Clinical trial NCT04404166: Phone-based Intervention Under Nurse Guidance After Stroke 2
Official title: Phone-based Intervention Under Nurse Guidance After Stroke 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blood Pressure
Stroke
Cardiovascular Diseases
Lead sponsor: Northern California Institute of Research and Education
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years (stroke is commoner above this age cut-off)
* male or females (sex is a biologic variable of interest)
* recent stroke (within one month of symptom onset)- stroke may be ischemic or hemorrhagic based on brain imaging or diagnosed clinically using the locally validated version of the 8-item questionnaire for verifying stroke free status (8-QVSFS) when neuroimaging is not feasible
* uncontrolled HTN (SBP ≥ 140 mmHg at both the last clinical encounter post-stroke and the eligibility screening visit) - SBP is used as the selection variable since most African hypertensives \<60 years have systolic or combination systolic/ diastolic HTN and for most patients, controlling SBP also results in DBP control
* patients or family carers should own a basic mobile phone that can receive text/audio messages.

Exclusion Criteria:

- Any condition that would limit participation in follow up assessments, such as severe cognitive impairment/dementia (MMSE ≤24).

Primary outcomes:
measure: Systolic blood pressure
timeFrame: 12 months
Secondary outcomes:
measure: Self-management
timeFrame: 12 months
measure: Medication adherence
timeFrame: 12 months
measure: Number of Cardiovascular ED encounters and Re-hospitalizations
timeFrame: 12 months
measure: Number of Major Adverse Cardiovascular Events
timeFrame: 12 months
measure: Health-related quality of Life: The Euro Quality of Life-5D questionnaire
timeFrame: 12 months
Other outcomes:
measure: Health Literacy in HPT/stroke
timeFrame: 12 months
measure: Disability/Functional status
timeFrame: 12 months
measure: Sex, Age, cultural, socio-economic Factors, study site
timeFrame: 12 months
Locations:
city: Aboaso
country: Ghana
facility: Ankaase Methodist Hospital
city: Accra
country: Ghana
facility: Korle Bu Teaching Hospital
city: Agogo
country: Ghana
facility: Agogo Presbyterian Hospital
city: Cape Coast
country: Ghana
facility: Cape Coast Teaching Hospital
city: Kumasi
country: Ghana
facility: Komfo Anokye Teaching Hospital
city: Kumasi
country: Ghana
facility: Kumasi South Hospital
city: Kumasi
country: Ghana
facility: Kwadaso SDA Hospital
city: Kumasi
country: Ghana
facility: Kwame Nkrumah University of Science and Technology
city: Kumasi
country: Ghana
facility: Manhyia Government Hospital
city: Kumasi
country: Ghana
facility: Tafo Government Hospital
Study officials:
References: