<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/NCT03271684</url>
  </required_header>
  <id_info>
    <org_study_id>BM17/2/7</org_study_id>
    <nct_id>NCT03271684</nct_id>
  </id_info>
  <brief_title>The Effectiveness of the Adapted Bridge's Self-management Programme</brief_title>
  <official_title>The Effectiveness of the Adapted Bridge's Self-management Programme in South African Community-dwelling Stroke Survivors: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of the Western Cape</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of the Western Cape</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 effectiveness of the adapted Bridge's self-management programme in South African&#xD;
      community-dwelling stroke survivors: A randomized controlled trial with two arms will be&#xD;
      used, with the intervention group receiving self-management sessions delivered by experienced&#xD;
      therapists and usual care and control group will only receive usual care which includes a&#xD;
      information booklet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aim to determine the effectiveness of the Adapted bridges self-management&#xD;
      intervention on South African stroke patients' functional activity, self-efficacy, and&#xD;
      participation. Method: This experimental study will make use of a randomized controlled&#xD;
      design (RCT), consisting of one hundred and sixty eight stroke survivors recruited from&#xD;
      different health care facilities within the Cape Metropolitan area. The study participants&#xD;
      will be divided randomly into two groups, with one receiving the intervention - the&#xD;
      experimental group - and the other receiving an educational booklet - the control group.&#xD;
      Participants will be assessed at baseline, immediately post-intervention (six weeks), three&#xD;
      and sixth-month post intervention, using standardized outcome measures (both subjective&#xD;
      outcome measures and objective clinical tools). Ethical clearance and permission to conduct&#xD;
      the study will be obtained and patient information will be kept confidential. Analyses will&#xD;
      be conducted using descriptive statistics of frequencies and percentages for categorical&#xD;
      variables and mean and standard deviation for continuous variables. Given the assumptions of&#xD;
      equal variance, a two-way full factorial ANOVA will be computed in order to assess&#xD;
      interaction between groups and intervention type.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2018</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 (Participant, Outcomes Assessor)</masking>
    <masking_description>Double-blinded, participant and assessor blinded, randomised trial.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Stroke Self-Efficacy Questionnaire(SSEQ):</measure>
    <time_frame>baseline to the 6 months after intervention</time_frame>
    <description>The SSEQ is a 13 point questionnaire developed by Jones et al (2008) and is aimed to determine the individuals perceived level of self-efficacy in completing a range of relevant functional tasks, such as walking, getting comfortable in bed, as well as several self-management tasks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Rivermead Mobility Index:</measure>
    <time_frame>baseline to the 6 months after intervention</time_frame>
    <description>is a 15 point index with various topics and questions aimed at objectively determining the participant's mobility level. According to Lennon &amp; Johnson (2000) highly reliable between raters (ICC = 0.98, p &lt; 0.001) with high internal consistency (Cronbach's alpha = 0.93).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rivermead Activities of Daily Living Scale:</measure>
    <time_frame>baseline to the 6 months after intervention</time_frame>
    <description>is a 31 point scale used to determine the level of independence a participant has with self-care and household tasks of varying difficulty. It has an excellent overall test-retest reliability (ICC = 0.96) (Chen et al, 2007) and an excellent concurrent validity at 180 days post stroke (r = 0.93) (Hsueh et al, 2003).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Mini-BESTest:</measure>
    <time_frame>baseline to the 6 months after intervention</time_frame>
    <description>is a 14-item clinical test that covers four components of balance control (anticipatory postural adjustments, postural responses, sensory orientation and stability in gait). Each item is scored from 0 (unable or requiring help) to 2 (normal) and the maximal score is 28 points. The Mini-BESTest has an excellent test-retest reliability (ICC = 0.96), with an excellent convergent validity (r = 0.96) (Godi et al, 2013).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Subjective Index of Physical and Social Outcome scale</measure>
    <time_frame>baseline to the 6 months after intervention</time_frame>
    <description>a 10 point rating index aimed at determining the participants' perceived extent of participation within the community, with its main domains as perceived functioning and social connectedness. SIPSO has been shown to present an excellent test-retest reliability with ICC = 0.96 and has indicated a proven validity (Trigg &amp; Wood, 2003).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>National Institute for Health Stroke Scale</measure>
    <time_frame>baseline to the 6 months after intervention</time_frame>
    <description>is a 15 item neurologic examination that provides a quantitative measure of stroke-related neurologic deficit. According to Kasner et al, (1999) reliability Agreement between pairs of raters was also very good to excellent, with ICCs ranging from 0.70 to 0.89.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Action Research Arm Test</measure>
    <time_frame>baseline to the 6 months after intervention</time_frame>
    <description>is a 19 item scale divided into four subscales: grasp, grip, pinch, and gross movement. The items within each subscale are arranged on a 4-point ordinal scale ranging from 0 to 3, with 3 indicating normal performance on each item. The maximum score on the ARAT is 57 points According to McDonnell, 2008 Inter-rater and retest reliability have been shown to be high (ICC &gt; 0.98) in studies involving patients with stroke and Concurrent validity has been confirmed by comparison with the upper limb component of the Fugl- Meyer Assessment and the Motor Assessment Scale (MAS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-minute walk test</measure>
    <time_frame>baseline to the 6 months after intervention</time_frame>
    <description>Functional ability will be assessed using the 6-minute walk test (6-MWT), a reliable and valid measure for the stroke population. Participants will be instructed to walk at a comfortable pace on a 30-m measured walkway for 6 minutes. The outcome will be the total distance covered during testing. 6MWT exhibits excellent test-retest reliability (ICC = 0.973; 95 % CI = 0.925 to 0.988), it presents a minimal detectable change of 54.1 m, and an acceptable concurrent validity (r = 0.52 to 0.89) (Fulk et al, 2008).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Self-Care</condition>
  <condition>Self Efficacy</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive one session of up to one-hour per week over a six-week period in self-management in addition to their usual rehabilitation and workbook.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Will receive booklet consist of home exercises and education besides the usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>self-management</intervention_name>
    <description>one session of up to one-hour per week over a six-week period in addition to their usual rehabilitation. During each session strategies will be used to promote specific behaviors that exemplify the hallmarks of self-management. These behaviors include enabling patients to work out ways of taking control of their daily lives by setting small targets, recording their progress and problem-solving. The content of the sessions is determined by the patient and their personal goals rather than being professionally directed</description>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Participants will receive usual rehabilitation treatment, they will also be given a booklet with education program and exercises they can perform at home.</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  having a first ever stroke, by a physician, based on the WHO (1988) definition of&#xD;
             stroke which is &quot;rapidly developing clinical signs of focal (or global) disturbance of&#xD;
             cerebral function, with symptoms lasting 24 hours or longer or leading to death, with&#xD;
             no apparent cause other than of vascular origin&quot;; ≥18 years of age; of sufficient&#xD;
             cognition to participate: having a score of ≥24 points on mini-mental state&#xD;
             examination (placing participants at matched mental status) ; are medically stable&#xD;
             and; and are within the sub-acute to chronic phase of their rehabilitation (10 weeks&#xD;
             to 6-months post stroke).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants will be excluded if they have serious medical conditions such as HIV/AIDS&#xD;
             or TB, which could additionally affect the outcomes evaluated in this study.&#xD;
             Participants with depression, having recurrent stroke, still receiving in inpatient&#xD;
             rehabilitation, with cognitive or receptive language difficulties and are unable to&#xD;
             comprehend the intervention will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Reham Nasir, MSc</last_name>
    <phone>+27613756412</phone>
    <email>3608175@myuwc.ac.za</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anthea Rhoda, Professor</last_name>
    <phone>+27827757748</phone>
    <email>arhoda@uwc.ac.za</email>
  </overall_contact_backup>
  <reference>
    <citation>Jones F, Partridge C, Reid F. The Stroke Self-Efficacy Questionnaire: measuring individual confidence in functional performance after stroke. J Clin Nurs. 2008 Apr;17(7B):244-52. doi: 10.1111/j.1365-2702.2008.02333.x.</citation>
    <PMID>18578800</PMID>
  </reference>
  <reference>
    <citation>Lennon S, Johnson L. The modified rivermead mobility index: validity and reliability. Disabil Rehabil. 2000 Dec 15;22(18):833-9. doi: 10.1080/09638280050207884.</citation>
    <PMID>11197520</PMID>
  </reference>
  <reference>
    <citation>Chen HM, Hsieh CL, Sing Kai Lo, Liaw LJ, Chen SM, Lin JH. The test-retest reliability of 2 mobility performance tests in patients with chronic stroke. Neurorehabil Neural Repair. 2007 Jul-Aug;21(4):347-52. doi: 10.1177/1545968306297864. Epub 2007 Mar 12.</citation>
    <PMID>17353463</PMID>
  </reference>
  <reference>
    <citation>Hsueh IP, Wang CH, Sheu CF, Hsieh CL. Comparison of psychometric properties of three mobility measures for patients with stroke. Stroke. 2003 Jul;34(7):1741-5. doi: 10.1161/01.STR.0000075295.45185.D4. Epub 2003 May 29.</citation>
    <PMID>12775883</PMID>
  </reference>
  <reference>
    <citation>Godi M, Franchignoni F, Caligari M, Giordano A, Turcato AM, Nardone A. Comparison of reliability, validity, and responsiveness of the mini-BESTest and Berg Balance Scale in patients with balance disorders. Phys Ther. 2013 Feb;93(2):158-67. doi: 10.2522/ptj.20120171. Epub 2012 Sep 27.</citation>
    <PMID>23023812</PMID>
  </reference>
  <reference>
    <citation>Trigg R, Wood VA. The Subjective Index of Physical and Social Outcome (SIPSO): a new measure for use with stroke patients. Clin Rehabil. 2000 Jun;14(3):288-99. doi: 10.1191/026921500678119607.</citation>
    <PMID>10868724</PMID>
  </reference>
  <reference>
    <citation>Kasner SE, Chalela JA, Luciano JM, Cucchiara BL, Raps EC, McGarvey ML, Conroy MB, Localio AR. Reliability and validity of estimating the NIH stroke scale score from medical records. Stroke. 1999 Aug;30(8):1534-7. doi: 10.1161/01.str.30.8.1534.</citation>
    <PMID>10436096</PMID>
  </reference>
  <reference>
    <citation>McDonnell M. Action research arm test. Aust J Physiother. 2008;54(3):220. doi: 10.1016/s0004-9514(08)70034-5. No abstract available.</citation>
    <PMID>18833688</PMID>
  </reference>
  <reference>
    <citation>The World Health Organization MONICA Project (monitoring trends and determinants in cardiovascular disease): a major international collaboration. WHO MONICA Project Principal Investigators. J Clin Epidemiol. 1988;41(2):105-14. doi: 10.1016/0895-4356(88)90084-4.</citation>
    <PMID>3335877</PMID>
  </reference>
  <reference>
    <citation>Fulk GD, Echternach JL, Nof L, O'Sullivan S. Clinometric properties of the six-minute walk test in individuals undergoing rehabilitation poststroke. Physiother Theory Pract. 2008 May-Jun;24(3):195-204. doi: 10.1080/09593980701588284.</citation>
    <PMID>18569856</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 3, 2017</last_update_submitted>
  <last_update_submitted_qc>September 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of the Western Cape</investigator_affiliation>
    <investigator_full_name>Reham Nasir</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>stroke, self-management, Bridges, participation, function, self-efficacy</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Currently not allowed by ethic to share the data with other researchers</ipd_description>
  </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/NCT03271684
org study id: BM17/2/7
nct id: NCT03271684
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The effectiveness of the adapted Bridge's self-management programme in South African
      community-dwelling stroke survivors: A randomized controlled trial with two arms will be
      used, with the intervention group receiving self-management sessions delivered by experienced
      therapists and usual care and control group will only receive usual care which includes a
      information booklet.
This study aim to determine the effectiveness of the Adapted bridges self-management
      intervention on South African stroke patients' functional activity, self-efficacy, and
      participation. Method: This experimental study will make use of a randomized controlled
      design (RCT), consisting of one hundred and sixty eight stroke survivors recruited from
      different health care facilities within the Cape Metropolitan area. The study participants
      will be divided randomly into two groups, with one receiving the intervention - the
      experimental group - and the other receiving an educational booklet - the control group.
      Participants will be assessed at baseline, immediately post-intervention (six weeks), three
      and sixth-month post intervention, using standardized outcome measures (both subjective
      outcome measures and objective clinical tools). Ethical clearance and permission to conduct
      the study will be obtained and patient information will be kept confidential. Analyses will
      be conducted using descriptive statistics of frequencies and percentages for categorical
      variables and mean and standard deviation for continuous variables. Given the assumptions of
      equal variance, a two-way full factorial ANOVA will be computed in order to assess
      interaction between groups and intervention type.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Double-blinded, participant and assessor blinded, randomised trial.
measure: Stroke Self-Efficacy Questionnaire(SSEQ):
time frame: baseline to the 6 months after intervention
description: The SSEQ is a 13 point questionnaire developed by Jones et al (2008) and is aimed to determine the individuals perceived level of self-efficacy in completing a range of relevant functional tasks, such as walking, getting comfortable in bed, as well as several self-management tasks
measure: The Rivermead Mobility Index:
time frame: baseline to the 6 months after intervention
description: is a 15 point index with various topics and questions aimed at objectively determining the participant's mobility level. According to Lennon & Johnson (2000) highly reliable between raters (ICC = 0.98, p < 0.001) with high internal consistency (Cronbach's alpha = 0.93).
measure: Rivermead Activities of Daily Living Scale:
time frame: baseline to the 6 months after intervention
description: is a 31 point scale used to determine the level of independence a participant has with self-care and household tasks of varying difficulty. It has an excellent overall test-retest reliability (ICC = 0.96) (Chen et al, 2007) and an excellent concurrent validity at 180 days post stroke (r = 0.93) (Hsueh et al, 2003).
measure: The Mini-BESTest:
time frame: baseline to the 6 months after intervention
description: is a 14-item clinical test that covers four components of balance control (anticipatory postural adjustments, postural responses, sensory orientation and stability in gait). Each item is scored from 0 (unable or requiring help) to 2 (normal) and the maximal score is 28 points. The Mini-BESTest has an excellent test-retest reliability (ICC = 0.96), with an excellent convergent validity (r = 0.96) (Godi et al, 2013).
measure: The Subjective Index of Physical and Social Outcome scale
time frame: baseline to the 6 months after intervention
description: a 10 point rating index aimed at determining the participants' perceived extent of participation within the community, with its main domains as perceived functioning and social connectedness. SIPSO has been shown to present an excellent test-retest reliability with ICC = 0.96 and has indicated a proven validity (Trigg & Wood, 2003).
measure: National Institute for Health Stroke Scale
time frame: baseline to the 6 months after intervention
description: is a 15 item neurologic examination that provides a quantitative measure of stroke-related neurologic deficit. According to Kasner et al, (1999) reliability Agreement between pairs of raters was also very good to excellent, with ICCs ranging from 0.70 to 0.89.
measure: Action Research Arm Test
time frame: baseline to the 6 months after intervention
description: is a 19 item scale divided into four subscales: grasp, grip, pinch, and gross movement. The items within each subscale are arranged on a 4-point ordinal scale ranging from 0 to 3, with 3 indicating normal performance on each item. The maximum score on the ARAT is 57 points According to McDonnell, 2008 Inter-rater and retest reliability have been shown to be high (ICC > 0.98) in studies involving patients with stroke and Concurrent validity has been confirmed by comparison with the upper limb component of the Fugl- Meyer Assessment and the Motor Assessment Scale (MAS).
measure: 6-minute walk test
time frame: baseline to the 6 months after intervention
description: Functional ability will be assessed using the 6-minute walk test (6-MWT), a reliable and valid measure for the stroke population. Participants will be instructed to walk at a comfortable pace on a 30-m measured walkway for 6 minutes. The outcome will be the total distance covered during testing. 6MWT exhibits excellent test-retest reliability (ICC = 0.973; 95 % CI = 0.925 to 0.988), it presents a minimal detectable change of 54.1 m, and an acceptable concurrent validity (r = 0.52 to 0.89) (Fulk et al, 2008).
arm group label: intervention group
arm group type: Experimental
description: Will receive one session of up to one-hour per week over a six-week period in self-management in addition to their usual rehabilitation and workbook.
arm group label: control group
arm group type: Other
description: Will receive booklet consist of home exercises and education besides the usual care
intervention type: Other
intervention name: self-management
description: one session of up to one-hour per week over a six-week period in addition to their usual rehabilitation. During each session strategies will be used to promote specific behaviors that exemplify the hallmarks of self-management. These behaviors include enabling patients to work out ways of taking control of their daily lives by setting small targets, recording their progress and problem-solving. The content of the sessions is determined by the patient and their personal goals rather than being professionally directed
arm group label: intervention group
intervention type: Other
intervention name: Control
description: Participants will receive usual rehabilitation treatment, they will also be given a booklet with education program and exercises they can perform at home.
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Reham Nasir, MSc
phone: +27613756412
email: 3608175@myuwc.ac.za
last name: Anthea Rhoda, Professor
phone: +27827757748
email: arhoda@uwc.ac.za
citation: Jones F, Partridge C, Reid F. The Stroke Self-Efficacy Questionnaire: measuring individual confidence in functional performance after stroke. J Clin Nurs. 2008 Apr;17(7B):244-52. doi: 10.1111/j.1365-2702.2008.02333.x.
PMID: 18578800
citation: Lennon S, Johnson L. The modified rivermead mobility index: validity and reliability. Disabil Rehabil. 2000 Dec 15;22(18):833-9. doi: 10.1080/09638280050207884.
PMID: 11197520
citation: Chen HM, Hsieh CL, Sing Kai Lo, Liaw LJ, Chen SM, Lin JH. The test-retest reliability of 2 mobility performance tests in patients with chronic stroke. Neurorehabil Neural Repair. 2007 Jul-Aug;21(4):347-52. doi: 10.1177/1545968306297864. Epub 2007 Mar 12.
PMID: 17353463
citation: Hsueh IP, Wang CH, Sheu CF, Hsieh CL. Comparison of psychometric properties of three mobility measures for patients with stroke. Stroke. 2003 Jul;34(7):1741-5. doi: 10.1161/01.STR.0000075295.45185.D4. Epub 2003 May 29.
PMID: 12775883
citation: Godi M, Franchignoni F, Caligari M, Giordano A, Turcato AM, Nardone A. Comparison of reliability, validity, and responsiveness of the mini-BESTest and Berg Balance Scale in patients with balance disorders. Phys Ther. 2013 Feb;93(2):158-67. doi: 10.2522/ptj.20120171. Epub 2012 Sep 27.
PMID: 23023812
citation: Trigg R, Wood VA. The Subjective Index of Physical and Social Outcome (SIPSO): a new measure for use with stroke patients. Clin Rehabil. 2000 Jun;14(3):288-99. doi: 10.1191/026921500678119607.
PMID: 10868724
citation: Kasner SE, Chalela JA, Luciano JM, Cucchiara BL, Raps EC, McGarvey ML, Conroy MB, Localio AR. Reliability and validity of estimating the NIH stroke scale score from medical records. Stroke. 1999 Aug;30(8):1534-7. doi: 10.1161/01.str.30.8.1534.
PMID: 10436096
citation: McDonnell M. Action research arm test. Aust J Physiother. 2008;54(3):220. doi: 10.1016/s0004-9514(08)70034-5. No abstract available.
PMID: 18833688
citation: The World Health Organization MONICA Project (monitoring trends and determinants in cardiovascular disease): a major international collaboration. WHO MONICA Project Principal Investigators. J Clin Epidemiol. 1988;41(2):105-14. doi: 10.1016/0895-4356(88)90084-4.
PMID: 3335877
citation: Fulk GD, Echternach JL, Nof L, O'Sullivan S. Clinometric properties of the six-minute walk test in individuals undergoing rehabilitation poststroke. Physiother Theory Pract. 2008 May-Jun;24(3):195-204. doi: 10.1080/09593980701588284.
PMID: 18569856
responsible party type: Principal Investigator
investigator affiliation: University of the Western Cape
investigator full name: Reham Nasir
investigator title: Principal investigator
sharing ipd: Undecided
ipd description: Currently not allowed by ethic to share the data with other researchers