Phone-based Intervention Under Nurse Guidance After Stroke 2

Sponsor
Northern California Institute of Research and Education
Study ID
NCT04404166
Phase
PHASE3
Status
Completed

Conditions

  • Blood Pressure
  • Cardiovascular Diseases
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • PINGS 2 — BEHAVIORAL
    Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction \& stroke
  • Standard of Care — OTHER
    Standard of Care (routine post-stroke management per guidelines)

Study Details

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.

Key Dates

Start date
Oct 23, 2020
Status verified
Jan 2026
Primary completion
Apr 5, 2024
Completion
Apr 5, 2024

Study Design

Enrollment
500 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PINGS 2
    Participants received a 12-month, multicomponent, nurse-led intervention in addition to usual post-stroke care. The intervention included: Home blood pressure monitoring at least weekly with nurse follow-up for threshold breaches. Mobile phone medication reminders (daily alarms set on the participant's own device). Weekly audio health education messages in local dialects emphasizing stroke risk factor control and medication adherence. Nurse navigators provided case management, coordinated clinic visits as needed, and tracked blood pressure readings and adherence.
  • Active Comparator: Standard of Care
    Participants received standard secondary prevention after stroke according to local guidelines. This typically included periodic physician follow-up, antihypertensive therapy, antiplatelets, and statins prescribed at the clinician's discretion. To maintain contact frequency similar to the intervention group, participants received neutral lifestyle text messages unrelated to hypertension or stroke prevention.

Primary Outcome Measure

Systolic Blood Pressure [ Time Frame: 12 months ]

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