Contemporary clinical trials · 2022
Effect of brief interventions to promote behavior change on clinical outcomes of selected non-communicable diseases: The World Health Organization (WHO) Package of Essential Non-communicable disease (PEN) Interventions for primary health care settings - study protocol of a quasi-experimental study.
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Parashar Anupam, Willeboordse Maartje, Gupta Anmol Kumar, van Schayck Onno C P
Аннотация
BACKGROUND: The World Health Organization designed a minimum set of interventions, the World Health Organization Package of Essential Noncommunicable disease interventions (WHO PEN), for detection, prevention, treatment, and care of Non-communicable diseases (NCDs) in resource constraint settings. This intervention study examines the effectiveness of the integration of components of WHO PEN protocols on improved clinical outcomes among patients of cardiovascular disease and diabetes mellitus in urban and rural primary health care settings.
METHODS: In this quasi-experimental study (pre-test post-test control group design), trained non-physician health workers will provide behavior change interventions regarding four major NCD risk factors, i.e., tobacco use, excessive alcohol intake, physical inactivity, an unhealthy diet; using 'Brief Advice' to the NCD patients enrolled in the experimental arm. The health centers in the control arm will provide the usual care to all the NCD patients. The intervention will last for six months, and the two groups will be followed up at two months, four months, and six months since enrolment in the study.
RESULTS: The primary outcome is improved mean blood pressure levels and the proportion of patients with controlled blood pressure levels. The secondary outcomes assess medication adherence, self-reported reductions in tobacco and alcohol intake, consumption of a heart-healthy diet, and regular physical activity.
DISCUSSION: This intervention trial will provide evidence for the utility of individual-level behavioral interventions for adequate management of NCDs.
TRIAL REGISTRATION: Clinical Trial Registry of India: CTRI/2018/12/016707.
METHODS: In this quasi-experimental study (pre-test post-test control group design), trained non-physician health workers will provide behavior change interventions regarding four major NCD risk factors, i.e., tobacco use, excessive alcohol intake, physical inactivity, an unhealthy diet; using 'Brief Advice' to the NCD patients enrolled in the experimental arm. The health centers in the control arm will provide the usual care to all the NCD patients. The intervention will last for six months, and the two groups will be followed up at two months, four months, and six months since enrolment in the study.
RESULTS: The primary outcome is improved mean blood pressure levels and the proportion of patients with controlled blood pressure levels. The secondary outcomes assess medication adherence, self-reported reductions in tobacco and alcohol intake, consumption of a heart-healthy diet, and regular physical activity.
DISCUSSION: This intervention trial will provide evidence for the utility of individual-level behavioral interventions for adequate management of NCDs.
TRIAL REGISTRATION: Clinical Trial Registry of India: CTRI/2018/12/016707.