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Published in: BMC Public Health 1/2017

Open Access 01-12-2017 | Study protocol

A PROgramme of Lifestyle Intervention in Families for Cardiovascular risk reduction (PROLIFIC Study): design and rationale of a family based randomized controlled trial in individuals with family history of premature coronary heart disease

Authors: Panniyammakal Jeemon, S. Harikrishnan, G. Sanjay, Sivasankaran Sivasubramonian, T. R. Lekha, Sandosh Padmanabhan, Nikhil Tandon, Dorairaj Prabhakaran

Published in: BMC Public Health | Issue 1/2017

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Abstract

Background

Recognizing patterns of coronary heart disease (CHD) risk in families helps to identify and target individuals who may have the most to gain from preventive interventions. The overall goal of the study is to test the effectiveness and sustainability of an integrated care model for managing cardiovascular risk in high risk families. The proposed care model targets the structural and environmental conditions that predispose high risk families to development of CHD through the following interventions: 1) screening for cardiovascular risk factors, 2) providing lifestyle interventions 3) providing a framework for linkage to appropriate primary health care facility, and 4) active follow-up of intervention adherence.

Methods

Initially, a formative qualitative research component will gather information on understanding of diseases, barriers to care, specific components of the intervention package and feedback on the intervention. Then a cluster randomized controlled trial involving 740 families comprising 1480 participants will be conducted to determine whether the package of interventions (integrated care model) is effective in reducing or preventing the progression of CHD risk factors and risk factor clustering in families. The sustainability and scalability of this intervention will be assessed through economic (cost-effectiveness analyses) and qualitative evaluation (process outcomes) to estimate value and acceptability. Scalability is informed by cost-effectiveness and acceptability of the integrated cardiovascular risk reduction approach.

Discussion

Knowledge generated from this trial has the potential to significantly affect new programmatic policy and clinical guidelines that will lead to improvements in cardiovascular health in India.

Trial registration number

Literature
1.
Mortality GBD, Causes of Death C. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;385(9963):117–71.CrossRef
2.
Joshi P, Islam S, Pais P, Reddy S, Dorairaj P, Kazmi K, Pandey MR, Haque S, Mendis S, Rangarajan S, et al. Risk factors for early myocardial infarction in South Asians compared with individuals in other countries. JAMA. 2007;297(3):286–94.CrossRefPubMed
3.
Prabhakaran D, Jeemon P, Roy A. Cardiovascular diseases in India: current epidemiology and future directions. Circulation. 2016;133(16):1605–20.CrossRefPubMed
4.
Xavier D, Pais P, Devereaux PJ, Xie C, Prabhakaran D, Reddy KS, Gupta R, Joshi P, Kerkar P, Thanikachalam S, et al. Treatment and outcomes of acute coronary syndromes in India (CREATE): a prospective analysis of registry data. Lancet. 2008;371(9622):1435–42.CrossRefPubMed
5.
Prabhakaran D, Jeemon P. Should your family history of coronary heart disease scare you? Mt Sinai J Med. 2012;79(6):721–32.CrossRefPubMed
6.
Hippisley-Cox J, Coupland C, Vinogradova Y, Robson J, May M, Brindle P. Derivation and validation of QRISK, a new cardiovascular disease risk score for the United Kingdom: prospective open cohort study. BMJ. 2007;335(7611):136.CrossRefPubMedPubMedCentral
7.
Ridker PM, Buring JE, Rifai N, Cook NR. Development and validation of improved algorithms for the assessment of global cardiovascular risk in women: the Reynolds Risk Score. JAMA. 2007;297(6):611–9.CrossRefPubMed
8.
Ridker PM, Paynter NP, Rifai N, Gaziano JM, Cook NR. C-reactive protein and parental history improve global cardiovascular risk prediction: the Reynolds Risk Score for men. Circulation. 2008;118(22):2243–51. 2244p following 2251.CrossRefPubMedPubMedCentral
9.
Woodward M, Brindle P, Tunstall-Pedoe H, estimation Sgor. Adding social deprivation and family history to cardiovascular risk assessment: the ASSIGN score from the Scottish Heart Health Extended Cohort (SHHEC). Heart. 2007;93(2):172–6.CrossRefPubMed
10.
Bachmann JM, Willis BL, Ayers CR, Khera A, Berry JD. Association between family history and coronary heart disease death across long-term follow-up in men: the Cooper Center Longitudinal Study. Circulation. 2012;125(25):3092–8.CrossRefPubMedPubMedCentral
11.
Williamson C, Jeemon P, Hastie CE, McCallum L, Muir S, Dawson J, Walters M, Sloan W, Morrison D, Dominiczak AF, et al. Family history of premature cardiovascular disease: blood pressure control and long-term mortality outcomes in hypertensive patients. Eur Heart J. 2014;35(9):563–70.CrossRefPubMed
12.
Vedanthan R, Bansilal S, Soto AV, Kovacic JC, Latina J, Jaslow R, Santana M, Gorga E, Kasarskis A, Hajjar R, et al. Family-based approaches to cardiovascular health promotion. J Am Coll Cardiol. 2016;67(14):1725–37.CrossRefPubMed
13.
Jeemon P, Prabhakaran D, Goenka S, Ramakrishnan L, Padmanabhan S, Huffman M, Joshi P, Sivasankaran S, Mohan BV, Ahmed F, et al. Impact of comprehensive cardiovascular risk reduction programme on risk factor clustering associated with elevated blood pressure in an Indian industrial population. Indian J Med Res. 2012;135(4):485–93.PubMedPubMedCentral
14.
Prabhakaran D, Jeemon P, Goenka S, Lakshmy R, Thankappan KR, Ahmed F, Joshi PP, Mohan BV, Meera R, Das MS, et al. Impact of a worksite intervention program on cardiovascular risk factors: a demonstration project in an Indian industrial population. J Am Coll Cardiol. 2009;53(18):1718–28.CrossRefPubMed
15.
Ton TG, Fogg TT, Fong CT, John C, Li SX, Marshall JA, Peters K, Neal W, Pearson TA. Knowledge, perception, and behaviors of relatives of people with premature heart disease: a systematic literature review. Circulation. 2011;124(8):958–64.CrossRefPubMed
16.
17.
Jeemon P, Narayanan G, Kondal D, Kahol K, Bharadwaj A, Purty A, Negi P, Ladhani S, Sanghvi J, Singh K, et al. Task shifting of frontline community health workers for cardiovascular risk reduction: design and rationale of a cluster randomised controlled trial (DISHA study) in India. BMC Public Health. 2016;16(1):264.CrossRefPubMedPubMedCentral
18.
Lloyd-Jones DM, Hong Y, Labarthe D, Mozaffarian D, Appel LJ, Van Horn L, Greenlund K, Daniels S, Nichol G, Tomaselli GF, et al. Defining and setting national goals for cardiovascular health promotion and disease reduction: the American Heart Association’s strategic Impact Goal through 2020 and beyond. Circulation. 2010;121(4):586–613.CrossRefPubMed
19.
D’Agostino Sr RB, Grundy S, Sullivan LM, Wilson P, Group CHDRP. Validation of the Framingham coronary heart disease prediction scores: results of a multiple ethnic groups investigation. JAMA. 2001;286(2):180–7.CrossRefPubMed
20.
Mendis S, Lindholm LH, Mancia G, Whitworth J, Alderman M, Lim S, Heagerty T. World Health Organization (WHO) and International Society of Hypertension (ISH) risk prediction charts: assessment of cardiovascular risk for prevention and control of cardiovascular disease in low and middle-income countries. J Hypertens. 2007;25(8):1578–82.CrossRefPubMed
21.
McGorrian C, Yusuf S, Islam S, Jung H, Rangarajan S, Avezum A, Prabhakaran D, Almahmeed W, Rumboldt Z, Budaj A, et al. Estimating modifiable coronary heart disease risk in multiple regions of the world: the INTERHEART Modifiable Risk Score. Eur Heart J. 2011;32(5):581–9.CrossRefPubMed
22.
Batistatou E, Roberts C, Roberts S. Sample size and power calculations for trials and quasiexperimental studies with clustering. The Stata Journal. 2014;1:159–75.
23.
Hanley JA, Negassa A, Edwardes MD, Forrester JE. Statistical analysis of correlated data using generalized estimating equations: an orientation. Am J Epidemiol. 2003;157(4):364–75.CrossRefPubMed
24.
Hernan MA, Brumback B, Robins JM. Marginal structural models to estimate the causal effect of zidovudine on the survival of HIV-positive men. Epidemiology. 2000;11(5):561–70.CrossRefPubMed
25.
Stone PW, Chapman RH, Sandberg EA, Liljas B, Neumann PJ. Measuring costs in cost-utility analyses. Variations in the literature. Int J Technol Assess Health Care. 2000;16(1):111–24.CrossRefPubMed
26.
Gilks W, Richardson S, Spiegelhalter D. Markov Chain Monte Carlo in practice. London: Chapman and Hall; 1996.
27.
Sachs J. Macroeconomics and health: investing in health for economic development. Geneva: World Health Organization; 2001.
28.
Evans DB, Edejer TT, Adam T, Lim SS. Methods to assess the costs and health effects of interventions for improving health in developing countries. BMJ. 2005;331(7525):1137–40.CrossRefPubMedPubMedCentral
29.
Shillcutt SD, Walker DG, Goodman CA, Mills AJ. Cost effectiveness in low- and middle-income countries: a review of the debates surrounding decision rules. Pharmacoeconomics. 2009;27(11):903–17.CrossRefPubMedPubMedCentral
30.
Broderick C. Understanding FAMILY PROCESS: Basics of Family Systems Theory. Thousand Oaks: Sage Publications; 1993.
31.
McCubbn HI, Patterson JM. The family stress process: the double ABCX model of adjustment and adaptation. Marriage Fam Rev. 1983;6:7–37.CrossRef
32.
Olson DH, Sprenkle DH, Russell CS. Circumplex model of marital and family system: I. Cohesion and adaptability dimensions, family types, and clinical applications. Fam Process. 1979;18(1):3–28.CrossRefPubMed
33.
Daivadanam M, Wahlstrom R, Thankappan KR, Ravindran TK. Balancing expectations amidst limitations: the dynamics of food decision-making in rural Kerala. BMC Public Health. 2015;15:644.CrossRefPubMedPubMedCentral
34.
Gaziano T, Abrahams-Gessel S, Surka S, Sy S, Pandya A, Denman CA, Mendoza C, Puoane T, Levitt NS. Cardiovascular disease screening by community health workers can be cost-effective in low-resource countries. Health Aff (Millwood). 2015;34(9):1538–45.CrossRef
35.
Uthman OA, Hartley L, Rees K, Taylor F, Ebrahim S, Clarke A. Multiple risk factor interventions for primary prevention of cardiovascular disease in low- and middle-income countries. Cochrane Database Syst Rev. 2015;8:CD011163.
Metadata
Title
A PROgramme of Lifestyle Intervention in Families for Cardiovascular risk reduction (PROLIFIC Study): design and rationale of a family based randomized controlled trial in individuals with family history of premature coronary heart disease
Authors
Panniyammakal Jeemon
S. Harikrishnan
G. Sanjay
Sivasankaran Sivasubramonian
T. R. Lekha
Sandosh Padmanabhan
Nikhil Tandon
Dorairaj Prabhakaran
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2017
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-016-3928-6

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