Phone-based Intervention Under Nurse Guidance After Stroke (PINGS)

September 29, 2017 updated by: Medical University of South Carolina
This research seeks to develop a culturally-acceptable, effective, and sustainable way of utilizing the rapidly growing penetration of mobile phones among people in Sub-Saharan Africa (SSA), to improve the currently poor control of hypertension among patients at high risk for future stroke. It also aims to develop human capital in SSA to conduct locally-relevant, high-quality stroke research in the future. Specifically, this study will preliminarily test a strategy that incorporates mobile phone texting and home blood pressure monitoring directed by trained nurses, to improve patient adherence to proven medical therapies for treating hypertension.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Uncoordinated care and shortage of physicians limit the capacity of countries in Sub-Saharan Africa (SSA) to implement effective and sustainable control of hypertension in routine clinical practice. Of the various cardiovascular disease entities, none is more strongly linked to hypertension than stroke. Recent estimates indicate that death from stroke in low-income and middle-income countries (LMIC) account for roughly 4 out of 5 stroke-related deaths worldwide, and the disability adjusted life years lost in these countries is almost seven times those lost in high-income countries (HIC). Most of these LIMC are in SSA. Moreover, given the transition from primarily infectious conditions to chronic non-communicable diseases, the burden of stroke in SSA is likely to increase substantially over the next several decades. Fortunately, with proper control of hypertension, the incidence of and mortality from stroke can be greatly reduced, as has been recently witnessed in several HIC. Despite its immense burden of stroke, SSA has the lowest density of neurologists worldwide, a situation exacerbated by the migration of providers and researchers to industrialized countries. Thus, an urgent priority in SSA is to develop human capital in the region to investigate and enhance stroke outcomes by partnering with established researchers. The theoretically-based Phone-based Intervention under Nurse Guidance after Stroke (PINGS) intervention will comprise protocol-driven mHealth technology (remote home blood pressure monitoring and mobile phone texting) under the guidance of nurse navigators, among patients with hypertension who have experienced a recent stroke (within one month of symptom onset) in Kumasi, Ghana. In Phase 1, the investigators will conduct a 3-month feasibility randomized trial with 6-month follow-up among 60 stroke patients with uncontrolled hypertension, randomly assigned to standard care or PINGS. The investigators will assess key methodological parameters, consumer responses, and clinical outcomes including recruitment and retention rates, intervention use, patient/provider satisfaction, real time medication adherence rates, medication possession ratios, and post-discharge clinic blood pressure levels. In Phase 2, the investigators will triangulate data from Phase 1 to further refine and optimize PINGS and prepare for a full-scale future efficacy/ effectiveness randomized clinical trial. Throughout PINGS, researchers in the United States will mentor their co-investigators in Ghana and impart knowledge about developing mHealth research capacity. Successful completion of PINGS will lead to a cadre of investigators in Ghana knowledgeable about clinical research methodology, and experienced in the execution of innovative, contextualized research targeted at stroke.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
      • Kumasi, Ghana
        • Kwame Nkrumah University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Above the age of 18 years; male or female
  2. Index stroke symptoms began no greater than one month before enrollment
  3. Uncontrolled hypertension (SBP ≥140 mmHg) based upon last inpatient or outpatient encounter clinic within previous 12 months
  4. Legally competent
  5. Owns or has close home-sharing family member with a cell phone

Exclusion Criteria:

  1. Failure to meet any inclusion criteria
  2. Severe cognitive impairment/dementia (Modified Mini-Mental Score [MMSE] ≤24)*
  3. Severe global disability (modified Rankin Scale Score [mRS] ≥ 3)*
  4. Renal dialysis; awaiting renal transplant or transplant recipient
  5. Cancer diagnosis or treatment in past 2 years
  6. Planned pregnancy

  7. Vulnerable populations such as pregnant or nursing women, prisoners, and institutionalized individuals.

    • MMSE ≤24 and global disability (mRS ≥ 3) excludes patients who have severe cognitive impairments and medical limitations that would interfere with adequate participation in the PINGS project.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Behavioral
Nurse-directed mobile health technology using smart phones to promote adherence to antihypertensive medication.
Behavioral: Smart-phone based technology
No Intervention: Usual background care
Standard care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Recruitment rates
Time Frame: 9 months
9 months
Patient Satisfaction Scales
Time Frame: 9 months
9 months
Clinic based Blood Pressure
Time Frame: 9 months
9 months
Retention rates
Time Frame: 9 months
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Med Possession Ratio
Time Frame: 9 months
9 months
Morisky Med Adherence Scale
Time Frame: 9 months
9 months
Provider Satisfaction Scales
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kwame Nkrumah University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R21NS094033 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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