Phone-based Intervention Under Nurse Guidance After Stroke (PINGS)
Primary Purpose
Stroke, Hypertension
Status
Completed
Phase
Not Applicable
Locations
Ghana
Study Type
Interventional
Intervention
Smart-phone based technology
Sponsored by

About this trial
This is an interventional health services research trial for Stroke focused on measuring mobile health, Behavior change, Africa
Eligibility Criteria
Inclusion Criteria:
- Above the age of 18 years; male or female
- Index stroke symptoms began no greater than one month before enrollment
- Uncontrolled hypertension (SBP ≥140 mmHg) based upon last inpatient or outpatient encounter clinic within previous 12 months
- Legally competent
- Owns or has close home-sharing family member with a cell phone
Exclusion Criteria:
- Failure to meet any inclusion criteria
- Severe cognitive impairment/dementia (Modified Mini-Mental Score [MMSE] ≤24)*
- Severe global disability (modified Rankin Scale Score [mRS] ≥ 3)*
- Renal dialysis; awaiting renal transplant or transplant recipient
- Cancer diagnosis or treatment in past 2 years
- Planned pregnancy
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.
Sites / Locations
- Kwame Nkrumah University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Behavioral
Usual background care
Arm Description
Nurse-directed mobile health technology using smart phones to promote adherence to antihypertensive medication.
Standard care
Outcomes
Primary Outcome Measures
Recruitment rates
Patient Satisfaction Scales
Clinic based Blood Pressure
Retention rates
Secondary Outcome Measures
Med Possession Ratio
Morisky Med Adherence Scale
Provider Satisfaction Scales
Full Information
NCT ID
NCT02568137
First Posted
July 13, 2015
Last Updated
September 29, 2017
Sponsor
Medical University of South Carolina
Collaborators
Kwame Nkrumah University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT02568137
Brief Title
Phone-based Intervention Under Nurse Guidance After Stroke
Acronym
PINGS
Official Title
Phone-based Intervention Under Nurse Guidance After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
Kwame Nkrumah University of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hypertension
Keywords
mobile health, Behavior change, Africa
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral
Arm Type
Experimental
Arm Description
Nurse-directed mobile health technology using smart phones to promote adherence to antihypertensive medication.
Arm Title
Usual background care
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Behavioral
Intervention Name(s)
Smart-phone based technology
Primary Outcome Measure Information:
Title
Recruitment rates
Time Frame
9 months
Title
Patient Satisfaction Scales
Time Frame
9 months
Title
Clinic based Blood Pressure
Time Frame
9 months
Title
Retention rates
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Med Possession Ratio
Time Frame
9 months
Title
Morisky Med Adherence Scale
Time Frame
9 months
Title
Provider Satisfaction Scales
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Above the age of 18 years; male or female
Index stroke symptoms began no greater than one month before enrollment
Uncontrolled hypertension (SBP ≥140 mmHg) based upon last inpatient or outpatient encounter clinic within previous 12 months
Legally competent
Owns or has close home-sharing family member with a cell phone
Exclusion Criteria:
Failure to meet any inclusion criteria
Severe cognitive impairment/dementia (Modified Mini-Mental Score [MMSE] ≤24)*
Severe global disability (modified Rankin Scale Score [mRS] ≥ 3)*
Renal dialysis; awaiting renal transplant or transplant recipient
Cancer diagnosis or treatment in past 2 years
Planned pregnancy
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.
Facility Information:
Facility Name
Kwame Nkrumah University of Science and Technology
City
Kumasi
Country
Ghana
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30465630
Citation
Sarfo FS, Treiber F, Gebregziabher M, Adamu S, Nichols M, Singh A, Obese V, Sarfo-Kantanka O, Sakyi A, Adu-Darko N, Tagge R, Agyei-Frimpong M, Kwarteng N, Badu E, Mensah N, Ampofo M, Jenkins C, Ovbiagele B; PINGS Team. Phone-based intervention for blood pressure control among Ghanaian stroke survivors: A pilot randomized controlled trial. Int J Stroke. 2019 Aug;14(6):630-638. doi: 10.1177/1747493018816423. Epub 2018 Nov 22.
Results Reference
derived
PubMed Identifier
29222227
Citation
Sarfo F, Treiber F, Gebregziabher M, Adamu S, Patel S, Nichols M, Awuah D, Sakyi A, Adu-Darko N, Singh A, Tagge R, Carolyn J, Ovbiagele B. PINGS (Phone-Based Intervention Under Nurse Guidance After Stroke): Interim Results of a Pilot Randomized Controlled Trial. Stroke. 2018 Jan;49(1):236-239. doi: 10.1161/STROKEAHA.117.019591. Epub 2017 Dec 8.
Results Reference
derived
PubMed Identifier
27596244
Citation
Sarfo FS, Treiber F, Jenkins C, Patel S, Gebregziabher M, Singh A, Sarfo-Kantanka O, Saulson R, Appiah L, Oparebea E, Ovbiagele B. Phone-based Intervention under Nurse Guidance after Stroke (PINGS): study protocol for a randomized controlled trial. Trials. 2016 Sep 5;17(1):436. doi: 10.1186/s13063-016-1557-0.
Results Reference
derived
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Phone-based Intervention Under Nurse Guidance After Stroke
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