<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/NCT03248518</url>
  </required_header>
  <id_info>
    <org_study_id>2.049.16</org_study_id>
    <secondary_id>Epi029</secondary_id>
    <nct_id>NCT03248518</nct_id>
  </id_info>
  <brief_title>Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases</brief_title>
  <acronym>LIFT</acronym>
  <official_title>Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases: A Randomised Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aberdeen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Versus Arthritis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aberdeen</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>
      Fatigue is common and disabling for most patients with inflammatory rheumatic disease.&#xD;
      Therapies designed to improve physical activity and 'talking' treatments, which positively&#xD;
      help patients change the way they think and behave, are both helpful in reducing the burden&#xD;
      of the fatigue. However, few patients have access to these treatments in most health&#xD;
      services. This situation results from the absence of standardised programmes and limited&#xD;
      availability of relevant therapists.&#xD;
&#xD;
      The investigators aim to enhance access to fatigue alleviating physical activity and talking&#xD;
      therapies by testing innovative,standardised and cost-effective approaches to treatment&#xD;
      delivery.&#xD;
&#xD;
      The investigators will also use this opportunity to understand how to select the best&#xD;
      treatment for a patient based on their individual profile and to better understand how these&#xD;
      treatments actually work. This in turn may lead to more refined and effective therapies in&#xD;
      the future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible participants will be identified from patients with inflammatory rheumatic diseases&#xD;
      attending major secondary care rheumatology services in the United Kingdom. Potential&#xD;
      participants will be identified using local databases/clinic lists and will then be mailed a&#xD;
      pre-study invite, which will include questions about fatigue. Potentially eligible&#xD;
      participants will be invited to attend a baseline assessment.&#xD;
&#xD;
      Once it has been confirmed at the baseline assessement that they are eligible to take part in&#xD;
      the study, the consented participant will be allocated to one of three treatment groups.&#xD;
      During the course of the trial, the participant will be invited to visit the study centre&#xD;
      three more times for assessments.&#xD;
&#xD;
      At each of the four assessment visits (baseline, and approximately 2, 7 and 13 months after)&#xD;
      they will be asked:&#xD;
&#xD;
        1. To complete questionnaires which collect information about various outcomes which we&#xD;
           think will improve in response to the therapies under evaluation as well as factors&#xD;
           which will help us understand how the treatments may work, and factors which may help&#xD;
           identify those patients better suited to one therapy over another&#xD;
&#xD;
        2. To provide a blood sample for research&#xD;
&#xD;
        3. To take part in an aerobic fitness test&#xD;
&#xD;
        4. To wear an activity monitor for the next 7 days which will be fitted at each visit&#xD;
&#xD;
        5. To answer three short questions about engagement with intervention delivered by&#xD;
           telephone from trial office at the time of session 4 and 8 (CBA and PEP intervention&#xD;
           only). Similarly, the allocated therapists will be asked to give their view of the&#xD;
           participants' engagement with the intervention.&#xD;
&#xD;
      All participants will be asked to keep a diary on any other treatments they are using in&#xD;
      addition to the treatments they may receive during the study and how costly these other&#xD;
      treatments are. The diary period will last for the first 6 months and then for 2 weeks after&#xD;
      the third visit and 2 weeks before the last visit.&#xD;
&#xD;
      After they finished the study, the investigators may approach a subgroup of participants who&#xD;
      received either the talking therapy or the personalised exercise programme again and ask for&#xD;
      an interview to enable more detailed feedback on if they found the intervention helpful and&#xD;
      how it has changed their daily life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">November 2, 2020</completion_date>
  <primary_completion_date type="Actual">November 2, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue (severity) using Chalder Fatigue Scale (Likert)</measure>
    <time_frame>56 weeks</time_frame>
    <description>Chalder Fatigue Scale (Likert), assessed at 56 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC with main estimate of treatment effect at 56 weeks after randomisation, Main estimate of treatment effect at 56 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue (severity) using Chalder Fatigue Scale (Likert)</measure>
    <time_frame>10 weeks</time_frame>
    <description>Chalder Fatigue Scale (Likert), assessed at 10 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue (severity) using Chalder Fatigue Scale (Likert)</measure>
    <time_frame>28 weeks</time_frame>
    <description>Chalder Fatigue Scale (Likert), assessed at 28 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue (impact) using Fatigue Severity Scale</measure>
    <time_frame>56 weeks</time_frame>
    <description>Fatigue Severity Scale, co-primary outcome assessed at 56 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC with main estimate of treatment effect at 56 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue (impact) using Fatigue Severity Scale</measure>
    <time_frame>10 weeks</time_frame>
    <description>Fatigue Severity Scale, co-primary outcome assessed at 10 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue (impact) using Fatigue Severity Scale</measure>
    <time_frame>28 weeks</time_frame>
    <description>Fatigue Severity Scale, co-primary outcome assessed at 28 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fatigue (physical, living, cognition and emotional aspects) using Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire</measure>
    <time_frame>0, 10 weeks, 28 weeks, 56 weeks after randomisation</time_frame>
    <description>Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life &amp; health utility index</measure>
    <time_frame>0, 10 weeks, 28 weeks, 56 weeks after randomisation</time_frame>
    <description>SF-12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain using numerical rating scale</measure>
    <time_frame>0, 10 weeks, 28 weeks, 56 weeks after randomisation</time_frame>
    <description>Pain numerical rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression using Hospital anxiety and depression scale</measure>
    <time_frame>0, 10 weeks, 28 weeks, 56 weeks after randomisation</time_frame>
    <description>Hospital anxiety and depression scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on work using Work Productivity and Activity Impairment Questionnaire</measure>
    <time_frame>0, 10 weeks, 28 weeks, 56 weeks after randomisation</time_frame>
    <description>Work Productivity and Activity Impairment Questionnaire: Specific Health Problem</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on activities using Valued Life Activities Scale</measure>
    <time_frame>0, 10 weeks, 28 weeks, 56 weeks after randomisation</time_frame>
    <description>Valued Life Activities Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of global health</measure>
    <time_frame>10 weeks, 28 weeks, 56 weeks after randomisation</time_frame>
    <description>Single question to indicate perceived change in global health compared with last assessment visit</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">368</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Lupus Erythematosus, Systemic</condition>
  <condition>Axial Spondyloarthritis</condition>
  <condition>Psoriatic Arthritis</condition>
  <condition>Sjogren's Syndrome</condition>
  <arm_group>
    <arm_group_label>Usual Care alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive written information about fatigue which is designed as self-management guide.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CBA + usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In addition to usual care, participants receive a talking therapy using a cognitive behavioural approach. The talking therapy will be delivered via telephone by a trained rheumatology health care professional who will contact the participant for 8 sessions over a period of 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEP + usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In addition to usual care, participants receive a personalised exercise programme. After an initial face-to-face assessment, the remaining programme will be delivered via telephone by a trained rheumatology health care professional who will contact the participant for 7 sessions over a period of 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Information booklet on fatigue which represents usual care in almost all UK rheumatology centres</description>
    <arm_group_label>CBA + usual care</arm_group_label>
    <arm_group_label>PEP + usual care</arm_group_label>
    <arm_group_label>Usual Care alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavioural approach</intervention_name>
    <description>A talking therapy which explicitly aims to replace unhelpful beliefs and behaviours through the application of patient-centred strategies and behavioural activities</description>
    <arm_group_label>CBA + usual care</arm_group_label>
    <other_name>CBA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Personalised Exercise Programme</intervention_name>
    <description>PEP is a graded exposure behaviour therapy which aims to gradually optimise patients levels of physical activity with view to modifying their altered perception of effort and ultimately reduce the severity and impact of fatigue.</description>
    <arm_group_label>PEP + usual care</arm_group_label>
    <other_name>PEP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be ≥ 18 years at the time of consent&#xD;
&#xD;
          -  have been diagnosed with rheumatoid arthritis (RA), systemic lupus erythematous (SLE),&#xD;
             axial spondyloarthritis (AxSpA) or psoriatic arthritis (PSA) by a rheumatologist&#xD;
&#xD;
          -  report fatigue to be a persistent problem&#xD;
&#xD;
          -  have access to a telephone landline or mobile telephone and/or internet based&#xD;
             audio/video calls&#xD;
&#xD;
          -  give permission for researchers to access their hospital medical notes&#xD;
&#xD;
          -  currently be under the care of a secondary care physician&#xD;
&#xD;
          -  have stable disease as evidenced by no change in immunomodulatory therapy within the&#xD;
             last three months based on the hospital medical record&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  there are significant abnormalities of thyroid function (TSH levels) on the most&#xD;
             recent blood test done within the last three months&#xD;
&#xD;
          -  there is evidence of severe anaemia (haemoglobin levels) on the most recent blood test&#xD;
             done within the last three months&#xD;
&#xD;
          -  there is evidence of severe renal dysfunction (eGFR) on the most recent blood test&#xD;
             done within the last three months&#xD;
&#xD;
          -  they have a medical condition which would make the proposed interventions unsuitable,&#xD;
             e.g. significant heart disease&#xD;
&#xD;
          -  they are pregnant&#xD;
&#xD;
          -  they are unable to understand English sufficiently to take part in the intervention&#xD;
&#xD;
          -  they are unable to provide written informed consent&#xD;
&#xD;
          -  they are not willing to be randomised&#xD;
&#xD;
          -  they are currently participating in an interventional clinical trial&#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>Gary Macfarlane, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aberdeen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Neil Basu, MBChB, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Glasgow</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NHS Grampian</name>
      <address>
        <city>Aberdeen</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Tayside</name>
      <address>
        <city>Dundee</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Lothian</name>
      <address>
        <city>Edinburgh</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Greater Glasgow and Clyde</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle upon Tyne Hospitals NHS Foundation Trust</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midlands Partnership NHS Foundation Trust</name>
      <address>
        <city>Stoke on Trent</city>
        <zip>ST6 7AG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://w3.abdn.ac.uk/hsru/lift/</url>
    <description>Click here for more information about this study</description>
  </link>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>February 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>September 7, 2021</last_update_submitted>
  <last_update_submitted_qc>September 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inflammatory Rheumatic Disease</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Exercise</keyword>
  <keyword>Behavioural Intervention</keyword>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>Systemic Lupus Erythematosus</keyword>
  <keyword>Axial Spondyloarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Arthritis, Psoriatic</mesh_term>
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Sjogren's Syndrome</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Axial Spondyloarthritis</mesh_term>
    <mesh_term>Collagen Diseases</mesh_term>
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03248518/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 6, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03248518/SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03248518/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>March 10, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03248518
org study id: 2.049.16
secondary id: Epi029
nct id: NCT03248518
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Fatigue is common and disabling for most patients with inflammatory rheumatic disease.
      Therapies designed to improve physical activity and 'talking' treatments, which positively
      help patients change the way they think and behave, are both helpful in reducing the burden
      of the fatigue. However, few patients have access to these treatments in most health
      services. This situation results from the absence of standardised programmes and limited
      availability of relevant therapists.

      The investigators aim to enhance access to fatigue alleviating physical activity and talking
      therapies by testing innovative,standardised and cost-effective approaches to treatment
      delivery.

      The investigators will also use this opportunity to understand how to select the best
      treatment for a patient based on their individual profile and to better understand how these
      treatments actually work. This in turn may lead to more refined and effective therapies in
      the future.
Eligible participants will be identified from patients with inflammatory rheumatic diseases
      attending major secondary care rheumatology services in the United Kingdom. Potential
      participants will be identified using local databases/clinic lists and will then be mailed a
      pre-study invite, which will include questions about fatigue. Potentially eligible
      participants will be invited to attend a baseline assessment.

      Once it has been confirmed at the baseline assessement that they are eligible to take part in
      the study, the consented participant will be allocated to one of three treatment groups.
      During the course of the trial, the participant will be invited to visit the study centre
      three more times for assessments.

      At each of the four assessment visits (baseline, and approximately 2, 7 and 13 months after)
      they will be asked:

        1. To complete questionnaires which collect information about various outcomes which we
           think will improve in response to the therapies under evaluation as well as factors
           which will help us understand how the treatments may work, and factors which may help
           identify those patients better suited to one therapy over another

        2. To provide a blood sample for research

        3. To take part in an aerobic fitness test

        4. To wear an activity monitor for the next 7 days which will be fitted at each visit

        5. To answer three short questions about engagement with intervention delivered by
           telephone from trial office at the time of session 4 and 8 (CBA and PEP intervention
           only). Similarly, the allocated therapists will be asked to give their view of the
           participants' engagement with the intervention.

      All participants will be asked to keep a diary on any other treatments they are using in
      addition to the treatments they may receive during the study and how costly these other
      treatments are. The diary period will last for the first 6 months and then for 2 weeks after
      the third visit and 2 weeks before the last visit.

      After they finished the study, the investigators may approach a subgroup of participants who
      received either the talking therapy or the personalised exercise programme again and ask for
      an interview to enable more detailed feedback on if they found the intervention helpful and
      how it has changed their daily life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Fatigue (severity) using Chalder Fatigue Scale (Likert)
time frame: 56 weeks
description: Chalder Fatigue Scale (Likert), assessed at 56 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC with main estimate of treatment effect at 56 weeks after randomisation, Main estimate of treatment effect at 56 weeks
measure: Fatigue (severity) using Chalder Fatigue Scale (Likert)
time frame: 10 weeks
description: Chalder Fatigue Scale (Likert), assessed at 10 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC
measure: Fatigue (severity) using Chalder Fatigue Scale (Likert)
time frame: 28 weeks
description: Chalder Fatigue Scale (Likert), assessed at 28 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC
measure: Fatigue (impact) using Fatigue Severity Scale
time frame: 56 weeks
description: Fatigue Severity Scale, co-primary outcome assessed at 56 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC with main estimate of treatment effect at 56 weeks
measure: Fatigue (impact) using Fatigue Severity Scale
time frame: 10 weeks
description: Fatigue Severity Scale, co-primary outcome assessed at 10 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC
measure: Fatigue (impact) using Fatigue Severity Scale
time frame: 28 weeks
description: Fatigue Severity Scale, co-primary outcome assessed at 28 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC
measure: Fatigue (physical, living, cognition and emotional aspects) using Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire
time frame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
description: Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire
measure: Quality of life & health utility index
time frame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
description: SF-12
measure: Pain using numerical rating scale
time frame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
description: Pain numerical rating scale
measure: Anxiety and depression using Hospital anxiety and depression scale
time frame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
description: Hospital anxiety and depression scale
measure: Impact on work using Work Productivity and Activity Impairment Questionnaire
time frame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
description: Work Productivity and Activity Impairment Questionnaire: Specific Health Problem
measure: Impact on activities using Valued Life Activities Scale
time frame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
description: Valued Life Activities Scale
measure: Change of global health
time frame: 10 weeks, 28 weeks, 56 weeks after randomisation
description: Single question to indicate perceived change in global health compared with last assessment visit
arm group label: Usual Care alone
arm group type: Active Comparator
description: Participants receive written information about fatigue which is designed as self-management guide.
arm group label: CBA + usual care
arm group type: Active Comparator
description: In addition to usual care, participants receive a talking therapy using a cognitive behavioural approach. The talking therapy will be delivered via telephone by a trained rheumatology health care professional who will contact the participant for 8 sessions over a period of 6 months.
arm group label: PEP + usual care
arm group type: Active Comparator
description: In addition to usual care, participants receive a personalised exercise programme. After an initial face-to-face assessment, the remaining programme will be delivered via telephone by a trained rheumatology health care professional who will contact the participant for 7 sessions over a period of 6 months.
intervention type: Behavioral
intervention name: Usual Care
description: Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
arm group label: CBA + usual care
arm group label: PEP + usual care
arm group label: Usual Care alone
intervention type: Behavioral
intervention name: Cognitive behavioural approach
description: A talking therapy which explicitly aims to replace unhelpful beliefs and behaviours through the application of patient-centred strategies and behavioural activities
arm group label: CBA + usual care
other name: CBA
intervention type: Behavioral
intervention name: Personalised Exercise Programme
description: PEP is a graded exposure behaviour therapy which aims to gradually optimise patients levels of physical activity with view to modifying their altered perception of effort and ultimately reduce the severity and impact of fatigue.
arm group label: PEP + usual care
other name: PEP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gary Macfarlane, PhD
role: Principal Investigator
affiliation: University of Aberdeen
last name: Neil Basu, MBChB, PhD
role: Principal Investigator
affiliation: University of Glasgow
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
url: https://w3.abdn.ac.uk/hsru/lift/
description: Click here for more information about this study
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Arthritis, Psoriatic
mesh term: Rheumatic Diseases
mesh term: Sjogren's Syndrome
mesh term: Spondylarthritis
mesh term: Axial Spondyloarthritis
mesh term: Collagen Diseases
mesh term: Lupus Erythematosus, Systemic
mesh term: Fatigue
sharing ipd: No
provided document: 
provided document: 
provided document: 
submitted: March 10, 2023