<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/NCT04452903</url>
  </required_header>
  <id_info>
    <org_study_id>0127-19-com2</org_study_id>
    <nct_id>NCT04452903</nct_id>
  </id_info>
  <brief_title>A Communication Enhancing Intervention to Improve Patients' Perception of Physiotherapy Consultations</brief_title>
  <official_title>A Communication Enhancing Intervention to Improve Patients' Perception of Physiotherapy Consultations: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ariel University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ariel 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>
      The aim of this study is to test the effectiveness of a single training session in&#xD;
      communication skills at improving patients' perceptions of physiotherapy consultations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Population: Physiotherapists Detail: Physiotherapists (n=30) who work at 'Clalit' institute's&#xD;
      (public health management organization in Israel) at four physiotherapy clinics.&#xD;
&#xD;
      Intervention: A single session of training in consultation-based communication skills Detail:&#xD;
      a 3-hour communication skill workshop, followed by a month-long period to assimilate and&#xD;
      implement the new set of skills, with supervision available by phone from the trainers.&#xD;
&#xD;
      Comparison: No training Detail: The control group receives no extra training. Outcome: New&#xD;
      patients' perception of consultations Detail: The Primary Outcome Measure is the&#xD;
      Consultation-Based Reassurance Questionnaire (CRQ) The CRQ measures patients' perceptions of&#xD;
      consultation. It consists of four subscales, each with three items: data-gathering,&#xD;
      relationship-building, generic reassurance, and cognitive reassurance. The investigators are&#xD;
      assessing change between two-time points (before and after the intervention). And also, the&#xD;
      difference between study groups. This is collected twice: at baseline, and at follow up, from&#xD;
      the intervention and control groups.&#xD;
&#xD;
      Type of Question: therapy Detail: The study tests whether a single training sessions can&#xD;
      improve communication in consultations with physiotherapists.&#xD;
&#xD;
      Type of Study: RCT&#xD;
&#xD;
      Detail: Stage 1: Pre-randomization:&#xD;
&#xD;
      The physiotherapists (n=30) will hand out a Consultation-Based Reassurance Questionnaire&#xD;
      (CRQ) in a sealed envelope to each eligible patient (age 18+) they receive for the first&#xD;
      consultation in two weeks period. The patient will complete the questionnaire in private,&#xD;
      post consultation, and place it in a closed box. The physiotherapist will recruit a minimum&#xD;
      of five patients each (n&gt;150).&#xD;
&#xD;
      Baseline measures are: age, gender, pain area, chronicity, pain severity, disability,&#xD;
      satisfaction from the consultation and the Consultation-Based Reassurance Questionnaire.&#xD;
&#xD;
      Stage 2: Randomization:&#xD;
&#xD;
      The process for randomization:&#xD;
&#xD;
      First, participating physiotherapists will be matched for gender, seniority, and quality of&#xD;
      reassurance in every clinic. They will then be allocated into one of the two arms at random&#xD;
      (1:1), according to a computer random number list.&#xD;
&#xD;
      Stage 3: Follow up:&#xD;
&#xD;
      After the intervention, both the intervention and control groups will again hand out the&#xD;
      questionnaires (age, gender, pain area, chronicity, pain severity, disability, satisfaction&#xD;
      from the consultation and the CRQ) to new eligible patients that arrive for the first&#xD;
      consultation. The physiotherapist will recruit a minimum of ten patients each (total sample&#xD;
      therefore n&gt; 300, minimum number per arm=150).&#xD;
&#xD;
      sample size The sample size was calculated with G*Power 3.1.9.4 using the t-test family to&#xD;
      detect the difference between two independent means (two groups). The input parameters were&#xD;
      as follows: for a two-tailed test, assuming a medium effect size of 0.5, α=0.05, and β=0.95,&#xD;
      the total sample size recommended was 210 participants. One hundred five participants in each&#xD;
      study group (intervention and control).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">December 20, 2020</completion_date>
  <primary_completion_date type="Actual">October 29, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A randomized controlled trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The participant (patients of the physiotherapists) are unaware of the intervention.&#xD;
The outcome assessor will not know who was in the intervention group and who was in the control</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Consultation reassurance questionnaire (0-72). Change is being assess before and after the intervention.</measure>
    <time_frame>measure assessing change between two time points: base line and at two month.</time_frame>
    <description>A questionnaire that measures patients' perceptions of consultation- higher values represent a better communication skills</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The numeric pain rating scale (0-10)</measure>
    <time_frame>2 month</time_frame>
    <description>For the most severe and average pain intensity ( 0= no pain and 10 =the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability (0-10)</measure>
    <time_frame>2 month</time_frame>
    <description>For disability (0= no disability and 10 =the worst disability)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction (0-10)</measure>
    <time_frame>2 month</time_frame>
    <description>For satisfaction from the first consultation with the physiotherapist (0= no satisfied at all and 10 =very satisfied)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">558</enrollment>
  <condition>Communication</condition>
  <arm_group>
    <arm_group_label>Reassurance intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The physiotherapist in the intervention group (n=15) will participate in a 3-hour communication skill workshop, followed by a month-long period to assimilate and implement the new set of skills, with supervision available by phone from the trainers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The physiotherapist in the control group (n=15) receives no training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>communication skills</intervention_name>
    <description>3-hour communication skill workshop, followed by a month-long period to assimilate and implement the new set of skills, with supervision available by phone from the trainers.</description>
    <arm_group_label>Reassurance intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physiotherapists:&#xD;
&#xD;
               -  Working for Clalit Health Services. Dan-Petach Tikva region&#xD;
&#xD;
               -  Willing to participate in a 3-hour communication skills workshop&#xD;
&#xD;
          -  Patients:&#xD;
&#xD;
               -  over the age of 18&#xD;
&#xD;
               -  literate in Hebrew&#xD;
&#xD;
               -  Willing to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling to participate in the trial&#xD;
&#xD;
          -  Illiterate in Hebrew&#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>Noa Ben Ami, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ariel University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Distric DAN - PETACH TIKVA</name>
      <address>
        <city>Petach Tikva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <results_reference>
    <citation>Holt N, Pincus T. Developing and testing a measure of consultation-based reassurance for people with low back pain in primary care: a cross-sectional study. BMC Musculoskelet Disord. 2016 Jul 12;17:277. doi: 10.1186/s12891-016-1144-2.</citation>
    <PMID>27405870</PMID>
  </results_reference>
  <results_reference>
    <citation>Pincus T, Holt N, Vogel S, Underwood M, Savage R, Walsh DA, Taylor SJC. Cognitive and affective reassurance and patient outcomes in primary care: a systematic review. Pain. 2013 Nov;154(11):2407-2416. doi: 10.1016/j.pain.2013.07.019. Epub 2013 Jul 18.</citation>
    <PMID>23872104</PMID>
  </results_reference>
  <results_reference>
    <citation>Holt N, Mansell G, Hill JC, Pincus T. Testing a Model of Consultation-based Reassurance and Back Pain Outcomes With Psychological Risk as Moderator: A Prospective Cohort Study. Clin J Pain. 2018 Apr;34(4):339-348. doi: 10.1097/AJP.0000000000000541.</citation>
    <PMID>29509169</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>communication skills</keyword>
  <keyword>Consultation reassurance questionnaire</keyword>
  <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/NCT04452903
org study id: 0127-19-com2
nct id: NCT04452903
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to test the effectiveness of a single training session in
      communication skills at improving patients' perceptions of physiotherapy consultations.
Population: Physiotherapists Detail: Physiotherapists (n=30) who work at 'Clalit' institute's
      (public health management organization in Israel) at four physiotherapy clinics.

      Intervention: A single session of training in consultation-based communication skills Detail:
      a 3-hour communication skill workshop, followed by a month-long period to assimilate and
      implement the new set of skills, with supervision available by phone from the trainers.

      Comparison: No training Detail: The control group receives no extra training. Outcome: New
      patients' perception of consultations Detail: The Primary Outcome Measure is the
      Consultation-Based Reassurance Questionnaire (CRQ) The CRQ measures patients' perceptions of
      consultation. It consists of four subscales, each with three items: data-gathering,
      relationship-building, generic reassurance, and cognitive reassurance. The investigators are
      assessing change between two-time points (before and after the intervention). And also, the
      difference between study groups. This is collected twice: at baseline, and at follow up, from
      the intervention and control groups.

      Type of Question: therapy Detail: The study tests whether a single training sessions can
      improve communication in consultations with physiotherapists.

      Type of Study: RCT

      Detail: Stage 1: Pre-randomization:

      The physiotherapists (n=30) will hand out a Consultation-Based Reassurance Questionnaire
      (CRQ) in a sealed envelope to each eligible patient (age 18+) they receive for the first
      consultation in two weeks period. The patient will complete the questionnaire in private,
      post consultation, and place it in a closed box. The physiotherapist will recruit a minimum
      of five patients each (n>150).

      Baseline measures are: age, gender, pain area, chronicity, pain severity, disability,
      satisfaction from the consultation and the Consultation-Based Reassurance Questionnaire.

      Stage 2: Randomization:

      The process for randomization:

      First, participating physiotherapists will be matched for gender, seniority, and quality of
      reassurance in every clinic. They will then be allocated into one of the two arms at random
      (1:1), according to a computer random number list.

      Stage 3: Follow up:

      After the intervention, both the intervention and control groups will again hand out the
      questionnaires (age, gender, pain area, chronicity, pain severity, disability, satisfaction
      from the consultation and the CRQ) to new eligible patients that arrive for the first
      consultation. The physiotherapist will recruit a minimum of ten patients each (total sample
      therefore n> 300, minimum number per arm=150).

      sample size The sample size was calculated with G*Power 3.1.9.4 using the t-test family to
      detect the difference between two independent means (two groups). The input parameters were
      as follows: for a two-tailed test, assuming a medium effect size of 0.5, α=0.05, and β=0.95,
      the total sample size recommended was 210 participants. One hundred five participants in each
      study group (intervention and control).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized controlled trial
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
masking description: The participant (patients of the physiotherapists) are unaware of the intervention.
The outcome assessor will not know who was in the intervention group and who was in the control
measure: Consultation reassurance questionnaire (0-72). Change is being assess before and after the intervention.
time frame: measure assessing change between two time points: base line and at two month.
description: A questionnaire that measures patients' perceptions of consultation- higher values represent a better communication skills
measure: The numeric pain rating scale (0-10)
time frame: 2 month
description: For the most severe and average pain intensity ( 0= no pain and 10 =the worst pain)
measure: Disability (0-10)
time frame: 2 month
description: For disability (0= no disability and 10 =the worst disability)
measure: Satisfaction (0-10)
time frame: 2 month
description: For satisfaction from the first consultation with the physiotherapist (0= no satisfied at all and 10 =very satisfied)
arm group label: Reassurance intervention
arm group type: Experimental
description: The physiotherapist in the intervention group (n=15) will participate in a 3-hour communication skill workshop, followed by a month-long period to assimilate and implement the new set of skills, with supervision available by phone from the trainers.
arm group label: Control
arm group type: No Intervention
description: The physiotherapist in the control group (n=15) receives no training.
intervention type: Behavioral
intervention name: communication skills
description: 3-hour communication skill workshop, followed by a month-long period to assimilate and implement the new set of skills, with supervision available by phone from the trainers.
arm group label: Reassurance intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Noa Ben Ami, PhD
role: Principal Investigator
affiliation: Ariel University
facility: 
country: Israel
citation: Holt N, Pincus T. Developing and testing a measure of consultation-based reassurance for people with low back pain in primary care: a cross-sectional study. BMC Musculoskelet Disord. 2016 Jul 12;17:277. doi: 10.1186/s12891-016-1144-2.
PMID: 27405870
citation: Pincus T, Holt N, Vogel S, Underwood M, Savage R, Walsh DA, Taylor SJC. Cognitive and affective reassurance and patient outcomes in primary care: a systematic review. Pain. 2013 Nov;154(11):2407-2416. doi: 10.1016/j.pain.2013.07.019. Epub 2013 Jul 18.
PMID: 23872104
citation: Holt N, Mansell G, Hill JC, Pincus T. Testing a Model of Consultation-based Reassurance and Back Pain Outcomes With Psychological Risk as Moderator: A Prospective Cohort Study. Clin J Pain. 2018 Apr;34(4):339-348. doi: 10.1097/AJP.0000000000000541.
PMID: 29509169
responsible party type: Sponsor
sharing ipd: No