NCT02368418

Brief Summary

China Rural Health Initiative (CRHI), a large-scale, factorial, cluster-randomized, controlled trial was conducted in 120 villages selected from 5 Northern Provinces of rural China between 2010 and 2012. Two interventions were evaluated through CRHI. One is the standard disease management program of individuals at high risk of cardiovascular disease delivered by Primary Care Providers (village doctors). Another one is a community-based Salt Reduction program delivered by community health educators. CRHI study interventions had ended for two years now and provide a good opportunity for us to understand whether its effects could be prolonged to a longer term. This study wants to evaluate the effects of CRHI interventions at 2 years after the end of CRHI (from Sep 2014 to Feb 2015). In this follow-up survey, the baseline cohort of 5050 and post-intervention cohort of 4887 CRHI participants who were randomly selected from the 120 villages from 5 northern provinces of rural China will be recruited for the follow up study from Sep 2014 to Feb 2015. A questionnaire derived from CRHI baseline and post-intervention surveys will be used to collect data on disease history, medication use, care seeking patterns, lifestyle factors and so on. Weight, height, blood pressure and heart rate will be measured in the standard ways.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9,164

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

5 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

Study Start

First participant enrolled

September 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 27, 2017

Status Verified

January 1, 2016

Enrollment Period

1.4 years

First QC Date

September 2, 2014

Last Update Submit

February 23, 2017

Conditions

Cardiovascular Disease

Keywords

Cardiovascular diseaseRural healthChinaCohort study

Outcome Measures

Primary Outcomes (1)

  • mean systolic blood pressure level among all participants and those at high risk

    from baseline and post-intervention to the follow up

Secondary Outcomes (8)

  • Proportion of individuals regularly visiting the village clinic among all participants and high-risk patients

    from baseline and post-intervention to the follow up

  • Proportion of individuals receiving lifestyle advice among all participants and high-risk patients

    from baseline and post-intervention to the follow up

  • Proportion of individuals treated with a blood pressure lowering agent among all participants and high-risk patients

    from baseline and post-intervention to the follow up

  • Proportion of individuals treated with aspirin among all participants and high-risk patients

    from baseline and post-intervention to the follow up

  • Proportion of individuals having knowledge on salt reduction among all participants and high-risk patients

    from baseline and post-intervention to the follow up

  • +3 more secondary outcomes

Study Arms (4)

PCP and SRS

participants had received two interventions (PCP and SRS)

Procedure: PCPProcedure: SRS

PCP only

participants had received PCP intervention only

Procedure: PCP

SRS only

participants had received SRS intervention only

Procedure: SRS

control group

participants had received usual care (neither PCP nor SRS)

Interventions

PCPPROCEDURE

PCP is short for the standard disease management program of individuals at high risk of cardiovascular disease delivered by Primary Care Providers (village doctors).

PCP and SRSPCP only
SRSPROCEDURE

SRS is short for a community-based Salt Reduction program delivered by community health educators.

PCP and SRSSRS only

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The baseline cohort of 5050 and post-intervention cohort of 4887 CRHI participants who were randomly selected from the 120 villages from 5 northern provinces (Liaoning, Hebei, Shanxi, Shaanxi and Ningxia) of rural China will be recruited for the follow up study.

You may qualify if:

  • Individuals had participated the baseline or post-intervention survey.

You may not qualify if:

  • Death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hebei Province Center for Disease Prevention and Control ,China

Shijiazhuang, Hebei, 050000, China

Location

The First Hospital Of China Medical University

Shenyang, Liaoning, 110000, China

Location

Ningxia Medical University School of Public Health

Yinchuan, Ningxia, 750000, China

Location

Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Location

Changzhi Medical College, China

Changzhi, Shanxi, 046000, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Yangfeng Wu, PhD

    The George Institute for Global Health, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

February 23, 2015

Study Start

September 1, 2014

Primary Completion

February 1, 2016

Study Completion

August 1, 2016

Last Updated

February 27, 2017

Record last verified: 2016-01

Locations

CN(5)