<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/NCT04404166</url>
  </required_header>
  <id_info>
    <org_study_id>20-30016</org_study_id>
    <nct_id>NCT04404166</nct_id>
  </id_info>
  <brief_title>Phone-based Intervention Under Nurse Guidance After Stroke 2</brief_title>
  <official_title>Phone-based Intervention Under Nurse Guidance After Stroke 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northern California Institute of Research and Education</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northern California Institute of Research and Education</source>
  <oversight_info>
    <has_dmc>Yes</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 overall objective of Phone-based Intervention under Nurse Guidance after Stroke II&#xD;
      (PINGS-2) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a&#xD;
      theoretical-model-based, mHealth technology-centered, nurse-led, multi-level integrated&#xD;
      approach to substantially improve longer term BP control among 500 recent stroke patients&#xD;
      encountered at 10 hospitals in Ghana. Secondly, PINGS II seeks to develop an implementation&#xD;
      strategy for routine integration and policy adoption of mhealth for post-stroke BP control in&#xD;
      a LMIC setting. The investigators will leverage experience gained from the NIH Global Brain&#xD;
      Disorders funded R21 pilot study (NS094033) to test efficacy of a refined,&#xD;
      culturally-tailored, and potentially implementable intervention aimed at addressing the&#xD;
      premier modifiable risk for stroke &amp; other key variables in an under-resourced system&#xD;
      burdened by suboptimal care &amp; outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 28, 2020</start_date>
  <completion_date type="Anticipated">October 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2023</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>12 months</time_frame>
    <description>Target goal of &lt;140/90 mmHg measured at baseline, months 3, 6, 9 and 12. Measured by blinded evaluator using an automated BP monitor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-management</measure>
    <time_frame>12 months</time_frame>
    <description>Compared between the two groups using the validated Hypertension Self-care Profile questionnaire (HBP SCP) with items that compositely assesses behavior, motivation and self-efficacy of hypertension management. Assessed at months 4, 8 and 12 (α.83-.93, r = .64). A total score can range from 20 to 80 with higher score indicating better self-care practice.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication adherence</measure>
    <time_frame>12 months</time_frame>
    <description>Measured using Medication possession ratio177 and 14-item Hill-Bone compliance (HBC) to high blood pressure therapy scale with items that assess medication adherence, clinic appointments and salt intake assessed at months 3, 6, 9 and 12 (α.76-.83, r = .64) MPR and HBC will be measured in both PINGS and usual care arms at stated time points. Higher scores (0-14) indicate lower adherence (i.e. higher non adherence).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Cardiovascular ED encounters and Re-hospitalizations</measure>
    <time_frame>12 months</time_frame>
    <description>To be assessed via once monthly calls to patients and/or carers over 12 months of follow up in both the PINGS and usual care groups.&#xD;
Patient carers in both arms will also be encouraged to contact study team within 48 hours of hospitalizations for prompt and blinded adjudication of all potential CVD ED encounters to minimize reporting bias between the two groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Major Adverse Cardiovascular Events</measure>
    <time_frame>12 months</time_frame>
    <description>Major Adverse Cardiovascular events (MACE) to be assessed include recurrent stroke: fatal/ severely disabling stroke or non-fatal stroke; Coronary Artery Disease: Acute STEMI/NSTEMI, sudden cardiac deaths. MACE will be confirmed by a blinded adjudicator by reviewing where available clinical notes supported by investigations e.g. CT scan, EKGs, review of death certificates or verbal autopsy if death occurs outside hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of Life: The Euro Quality of Life-5D questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>The EQ-5D questionnaire,186 will assess state of health of study participants at baseline and Month 12. Scores range from 0 (the worst possible health status) to 100 (the best possible health status).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Health Literacy in HPT/stroke</measure>
    <time_frame>12 months</time_frame>
    <description>Self-Report: HTN/stroke Knowledge questionnaire (r=.70) Health literacy questionnaire (r = .74, .82) Assessed at months 0, 6,12. Higher scores indicate higher health literacy. Scales 1-5 are scored on a 4-point Likert-type response scale (strongly disagree, disagree, agree, strongly agree) and scales 6-9 are scored on a 5-point Likert-type scale with response options focusing on difficulty (cannot do or always difficult, usually difficult, sometimes difficult, usually easy, always easy).</description>
  </other_outcome>
  <other_outcome>
    <measure>Disability/Functional status</measure>
    <time_frame>12 months</time_frame>
    <description>Functional status after stroke will be assessed by Research Assistants using the Modified Rankin Scale with a scores ranging from 0 to 6, where 0=no functional limitation and 6 = death. Assessed at months 0, 3, 6, 9 and 12.</description>
  </other_outcome>
  <other_outcome>
    <measure>Sex, Age, cultural, socio-economic Factors, study site</measure>
    <time_frame>12 months</time_frame>
    <description>Assessed based on self reports at baseline. Cultural factors to assess include language spoken at home, religious observances, acceptance of gender roles; occupation, religious beliefs and dietary practices.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Blood Pressure</condition>
  <condition>Stroke</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>PINGS 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PINGS 2</intervention_name>
    <description>Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction &amp; stroke</description>
    <arm_group_label>PINGS 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 18 years (stroke is commoner above this age cut-off)&#xD;
&#xD;
          -  male or females (sex is a biologic variable of interest)&#xD;
&#xD;
          -  recent stroke (within one month of symptom onset)- stroke may be ischemic or&#xD;
             hemorrhagic based on brain imaging or diagnosed clinically using the locally validated&#xD;
             version of the 8-item questionnaire for verifying stroke free status (8-QVSFS) when&#xD;
             neuroimaging is not feasible&#xD;
&#xD;
          -  uncontrolled HTN (SBP ≥ 140 mmHg at both the last clinical encounter post-stroke and&#xD;
             the eligibility screening visit) - SBP is used as the selection variable since most&#xD;
             African hypertensives &lt;60 years have systolic or combination systolic/ diastolic HTN&#xD;
             and for most patients, controlling SBP also results in DBP control&#xD;
&#xD;
          -  patients or family carers should own a basic mobile phone that can receive text/audio&#xD;
             messages.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Any condition that would limit participation in follow up assessments, such as severe&#xD;
        cognitive impairment/dementia (MMSE ≤24).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ankaase Methodist Hospital</name>
      <address>
        <city>Aboaso</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korle Bu Teaching Hospital</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Agogo Presbyterian Hospital</name>
      <address>
        <city>Agogo</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cape Coast Teaching Hospital</name>
      <address>
        <city>Cape Coast</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Komfo Anokye Teaching Hospital</name>
      <address>
        <city>Kumasi</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kumasi South Hospital</name>
      <address>
        <city>Kumasi</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kwadaso SDA Hospital</name>
      <address>
        <city>Kumasi</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kwame Nkrumah University of Science and Technology</name>
      <address>
        <city>Kumasi</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manhyia Government Hospital</name>
      <address>
        <city>Kumasi</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tafo Government Hospital</name>
      <address>
        <city>Kumasi</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ghana</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 5, 2023</last_update_submitted>
  <last_update_submitted_qc>July 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northern California Institute of Research and Education</investigator_affiliation>
    <investigator_full_name>Bruce Ovbiagele</investigator_full_name>
    <investigator_title>Chief of Staff</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <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/NCT04404166
org study id: 20-30016
nct id: NCT04404166
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The overall objective of Phone-based Intervention under Nurse Guidance after Stroke II
      (PINGS-2) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a
      theoretical-model-based, mHealth technology-centered, nurse-led, multi-level integrated
      approach to substantially improve longer term BP control among 500 recent stroke patients
      encountered at 10 hospitals in Ghana. Secondly, PINGS II seeks to develop an implementation
      strategy for routine integration and policy adoption of mhealth for post-stroke BP control in
      a LMIC setting. The investigators will leverage experience gained from the NIH Global Brain
      Disorders funded R21 pilot study (NS094033) to test efficacy of a refined,
      culturally-tailored, and potentially implementable intervention aimed at addressing the
      premier modifiable risk for stroke & other key variables in an under-resourced system
      burdened by suboptimal care & outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Systolic blood pressure
time frame: 12 months
description: Target goal of <140/90 mmHg measured at baseline, months 3, 6, 9 and 12. Measured by blinded evaluator using an automated BP monitor.
measure: Self-management
time frame: 12 months
description: Compared between the two groups using the validated Hypertension Self-care Profile questionnaire (HBP SCP) with items that compositely assesses behavior, motivation and self-efficacy of hypertension management. Assessed at months 4, 8 and 12 (α.83-.93, r = .64). A total score can range from 20 to 80 with higher score indicating better self-care practice.
measure: Medication adherence
time frame: 12 months
description: Measured using Medication possession ratio177 and 14-item Hill-Bone compliance (HBC) to high blood pressure therapy scale with items that assess medication adherence, clinic appointments and salt intake assessed at months 3, 6, 9 and 12 (α.76-.83, r = .64) MPR and HBC will be measured in both PINGS and usual care arms at stated time points. Higher scores (0-14) indicate lower adherence (i.e. higher non adherence).
measure: Number of Cardiovascular ED encounters and Re-hospitalizations
time frame: 12 months
description: To be assessed via once monthly calls to patients and/or carers over 12 months of follow up in both the PINGS and usual care groups.
Patient carers in both arms will also be encouraged to contact study team within 48 hours of hospitalizations for prompt and blinded adjudication of all potential CVD ED encounters to minimize reporting bias between the two groups.
measure: Number of Major Adverse Cardiovascular Events
time frame: 12 months
description: Major Adverse Cardiovascular events (MACE) to be assessed include recurrent stroke: fatal/ severely disabling stroke or non-fatal stroke; Coronary Artery Disease: Acute STEMI/NSTEMI, sudden cardiac deaths. MACE will be confirmed by a blinded adjudicator by reviewing where available clinical notes supported by investigations e.g. CT scan, EKGs, review of death certificates or verbal autopsy if death occurs outside hospital.
measure: Health-related quality of Life: The Euro Quality of Life-5D questionnaire
time frame: 12 months
description: The EQ-5D questionnaire,186 will assess state of health of study participants at baseline and Month 12. Scores range from 0 (the worst possible health status) to 100 (the best possible health status).
measure: Health Literacy in HPT/stroke
time frame: 12 months
description: Self-Report: HTN/stroke Knowledge questionnaire (r=.70) Health literacy questionnaire (r = .74, .82) Assessed at months 0, 6,12. Higher scores indicate higher health literacy. Scales 1-5 are scored on a 4-point Likert-type response scale (strongly disagree, disagree, agree, strongly agree) and scales 6-9 are scored on a 5-point Likert-type scale with response options focusing on difficulty (cannot do or always difficult, usually difficult, sometimes difficult, usually easy, always easy).
measure: Disability/Functional status
time frame: 12 months
description: Functional status after stroke will be assessed by Research Assistants using the Modified Rankin Scale with a scores ranging from 0 to 6, where 0=no functional limitation and 6 = death. Assessed at months 0, 3, 6, 9 and 12.
measure: Sex, Age, cultural, socio-economic Factors, study site
time frame: 12 months
description: Assessed based on self reports at baseline. Cultural factors to assess include language spoken at home, religious observances, acceptance of gender roles; occupation, religious beliefs and dietary practices.
arm group label: PINGS 2
arm group type: Experimental
arm group label: Standard of Care
arm group type: No Intervention
intervention type: Behavioral
intervention name: PINGS 2
description: Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction & stroke
arm group label: PINGS 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Ghana
responsible party type: Principal Investigator
investigator affiliation: Northern California Institute of Research and Education
investigator full name: Bruce Ovbiagele
investigator title: Chief of Staff
mesh term: Stroke
mesh term: Cardiovascular Diseases
sharing ipd: No