NCT06230835

Brief Summary

With its high prevalence and concomitant increased risk of cardiovascular disease (CVD), hypertension (HTN) is a major global public health challenge. About 13.5% of premature deaths, 54% of incident stroke and 47% of incident coronary heart disease (CHD) worldwide are attributed to high blood pressure (BP). In Nepal, the prevalence of HTN among adults is 25% is similar to the global prevalence. In Nepal, however, a comparatively larger proportion of adults (44%) are unaware of their HTN status, 33% of HTN patients are receiving treatment, and only 12% of the patients have their BP under control. There are proven evidence-based interventions that have been recommended for the prevention and control of HTN including weight loss; healthy diet incorporating reduced sodium, increased fruits and vegetables, and reduced saturated fats; increased physical activity; lowered alcohol; and anti-HTN medications. Despite the availability of these proven effective lifestyle changes and low-cost anti-HTN treatment in preventing major vascular events and total mortality, these recommendations have not been translated into practice to improve population health. In Nepal, the Package of Essential Non Communicable Diseases (PEN) Implementation Plan (2016-2020) was adopted in line with the Multi-sectoral Action Plan for the prevention and control of non communicable diseases (NCD). The PEN includes protocols to detect and manage HTN at the basic health facilities that provide primary health care incorporating all of the above-mentioned evidence-based interventions. However, our just-concluded study to evaluate the implementation of PEN in Nepal (1R21TW011718-01) demonstrated major implementation barriers at multiple levels that cannot be addressed by just health facility-based PEN: (a) Individual level: b) Interpersonal level (c) Community level (d) Organizational level. In response to these multi-level implementation barriers, investigators propose to implement and evaluate a new task-shifting strategy to community health workers (CHW), leading to improved HTN prevention and control. Task-shifting has been proposed as a potential solution to not only address an overburdened health care system but also as a viable method for implementing primary and secondary prevention at the community-level. There is growing evidence that HTN patients can be cared for by CHW in other settings.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,432

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
15mo left

Started Apr 2024

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Apr 2024Aug 2027

First Submitted

Initial submission to the registry

January 11, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Expected
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

January 11, 2024

Last Update Submit

January 25, 2024

Conditions

Hypertension

Outcome Measures

Primary Outcomes (8)

  • Reach

    Percentage of CHWs implementing the program will participate in at least 8 of the12 monthly meetings; Percentage of the hypertensive patients in the community are aware of their high BP status.

    1 year

  • Adoption

    Percentage of the health facilities asked to participate in adopting the program. Adoption will be a dichotomous measure --(adopted/no adopted). Health facility (HF) will be coded as adopting the program in CHWs completes the initial CHW training session.

    1 year

  • Program Implementation

    A of the health facility will implement a minimum standard to program implementation. Implementation will be a dichotomous measure (successful v inadequate).

    1 year

  • Maintenance:

    Percentage of the health facility that will implement a minimum standard to program implementation during the maintenance period. As secondary outcomes, investigators will assess the extent to which each of the individual core components were maintained, and examine the percent of health facilities implementing all core components.

    1 year

  • Differences in in mean systolic blood pressure

    Net difference in mean systolic BP (mmHg) measured after 12 months between intervention and control group.

    1 year

  • Costing

    Total costs of the implementation and maintenance years by summing the costs of the individual components.

    1 year

  • Cost-effectiveness

    Investigators will estimate the cost-effectiveness in terms of incremental cost per HTN awareness, and incremental cost per BP controlled client. The primary analysis will take a financial perspective and the secondary analysis will take a societal perspective.

    1 year

  • Difference in Body Mass Index (BMI)

    The net difference in mean BMI was measured after 12 months between the intervention and control group. BMI will be calculated as weight in kilograms divided by hight in meters square.

    1 year

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention of the study will be the Community Health Workers implementation strategy

Behavioral: Intervention Group

Control Arm

NO INTERVENTION

Routine hypertension care

Interventions

Intervention GroupBEHAVIORAL

Community Health Workers (CHWs) will undergo a 4-day training program on hypertension management, including screening, counseling, medication adherence, self-care, and referrals. They will then collaborate with healthcare facilities to conduct one-day hypertension screening camps. CHWs will form self-support groups for individuals with hypertension and hold monthly meetings to discuss control strategies, review BP logs, and promote healthcare visits, including family involvement. They will also maintain regular communication with healthcare facility in-charges to ensure effective collaboration in the 'Hypertension Care Cascade Model'. No any drugs will be used in the intervention group.

Intervention Group

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • have high blood pressure of 130/85 mmHg
  • can provide informed consent.

You may not qualify if:

  • severe illness requiring bed rest,
  • pregnant women due to their special health needs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Archana Shrestha

Dhulikhel, Bagmati, 45210, Nepal

Location

Related Publications (20)

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    PMID: 16731270BACKGROUND

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    PMID: 26244512BACKGROUND

  • Karmacharya BM, Koju RP, LoGerfo JP, Chan KC, Mokdad AH, Shrestha A, Sotoodehnia N, Fitzpatrick AL. Awareness, treatment and control of hypertension in Nepal: findings from the Dhulikhel Heart Study. Heart Asia. 2017 Jan 4;9(1):1-8. doi: 10.1136/heartasia-2016-010766. eCollection 2017.

    PMID: 28123454BACKGROUND

  • Ascherio A, Rimm EB, Giovannucci EL, Colditz GA, Rosner B, Willett WC, Sacks F, Stampfer MJ. A prospective study of nutritional factors and hypertension among US men. Circulation. 1992 Nov;86(5):1475-84. doi: 10.1161/01.cir.86.5.1475.

    PMID: 1330360BACKGROUND

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    PMID: 8634612BACKGROUND

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    PMID: 1999367BACKGROUND

  • Cutler JA, Follmann D, Allender PS. Randomized trials of sodium reduction: an overview. Am J Clin Nutr. 1997 Feb;65(2 Suppl):643S-651S. doi: 10.1093/ajcn/65.2.643S.

    PMID: 9022560BACKGROUND

  • Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER 3rd, Simons-Morton DG, Karanja N, Lin PH; DASH-Sodium Collaborative Research Group. Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. DASH-Sodium Collaborative Research Group. N Engl J Med. 2001 Jan 4;344(1):3-10. doi: 10.1056/NEJM200101043440101.

    PMID: 11136953BACKGROUND

  • Garcia-Hermoso A, Saavedra JM, Escalante Y. Effects of exercise on resting blood pressure in obese children: a meta-analysis of randomized controlled trials. Obes Rev. 2013 Nov;14(11):919-28. doi: 10.1111/obr.12054. Epub 2013 Jun 21.

    PMID: 23786645BACKGROUND

  • Lawes CM, Vander Hoorn S, Rodgers A; International Society of Hypertension. Global burden of blood-pressure-related disease, 2001. Lancet. 2008 May 3;371(9623):1513-8. doi: 10.1016/S0140-6736(08)60655-8.

    PMID: 18456100BACKGROUND

  • Psaty BM, Lumley T, Furberg CD, Schellenbaum G, Pahor M, Alderman MH, Weiss NS. Health outcomes associated with various antihypertensive therapies used as first-line agents: a network meta-analysis. JAMA. 2003 May 21;289(19):2534-44. doi: 10.1001/jama.289.19.2534.

    PMID: 12759325BACKGROUND

  • Garg R, Yusuf S. Overview of randomized trials of angiotensin-converting enzyme inhibitors on mortality and morbidity in patients with heart failure. Collaborative Group on ACE Inhibitor Trials. JAMA. 1995 May 10;273(18):1450-6.

    PMID: 7654275BACKGROUND

  • Psaty BM, Smith NL, Siscovick DS, Koepsell TD, Weiss NS, Heckbert SR, Lemaitre RN, Wagner EH, Furberg CD. Health outcomes associated with antihypertensive therapies used as first-line agents. A systematic review and meta-analysis. JAMA. 1997 Mar 5;277(9):739-45.

    PMID: 9042847BACKGROUND

  • Parker ED, Schmitz KH, Jacobs DR Jr, Dengel DR, Schreiner PJ. Physical activity in young adults and incident hypertension over 15 years of follow-up: the CARDIA study. Am J Public Health. 2007 Apr;97(4):703-9. doi: 10.2105/AJPH.2004.055889. Epub 2007 Feb 28.

    PMID: 17329668BACKGROUND

  • Ascherio A, Hennekens C, Willett WC, Sacks F, Rosner B, Manson J, Witteman J, Stampfer MJ. Prospective study of nutritional factors, blood pressure, and hypertension among US women. Hypertension. 1996 May;27(5):1065-72. doi: 10.1161/01.hyp.27.5.1065.

    PMID: 8621198BACKGROUND

  • Zachariah R, Ford N, Philips M, Lynch S, Massaquoi M, Janssens V, Harries AD. Task shifting in HIV/AIDS: opportunities, challenges and proposed actions for sub-Saharan Africa. Trans R Soc Trop Med Hyg. 2009 Jun;103(6):549-58. doi: 10.1016/j.trstmh.2008.09.019. Epub 2008 Nov 6.

    PMID: 18992905BACKGROUND

  • Jindal D, Sharma H, Gupta Y, Ajay VS, Roy A, Sharma R, Ali M, Jarhyan P, Gupta P, Srinivasapura Venkateshmurthy N, Ali MK, Narayan KMV, Prabhakaran D, Weber MB, Mohan S, Patel SA, Tandon N. Improving care for hypertension and diabetes in india by addition of clinical decision support system and task shifting in the national NCD program: I-TREC model of care. BMC Health Serv Res. 2022 May 23;22(1):688. doi: 10.1186/s12913-022-08025-y.

    PMID: 35606762BACKGROUND

  • Labhardt ND, Balo JR, Ndam M, Grimm JJ, Manga E. Task shifting to non-physician clinicians for integrated management of hypertension and diabetes in rural Cameroon: a programme assessment at two years. BMC Health Serv Res. 2010 Dec 14;10:339. doi: 10.1186/1472-6963-10-339.

    PMID: 21144064BACKGROUND

  • Sun Y, Mu J, Wang DW, Ouyang N, Xing L, Guo X, Zhao C, Ren G, Ye N, Zhou Y, Wang J, Li Z, Sun G, Yang R, Chen CS, He J; CRHCP Study Group. A village doctor-led multifaceted intervention for blood pressure control in rural China: an open, cluster randomised trial. Lancet. 2022 May 21;399(10339):1964-1975. doi: 10.1016/S0140-6736(22)00325-7. Epub 2022 Apr 29.

    PMID: 35500594BACKGROUND

  • Mbuthia GW, Magutah K, Pellowski J. Approaches and outcomes of community health worker's interventions for hypertension management and control in low-income and middle-income countries: systematic review. BMJ Open. 2022 Apr 1;12(4):e053455. doi: 10.1136/bmjopen-2021-053455.

    PMID: 35365519BACKGROUND

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Archana Shrestha, PhD

CONTACT

9779801002245archana@kusms.edu.np

Dinesh Timalsena, MPH

CONTACT

9779851037229dinesh@kusms.edu.np

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 11, 2024

First Posted

January 30, 2024

Study Start

April 1, 2024

Primary Completion

August 1, 2024

Study Completion (Estimated)

August 1, 2027

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

NE(1)