<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/NCT02202330</url>
  </required_header>
  <id_info>
    <org_study_id>URC132001MED</org_study_id>
    <nct_id>NCT02202330</nct_id>
  </id_info>
  <brief_title>Using 5 Minute Videos for Numeracy and Literacy Challenged Stroke Survivors to Improve Outcomes</brief_title>
  <official_title>Translating Knowledge for Action Against Stroke - Using 5 Minute Videos for Numeracy and Literacy Challenged Stroke Survivors and Caregivers to Improve Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aga Khan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Two thirds of all strokes happen in developing countries like Pakistan. There is a serious&#xD;
      lack of health literacy regarding survival after stroke. We hypothesize that our set of 5&#xD;
      minute videos that teach important skills to stroke survivors and their caregivers , that can&#xD;
      be replayed in cell phones for extended learning, will increase their adherence to&#xD;
      Medications after stroke and improve the control of blood pressure, elevated cholesterol and&#xD;
      glucose in the participants getting cell phone based educational videos.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 80% of patients with stroke, further events may be prevented by altering lifestyle&#xD;
      behavioral risk, and increasing adherence to medications to control hypertension, diabetes,&#xD;
      lipids. Yet, there exists a huge science to implementation gap to adopt these widely&#xD;
      recognized beneficial medicines and lifestyle changes. Those most in need remain unable to&#xD;
      actualize the benefits of science, due to lack of knowledge, perceived complexity, literacy&#xD;
      challenges, limited time by poorly communicating doctors in crowded clinics and essentially,&#xD;
      failure by regional scientists to translate Western science in creative resonant ways that&#xD;
      enable wider uptake.&#xD;
&#xD;
      In this randomized double blind translational implementation study, we will study the&#xD;
      effectiveness of the implementation tactic of delivering enabling stroke education and risk&#xD;
      reduction to literacy and numeracy challenged Pakistani stroke survivors and their&#xD;
      caregivers, via short films teaching stroke recognition, healthy habits, medication adherence&#xD;
      and self-care. These 5 minute films , using a 'show me not tell me ' approach, will be&#xD;
      replayed in tablets, and shown to all stroke patients in the intervention arm. The primary&#xD;
      objective of this study is to answer the research question - Does video based education given&#xD;
      to stroke patients (with mild to moderate disability) and their caregivers before discharge,&#xD;
      and during follow up, improve adherence to therapy and control of three major risk factors&#xD;
      (Diabetes, hypertension and dyslipidemia) at twelve months post index stroke?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Increase in Adherence and Control of Stroke Risk Factors</measure>
    <time_frame>1, 3, 6, 9 and 12 months</time_frame>
    <description>Proportion of participants adhering to medications prescribed (Definition of adherence- use of prescribed medications on &gt;5 days a week and measured by the Morisky adherence scale(18).&#xD;
Proportion of participants achieving control of blood pressure (control is defined as BP&lt;125/85), blood sugar (HbA1c&lt;7) and blood cholesterol (LDL &lt; 100)(19).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Increase in Knowledge and Decrease in Complications</measure>
    <time_frame>1, 3, 6, 9 and 12 months</time_frame>
    <description>Increase in knowledge of caretakers concerning stroke risk factors, stroke rehabilitation and medications (A knowledge questionnaire will be designed to cover all aspects. This will be administered at 1, 3, 6, 9 and 12 months and improvement in score will be ascertained).&#xD;
Readmission to hospital with any of the stroke related complications - Urinary Tract infection, pneumonia, Deep vein Thrombosis (This information will be elicited at the follow-up time, based on recall. All subjects will be asked to bring documents related to any hospital admissions in the period following discharge )</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">310</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Standard Care, Organized Discharge</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Stroke patients are given instructions before discharge regarding diet, need for rehabilitation, possible complications, medication use and information booklets are also handed out. This information is imparted by a multidisciplinary team consisting of a neuro physician, a stroke nurse, a dietitian and a physiotherapist. These are verbal instructions and handouts are written in English. On the day of discharge, or 24 hours prior to discharge, a discharge coordinator details the skills learnt . A detailed written discharge summary is given out detailing all aspects of care, follow-up, medications and test results.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video Arm, Standard Discharge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention is as follows:&#xD;
5 minute videos, on various stroke related topics/ themes delivered in one session before discharge from the hospital (list topics on which videos have to made)&#xD;
Discussion and questions and answers after viewing video to ensure that core message has been understood and there are no lacunae in understanding the message of video.&#xD;
Phone card - a memory chip installed in the cell phones of intervention team that ensures that the videos can be replayed at home to refresh memory of some details that may not have been captured in the mandatory viewing sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Video Arm</intervention_name>
    <description>5 minute videos, on various stroke related topics/ themes delivered in one session before discharge from the hospital (list topics on which videos have to made)&#xD;
Discussion and questions and answers after viewing video to ensure that core message has been understood and there are no lacunae in understanding the message of video.&#xD;
Phone card - a memory chip installed in the cell phones of intervention team that ensures that the videos can be replayed at home to refresh memory of some details that may not have been captured in the mandatory viewing sessions.</description>
    <arm_group_label>Standard Care, Organized Discharge</arm_group_label>
    <arm_group_label>Video Arm, Standard Discharge</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult men and women, &gt; 18 years of age&#xD;
&#xD;
          2. Resident of Karachi and planning to live in Karachi to complete long term follow up&#xD;
&#xD;
          3. Able to understand Urdu (language of the videos)&#xD;
&#xD;
          4. Admitted with first ever stroke (ischemic or hemorrhagic)&#xD;
&#xD;
          5. Modified Rankin score &lt;3 ( Mild strokes)&#xD;
&#xD;
          6. Have at least one vascular risk factor that requires medical intervention&#xD;
&#xD;
          7. Consent to participate in the study and follow up, both stroke and caregiver.&#xD;
&#xD;
          8. Have a stable surrogate caregiver at home who is responsible for appointments,&#xD;
             follow-ups, overall care, e.g., wife, daughters, daughter- in- law, etc.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Serious aphasia, visual hemi neglect, short term memory loss in the patient precluding&#xD;
             understanding, visualization or retention of the video material, despite overall &quot;a&#xD;
             small stroke&quot;, this would be a cognitively critical stroke.&#xD;
&#xD;
          2. Serious aphasia, visual hemi neglect, short term memory loss, dementia in the&#xD;
             caregiver precluding understanding, visualization or retention of the video material.&#xD;
&#xD;
          3. Iatrogenic stroke, stroke due to non-atherosclerotic vascular disease and rare causes&#xD;
             e.g. moya moya, carotid dissections, gunshot to neck, post Coronary Artery Bypass&#xD;
             surgery etc.&#xD;
&#xD;
          4. Serious concurrent medical illnesses, like cancer, renal failure, acute liver disease&#xD;
             in past 6 months (that precludes use of statins), chronic liver disease, that exclude&#xD;
             the use of stroke preventive medications, or require non standardized therapy.&#xD;
&#xD;
          5. Any use of off label, non-guideline medications, due to patient unique comorbid&#xD;
             conditions that interfere with medication compliance to antihypertensive, statins,&#xD;
             antiplatelet agents and diabetes control.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Ayeesha K Kamal, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aga Khan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aga Khan University, Clinical Trial Unit</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <zip>74800</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>August 5, 2016</last_update_submitted>
  <last_update_submitted_qc>August 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Dr. Ayeesha Kamran Kamal</investigator_full_name>
    <investigator_title>Associate Professor Neurology,Director Stroke Services</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- 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/NCT02202330
org study id: URC132001MED
nct id: NCT02202330
lead sponsor: 
has dmc: Yes
Two thirds of all strokes happen in developing countries like Pakistan. There is a serious
      lack of health literacy regarding survival after stroke. We hypothesize that our set of 5
      minute videos that teach important skills to stroke survivors and their caregivers , that can
      be replayed in cell phones for extended learning, will increase their adherence to
      Medications after stroke and improve the control of blood pressure, elevated cholesterol and
      glucose in the participants getting cell phone based educational videos.
In 80% of patients with stroke, further events may be prevented by altering lifestyle
      behavioral risk, and increasing adherence to medications to control hypertension, diabetes,
      lipids. Yet, there exists a huge science to implementation gap to adopt these widely
      recognized beneficial medicines and lifestyle changes. Those most in need remain unable to
      actualize the benefits of science, due to lack of knowledge, perceived complexity, literacy
      challenges, limited time by poorly communicating doctors in crowded clinics and essentially,
      failure by regional scientists to translate Western science in creative resonant ways that
      enable wider uptake.

      In this randomized double blind translational implementation study, we will study the
      effectiveness of the implementation tactic of delivering enabling stroke education and risk
      reduction to literacy and numeracy challenged Pakistani stroke survivors and their
      caregivers, via short films teaching stroke recognition, healthy habits, medication adherence
      and self-care. These 5 minute films , using a 'show me not tell me ' approach, will be
      replayed in tablets, and shown to all stroke patients in the intervention arm. The primary
      objective of this study is to answer the research question - Does video based education given
      to stroke patients (with mild to moderate disability) and their caregivers before discharge,
      and during follow up, improve adherence to therapy and control of three major risk factors
      (Diabetes, hypertension and dyslipidemia) at twelve months post index stroke?
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: Increase in Adherence and Control of Stroke Risk Factors
time frame: 1, 3, 6, 9 and 12 months
description: Proportion of participants adhering to medications prescribed (Definition of adherence- use of prescribed medications on >5 days a week and measured by the Morisky adherence scale(18).
Proportion of participants achieving control of blood pressure (control is defined as BP<125/85), blood sugar (HbA1c<7) and blood cholesterol (LDL < 100)(19).
measure: Increase in Knowledge and Decrease in Complications
time frame: 1, 3, 6, 9 and 12 months
description: Increase in knowledge of caretakers concerning stroke risk factors, stroke rehabilitation and medications (A knowledge questionnaire will be designed to cover all aspects. This will be administered at 1, 3, 6, 9 and 12 months and improvement in score will be ascertained).
Readmission to hospital with any of the stroke related complications - Urinary Tract infection, pneumonia, Deep vein Thrombosis (This information will be elicited at the follow-up time, based on recall. All subjects will be asked to bring documents related to any hospital admissions in the period following discharge )
arm group label: Standard Care, Organized Discharge
arm group type: Placebo Comparator
description: Stroke patients are given instructions before discharge regarding diet, need for rehabilitation, possible complications, medication use and information booklets are also handed out. This information is imparted by a multidisciplinary team consisting of a neuro physician, a stroke nurse, a dietitian and a physiotherapist. These are verbal instructions and handouts are written in English. On the day of discharge, or 24 hours prior to discharge, a discharge coordinator details the skills learnt . A detailed written discharge summary is given out detailing all aspects of care, follow-up, medications and test results.
arm group label: Video Arm, Standard Discharge
arm group type: Experimental
description: Intervention is as follows:
5 minute videos, on various stroke related topics/ themes delivered in one session before discharge from the hospital (list topics on which videos have to made)
Discussion and questions and answers after viewing video to ensure that core message has been understood and there are no lacunae in understanding the message of video.
Phone card - a memory chip installed in the cell phones of intervention team that ensures that the videos can be replayed at home to refresh memory of some details that may not have been captured in the mandatory viewing sessions.
intervention type: Other
intervention name: Video Arm
description: 5 minute videos, on various stroke related topics/ themes delivered in one session before discharge from the hospital (list topics on which videos have to made)
Discussion and questions and answers after viewing video to ensure that core message has been understood and there are no lacunae in understanding the message of video.
Phone card - a memory chip installed in the cell phones of intervention team that ensures that the videos can be replayed at home to refresh memory of some details that may not have been captured in the mandatory viewing sessions.
arm group label: Standard Care, Organized Discharge
arm group label: Video Arm, Standard Discharge
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dr Ayeesha K Kamal, MBBS
role: Principal Investigator
affiliation: Aga Khan University
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Dr. Ayeesha Kamran Kamal
investigator title: Associate Professor Neurology,Director Stroke Services
mesh term: Stroke