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A multifaceted strategy using mobile technology to assist rural primary healthcare doctors and frontline health workers in cardiovascular disease risk management: protocol for the SMARTHealth India cluster randomised controlled trial.

Praveen D, Patel A, McMahon S, Prabhakaran D, Clifford GD, Maulik PK, Joshi R, Jan S, Heritier S, Peiris D - Implement Sci (2013)

Bottom Line: Around one in four adults in rural India have hypertension, and of those, only a minority are accessing appropriate care.Health systems in India face substantial challenges to meet these gaps in care, and innovative solutions are needed.We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare.

View Article: PubMed Central - HTML - PubMed

Affiliation: The George Institute for Global Health, Hyderabad, India. dpraveen@georgeinstitute.org.in.

ABSTRACT

Background: Blood Pressure related disease affected 118 million people in India in the year 2000; this figure will double by 2025. Around one in four adults in rural India have hypertension, and of those, only a minority are accessing appropriate care. Health systems in India face substantial challenges to meet these gaps in care, and innovative solutions are needed.

Methods: We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare. This intervention will be implemented as a stepped wedge, cluster randomised controlled trial in 18 primary health centres and 54 villages in rural Andhra Pradesh involving adults aged ≥40 years at high cardiovascular disease event risk (approximately 15,000 people). Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension's region-specific risk charts. Cluster randomisation will occur at the level of the primary health centres. Outcome analyses will be conducted blinded to intervention allocation.

Expected outcomes: The primary study outcome is the difference in the proportion of people meeting guideline-recommended blood pressure targets in the intervention period vs. the control period. Secondary outcomes include mean reduction in blood pressure levels; change in other cardiovascular disease risk factors, including body mass index, current smoking, reported healthy eating habits, and reported physical activity levels; self-reported use of blood pressure and other cardiovascular medicines; quality of life (using the EQ-5D); and cardiovascular disease events (using hospitalisation data). Trial outcomes will be accompanied by detailed process and economic evaluations.

Significance: The findings are likely to inform policy on a scalable strategy to overcome entrenched inequities in access to effective healthcare for under-served populations in low and middle income country settings.

Trial registration: Clinical Trial Registry India CTRI/2013/06/003753.

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Related in: MedlinePlus

SMARTHealth study schema.
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Related In: Results  -  Collection

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Figure 2: SMARTHealth study schema.

Mentions: The study schema is outlined in Figure 2. Independent data collection will be conducted by trained household surveyors based on previous well-established and acceptable methods [6,8-10,13]. Collection will occur on five occasions for each village – at baseline, at each interim time-interval (i.e., each ‘step,’ see Table 1), and at the end of follow-up. This allows unbiased evaluation of effectiveness through comparison of ‘control periods’ (for each village, the period between baseline and pre-intervention) and ‘intervention periods’ (for each village, the period between pre-intervention and end of follow-up).


A multifaceted strategy using mobile technology to assist rural primary healthcare doctors and frontline health workers in cardiovascular disease risk management: protocol for the SMARTHealth India cluster randomised controlled trial.

Praveen D, Patel A, McMahon S, Prabhakaran D, Clifford GD, Maulik PK, Joshi R, Jan S, Heritier S, Peiris D - Implement Sci (2013)

SMARTHealth study schema.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4222027&req=5

Figure 2: SMARTHealth study schema.
Mentions: The study schema is outlined in Figure 2. Independent data collection will be conducted by trained household surveyors based on previous well-established and acceptable methods [6,8-10,13]. Collection will occur on five occasions for each village – at baseline, at each interim time-interval (i.e., each ‘step,’ see Table 1), and at the end of follow-up. This allows unbiased evaluation of effectiveness through comparison of ‘control periods’ (for each village, the period between baseline and pre-intervention) and ‘intervention periods’ (for each village, the period between pre-intervention and end of follow-up).

Bottom Line: Around one in four adults in rural India have hypertension, and of those, only a minority are accessing appropriate care.Health systems in India face substantial challenges to meet these gaps in care, and innovative solutions are needed.We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare.

View Article: PubMed Central - HTML - PubMed

Affiliation: The George Institute for Global Health, Hyderabad, India. dpraveen@georgeinstitute.org.in.

ABSTRACT

Background: Blood Pressure related disease affected 118 million people in India in the year 2000; this figure will double by 2025. Around one in four adults in rural India have hypertension, and of those, only a minority are accessing appropriate care. Health systems in India face substantial challenges to meet these gaps in care, and innovative solutions are needed.

Methods: We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare. This intervention will be implemented as a stepped wedge, cluster randomised controlled trial in 18 primary health centres and 54 villages in rural Andhra Pradesh involving adults aged ≥40 years at high cardiovascular disease event risk (approximately 15,000 people). Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension's region-specific risk charts. Cluster randomisation will occur at the level of the primary health centres. Outcome analyses will be conducted blinded to intervention allocation.

Expected outcomes: The primary study outcome is the difference in the proportion of people meeting guideline-recommended blood pressure targets in the intervention period vs. the control period. Secondary outcomes include mean reduction in blood pressure levels; change in other cardiovascular disease risk factors, including body mass index, current smoking, reported healthy eating habits, and reported physical activity levels; self-reported use of blood pressure and other cardiovascular medicines; quality of life (using the EQ-5D); and cardiovascular disease events (using hospitalisation data). Trial outcomes will be accompanied by detailed process and economic evaluations.

Significance: The findings are likely to inform policy on a scalable strategy to overcome entrenched inequities in access to effective healthcare for under-served populations in low and middle income country settings.

Trial registration: Clinical Trial Registry India CTRI/2013/06/003753.

Show MeSH
Related in: MedlinePlus