NCT02568137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 2, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

July 13, 2015

Last Update Submit

September 29, 2017

Conditions

StrokeHypertension

Keywords

mobile healthBehavior changeAfrica

Outcome Measures

Primary Outcomes (4)

  • Recruitment rates

    9 months

  • Patient Satisfaction Scales

    9 months

  • Clinic based Blood Pressure

    9 months

  • Retention rates

    9 months

Secondary Outcomes (3)

  • Med Possession Ratio

    9 months

  • Morisky Med Adherence Scale

    9 months

  • Provider Satisfaction Scales

    9 months

Study Arms (2)

Behavioral

EXPERIMENTAL

Nurse-directed mobile health technology using smart phones to promote adherence to antihypertensive medication.

Behavioral: Smart-phone based technology

Usual background care

NO INTERVENTION

Standard care

Interventions

Smart-phone based technologyBEHAVIORAL
Behavioral

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kwame Nkrumah University of Science and Technology

Kumasi, Ghana

Location

Related Publications (3)

  • 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.

    PMID: 30465630DERIVED

  • 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.

    PMID: 29222227DERIVED

  • 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.

    PMID: 27596244DERIVED

MeSH Terms

Conditions

StrokeHypertension

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2015

First Posted

October 5, 2015

Study Start

January 1, 2017

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

October 2, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

GH(1)