Phone-Based Intervention under Nurse Guidance after Stroke (PINGS II) Study: Protocol for a Phase III Randomized Clinical Trial.
Antihypertensive Agents
/ therapeutic use
Blood Pressure
/ drug effects
Blood Pressure Monitoring, Ambulatory
/ nursing
Cell Phone
Clinical Trials, Phase III as Topic
Female
Ghana
Health Knowledge, Attitudes, Practice
Humans
Hypertension
/ diagnosis
Male
Multicenter Studies as Topic
Nurse's Role
Patient Education as Topic
Randomized Controlled Trials as Topic
Reminder Systems
Stroke
/ diagnosis
Telemedicine
Time Factors
Treatment Outcome
Hypertension
M-health
RCT
Stroke recurrence
Journal
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
ISSN: 1532-8511
Titre abrégé: J Stroke Cerebrovasc Dis
Pays: United States
ID NLM: 9111633
Informations de publication
Date de publication:
Aug 2021
Aug 2021
Historique:
received:
24
01
2021
revised:
24
04
2021
accepted:
08
05
2021
pubmed:
9
6
2021
medline:
27
7
2021
entrez:
8
6
2021
Statut:
ppublish
Résumé
The Sub-Saharan African (SSA) region now has the highest estimated effect size of hypertension for stroke causation worldwide. An urgent priority for countries in SSA is to develop and test self-management interventions to control hypertension among those at highest risk of adverse outcomes. Thus the overall objective of the Phone-based Intervention under Nurse Guidance after Stroke II study (PINGS-2) is to deploy a hybrid study design to assess the efficacy of a theoretical-model-based, mHealth technology-centered, nurse-led, multi-level integrated approach to improve longer term blood pressure (BP) control among stroke survivors. A phase III randomized controlled trial involving 500 recent stroke survivors to be enrolled across 10 Ghanaian hospitals. Using a computer-generated sequence, patients will be randomly assigned 1:1 into the intervention or usual care arms. The intervention comprises of (i) home BP monitoring at least once weekly with nurse navigation for high domiciliary BP readings; (2) medication reminders using mobile phone alerts and (3) education on hypertension and stroke delivered once weekly via audio messages in preferred local dialects. The intervention will last for 12 months. The control group will receive usual care as determined by local guidelines. The primary outcome is the proportion of patients with systolic BP <140 mm Hg at 12 months. Secondary outcomes will include medication adherence, self-management of hypertension, major adverse cardiovascular events, health related quality of life and implementation outcomes. An effective PINGS intervention can potentially be scaled up and disseminated across healthcare systems in low-and-middle income countries challenged with resource constraints to reduce poor outcomes among stroke survivors.
Identifiants
pubmed: 34102553
pii: S1052-3057(21)00291-3
doi: 10.1016/j.jstrokecerebrovasdis.2021.105888
pmc: PMC8282744
mid: NIHMS1706455
pii:
doi:
Substances chimiques
Antihypertensive Agents
0
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
105888Subventions
Organisme : NHLBI NIH HHS
ID : R01 HL152188
Pays : United States
Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest None to declare.
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