 items), and Psychosocial functioning (20 items). Each item is rated on a 5-point scale ranging from 0 (no problem) to 4 (extreme problem), and the global score is the sum of 40 items, ranging from 0 to 160.
measure: Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form Ver 1.0 Fatigue 8a
time frame: Pretest (Week 0), Posttest (Week 7)
description: The PROMIS Fatigue 8a is a test measuring the experience and impact of fatigue. This assessment consists of 8 questions on fatigue experience and impact, and the raw score is converted to T-score (50% is the mean of the population). Higher the T-score, worse the fatigue.
measure: Changes in Activity Card Sort (ACS)
time frame: Pretest (Week 0), Posttest (Week 7)
description: The ACS is a measure of the participation level in instrumental, leisure, and social activities. The ACS uses 89 photographs to calculate the percentage of retained activities since their diagnosis
arm group label: Energy Conservation plus Problem Solving Therapy Intervention
arm group type: Experimental
description: Receiving experimental intervention
arm group label: Health Education Intervention
arm group type: Active Comparator
description: Receiving control intervention
intervention type: Other
intervention name: Energy Conservation plus Problem Solving Therapy
description: EC-PST is a client-centered intervention aiming to guide people with chronic fatigue to create their own solutions so that they can generalize those learned solutions and strategies to other fatigue-related problems even after completing the study participation. Some of the topics covered during the first two introductory sessions are facts regarding fatigue, budgeting and banking energy, and the introduction of EC+PST Intervention.
arm group label: Energy Conservation plus Problem Solving Therapy Intervention
intervention type: Other
intervention name: Health Education Intervention
description: The interventionist will be the PI, an occupational therapist (co-I), or OT graduate student who will be trained in the health education topics. During the Health Education sessions, participants will be educated on health-related topics relevant to CHF and EC strategies, although they will not learn how to apply the information to their daily life. Health Education Workbook containing information on the topics taught during the sessions will be provided during the Pretest visit and used throughout the Health Education sessions.
arm group label: Health Education Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: East Carolina University
investigator full name: Young Joo Kim
investigator title: Assistant Professor
mesh term: Heart Failure
mesh term: Fatigue