<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/NCT03825770</url>
  </required_header>
  <id_info>
    <org_study_id>18-1657</org_study_id>
    <nct_id>NCT03825770</nct_id>
  </id_info>
  <brief_title>Pilot Study of an Educational Program for Adults on Hemodialysis With Fatigue</brief_title>
  <acronym>Fatigue-HD</acronym>
  <official_title>A Pilot Randomized Controlled Trial of an Educational Program for Adults on Hemodialysis With Fatigue</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Calgary</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>
      Fatigue is a common and problematic symptom of end-stage renal disease (ESRD). The&#xD;
      investigators have developed a new program, called the Personal Energy Planning (PEP)&#xD;
      program, that teaches people with ESRD to manage fatigue by using energy conservation&#xD;
      strategies during everyday life (eg. organization, prioritization, using good body postures&#xD;
      and assistive tools). A large study is needed to test whether the program is helpful for&#xD;
      people with ESRD. First, the investigators need to do a smaller-scale pilot study to help&#xD;
      plan the large study. The main purposes of this pilot study are to see how many people with&#xD;
      ESRD are willing and able to complete the PEP program, and to explore whether the program&#xD;
      helps people feel less fatigued. The investigators plan to invite 40 people with ESRD from 4&#xD;
      dialysis units in Calgary, Alberta to participate. People with ESRD who report feeling&#xD;
      unusually tired a lot of the time (using a symptom assessment tool completed every 2 months)&#xD;
      will be asked to take part. Study participants will either do the PEP program, or another&#xD;
      program (the control) that gives them general information about kidney disease. Participants&#xD;
      will also be asked to complete questionnaires about fatigue before and after the study. The&#xD;
      investigators will compare fatigue scores between the PEP program group and the control&#xD;
      group, and record how many agree to take part in the study and complete all study activities.&#xD;
      This pilot study will help the investigators plan next steps for research into the PEP&#xD;
      program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND: Fatigue is one of the most common, disabling, and distressing symptoms&#xD;
      experienced by people with end-stage renal disease (ESRD; kidney failure). There are&#xD;
      currently few evidence-based treatment options to address fatigue in the ESRD population.&#xD;
      Energy conservation education (ECE) is a rehabilitative approach shown to improve&#xD;
      fatigue-related outcomes in other chronic disease populations, that has yet to be studied in&#xD;
      people with ESRD. The investigators recently developed a novel ECE program for people with&#xD;
      ESRD, conducted acceptability and usability testing, and showed improvements in fatigue and&#xD;
      disability in single-case studies. A large randomized controlled trial (RCT) is now required&#xD;
      to establish the efficacy of the PEP program, but additional feasibility information is first&#xD;
      needed to design the definitive RCT.&#xD;
&#xD;
      OBJECTIVES:&#xD;
&#xD;
        1. To estimate the proportion of ESRD patients that are eligible for the RCT, will consent&#xD;
           to participate, and will complete all study procedures&#xD;
&#xD;
        2. To identify the optimal primary outcome for the RCT and estimate the treatment effect&#xD;
           size for RCT sample size calculations&#xD;
&#xD;
        3. To examine treatment fidelity to the PEP program among non-rehabilitation staff who&#xD;
           undergo program administration training&#xD;
&#xD;
        4. To explore the effects of the PEP program on fatigue and disability at 3 months&#xD;
           post-treatment&#xD;
&#xD;
      METHODS: Single-center, 1:1, parallel-arm pilot RCT. Adults on hemodialysis in Calgary at 4&#xD;
      dialysis units will be screened for eligibility. Prospective participants will be identified&#xD;
      and approached by a clinical team member to assess their interest in the study. Interested&#xD;
      patients will then be approached by a research team member to undergo informed consent and&#xD;
      eligibility screening. Consenting participants will be randomized using a computer-generated&#xD;
      randomization list and blocked randomization. Patients and outcome adjudicators will be&#xD;
      blinded as to which is the treatment vs. control condition (blinding of providers is not&#xD;
      feasible). Participants randomized to intervention will undergo the PEP energy conservation&#xD;
      education program, consisting of two web modules and 4-7 sessions with a study clinician.&#xD;
      Participants randomized to control will review the &quot;Living with Kidney Disease&quot; patient&#xD;
      handbooks with a study clinician. Routine demographic and clinical data will be obtained at&#xD;
      baseline, and the following measures will be administered to participants at baseline,&#xD;
      mid-treatment, immediate post-treatment, and three months post-treatment: the Fatigue&#xD;
      Severity Scale, Fatigue Impact Scale, Fatigue Management Questionnaire, Reintegration to&#xD;
      Normal Living Index, and Canadian Occupational Performance Measure. A sample size of 40&#xD;
      patients (20 per arm) will provide an optimal estimate of treatment effect size for RCT&#xD;
      sample size calculations, given 80% power, a small/medium effect size, and an attrition rate&#xD;
      of ≤20%.&#xD;
&#xD;
      DATA ANALYSIS: The proportion of patients meeting each of the feasibility endpoints&#xD;
      (eligibility, recruitment and attrition rates) will be calculated. Pre-to-post effect sizes&#xD;
      will be calculated for all outcome measures used, and the outcome measure with the largest&#xD;
      effect size will be chosen as the primary outcome for the RCT. Sample size calculations will&#xD;
      then be made using the treatment effect size and variance from the pilot RCT data. Audio&#xD;
      recordings of treatment sessions will be reviewed and rated using a Likert-scale rating&#xD;
      system to estimate treatment fidelity. Effect sizes will also be calculated from&#xD;
      pre-intervention to 3 months post-intervention.&#xD;
&#xD;
      IMPLICATIONS: Findings from this pilot RCT will help in the design of a robust RCT of the PEP&#xD;
      program, which has the potential to improve fatigue management in the ESRD population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2019</start_date>
  <completion_date type="Actual">February 15, 2020</completion_date>
  <primary_completion_date type="Actual">February 15, 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>1:1 pilot randomized controlled trial. Participants will be randomized to intervention (energy conservation education) or active control (general information about kidney disease).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Study participants will be blinded as to which educational program is the &quot;active&quot; treatment under study. Patient study materials and communications will only describe the study as being about an educational program for adults on hemodialysis with fatigue.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Eligibility rate</measure>
    <time_frame>From start to end of study screening (approximately 9 months)</time_frame>
    <description>The proportion of patients screened who are eligible for the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>From start to end of study recruitment (approximately 9 months)</time_frame>
    <description>The proportion of patients eligible for the study who consent to participate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attrition rate</measure>
    <time_frame>From start to end of study data collection (approximately 15 months)</time_frame>
    <description>The proportion of consenting patients who withdraw from the study before completing all study activities</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fatigue Severity Scale</measure>
    <time_frame>From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention</time_frame>
    <description>A 9-item self-report questionnaire which measures the severity of fatigue and its impact on activities and lifestyle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Impact Scale</measure>
    <time_frame>From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention</time_frame>
    <description>A 21-item self-report questionnaire which assesses the effects of fatigue on physical, cognitive, and psychosocial functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Management Questionnaire</measure>
    <time_frame>From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention</time_frame>
    <description>A 5-item self-report questionnaire which assesses self-perceived competence at fatigue management</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reintegration to Normal Living Index</measure>
    <time_frame>From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention</time_frame>
    <description>An 11-item self-report questionnaire which assesses the degree to which individuals who have experienced traumatic or incapacitating illness, achieve reintegration into normal social activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Canadian Occupational Performance Measure</measure>
    <time_frame>From 2 weeks mid-intervention to 1 week post-intervention, and 3 months post-intervention</time_frame>
    <description>An outcome measure designed to capture a client's self-perception of performance in everyday living, over time</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fidelity to treatment protocol</measure>
    <time_frame>From start to end of study intervention (approximately 10 weeks per participant)</time_frame>
    <description>Adherence to PEP program protocol by program administrators, measured by the Co-op Fidelity Checklist</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Renal Dialysis</condition>
  <condition>Fatigue</condition>
  <condition>Rehabilitation</condition>
  <condition>Quality of Life</condition>
  <condition>Kidney Diseases</condition>
  <arm_group>
    <arm_group_label>The &quot;PEP&quot; Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The &quot;PEP&quot; (Personal Energy Planning) Program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>General Education about Kidney Disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The &quot;PEP&quot; (Personal Energy Planning) Program</intervention_name>
    <description>The PEP program is designed to teach people on dialysis with fatigue how to conserve energy during day-to-day tasks, and how to use energy conservation to accomplish their goals. The program is delivered over 7-9 weekly sessions. It consists of 2 educational web modules about energy conservation, and 5-7 goal-focused training sessions with a study clinician that utilize a problem-solving training approach known as the Cognitive Orientation to Occupational Performance (CO-OP) approach. Each program session lasts ~20-30 mins. Sessions are completed either in person during hemodialysis, or via telephone (based on patient preference). The program is administered by a trained study clinician (occupational therapist or nurse).</description>
    <arm_group_label>The &quot;PEP&quot; Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>General Education about Kidney Disease</intervention_name>
    <description>General education about kidney disease involves a review of information from the Kidney Foundation of Canada's patient handbooks &quot;Living with Reduced Kidney Function&quot; and &quot;Living with Kidney Failure&quot; (www.kidney.ca/manual) during 6-8 brief individual sessions with a trained study clinician (occupational therapist or nurse).The handbooks contains general information about managing kidney disease, addressing topics such as medication management, diet, and emotional well-being on dialysis. Sessions will take place either in person during hemodialysis, or via telephone (based on patient preference).</description>
    <arm_group_label>General Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged ≥18 years&#xD;
&#xD;
          -  On chronic dialysis therapy for ≥3 months at time of recruitment&#xD;
&#xD;
          -  Clinically and cognitively stable (able to provide informed consent)&#xD;
&#xD;
          -  Scores an avg. of ≥4 on items 5, 7 , 8 and 9 of the Fatigue Severity Scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inadequate written and verbal English comprehension for study activities&#xD;
&#xD;
          -  Plan in place to discontinue in-center hemodialysis at the participating center within&#xD;
             6 months of the time of recruitment (due to modality change, relocation,&#xD;
             transplantation, or dialysis withdrawal)&#xD;
&#xD;
          -  Resides in a nursing home facility&#xD;
&#xD;
          -  Significant visual impairment (ie. unable to read size 14-pt font, Times New Roman)&#xD;
&#xD;
          -  Scores &gt;3 on Personal Health Questionnaire 2 (PHQ-2) depression screening tool&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brenda R Hemmelgarn, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>South Calgary Health Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2X 3W5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Murtagh FE, Addington-Hall J, Higginson IJ. The prevalence of symptoms in end-stage renal disease: a systematic review. Adv Chronic Kidney Dis. 2007 Jan;14(1):82-99. doi: 10.1053/j.ackd.2006.10.001.</citation>
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    <citation>Davison SN, Jhangri GS. Impact of pain and symptom burden on the health-related quality of life of hemodialysis patients. J Pain Symptom Manage. 2010 Mar;39(3):477-85. doi: 10.1016/j.jpainsymman.2009.08.008.</citation>
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    <citation>Manns B, Hemmelgarn B, Lillie E, Dip SC, Cyr A, Gladish M, Large C, Silverman H, Toth B, Wolfs W, Laupacis A. Setting research priorities for patients on or nearing dialysis. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1813-21. doi: 10.2215/CJN.01610214. Epub 2014 May 15.</citation>
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    <citation>Artom M, Moss-Morris R, Caskey F, Chilcot J. Fatigue in advanced kidney disease. Kidney Int. 2014 Sep;86(3):497-505. doi: 10.1038/ki.2014.86. Epub 2014 Apr 2.</citation>
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    <citation>Mathiowetz VG, Finlayson ML, Matuska KM, Chen HY, Luo P. Randomized controlled trial of an energy conservation course for persons with multiple sclerosis. Mult Scler. 2005 Oct;11(5):592-601. doi: 10.1191/1352458505ms1198oa.</citation>
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    <citation>Vanage SM, Gilbertson KK, Mathiowetz V. Effects of an energy conservation course on fatigue impact for persons with progressive multiple sclerosis. Am J Occup Ther. 2003 May-Jun;57(3):315-23. doi: 10.5014/ajot.57.3.315.</citation>
    <PMID>12785670</PMID>
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    <citation>Kim YJ, Rogers JC, Raina KD, Callaway CW, Rittenberger JC, Leibold ML, Holm MB. Solving fatigue-related problems with cardiac arrest survivors living in the community. Resuscitation. 2017 Sep;118:70-74. doi: 10.1016/j.resuscitation.2017.07.005. Epub 2017 Jul 8.</citation>
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    <citation>Norberg EB, Lofgren B, Boman K, Wennberg P, Brannstrom M. A client-centred programme focusing energy conservation for people with heart failure. Scand J Occup Ther. 2017 Nov;24(6):455-467. doi: 10.1080/11038128.2016.1272631. Epub 2017 Jan 5.</citation>
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    <PMID>11345506</PMID>
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    <citation>Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.</citation>
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    <citation>Learmonth YC, Dlugonski D, Pilutti LA, Sandroff BM, Klaren R, Motl RW. Psychometric properties of the Fatigue Severity Scale and the Modified Fatigue Impact Scale. J Neurol Sci. 2013 Aug 15;331(1-2):102-7. doi: 10.1016/j.jns.2013.05.023. Epub 2013 Jun 20.</citation>
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    <citation>Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994 Jan;18 Suppl 1:S79-83. doi: 10.1093/clinids/18.supplement_1.s79.</citation>
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    <citation>Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.</citation>
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  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Dr. Brenda Hemmelgarn</investigator_full_name>
    <investigator_title>Department Head, Community Health Sciences</investigator_title>
  </responsible_party>
  <keyword>Fatigue</keyword>
  <keyword>Energy conservation</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Occupational therapy</keyword>
  <keyword>End-stage renal disease</keyword>
  <keyword>Chronic kidney disease</keyword>
  <keyword>Hemodialysis</keyword>
  <keyword>Disability</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Fatigue</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/NCT03825770
org study id: 18-1657
nct id: NCT03825770
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Fatigue is a common and problematic symptom of end-stage renal disease (ESRD). The
      investigators have developed a new program, called the Personal Energy Planning (PEP)
      program, that teaches people with ESRD to manage fatigue by using energy conservation
      strategies during everyday life (eg. organization, prioritization, using good body postures
      and assistive tools). A large study is needed to test whether the program is helpful for
      people with ESRD. First, the investigators need to do a smaller-scale pilot study to help
      plan the large study. The main purposes of this pilot study are to see how many people with
      ESRD are willing and able to complete the PEP program, and to explore whether the program
      helps people feel less fatigued. The investigators plan to invite 40 people with ESRD from 4
      dialysis units in Calgary, Alberta to participate. People with ESRD who report feeling
      unusually tired a lot of the time (using a symptom assessment tool completed every 2 months)
      will be asked to take part. Study participants will either do the PEP program, or another
      program (the control) that gives them general information about kidney disease. Participants
      will also be asked to complete questionnaires about fatigue before and after the study. The
      investigators will compare fatigue scores between the PEP program group and the control
      group, and record how many agree to take part in the study and complete all study activities.
      This pilot study will help the investigators plan next steps for research into the PEP
      program.
BACKGROUND: Fatigue is one of the most common, disabling, and distressing symptoms
      experienced by people with end-stage renal disease (ESRD; kidney failure). There are
      currently few evidence-based treatment options to address fatigue in the ESRD population.
      Energy conservation education (ECE) is a rehabilitative approach shown to improve
      fatigue-related outcomes in other chronic disease populations, that has yet to be studied in
      people with ESRD. The investigators recently developed a novel ECE program for people with
      ESRD, conducted acceptability and usability testing, and showed improvements in fatigue and
      disability in single-case studies. A large randomized controlled trial (RCT) is now required
      to establish the efficacy of the PEP program, but additional feasibility information is first
      needed to design the definitive RCT.

      OBJECTIVES:

        1. To estimate the proportion of ESRD patients that are eligible for the RCT, will consent
           to participate, and will complete all study procedures

        2. To identify the optimal primary outcome for the RCT and estimate the treatment effect
           size for RCT sample size calculations

        3. To examine treatment fidelity to the PEP program among non-rehabilitation staff who
           undergo program administration training

        4. To explore the effects of the PEP program on fatigue and disability at 3 months
           post-treatment

      METHODS: Single-center, 1:1, parallel-arm pilot RCT. Adults on hemodialysis in Calgary at 4
      dialysis units will be screened for eligibility. Prospective participants will be identified
      and approached by a clinical team member to assess their interest in the study. Interested
      patients will then be approached by a research team member to undergo informed consent and
      eligibility screening. Consenting participants will be randomized using a computer-generated
      randomization list and blocked randomization. Patients and outcome adjudicators will be
      blinded as to which is the treatment vs. control condition (blinding of providers is not
      feasible). Participants randomized to intervention will undergo the PEP energy conservation
      education program, consisting of two web modules and 4-7 sessions with a study clinician.
      Participants randomized to control will review the "Living with Kidney Disease" patient
      handbooks with a study clinician. Routine demographic and clinical data will be obtained at
      baseline, and the following measures will be administered to participants at baseline,
      mid-treatment, immediate post-treatment, and three months post-treatment: the Fatigue
      Severity Scale, Fatigue Impact Scale, Fatigue Management Questionnaire, Reintegration to
      Normal Living Index, and Canadian Occupational Performance Measure. A sample size of 40
      patients (20 per arm) will provide an optimal estimate of treatment effect size for RCT
      sample size calculations, given 80% power, a small/medium effect size, and an attrition rate
      of ≤20%.

      DATA ANALYSIS: The proportion of patients meeting each of the feasibility endpoints
      (eligibility, recruitment and attrition rates) will be calculated. Pre-to-post effect sizes
      will be calculated for all outcome measures used, and the outcome measure with the largest
      effect size will be chosen as the primary outcome for the RCT. Sample size calculations will
      then be made using the treatment effect size and variance from the pilot RCT data. Audio
      recordings of treatment sessions will be reviewed and rated using a Likert-scale rating
      system to estimate treatment fidelity. Effect sizes will also be calculated from
      pre-intervention to 3 months post-intervention.

      IMPLICATIONS: Findings from this pilot RCT will help in the design of a robust RCT of the PEP
      program, which has the potential to improve fatigue management in the ESRD population.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 1:1 pilot randomized controlled trial. Participants will be randomized to intervention (energy conservation education) or active control (general information about kidney disease).
primary purpose: Treatment
masking: Single (Participant)
masking description: Study participants will be blinded as to which educational program is the "active" treatment under study. Patient study materials and communications will only describe the study as being about an educational program for adults on hemodialysis with fatigue.
measure: Eligibility rate
time frame: From start to end of study screening (approximately 9 months)
description: The proportion of patients screened who are eligible for the study
measure: Recruitment rate
time frame: From start to end of study recruitment (approximately 9 months)
description: The proportion of patients eligible for the study who consent to participate
measure: Attrition rate
time frame: From start to end of study data collection (approximately 15 months)
description: The proportion of consenting patients who withdraw from the study before completing all study activities
measure: Fatigue Severity Scale
time frame: From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention
description: A 9-item self-report questionnaire which measures the severity of fatigue and its impact on activities and lifestyle
measure: Fatigue Impact Scale
time frame: From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention
description: A 21-item self-report questionnaire which assesses the effects of fatigue on physical, cognitive, and psychosocial functioning
measure: Fatigue Management Questionnaire
time frame: From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention
description: A 5-item self-report questionnaire which assesses self-perceived competence at fatigue management
measure: Reintegration to Normal Living Index
time frame: From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention
description: An 11-item self-report questionnaire which assesses the degree to which individuals who have experienced traumatic or incapacitating illness, achieve reintegration into normal social activities
measure: Canadian Occupational Performance Measure
time frame: From 2 weeks mid-intervention to 1 week post-intervention, and 3 months post-intervention
description: An outcome measure designed to capture a client's self-perception of performance in everyday living, over time
measure: Fidelity to treatment protocol
time frame: From start to end of study intervention (approximately 10 weeks per participant)
description: Adherence to PEP program protocol by program administrators, measured by the Co-op Fidelity Checklist
arm group label: The "PEP" Program
arm group type: Experimental
description: The "PEP" (Personal Energy Planning) Program
arm group label: General Education
arm group type: Active Comparator
description: General Education about Kidney Disease
intervention type: Behavioral
intervention name: The "PEP" (Personal Energy Planning) Program
description: The PEP program is designed to teach people on dialysis with fatigue how to conserve energy during day-to-day tasks, and how to use energy conservation to accomplish their goals. The program is delivered over 7-9 weekly sessions. It consists of 2 educational web modules about energy conservation, and 5-7 goal-focused training sessions with a study clinician that utilize a problem-solving training approach known as the Cognitive Orientation to Occupational Performance (CO-OP) approach. Each program session lasts ~20-30 mins. Sessions are completed either in person during hemodialysis, or via telephone (based on patient preference). The program is administered by a trained study clinician (occupational therapist or nurse).
arm group label: The "PEP" Program
intervention type: Behavioral
intervention name: General Education about Kidney Disease
description: General education about kidney disease involves a review of information from the Kidney Foundation of Canada's patient handbooks "Living with Reduced Kidney Function" and "Living with Kidney Failure" (www.kidney.ca/manual) during 6-8 brief individual sessions with a trained study clinician (occupational therapist or nurse).The handbooks contains general information about managing kidney disease, addressing topics such as medication management, diet, and emotional well-being on dialysis. Sessions will take place either in person during hemodialysis, or via telephone (based on patient preference).
arm group label: General Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brenda R Hemmelgarn, MD, PhD
role: Principal Investigator
affiliation: University of Calgary
facility: 
country: Canada
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responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Dr. Brenda Hemmelgarn
investigator title: Department Head, Community Health Sciences
mesh term: Kidney Diseases
mesh term: Fatigue
sharing ipd: No