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Trial record 34 of 1347 for:    rural

China Rural Health Initiative Follow up Study (CRHIFU)

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ClinicalTrials.gov Identifier: NCT02368418
Recruitment Status : Completed
First Posted : February 23, 2015
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
The George Institute for Global Health, China

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.


Condition or disease Intervention/treatment
Cardiovascular Disease Procedure: PCP Procedure: SRS

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 9164 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: China Rural Health Initiative Follow up Study
Study Start Date : September 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
PCP and SRS
participants had received two interventions (PCP and SRS)
Procedure: PCP
PCP is short for the standard disease management program of individuals at high risk of cardiovascular disease delivered by Primary Care Providers (village doctors).

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

PCP only
participants had received PCP intervention only
Procedure: PCP
PCP is short for the standard disease management program of individuals at high risk of cardiovascular disease delivered by Primary Care Providers (village doctors).

SRS only
participants had received SRS intervention only
Procedure: SRS
SRS is short for a community-based Salt Reduction program delivered by community health educators.

control group
participants had received usual care (neither PCP nor SRS)



Primary Outcome Measures :
  1. mean systolic blood pressure level among all participants and those at high risk [ Time Frame: from baseline and post-intervention to the follow up ]

Secondary Outcome Measures :
  1. Proportion of individuals regularly visiting the village clinic among all participants and high-risk patients [ Time Frame: from baseline and post-intervention to the follow up ]
  2. Proportion of individuals receiving lifestyle advice among all participants and high-risk patients [ Time Frame: from baseline and post-intervention to the follow up ]
  3. Proportion of individuals treated with a blood pressure lowering agent among all participants and high-risk patients [ Time Frame: from baseline and post-intervention to the follow up ]
  4. Proportion of individuals treated with aspirin among all participants and high-risk patients [ Time Frame: from baseline and post-intervention to the follow up ]
  5. Proportion of individuals having knowledge on salt reduction among all participants and high-risk patients [ Time Frame: from baseline and post-intervention to the follow up ]
  6. Proportion of individuals using low sodium salt among all participants and high-risk patients [ Time Frame: from baseline and post-intervention to the follow up ]
  7. Proportion of individuals adopting healthy behavior among all participants and high-risk patients [ Time Frame: from baseline and post-intervention to the follow up ]
  8. Proportion of individuals developing CVD event among all participants and high-risk patients [ Time Frame: from baseline and post-intervention to the follow up ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Death

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368418


Locations
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China, Hebei
Hebei Province Center for Disease Prevention and Control ,China
Shijiazhuang, Hebei, China, 050000
China, Liaoning
The First Hospital Of China Medical University
Shenyang, Liaoning, China, 110000
China, Ningxia
Ningxia Medical University School of Public Health
Yinchuan, Ningxia, China, 750000
China, Shaanxi
Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710000
China, Shanxi
Changzhi Medical College, China
Changzhi, Shanxi, China, 046000
Sponsors and Collaborators
The George Institute for Global Health, China
Investigators
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Principal Investigator: Yangfeng Wu, PhD The George Institute for Global Health, China

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Responsible Party: The George Institute for Global Health, China
ClinicalTrials.gov Identifier: NCT02368418     History of Changes
Other Study ID Numbers: PKU00001052
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: January 2016
Keywords provided by The George Institute for Global Health, China:
Cardiovascular disease
Rural health
China
Cohort study
Additional relevant MeSH terms:
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Cardiovascular Diseases