<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/NCT02996955</url>
  </required_header>
  <id_info>
    <org_study_id>NL58005.096.16</org_study_id>
    <nct_id>NCT02996955</nct_id>
  </id_info>
  <brief_title>Patient Adherence to a Physical Activity Advice</brief_title>
  <acronym>PAPA</acronym>
  <official_title>Influence of Social Support and Treatment of Illness Perceptions on Patient's Adherence to a Physical Activity Advice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Low back pain is worldwide a common musculoskeletal condition with a high number of&#xD;
      recurrences. Recurrence rate and the number of recurrences could be reduced and time to a&#xD;
      next episode could be prolonged by advising an active lifestyle. Advising regular physical&#xD;
      activity is the mainstay in physical therapy treatment. This includes an appeal to patients&#xD;
      to adhere to an activity advice. Patient adherence to an activity advice is poor. In this&#xD;
      study an intervention consisting of treatment of illness perceptions with or without&#xD;
      organizing social support to increase adherence to an activity advice will be investigated.&#xD;
&#xD;
      The primary objective of this study is to investigate whether social support by a partner or&#xD;
      friend and treatment of patients' illness perceptions influences the rate of adherence to an&#xD;
      activity advice compared to treatment of patients' illness perceptions alone in patients&#xD;
      suffering non-specific low back pain. Secondary objectives are; a) whether 'treatment of&#xD;
      illness perceptions' changes patients' maladaptive illness perceptions into realistic ones,&#xD;
      b) whether maladaptive illness perceptions, comorbidity and/or overweighed/obesity and/or&#xD;
      rate of recurrences of non-specific low back pain and/or attitude and intention to physical&#xD;
      activity influences patient's adherence .&#xD;
&#xD;
      This study is a multi-centre randomized two-arm controlled clinical trial. Patients ≥18 years&#xD;
      presenting with at least a second episode of non-specific low back pain.&#xD;
&#xD;
      Patients in the intervention and control group will be asked to perform a physical activity&#xD;
      advice. During two physiotherapy treatment sessions treatment of illness perceptions is&#xD;
      performed in both groups. In the intervention group organizing social support by a partner or&#xD;
      friend is added.&#xD;
&#xD;
      Twenty-five percent absolute improvement of walking and/or cycling according the NNGB in the&#xD;
      intervention group is clinically relevant.&#xD;
&#xD;
      During four appointments several questionnaires have to be filled in and during two&#xD;
      physiotherapy treatment sessions half an hour treatment of illness perceptions will be&#xD;
      performed. Social support by a partner or friend will be organized during the same&#xD;
      physiotherapy treatment sessions in the intervention group. During three separate weeks&#xD;
      patients have to wear an activity monitor. Patients will be treated according to the Dutch&#xD;
      Low Back Pain guideline; no adverse effects will be expected.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective of the study:&#xD;
&#xD;
      The primary objective of this study is to investigate whether social support by a partner or&#xD;
      friend and treatment of patients' illness perceptions influences the rate of adherence to an&#xD;
      activity advice compared to treatment of patients' illness perceptions alone in patients&#xD;
      suffering non-specific low back pain. Secondary objectives are; 1) Whether 'treatment of&#xD;
      illness perceptions' changes patients' maladaptive illness perceptions into realistic ones,&#xD;
      2) Whether maladaptive illness perceptions, comorbidity and/or obesity and/or rate of&#xD;
      recurrences of non-specific low back pain and/or attitude and intention to physical activity&#xD;
      influences patient's adherence to an activity advice.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      This study is a multicentre randomized two arm, controlled clinical trial. During a&#xD;
      twelve-week intervention period, one group of patients will receive an activity advice added&#xD;
      to usual treatment including 'treatment of illness perceptions' (C-group). The other group&#xD;
      will receive an activity advice and the intervention addressing social support by a partner&#xD;
      or friend added to usual treatment including 'treatment of illness perceptions'&#xD;
      (SoSup-group). Patients will be assessed at baseline, and after one, 6 and 12 weeks.&#xD;
      Recruitment is scheduled from October 2016 to July 2017. The study will be performed in 12&#xD;
      centres for physiotherapy in the province Zuid-Holland, the Netherlands.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      It is mentioned that individuals with recurrent non-specific low back pain score more&#xD;
      unfavourable on lifestyle risk factors including physical inactivity than individuals without&#xD;
      or first time non-specific low back pain (van Oostrom et al., 2012). To include potential&#xD;
      physically inactive non-specific low back pain sufferers, patients ≥18 years presenting with&#xD;
      at least a second episode of non-specific low back pain who are not physical active in&#xD;
      accordance with the NNGB are recruited for the study.&#xD;
&#xD;
      Intervention (if applicable):&#xD;
&#xD;
      In both the C- and SoSup-group an activity advice will be added to usual treatment. The&#xD;
      advised activities will be walking and/or cycling outdoors, meeting the Dutch Standard&#xD;
      Healthy Physical Activity (NNGB) (Hildebrandt et al., 2007). In both groups cognitive&#xD;
      treatment on illness perceptions according to the common sense model to the patient in the&#xD;
      presence of the partner or friend will be given. During a maximum of two half-hour contacts&#xD;
      in a standardised dialogue on maladaptive beliefs and feelings about identity, time-line,&#xD;
      causes, controllability, and curability of low back pain are mapped, maladaptive perceptions&#xD;
      are challenged, alternative perceptions are formulated (Siemonsma et al., 2013). The&#xD;
      intervention in the SoSup-group (intervention group), organizing social support by a partner&#xD;
      or friend depending on patient's preferences, will be added. During a maximum of two&#xD;
      half-hour contacts (one for explanation and one for evaluation), in a standardised discussion&#xD;
      the partner or friend will be stimulated to support the patient in executing the activity&#xD;
      advice. During 12 weeks the social support by a partner or friend will be executed for at&#xD;
      least 5 times a week.&#xD;
&#xD;
      Primary study parameters/outcome of the study:&#xD;
&#xD;
      The primary outcome measure will be walking and/or cycling according to the NNGB and social&#xD;
      support.&#xD;
&#xD;
      Secundary study parameters/outcome of the study (if applicable):&#xD;
&#xD;
      Other outcomes will be 1. measures of illness perceptions. 2. measures of comorbidity, BMI,&#xD;
      number of recurrences of non-specific low back pain, measures of attitude and intention to&#xD;
      physical activity 3. measures of refusal of the study.&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness (if applicable):&#xD;
&#xD;
      The social support described in this study is designed for better outcomes of physical&#xD;
      activity levels patients suffering low back pain, and has no proven advantage on better&#xD;
      outcomes on pain and disability in non-specific low back pain sufferers. Therefore we&#xD;
      consider there is no disadvantage in the SoSup-group versus the C-group because patients in&#xD;
      both groups receive concomitant best evidence healthcare according to the Dutch guideline for&#xD;
      low back pain (Staal et al., 2013). No adverse effects of the interventions are expected.&#xD;
      There are no ethical implications to be expected as a result of this study, treatment of all&#xD;
      patients during the intervention period will be according to the Dutch guideline for low back&#xD;
      pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>adherence to the activity advice</measure>
    <time_frame>12 weeks</time_frame>
    <description>proportion of patients (non)adhering to the activity advice measured by the Activ8</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in patient's illness perceptions</measure>
    <time_frame>base line, one week, 6 and 12 weeks</time_frame>
    <description>proportion of patients with (un)changed illness perceptions measured by the Brief Illness Perception Questionnaire- short, Dutch version.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>influence of illness perception on adherence</measure>
    <time_frame>12 weeks</time_frame>
    <description>proportion of patients with (mal)adaptive illness perception measured by the BIPQ-s Dutch version (non)adhering the activity advice measured by the Activ8</description>
  </other_outcome>
  <other_outcome>
    <measure>influence of comorbidity on adherence</measure>
    <time_frame>12 weeks</time_frame>
    <description>proportion of patients with or without comorbidity measured by the Cumulative Illness Rating Scale (non)adhering the activity advice measured by the Activ8</description>
  </other_outcome>
  <other_outcome>
    <measure>influence of overweight/obesity on adherence</measure>
    <time_frame>12 weeks</time_frame>
    <description>proportion of patients with or without overweight/obesity measured with Body Mass Index (non)adhering the activity advice measured by the Activ8</description>
  </other_outcome>
  <other_outcome>
    <measure>influence of number of episodes of low back pain on adherence</measure>
    <time_frame>12 weeks</time_frame>
    <description>proportion of patients with or without more than 2 episodes low back pain (non)adhering the activity advice measured by the activ8</description>
  </other_outcome>
  <other_outcome>
    <measure>change of influence of attitude and intention to a physical activity on adherence</measure>
    <time_frame>base line, one week, 6 and 12 weeks</time_frame>
    <description>proportion of patients with or without adequate atitude/intention to physical activity measured by the Module Houding en Intentie Questionnaire (non)adhering the activity advice measured by the activ8</description>
  </other_outcome>
  <other_outcome>
    <measure>influence of perceived pain and disability on adherence</measure>
    <time_frame>base line</time_frame>
    <description>proportion of patients with or without high scores on VAS pain and Quebec Back Pain and Disability scale (non) adhering the activity advice measured by the activ8</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Patient Adherence</condition>
  <arm_group>
    <arm_group_label>SoSup group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>usual care will be provided and social support and treatment of illness perceptions and activity advice and wearing the activ8</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>usual care will be provided and treatment of illness perceptions and activity advice and wearing the Activ8</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>social support</intervention_name>
    <description>behaviour change intervention</description>
    <arm_group_label>SoSup group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>treatment of illness perceptions</intervention_name>
    <description>educational interview</description>
    <arm_group_label>C group</arm_group_label>
    <arm_group_label>SoSup group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Activ8</intervention_name>
    <description>wearing a move monitor</description>
    <arm_group_label>C group</arm_group_label>
    <arm_group_label>SoSup group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>activity advice</intervention_name>
    <description>walking or cycling 5 days a week during at least half an hour</description>
    <arm_group_label>C group</arm_group_label>
    <arm_group_label>SoSup group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Non-specific low back pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients physical active in accordance with the Dutch Standard Healthy Physical&#xD;
             Activity (NNGB) (Hildebrandt et al., 2007)&#xD;
&#xD;
          -  Patients with specific low back pain&#xD;
&#xD;
          -  Onset of the low back pain after age 50 years,&#xD;
&#xD;
          -  Continuous pain regardless of posture or movement,&#xD;
&#xD;
          -  Nocturnal pain,&#xD;
&#xD;
          -  General malaise,&#xD;
&#xD;
          -  History of malignancy,&#xD;
&#xD;
          -  Unexplained weight loss,&#xD;
&#xD;
          -  Elevated erythrocyte sedimentation rate (ESR)&#xD;
&#xD;
          -  Previous vertebral fracture,&#xD;
&#xD;
          -  Older person with hip fracture,&#xD;
&#xD;
          -  Prolonged use of corticosteroids,&#xD;
&#xD;
          -  Onset of low back pain before age 20 years,&#xD;
&#xD;
          -  Iridocyclitis,&#xD;
&#xD;
          -  History of unexplained peripheral arthritis or inflammatory bowel disease,&#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>Rob de Bie, Prof. PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Maastricht University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Henk v Mameren, Em Prof PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Maastricht University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ben v Koppen</last_name>
    <phone>0031102937111</phone>
    <email>ben.van.koppen.mmt@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pim Zandwijk</last_name>
    <phone>0031786428848</phone>
    <email>pzandwijk@kpnplanet.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Maastricht University</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6200MD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</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 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maastricht University</investigator_affiliation>
    <investigator_full_name>Ben van Koppen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Low Back Pain</keyword>
  <keyword>Social Support</keyword>
  <keyword>Illness Perceptions</keyword>
  <keyword>Activity Advice</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/NCT02996955
org study id: NL58005.096.16
nct id: NCT02996955
lead sponsor: 
has dmc: No
Low back pain is worldwide a common musculoskeletal condition with a high number of
      recurrences. Recurrence rate and the number of recurrences could be reduced and time to a
      next episode could be prolonged by advising an active lifestyle. Advising regular physical
      activity is the mainstay in physical therapy treatment. This includes an appeal to patients
      to adhere to an activity advice. Patient adherence to an activity advice is poor. In this
      study an intervention consisting of treatment of illness perceptions with or without
      organizing social support to increase adherence to an activity advice will be investigated.

      The primary objective of this study is to investigate whether social support by a partner or
      friend and treatment of patients' illness perceptions influences the rate of adherence to an
      activity advice compared to treatment of patients' illness perceptions alone in patients
      suffering non-specific low back pain. Secondary objectives are; a) whether 'treatment of
      illness perceptions' changes patients' maladaptive illness perceptions into realistic ones,
      b) whether maladaptive illness perceptions, comorbidity and/or overweighed/obesity and/or
      rate of recurrences of non-specific low back pain and/or attitude and intention to physical
      activity influences patient's adherence .

      This study is a multi-centre randomized two-arm controlled clinical trial. Patients ≥18 years
      presenting with at least a second episode of non-specific low back pain.

      Patients in the intervention and control group will be asked to perform a physical activity
      advice. During two physiotherapy treatment sessions treatment of illness perceptions is
      performed in both groups. In the intervention group organizing social support by a partner or
      friend is added.

      Twenty-five percent absolute improvement of walking and/or cycling according the NNGB in the
      intervention group is clinically relevant.

      During four appointments several questionnaires have to be filled in and during two
      physiotherapy treatment sessions half an hour treatment of illness perceptions will be
      performed. Social support by a partner or friend will be organized during the same
      physiotherapy treatment sessions in the intervention group. During three separate weeks
      patients have to wear an activity monitor. Patients will be treated according to the Dutch
      Low Back Pain guideline; no adverse effects will be expected.
Objective of the study:

      The primary objective of this study is to investigate whether social support by a partner or
      friend and treatment of patients' illness perceptions influences the rate of adherence to an
      activity advice compared to treatment of patients' illness perceptions alone in patients
      suffering non-specific low back pain. Secondary objectives are; 1) Whether 'treatment of
      illness perceptions' changes patients' maladaptive illness perceptions into realistic ones,
      2) Whether maladaptive illness perceptions, comorbidity and/or obesity and/or rate of
      recurrences of non-specific low back pain and/or attitude and intention to physical activity
      influences patient's adherence to an activity advice.

      Study design:

      This study is a multicentre randomized two arm, controlled clinical trial. During a
      twelve-week intervention period, one group of patients will receive an activity advice added
      to usual treatment including 'treatment of illness perceptions' (C-group). The other group
      will receive an activity advice and the intervention addressing social support by a partner
      or friend added to usual treatment including 'treatment of illness perceptions'
      (SoSup-group). Patients will be assessed at baseline, and after one, 6 and 12 weeks.
      Recruitment is scheduled from October 2016 to July 2017. The study will be performed in 12
      centres for physiotherapy in the province Zuid-Holland, the Netherlands.

      Study population:

      It is mentioned that individuals with recurrent non-specific low back pain score more
      unfavourable on lifestyle risk factors including physical inactivity than individuals without
      or first time non-specific low back pain (van Oostrom et al., 2012). To include potential
      physically inactive non-specific low back pain sufferers, patients ≥18 years presenting with
      at least a second episode of non-specific low back pain who are not physical active in
      accordance with the NNGB are recruited for the study.

      Intervention (if applicable):

      In both the C- and SoSup-group an activity advice will be added to usual treatment. The
      advised activities will be walking and/or cycling outdoors, meeting the Dutch Standard
      Healthy Physical Activity (NNGB) (Hildebrandt et al., 2007). In both groups cognitive
      treatment on illness perceptions according to the common sense model to the patient in the
      presence of the partner or friend will be given. During a maximum of two half-hour contacts
      in a standardised dialogue on maladaptive beliefs and feelings about identity, time-line,
      causes, controllability, and curability of low back pain are mapped, maladaptive perceptions
      are challenged, alternative perceptions are formulated (Siemonsma et al., 2013). The
      intervention in the SoSup-group (intervention group), organizing social support by a partner
      or friend depending on patient's preferences, will be added. During a maximum of two
      half-hour contacts (one for explanation and one for evaluation), in a standardised discussion
      the partner or friend will be stimulated to support the patient in executing the activity
      advice. During 12 weeks the social support by a partner or friend will be executed for at
      least 5 times a week.

      Primary study parameters/outcome of the study:

      The primary outcome measure will be walking and/or cycling according to the NNGB and social
      support.

      Secundary study parameters/outcome of the study (if applicable):

      Other outcomes will be 1. measures of illness perceptions. 2. measures of comorbidity, BMI,
      number of recurrences of non-specific low back pain, measures of attitude and intention to
      physical activity 3. measures of refusal of the study.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness (if applicable):

      The social support described in this study is designed for better outcomes of physical
      activity levels patients suffering low back pain, and has no proven advantage on better
      outcomes on pain and disability in non-specific low back pain sufferers. Therefore we
      consider there is no disadvantage in the SoSup-group versus the C-group because patients in
      both groups receive concomitant best evidence healthcare according to the Dutch guideline for
      low back pain (Staal et al., 2013). No adverse effects of the interventions are expected.
      There are no ethical implications to be expected as a result of this study, treatment of all
      patients during the intervention period will be according to the Dutch guideline for low back
      pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: adherence to the activity advice
time frame: 12 weeks
description: proportion of patients (non)adhering to the activity advice measured by the Activ8
measure: changes in patient's illness perceptions
time frame: base line, one week, 6 and 12 weeks
description: proportion of patients with (un)changed illness perceptions measured by the Brief Illness Perception Questionnaire- short, Dutch version.
measure: influence of illness perception on adherence
time frame: 12 weeks
description: proportion of patients with (mal)adaptive illness perception measured by the BIPQ-s Dutch version (non)adhering the activity advice measured by the Activ8
measure: influence of comorbidity on adherence
time frame: 12 weeks
description: proportion of patients with or without comorbidity measured by the Cumulative Illness Rating Scale (non)adhering the activity advice measured by the Activ8
measure: influence of overweight/obesity on adherence
time frame: 12 weeks
description: proportion of patients with or without overweight/obesity measured with Body Mass Index (non)adhering the activity advice measured by the Activ8
measure: influence of number of episodes of low back pain on adherence
time frame: 12 weeks
description: proportion of patients with or without more than 2 episodes low back pain (non)adhering the activity advice measured by the activ8
measure: change of influence of attitude and intention to a physical activity on adherence
time frame: base line, one week, 6 and 12 weeks
description: proportion of patients with or without adequate atitude/intention to physical activity measured by the Module Houding en Intentie Questionnaire (non)adhering the activity advice measured by the activ8
measure: influence of perceived pain and disability on adherence
time frame: base line
description: proportion of patients with or without high scores on VAS pain and Quebec Back Pain and Disability scale (non) adhering the activity advice measured by the activ8
arm group label: SoSup group
arm group type: Experimental
description: usual care will be provided and social support and treatment of illness perceptions and activity advice and wearing the activ8
arm group label: C group
arm group type: Active Comparator
description: usual care will be provided and treatment of illness perceptions and activity advice and wearing the Activ8
intervention type: Behavioral
intervention name: social support
description: behaviour change intervention
arm group label: SoSup group
intervention type: Behavioral
intervention name: treatment of illness perceptions
description: educational interview
arm group label: C group
arm group label: SoSup group
intervention type: Device
intervention name: Activ8
description: wearing a move monitor
arm group label: C group
arm group label: SoSup group
intervention type: Other
intervention name: activity advice
description: walking or cycling 5 days a week during at least half an hour
arm group label: C group
arm group label: SoSup group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rob de Bie, Prof. PhD
role: Study Chair
affiliation: Maastricht University
last name: Henk v Mameren, Em Prof PhD
role: Study Chair
affiliation: Maastricht University
last name: Ben v Koppen
phone: 0031102937111
email: ben.van.koppen.mmt@gmail.com
last name: Pim Zandwijk
phone: 0031786428848
email: pzandwijk@kpnplanet.nl
facility: 
status: Recruiting
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Maastricht University
investigator full name: Ben van Koppen
investigator title: Principal Investigator
sharing ipd: No