NCT01503814

Brief Summary

The goal of this study is to develop, pilot test, and evaluate a highly simplified but guideline-based program for cardiovascular management for application in resource-scarce settings. The study aims to assess the effects of implementing a simple low-cost cardiovascular management program for high-risk individuals, delivered by primary care providers (PCPs) or community health workers (CHWs), on the proportion of patients appropriately treated with diuretics as well as a number of secondary outcomes in resource-scarce Tibet, China and Haryana India.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
2,086

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

December 30, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 16, 2017

Status Verified

August 1, 2014

Enrollment Period

2.2 years

First QC Date

December 30, 2011

Last Update Submit

May 15, 2017

Conditions

Cardiovascular Disease

Keywords

hypertensionprimary carecardiovascular disease preventionhigh cardiovascular riskdiureticsaspirinsmoking cessationsalt reductionTibet

Outcome Measures

Primary Outcomes (1)

  • Net Difference in Proportion Treated with Low-dose Diuretics

    The primary outcome will be the net differences between the changes in the proportion of high-risk individuals treated with low-dose diuretics pre-and-post intervention between intervention and control villages. The outcome measure will be assessed via a questionnaire that will ask about low-dose diuretics usage that will be administered at baseline and then again following the intervention period at around one year.

    baseline and at one year

Secondary Outcomes (1)

  • Net Difference from Baseline in Mean Blood Pressure

    baseline and at one year

Study Arms (2)

Control (Usual Care)

NO INTERVENTION

Control

Intervention

EXPERIMENTAL

Use of a simplified guideline-based CVD prevention and management scheme by village doctors targeting high risk individuals focusing on a"2+2"model: 2 therapeutic lifestyle recommendations (smoking cessation and salt consumption reduction) plus prescription of 2 low-cost drugs (aspirin and low-dose diuretics) when applicable

Other: Simplified cardiovascular disease management

Interventions

Simplified cardiovascular disease managementOTHER

This study is a complex pragmatic trial.The intervention includes a "package" of 4 main established measures for cardiovascular prevention and management: 2 therapeutic lifestyle recommendations- smoking cessation (if applicable) and reduced salt consumption 2 drug therapies (if applicable)- hydrochlorothiazide, 25mg tab, 1/2 tab daily (12.5mg/day) and aspirin, 25mg tab, 3 tabs daily (75mg/day)

Intervention

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age is equal or older than 40 years old AND the subject has a self-reported history of ANY of the following diseases:
  • CVD OR
  • Diabetes OR
  • Stroke (including both Ischemic Stroke and Haemorrhagic Stroke) OR
  • Measured systolic blood pressure is equal or greater than 160mmHg at two different time points in the same day during the baseline survey.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Linzhou

Lhasa, Tibet, China

Location

Gongbujiangda

Linzhi, Tibet, China

Location

Faridabad

Haryāna, India

Location

Related Publications (12)

  • Oakley A, Strange V, Bonell C, Allen E, Stephenson J; RIPPLE Study Team. Process evaluation in randomised controlled trials of complex interventions. BMJ. 2006 Feb 18;332(7538):413-6. doi: 10.1136/bmj.332.7538.413.

    PMID: 16484270BACKGROUND

  • Manuel DG, Lim J, Tanuseputro P, Anderson GM, Alter DA, Laupacis A, Mustard CA. Revisiting Rose: strategies for reducing coronary heart disease. BMJ. 2006 Mar 18;332(7542):659-62. doi: 10.1136/bmj.332.7542.659.

    PMID: 16543339BACKGROUND

  • O'Brien E, Pickering T, Asmar R, Myers M, Parati G, Staessen J, Mengden T, Imai Y, Waeber B, Palatini P, Gerin W; Working Group on Blood Pressure Monitoring of the European Society of Hypertension. Working Group on Blood Pressure Monitoring of the European Society of Hypertension International Protocol for validation of blood pressure measuring devices in adults. Blood Press Monit. 2002 Feb;7(1):3-17. doi: 10.1097/00126097-200202000-00002. No abstract available.

    PMID: 12040236BACKGROUND

  • World Health Organization. Global strategy on diet, physical activity and health, F.-S.W.H. Assembly, Editor. 2004: Available from: http://www.who.int/dietphysicalactivity/goals/en/index.html.

    BACKGROUND

  • Murray C, and Lopez A. The Global Burden of Disease: A Comprehensive Assessment of Mortality and Disability from Disease, Injuries and Risk Factors in 1990 and Projected to 2020. Boston, Mass: Harvard School of Public Health., 1996.

    BACKGROUND

  • Yusuf S, Reddy S, Ounpuu S, Anand S. Global burden of cardiovascular diseases: part I: general considerations, the epidemiologic transition, risk factors, and impact of urbanization. Circulation. 2001 Nov 27;104(22):2746-53. doi: 10.1161/hc4601.099487.

    PMID: 11723030BACKGROUND

  • China guideline of hypertension updated 2005 Progression in the diagnosis and management of hypertension. China Hypertension League, 2005.

    BACKGROUND

  • Li SS, Zhao XS, Ba S, He F, Ke L, Li N, Yan LL, Wu YF. (2009, November). Validation of electronic sphygmomanometers against mercury sphygmomanometers at high altitude in Tibet. Poster presented at The Word Hypertension Congress 2009.

    BACKGROUND

  • National Vascular Disease Prevention Alliance, Guidelines for the Assessment of Absolute Cardiovascular Disease Risk. 2009, National Heart Foundation of Australia: Melbourne.

    BACKGROUND

  • Tian M, Yin X, Dunzhu D, Liu Z, Li C, Sun H, Song C, Sangzhu L, Patel A, Redfern J, Yan LL. A qualitative evaluation of a simplified cardiovascular management program in Tibet, China. Global Health. 2018 Mar 1;14(1):24. doi: 10.1186/s12992-018-0342-0.

    PMID: 29490675DERIVED

  • Tian M, Ajay VS, Dunzhu D, Hameed SS, Li X, Liu Z, Li C, Chen H, Cho K, Li R, Zhao X, Jindal D, Rawal I, Ali MK, Peterson ED, Ji J, Amarchand R, Krishnan A, Tandon N, Xu LQ, Wu Y, Prabhakaran D, Yan LL. A Cluster-Randomized, Controlled Trial of a Simplified Multifaceted Management Program for Individuals at High Cardiovascular Risk (SimCard Trial) in Rural Tibet, China, and Haryana, India. Circulation. 2015 Sep 1;132(9):815-24. doi: 10.1161/CIRCULATIONAHA.115.015373. Epub 2015 Jul 17.

    PMID: 26187183DERIVED

  • Ajay VS, Tian M, Chen H, Wu Y, Li X, Dunzhu D, Ali MK, Tandon N, Krishnan A, Prabhakaran D, Yan LL. A cluster-randomized controlled trial to evaluate the effects of a simplified cardiovascular management program in Tibet, China and Haryana, India: study design and rationale. BMC Public Health. 2014 Sep 6;14:924. doi: 10.1186/1471-2458-14-924.

    PMID: 25194850DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionSmoking Cessation

Condition Hierarchy (Ancestors)

Vascular DiseasesHealth BehaviorBehavior

Study Officials

  • Lijing Yan, PhD

    The George Institute, China (Beijing, CN)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2011

First Posted

January 4, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2014

Study Completion

September 1, 2015

Last Updated

May 16, 2017

Record last verified: 2014-08

Locations

CN(2)IN(1)