<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/NCT03823495</url>
  </required_header>
  <id_info>
    <org_study_id>PLPMP</org_study_id>
    <nct_id>NCT03823495</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Peer-led Pain Management Program</brief_title>
  <official_title>Effectiveness of a Peer-led Pain Management Program in Relieving Chronic Pain and Enhancing Pain Self-efficacy Among Older Adults: a Clustered Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic 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>
      Objective: To evaluate the efficacy of a peer-led pain management program (PAP) in improving&#xD;
      pain self-efficacy, reduce pain, enhancing use of drugs and non-drug methods and quality of&#xD;
      life among nursing home residents&#xD;
&#xD;
      Hypothesis: PAP lead by peer volunteer (PV) is more effective than receive usual care and&#xD;
      pain management pamphlet, in reducing pain intensity, enhancing pain self-efficacy, use of&#xD;
      drugs and non-drug methods, health-related quality of life upon completion of the PAP (week&#xD;
      12) and over time (week 24).&#xD;
&#xD;
      Design and subjects: Clustered randomized controlled trial with nursing homes as cluster; 288&#xD;
      residents will be recruited from 12 nursing homes. Each nursing home will be randomly&#xD;
      allocated to experimental group (PV led PAP), control group (receive usual care and pain&#xD;
      management pamphlet).&#xD;
&#xD;
      Study instruments: Brief Pain Inventory, Pain Self-Efficacy Questionnaire, Use of drugs and&#xD;
      non-drug methods log book, Short Form Health Survey-12 and process evaluation.&#xD;
&#xD;
      Intervention: 12-week PAP (one 1-hour session per week).&#xD;
&#xD;
      Outcome measures: Pain intensity, pain self-efficacy, use of non-drug pain relief methods,&#xD;
      perceived health-related quality of life and experience in participating PAP, to be collected&#xD;
      at baseline (T0), week 12 (T1), and week 24 (T2).&#xD;
&#xD;
      Data analysis: Multilevel regression and/or Generalized Estimating Equation will be used for&#xD;
      within-group and between- group comparisons.&#xD;
&#xD;
      Expected results: Significant reduction in pain and enhancement in pain-related parameters,&#xD;
      making peers support models in elderly care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To evaluate the efficacy of a peer-led pain management program (PAP) in improving&#xD;
      pain self-efficacy, reduce pain, enhancing use of drugs and non-drug methods and quality of&#xD;
      life among nursing home residents&#xD;
&#xD;
      Hypothesis: PAP lead by peer volunteer (PV) is more effective than receive usual care and&#xD;
      pain management pamphlet, in reducing pain intensity, enhancing pain self-efficacy, use of&#xD;
      drugs and non-drug methods, health-related quality of life upon completion of the PAP (week&#xD;
      12) and over time (week 24).&#xD;
&#xD;
      Design and subjects: Clustered randomized controlled trial with nursing homes as cluster; 288&#xD;
      residents will be recruited from 12 nursing homes. Each nursing home will be randomly&#xD;
      allocated to experimental group (PV led PAP), control group (receive usual care and pain&#xD;
      management pamphlet).&#xD;
&#xD;
      Study instruments: Brief Pain Inventory, Pain Self-Efficacy Questionnaire, Use of drugs and&#xD;
      non-drug methods log book, Short Form Health Survey-12 and process evaluation.&#xD;
&#xD;
      Intervention: 12-week PAP (one 1-hour session per week). Each session includes 20-minute&#xD;
      exercise, 30-minute interactive pain management education, practices on non-drug management&#xD;
      techniques, and portfolio entry for activities of the day. The interventionist is the PV. The&#xD;
      one hour session per week will consisted of 20-minute exercise, include correct body posture&#xD;
      and alignment, stretching of arms, legs, and body muscles, balancing exercise; shoulder &amp;&#xD;
      neck exercise; knee exercise; towel dancing. While the 30-minute interactive pain management&#xD;
      education as well as practices on non-drug management techniques. Topics include: 1) pain&#xD;
      situations among older adults; effects of pain in daily life; can we do something? 2) The use&#xD;
      of oral drugs for pain: effects and side-effects; 3) The use of non-drug therapy: hot pad &amp;&#xD;
      cold pad; how to use &amp; safety issues? 4) The use of non-drug therapy: listening to music; 5)&#xD;
      the use of non-drug therapy: massage; 6) the use of non-drug therapy: visual stimulation -&#xD;
      watching the natural environment &amp; making a photo album; 7) the use of non-drug therapy:&#xD;
      sense of smell &amp; taste- making a bag of dried flowers &amp; tasting tea; 8) Revision &amp; wrapping&#xD;
      up. Portfolio entry include the PV will work with the participants to make entry on the&#xD;
      activity of the day in the portfolio.&#xD;
&#xD;
      Outcome measures: Pain intensity, pain self-efficacy, use of non-drug pain relief methods,&#xD;
      perceived health-related quality of life and experience in participating PAP, to be collected&#xD;
      at baseline (T0), week 12 (T1), and week 24 (T2).&#xD;
&#xD;
      Data analysis: Multilevel regression and/or Generalized Estimating Equation will be used for&#xD;
      within-group and between- group comparisons.&#xD;
&#xD;
      Expected results: Significant reduction in pain and enhancement in pain-related parameters,&#xD;
      making peers support models in elderly care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 3, 2018</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brief Pain Intensity (questionnaire)</measure>
    <time_frame>Change from baseline to 12-week (after the intervention) and 24-week (follow up)</time_frame>
    <description>Brief Pain Inventory is a 10 point likert scale ranging from 0 to 10. It will be used to assess the multidimensional nature of the participants' pain, including its intensity and subsequent interference with life activities</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain self-efficacy questionnaire (questionnaire)</measure>
    <time_frame>Change from baseline to 12-week (after the intervention) and 24-week (follow up)</time_frame>
    <description>Pain self-efficacy questionnaire is a 7-point likert scale ranging from 0 to 6. It will be used to assess the participants' confidence in their ability to perform specific tasks or their confidence in performing more generalized constructs such as coping with chronic non-malignant pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of drugs and non-drug methods</measure>
    <time_frame>Change from baseline to 12-week (after the intervention) and 24-week (follow up)</time_frame>
    <description>The drugs that are used, and their frequency of use will be collected from medication charts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived health-related quality of life</measure>
    <time_frame>Change from baseline to 12-week (after the intervention) and 24-week (follow up)</time_frame>
    <description>The chinese version of the SF-12 questionnaire is a likert scale to assess participants perceived physical and mental health-related quality of life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">288</enrollment>
  <condition>Randomized Controlled Trial</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12-week PAP (one 1-hour session per week). Each session includes 20-minute exercise, 30-minute interactive pain management education, practices on non-drug management techniques, and portfolio entry for activities of the day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive the usual care and a pain management pamphlet distributed by nursing home staff</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>12-week PAP</intervention_name>
    <description>It is a non-drug intervention, using exercises to reduce elderlies chronic pain.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  scored ≥ 6 in the Abbreviated Mental Test Chinese Version&#xD;
&#xD;
          -  scored ≥ 4 in the Brief Pain Inventory Chinese Version&#xD;
&#xD;
          -  scored ≥ 60 in the Modified Barthel Index Chinese Version&#xD;
&#xD;
          -  able to speak and understand Cantonese&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  scored ≥ 8 in the Geriatric Depression Scale Chinese Version&#xD;
&#xD;
          -  history of psychotic disorders&#xD;
&#xD;
          -  currently undergoing cancer treatment&#xD;
&#xD;
          -  has conditions that limit safe participation in exercising&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mimi Mun Yee Tse, PhD</last_name>
    <phone>2766 6541</phone>
    <phone_ext>6541</phone_ext>
    <email>mimi.tse@polyu.edu.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kai Chun Johnson Law, MSc</last_name>
    <phone>2766 7880</phone>
    <phone_ext>7880</phone_ext>
    <email>johnson.law@polyu.edu.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>School of Nursing</name>
      <address>
        <city>Hung Hom</city>
        <state>Kowloon</state>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>TSE Mun Yee Mimi</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>pain management</keyword>
  <keyword>nursing home</keyword>
  <keyword>elderly</keyword>
  <keyword>non-drug</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03823495
org study id: PLPMP
nct id: NCT03823495
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: To evaluate the efficacy of a peer-led pain management program (PAP) in improving
      pain self-efficacy, reduce pain, enhancing use of drugs and non-drug methods and quality of
      life among nursing home residents

      Hypothesis: PAP lead by peer volunteer (PV) is more effective than receive usual care and
      pain management pamphlet, in reducing pain intensity, enhancing pain self-efficacy, use of
      drugs and non-drug methods, health-related quality of life upon completion of the PAP (week
      12) and over time (week 24).

      Design and subjects: Clustered randomized controlled trial with nursing homes as cluster; 288
      residents will be recruited from 12 nursing homes. Each nursing home will be randomly
      allocated to experimental group (PV led PAP), control group (receive usual care and pain
      management pamphlet).

      Study instruments: Brief Pain Inventory, Pain Self-Efficacy Questionnaire, Use of drugs and
      non-drug methods log book, Short Form Health Survey-12 and process evaluation.

      Intervention: 12-week PAP (one 1-hour session per week).

      Outcome measures: Pain intensity, pain self-efficacy, use of non-drug pain relief methods,
      perceived health-related quality of life and experience in participating PAP, to be collected
      at baseline (T0), week 12 (T1), and week 24 (T2).

      Data analysis: Multilevel regression and/or Generalized Estimating Equation will be used for
      within-group and between- group comparisons.

      Expected results: Significant reduction in pain and enhancement in pain-related parameters,
      making peers support models in elderly care.
Objective: To evaluate the efficacy of a peer-led pain management program (PAP) in improving
      pain self-efficacy, reduce pain, enhancing use of drugs and non-drug methods and quality of
      life among nursing home residents

      Hypothesis: PAP lead by peer volunteer (PV) is more effective than receive usual care and
      pain management pamphlet, in reducing pain intensity, enhancing pain self-efficacy, use of
      drugs and non-drug methods, health-related quality of life upon completion of the PAP (week
      12) and over time (week 24).

      Design and subjects: Clustered randomized controlled trial with nursing homes as cluster; 288
      residents will be recruited from 12 nursing homes. Each nursing home will be randomly
      allocated to experimental group (PV led PAP), control group (receive usual care and pain
      management pamphlet).

      Study instruments: Brief Pain Inventory, Pain Self-Efficacy Questionnaire, Use of drugs and
      non-drug methods log book, Short Form Health Survey-12 and process evaluation.

      Intervention: 12-week PAP (one 1-hour session per week). Each session includes 20-minute
      exercise, 30-minute interactive pain management education, practices on non-drug management
      techniques, and portfolio entry for activities of the day. The interventionist is the PV. The
      one hour session per week will consisted of 20-minute exercise, include correct body posture
      and alignment, stretching of arms, legs, and body muscles, balancing exercise; shoulder &
      neck exercise; knee exercise; towel dancing. While the 30-minute interactive pain management
      education as well as practices on non-drug management techniques. Topics include: 1) pain
      situations among older adults; effects of pain in daily life; can we do something? 2) The use
      of oral drugs for pain: effects and side-effects; 3) The use of non-drug therapy: hot pad &
      cold pad; how to use & safety issues? 4) The use of non-drug therapy: listening to music; 5)
      the use of non-drug therapy: massage; 6) the use of non-drug therapy: visual stimulation -
      watching the natural environment & making a photo album; 7) the use of non-drug therapy:
      sense of smell & taste- making a bag of dried flowers & tasting tea; 8) Revision & wrapping
      up. Portfolio entry include the PV will work with the participants to make entry on the
      activity of the day in the portfolio.

      Outcome measures: Pain intensity, pain self-efficacy, use of non-drug pain relief methods,
      perceived health-related quality of life and experience in participating PAP, to be collected
      at baseline (T0), week 12 (T1), and week 24 (T2).

      Data analysis: Multilevel regression and/or Generalized Estimating Equation will be used for
      within-group and between- group comparisons.

      Expected results: Significant reduction in pain and enhancement in pain-related parameters,
      making peers support models in elderly care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Brief Pain Intensity (questionnaire)
time frame: Change from baseline to 12-week (after the intervention) and 24-week (follow up)
description: Brief Pain Inventory is a 10 point likert scale ranging from 0 to 10. It will be used to assess the multidimensional nature of the participants' pain, including its intensity and subsequent interference with life activities
measure: Pain self-efficacy questionnaire (questionnaire)
time frame: Change from baseline to 12-week (after the intervention) and 24-week (follow up)
description: Pain self-efficacy questionnaire is a 7-point likert scale ranging from 0 to 6. It will be used to assess the participants' confidence in their ability to perform specific tasks or their confidence in performing more generalized constructs such as coping with chronic non-malignant pain.
measure: Use of drugs and non-drug methods
time frame: Change from baseline to 12-week (after the intervention) and 24-week (follow up)
description: The drugs that are used, and their frequency of use will be collected from medication charts
measure: Perceived health-related quality of life
time frame: Change from baseline to 12-week (after the intervention) and 24-week (follow up)
description: The chinese version of the SF-12 questionnaire is a likert scale to assess participants perceived physical and mental health-related quality of life.
arm group label: Experimental group
arm group type: Experimental
description: 12-week PAP (one 1-hour session per week). Each session includes 20-minute exercise, 30-minute interactive pain management education, practices on non-drug management techniques, and portfolio entry for activities of the day.
arm group label: Control group
arm group type: No Intervention
description: The control group will receive the usual care and a pain management pamphlet distributed by nursing home staff
intervention type: Other
intervention name: 12-week PAP
description: It is a non-drug intervention, using exercises to reduce elderlies chronic pain.
arm group label: Experimental group
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mimi Mun Yee Tse, PhD
phone: 2766 6541
phone ext: 6541
email: mimi.tse@polyu.edu.hk
last name: Kai Chun Johnson Law, MSc
phone: 2766 7880
phone ext: 7880
email: johnson.law@polyu.edu.hk
facility: 
status: Recruiting
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: TSE Mun Yee Mimi
investigator title: Assistant Professor
sharing ipd: Undecided