Effectiveness of a scalable group-based education and monitoring program, delivered by health workers, to improve control of hypertension in rural India: A cluster randomised controlled trial

English version

Autoři: Dilan Giguruwa Gamage ^aff001; Michaela A. Riddell ^aff001; Rohina Joshi ^aff002; Kavumpurathu R. Thankappan ^aff005; Clara K. Chow ^aff002; Brian Oldenburg ^aff007; Roger G. Evans ^aff008; Ajay S. Mahal ^aff009; Kartik Kalyanram ^aff011; Kamakshi Kartik ^aff011; Oduru Suresh ^aff001; Nihal Thomas ^aff012; Gomathyamma K. Mini ^aff005; Pallab K. Maulik ^aff002; Velandai K. Srikanth ^aff001; Simin Arabshahi ^aff001; Ravi P. Varma ^aff005; Rama K. Guggilla ^aff004; Fabrizio D’Esposito ^aff007; Thirunavukkarasu Sathish ^aff007; Mohammed Alim ^aff004; Amanda G. Thrift ^aff001
Působiště autorů: Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia ^aff001; George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia ^aff002; University of Sydney, Sydney, New South Wales, Australia ^aff003; George Institute for Global Health, New Delhi, India ^aff004; Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India ^aff005; Department of Cardiology, Westmead Hospital, Sydney, New South Wales, Australia ^aff006; Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia ^aff007; Cardiovascular Disease Program, Biomedicine Discovery Institute and Department of Physiology, Monash University, Melbourne, Victoria, Australia ^aff008; School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia ^aff009; Nossal Institute for Global Health, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia ^aff010; Rishi Valley Rural Health Centre, Chittoor District, Andhra Pradesh, India ^aff011; Department of Endocrinology, Diabetes & Metabolism, Christian Medical College, Vellore, Tamil Nadu, India ^aff012; Global Institute of Public Health, Ananthapuri Hospitals and Research Institute, Trivandrum, Kerala, India ^aff013; George Institute for Global Health, Oxford University, Oxford, United Kingdom ^aff014; Peninsula Clinical School, Central Clinical School, Monash University, Frankston, Victoria, Australia ^aff015; Department of Population Medicine and Civilization Diseases Prevention, Faculty of Medicine, Division of Dentistry and Division of Medical Education in English, Medical University of Bialystok, Bialystok, Poland ^aff016; Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore ^aff017; University of Central Lancashire, Preston, United Kingdom ^aff018
Vyšlo v časopise: Effectiveness of a scalable group-based education and monitoring program, delivered by health workers, to improve control of hypertension in rural India: A cluster randomised controlled trial. PLoS Med 17(1): e32767. doi:10.1371/journal.pmed.1002997
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pmed.1002997

Souhrn

Background

New methods are required to manage hypertension in resource-poor settings. We hypothesised that a community health worker (CHW)–led group-based education and monitoring intervention would improve control of blood pressure (BP).

Methods and findings

We conducted a baseline community-based survey followed by a cluster randomised controlled trial of people with hypertension in 3 rural regions of South India, each at differing stages of epidemiological transition. Participants with hypertension, defined as BP ≥ 140/90 mm Hg or taking antihypertensive medication, were advised to visit a doctor. In each region, villages were randomly assigned to intervention or usual care (UC) in a 1:2 ratio. In intervention clusters, trained CHWs delivered a group-based intervention to people with hypertension. The program, conducted fortnightly for 3 months, included monitoring of BP, education about hypertension, and support for healthy lifestyle change. Outcomes were assessed approximately 2 months after completion of the intervention. The primary outcome was control of BP (BP < 140/90 mm Hg), analysed using mixed effects regression, clustered by village within region and adjusted for baseline control of hypertension (using intention-to-treat principles). Of 2,382 potentially eligible people, 637 from 5 intervention clusters and 1,097 from 10 UC clusters were recruited between November 2015 and April 2016, with follow-up occurring in 459 in the intervention group and 1,012 in UC. Mean age was 56.9 years (SD 13.7). Baseline BP was similar between groups. Control of BP improved from baseline to follow-up more in the intervention group (from 227 [49.5%] to 320 [69.7%] individuals) than in the UC group (from 528 [52.2%] to 624 [61.7%] individuals) (odds ratio [OR] 1.6, 95% CI 1.2–2.1; P = 0.001). In secondary outcome analyses, there was a greater decline in systolic BP in the intervention than UC group (−5.0 mm Hg, 95% CI −7.1 to −3.0; P < 0.001) and a greater decline in diastolic BP (−2.1 mm Hg, 95% CI −3.6 to −0.6; P < 0.006), but no detectable difference in the use of BP-lowering medications between groups (OR 1.2, 95% CI 0.8–1.9; P = 0.34). Similar results were found when using imputation analyses that included those lost to follow-up. Limitations include a relatively short follow-up period and use of outcome assessors who were not blinded to the group allocation.

Conclusions

While the durability of the effect is uncertain, this trial provides evidence that a low-cost program using CHWs to deliver an education and monitoring intervention is effective in controlling BP and is potentially scalable in resource-poor settings globally.

Trial registration

The trial was registered with the Clinical Trials Registry-India (CTRI/2016/02/006678).

Klíčová slova:

Alcohol consumption – Antihypertensives – Blood pressure – Hypertension – India – Primary hypertension – Secondary hypertension – Valleys

Zdroje

1. Forouzanfar MH, Liu P, Roth GA, Ng M, Biryukov S, Marczak L, et al. Global burden of hypertension and systolic blood pressure of at least 110 to 115 mm Hg, 1990–2015. JAMA. 2017;317(2):165–82. doi: 10.1001/jama.2016.19043 28097354

2. NCD Risk Factor Collaboration. Worldwide trends in blood pressure from 1975 to 2015: a pooled analysis of 1479 population-based measurement studies with 19.1 million participants. Lancet. 2017;389(10064):37–55. doi: 10.1016/S0140-6736(16)31919-5 27863813

3. Gupta R. Convergence in urban-rural prevalence of hypertension in India. J Hum Hypertens. 2016;30(2):79–82. doi: 10.1038/jhh.2015.48 26108364

4. Joshi SR, Parikh RM. India—diabetes capital of the world: now heading towards hypertension. J Assoc Physicians India. 2007;55:323–4. 17844690

5. Anchala R, Kannuri NK, Pant H, Khan H, Franco OH, Di Angelantonio E, et al. Hypertension in India: a systematic review and meta-analysis of prevalence, awareness, and control of hypertension. J Hypertens. 2014;32(6):1170–7. doi: 10.1097/HJH.0000000000000146 24621804

6. Central Bureau of Health Intelligence. National health profile 2015. New Delhi: Central Bureau of Health Intelligence; 2015 [cited 2018 Nov 9]. Available from: https://www.thehinducentre.com/multimedia/archive/02557/National_Health_Pr_2557764a.pdf.

7. Muralidharan K, Chaudhury N, Hammer J, Kremer M, Rogers FH. Is there a doctor in the house? Medical worker absence in India. San Diego: University of California, San Diego, Department of Economics; 2011 [cited 2018 Nov 9]. Available from: http://econweb.ucsd.edu/~kamurali/papers/Working%20Papers/Is%20There%20a%20Doctor%20in%20the%20House%20-%2012%20April,%202011.pdf.

8. Busingye D, Arabshahi S, Evans RG, Srikanth VK, Kartik K, Kalyanram K, et al. Factors associated with awareness, treatment and control of hypertension in a disadvantaged rural Indian population. J Hum Hypertens. 2017;31(5):347–53. doi: 10.1038/jhh.2016.85 28054571

9. Attaei MW, Khatib R, McKee M, Lear S, Dagenais G, Igumbor EU, et al. Availability and affordability of blood pressure-lowering medicines and the effect on blood pressure control in high-income, middle-income, and low-income countries: an analysis of the PURE study data. Lancet Public Health. 2017;2(9):e411–9. doi: 10.1016/S2468-2667(17)30141-X 29253412

10. World Health Organization. Taking stock: task shifting to tackle health worker shortages. Geneva: World Health Organization; 2007 [cited 2018 Nov 9]. Available from: http://www.who.int/healthsystems/task_shifting/TTR_tackle.pdf?ua=1.

11. Joshi R, Alim M, Kengne AP, Jan S, Maulik PK, Peiris D, et al. Task shifting for non-communicable disease management in low and middle income countries—a systematic review. PLoS ONE. 2014;9(8):e103754. doi: 10.1371/journal.pone.0103754 25121789

12. He J, Irazola V, Mills KT, Poggio R, Beratarrechea A, Dolan J, et al. Effect of a community health worker–led multicomponent intervention on blood pressure control in low-income patients in Argentina: a randomized clinical trial. JAMA. 2017;318(11):1016–25. doi: 10.1001/jama.2017.11358 28975305

13. Neupane D, McLachlan CS, Mishra SR, Olsen MH, Perry HB, Karki A, et al. Effectiveness of a lifestyle intervention led by female community health volunteers versus usual care in blood pressure reduction (COBIN): an open-label, cluster-randomised trial. Lancet Glob Health. 2018;6(1):e66–73. doi: 10.1016/S2214-109X(17)30411-4 29241617

14. Jafar TH, Silva A, Naheed A, Jehan I, Liang F, Assam PN, et al. Control of blood pressure and risk attenuation: a public health intervention in rural Bangladesh, Pakistan, and Sri Lanka: feasibility trial results. J Hypertens. 2016;34(9):1872–81. doi: 10.1097/HJH.0000000000001014 27488552

15. Kar SS, Thakur JS, Jain S, Kumar R. Cardiovascular disease risk management in a primary health care setting of north India. Indian Heart J. 2008;60(1):19–25. 19212017

16. Newman PM, Franke MF, Arrieta J, Carrasco H, Elliott P, Flores H, et al. Community health workers improve disease control and medication adherence among patients with diabetes and/or hypertension in Chiapas, Mexico: an observational stepped-wedge study. BMJ Glob Health. 2018;3(1):e000566. doi: 10.1136/bmjgh-2017-000566 29527344

17. Jafar TH, Hatcher J, Poulter N, Islam M, Hashmi S, Qadri Z, et al. Community-based interventions to promote blood pressure control in a developing country: a cluster randomized trial. Ann Intern Med. 2009;151(9):593–601. doi: 10.7326/0003-4819-151-9-200911030-00004 19884620

18. Peiris D, Praveen D, Mogulluru K, Ameer MA, Raghu A, Li Q, et al. SMARThealth India: a stepped-wedge, cluster randomised controlled trial of a community health worker managed mobile health intervention for people assessed at high cardiovascular disease risk in rural India. PLoS ONE. 2019;14(3):e0213708. doi: 10.1371/journal.pone.0213708 30913216

19. Mendis S, Johnston SC, Fan W, Oladapo O, Cameron A, Faramawi MF. Cardiovascular risk management and its impact on hypertension control in primary care in low-resource settings: a cluster-randomized trial. Bull World Health Organ. 2010;88(6):412–9. doi: 10.2471/BLT.08.062364 20539854

20. Riley SB, Marshall ES. Group visits in diabetes care: a systematic review. Diabetes Educ. 2010;36(6):936–44. doi: 10.1177/0145721710385013 20974905

21. Riddell MA, Joshi R, Oldenburg B, Chow C, Thankappan KR, Mahal A, et al. Cluster randomised feasibility trial to improve the Control of Hypertension In Rural India (CHIRI): a study protocol. BMJ Open. 2016;6(10):e012404. doi: 10.1136/bmjopen-2016-012404 27855099

22. Government of Kerala State Planning Board. Human development report 2005. Thiruvananthapuram: Government of Kerala State Planning Board; 2005 [cited 2018 Nov 9]. Available from: http://planningcommission.nic.in/plans/stateplan/sdr_pdf/shdr_kerala05.pdf.

23. Government of India. District census 2011. Government of India; 2015 [cited 2018 Nov 9]. Available from: http://www.census2011.co.in/district.php.

24. Thrift AG, Evans RG, Kalyanram K, Kartik K, Fitzgerald SM, Srikanth V. Gender-specific effects of caste and salt on hypertension in poverty: a population-based study. J Hypertens. 2011;29(3):443–50. doi: 10.1097/HJH.0b013e328341888c 21119531

25. World Health Organization. WHO STEPS: surveillance manual: the WHO STEPwise approach to noncommunicable disease risk factor surveillance. Geneva: World Health Organization; 2017 [cited 2018 Oct 10]. Available from: http://www.who.int/ncds/surveillance/steps/STEPS_Manual.pdf.

26. Abdel-All M, Thrift AG, Riddell M, Thankappan KRT, Mini GK, Chow CK, et al. Evaluation of a training program of hypertension for accredited social health activists (ASHA) in rural India. BMC Health Serv Res. 2018;18(1):320. doi: 10.1186/s12913-018-3140-8 29720161

27. Råstam L, Berglund G, Isacsson SO, Rydén L. The Skaraborg hypertension project. III. Influence on blood pressure of a medical care program for hypertension. Acta Med Scand. 1986;219(3):261–9. 3486551

28. Parker DR, Evangelou E, Eaton CB. Intraclass correlation coefficients for cluster randomized trials in primary care: the cholesterol education and research trial (CEART). Contemp Clin Trials. 2005;26(2):260–7. doi: 10.1016/j.cct.2005.01.002 15837446

29. Blood Pressure Lowering Treatment Trialists’ Collaboration. Effects of different blood-pressure-lowering regimens on major cardiovascular events: results of prospectively-designed overviews of randomised trials. Lancet. 2003;362(9395):1527–35. doi: 10.1016/s0140-6736(03)14739-3 14615107

30. White ND, Lenz TL, Smith K. Tool guide for lifestyle behavior change in a cardiovascular risk reduction program. Psychol Res Behav Manag. 2013;6:55–63. doi: 10.2147/PRBM.S40490 23983496

31. Matsumura K, Arima H, Tominaga M, Ohtsubo T, Sasaguri T, Fujii K, et al. Impact of antihypertensive medication adherence on blood pressure control in hypertension: the COMFORT study. QJM. 2013;106(10):909–14. doi: 10.1093/qjmed/hct121 23696676

32. Aucott L, Rothnie H, McIntyre L, Thapa M, Waweru C, Gray D. Long-term weight loss from lifestyle intervention benefits blood pressure?: a systematic review. Hypertension. 2009;54(4):756–62. doi: 10.1161/HYPERTENSIONAHA.109.135178 19704106

33. Giraudeau B, Ravaud P. Preventing bias in cluster randomised trials. PLoS Med. 2009;6(5):e1000065. doi: 10.1371/journal.pmed.1000065 19536323