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Addressing Hypertension Care in Africa (ADHINCRA)

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ClinicalTrials.gov Identifier: NCT04010344
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
Johns Hopkins Alliance for a Healthier World
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE July 3, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date November 14, 2019
Actual Study Start Date  ICMJE July 14, 2019
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • Change in Blood Pressure levels from Baseline [ Time Frame: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months ]
    Changes in Blood pressure levels, measured in mmHg, will be assessed at the baseline, 1-month, 3-month, 6-month, 9-month, and 12-month visits.
  • Change in Blood Pressure control by poverty status from Baseline [ Time Frame: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months ]
    Blood pressure control - defined as systolic blood pressure (SBP) < 140 mm Hg SBP reduction will be compared by deprivation status defined by monthly income < 210 Ghana cedis determined at the enrollment visit.
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Clinical Outcomes - Change in Blood Pressure levels from Baseline [ Time Frame: BP assessed at baseline, 1 month , 3 months, 6 months, 9 months, 12 months ]
    Changes in Blood pressure levels, measured in mm Hg, will be assessed at the baseline, 1-month, 3-month, 6-month, 9-month, and 12-month visits
  • Clinical Outcomes - Change in Blood Pressure control by poverty status from Baseline [ Time Frame: BP assessed at baseline, 1 month , 3 months, 6 months, 9 months, 12 months ]
    Blood pressure control - defined as systolic blood pressure (SBP) < 140 mm Hg SBP reduction will be compared by deprivation status defined by monthly income < 210 GH Cedis determined at the enrollment visit.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • Change in Hemoglobin A1C between arms [ Time Frame: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months ]
    Hgb A1C in both study arms will be examined for change at the 1-month, 3-month, 6-month, 9-month, and 12-month visits after the initial baseline assessment.
  • Difference in Hypertensive Urgencies and Emergencies between arms [ Time Frame: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months ]
    Difference in the number of emergency room visits (for hypertensive urgencies and/or emergencies) for both arms will be examined at the 1-month, 3-month, 6-month, 9-month, and 12-month visits. after the initial baseline assessment.
  • Difference in Cardiovascular Disease (CVD) Events between study arms [ Time Frame: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months ]
    Difference in the number of CVD events (such as strokes, coronary artery disease, heart failures, and deaths) for both arms will be examined at the 1-month, 3-month, 6-month, 9-month, and 12-month visits after the initial baseline assessment.
  • Difference in treatment adherence as assessed by the Hill-Bone Medication Adherence Scale [ Time Frame: At 6 months ]
    Self-Reported Medication Adherence will be assessed with the 9-item Hill-Bone Medication Adherence Scale and compared in both arms at months 6 and 12 by poverty status. The Hill-Bone has broad applicability in measuring medication adherence in patients with hypertension, diabetes, chronic obstructive pulmonary disease, stroke among others. Scores range from 9 - 36 with higher scores indicating poorer adherence to antihypertensive drug therapy.
  • Difference in treatment adherence as assessed by the Hill-Bone Medication Adherence Scale [ Time Frame: At 12 months ]
    Self-Reported Medication Adherence will be assessed with the 9-item Hill-Bone Medication Adherence Scale and compared in both arms at months 6 and 12 by poverty status. The Hill-Bone has broad applicability in measuring medication adherence in patients with hypertension, diabetes, chronic obstructive pulmonary disease, stroke among others. Scores range from 9 - 36 with higher scores indicating poorer adherence to antihypertensive drug therapy.
  • Change in the acceptability and usability of the Akoma pa app score as assessed by the Marshfield System Usability Survey [ Time Frame: At 1 month , 3 months, 6 months, 9 months, 12 months ]
    The acceptability and usability of the Akoma pa app will be assessed with the 16-item Marshfield System Usability Survey. Scores on this instrument range from 16 to 80 with higher scores indicating better usability. This will be examined at the 1-month, 3-month, 6-month, 9-month, and 12-month visits after the initial baseline assessment.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Change in Hemoglobin A1C between arms [ Time Frame: Hgb A1C assessed at baseline, 1 month , 3 months, 6 months, 9 months, 12 months ]
    Hgb A1C in both study arms will be examined for change at the 1-month, 3-month, 6-month, 9-month, and 12-month visits after the initial baseline assessment.
  • Difference in Hypertensive Urgencies and Emergencies between arms [ Time Frame: Assessed at baseline, 1 month , 3 months, 6 months, 9 months, 12 months ]
    Differences in the number of emergency room visits (for hypertensive urgencies and emergencies) for both arms will be examined at the 1-month, 3-month, 6-month, 9-month, and 12-month visits. after the initial baseline assessment.
  • Difference in Cardiovascular Disease (CVD) Events between study arms [ Time Frame: Assessed at baseline, 1 month , 3 months, 6 months, 9 months, 12 months ]
    Difference in the number of CVD events (such as strokes, coronary artery disease, heart failures, and deaths) for both arms will be examined at the 1-month, 3-month, 6-month, 9-month, and 12-month visits after the initial baseline assessment.
  • Intermediate Outcomes: Intermediate Outcomes: Disparities in Disparities in treatment adherence will be compared by poverty status. [ Time Frame: Assessed at 6 months and 12 months ]
    Self-Reported Medication Adherence will be assessed with the 9-item Hill-Bone Medication Adherence Scale and compared in both arms at months 6 and 12 by poverty status. The Hill-Bone has broad applicability in measuring medication adherence in patients with hypertension, diabetes, chronic obstructive pulmonary disease, stroke among others. Scores range from 9 - 36 with higher scores indicating poorer adherence to antihypertensive drug therapy
  • Patient-Reported Outcome. The acceptability and usability of the Akoma pa app [ Time Frame: Assessed at baseline, 1 month , 3 months, 6 months, 9 months, 12 months ]
    The acceptability and usability of the Akoma pa app assessed with the 16-item Marshfield System Usability Survey. Scores on this instrument range from 16 to 80 with higher scores indicating better usability. This will be examined at the 1-month, 3-month, 6-month, 9-month, and 12-month visits after the initial baseline assessment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Addressing Hypertension Care in Africa
Official Title  ICMJE Addressing Hypertension Control in Africa (ADHINCRA) Study
Brief Summary A pilot cluster randomized control trial to test the feasibility of a multilevel, nurse-led, mobile health enhanced intervention in patients with uncontrolled hypertension in Ghana
Detailed Description

This is a two-arm pilot cluster randomized controlled trial (RCT) involving 240 participants with uncontrolled hypertension (HTN) with the healthcare setting as the unit of randomization and patients as the unit of analysis. Each of the four healthcare settings will be recruited and randomly assigned to the multilevel intervention or control group. A statistician will generate the randomization using a computer-generated random sequence program with an allocation ratio of 1:1 and a block size of 6 (to assure equal numbers in each arm). After having met study criteria for enrollment, 60 eligible patients for each setting will be assigned to either control or intervention arm according to the patients' healthcare setting's intervention assignment by the study coordinator. A cluster RCT has been chosen to avoid potential treatment contamination in which physicians within healthcare settings might unintentionally provide patients with different degrees of attention or blending of treatment protocols. The intervention will be administered for six months following which it will be withdrawn, and patients will be followed for six more months to assess outcomes.

The investigators will use quota sampling to oversample socioeconomically deprived persons to ensure that socioeconomically deprived persons comprise 50% of the sample. Poverty will be defined by (1) Household income, based on Ghana minimum monthly wage of 210 Ghana cedis (equivalent of $55). After screening eligible participants, the investigators will assign four clusters of 60 patients to the intervention or control arms. The investigators will require 30 patients in each cluster to be male and 30 to be female since in the investigators' previous work, men have been underrepresented potentially due to gender-differences in healthcare seeking behaviors. Men have also had inferior treatment and control rates in previous studies.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two-arm pilot cluster randomized control trial involving 240 participants with uncontrolled hypertension. The healthcare setting is the unit of randomization and patients are the unit of analysis. Each of the four healthcare settings will be recruited and randomly assigned to the multilevel intervention or control group. Randomization will be performed using a computer-generated random sequence program with a 1:1 allocation and a block size of 6 (to assure equal numbers in each arm). After meeting the study criteria for enrollment, 60 eligible patients for each setting will be assigned to either control or intervention arm according to their healthcare setting's intervention assignment by the study coordinator. The intervention will be administered for six months following which it will be withdrawn, and patients will be followed for six more months to assess outcomes.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Other staff will conduct the evaluations using established protocols. They will remain blinded as to patients' group status throughout the study (i.e., pre-intervention, 1, 3, 6 & 9-month evaluations).
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Diabetes
  • Telemedicine
Intervention  ICMJE
  • Behavioral: Enhanced Usual Care Group

    Medtronic® Labs' Akoma pa app, a culturally-tested and locally attuned mobile health platform, will be used in the intervention arm of the study to improve communication between the Community Health Officer (CHO) and the participant. This platform will be used to enhance shared decision making, clinical decision support, participatory communication, knowledge, treatment adherence (medication and lifestyle modification), and self-monitoring of hypertension. We will test the feasibility of the Akoma pa app in addressing patient-level and provider-level barriers to hypertension control.

    The app will consist of the following components:

    1. Reminders
    2. Participant to CHO messaging
    3. Home BP tracking
    4. Educational materials on cardiovascular disease (CVD) and Stroke- Participants will have access to education modules on reducing the risk of CVD and stroke tailored to their knowledge level.
    5. CHO provider portal- The provider portal will include decision support tools.
  • Other: Usual Care Group
    Regular/usual appointments or visits to patients' healthcare provider for management of study outcomes
Study Arms  ICMJE
  • Experimental: Enhanced Usual Care Group
    All participants in the enhanced usual care arm must own a cell phone with at least short message service (SMS) and voicemail. To control for attention exposure, they will receive SMS messages daily dealing with healthy lifestyle behaviors (smoking, diet, physical activity) but not with medication adherence or hypertension-specific issues. Every three days (comparable to intervention group monitoring) they will receive an automated SMS directing them to a different 2-3 min video/YouTube™ clips on healthy lifestyles. Patients in this arm of the study will also receive usual care as determined by their providers. Usual care is described in the next section.
    Intervention: Behavioral: Enhanced Usual Care Group
  • Active Comparator: Usual Care
    Patients in this arm of the study will receive usual care as determined by their providers. Usual care in the region typically involves at least one visit every 2-3 months for review of adherence to treatment, blood pressure control, and prescriptions for medication refills. Similar to the intervention group, participants will have a total of three follow-up visits which will be separate from their regular appointments during which study outcomes will be assessed.
    Intervention: Other: Usual Care Group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2019)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2021
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients will be included if they are 18-70 years old;
  • Male or female
  • Uncontrolled hypertension (SBP ≥140 mm Hg) based upon last outpatient encounter within the previous three months
  • Patients with previous strokes, coronary artery disease, up to stage three kidney disease and diabetes mellitus meeting BP cut-off criteria will be eligible for enrollment.

Exclusion Criteria:

  • Patients will be excluded if they fail to meet any of the above inclusion criteria
  • Severe cognitive impairment/dementia (Modified Mini-Mental State Examination (MMSE) score ≤24)
  • Severe global disability (modified Rankin Scale (mRS) score ≥3)
  • Not able to independently follow blood pressure measurement protocol or use of Smartphone for study protocol or without a care-giver to assist with BP monitoring at home
  • Patients with estimated glomerular filtration rate (eGFR) <30ml/min
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yvonne Y Commodore-Mensah, PhD, MHS, RN 14106141519 ycommod1@jhmi.edu
Listed Location Countries  ICMJE Ghana
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04010344
Other Study ID Numbers  ICMJE IRB00218586
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Johns Hopkins Alliance for a Healthier World
Investigators  ICMJE
Principal Investigator: Yvonne Commodore-Mensah, PhD, MHS, RN Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP