NCT03604939

Brief Summary

The aim of this study is to evaluate the feasibility and acceptability of the model of delivering CHW-driven home-based comprehensive NCD control services aimed to prevent premature deaths from cardio-vascular diseases, stroke and breast, cervix and oral cancers in the hard-to-reach women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2017

Completed
12 months until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1.6 years

First QC Date

August 17, 2017

Last Update Submit

August 31, 2021

Conditions

Cardio-vascular DiseaseStroke CancerBreast CancerOral CancerCervical Cancer

Keywords

cardio-vascular diseasestroke cancerbreast canceroral cancercervical cancer

Outcome Measures

Primary Outcomes (16)

  • Outcomes of the questionnaire survey 1/5

    proportion of the participants who know about the adverse effect of smoking, chewing tobacco and consuming alcohol on health in general and NCDs in particular

    1 year

  • Outcomes of the questionnaire survey 2/5

    proportion of the participants who know about the common NCDs including cancers and their early symptoms

    1 year

  • Outcomes of the questionnaire survey 3/5

    proportion of the participants with a diagnosis of hypertension who adhere to the treatment advised

    1 year

  • Outcomes of the questionnaire survey 4/5

    proportion of the participants with a diagnosis of diabetes who adhere to the treatment advised

    1 year

  • Outcomes of the questionnaire survey 5/5

    proportion of the participants with a diagnosis of cancer who adhere to the treatment advised

    1 year

  • NCD Screening study 1/11

    screen positivity - proportion of the screened participants detected to have high blood pressure

    1 year

  • NCD Screening study 2/11

    screen positivity - proportion of the screened participants detected to have high BMI

    1 year

  • NCD Screening study 3/11

    screen positivity - proportion of the screened participants detected to have abnormal HPV detection test

    1 year

  • NCD Screening study 4/11

    screen positivity - proportion of the screened participants detected to have abnormal oral examination test

    1 year

  • NCD Screening study 5/11

    screen positivity - proportion of the screened participants detected to have abnormal visual examination test

    1 year

  • NCD Screening study 6/11

    compliance to further assessment - proportion of screen positive participants undergoing further assessment at the primary health center or at the hospital

    1 year

  • NCD Screening study 7/11

    positive predictive values of further assessment - proportion of participants with confirmed diagnosis of hypertension among those assessed for high BP

    1 year

  • NCD Screening study 8/11

    positive predictive values of further assessment - proportion of participants with confirmed diabetes among those assessed for high sugar

    1 year

  • NCD Screening study 9/11

    positive predictive values of further assessment - proportion of participants with confirmed cervical neoplasias on colposcopy and/or biopsy among those assessed for positive HPV test

    1 year

  • NCD Screening study 10/11

    positive predictive values of further assessment - proportion of participants with confirmed oral premalignant and malignant lesions on examination and/or biopsy among those assessed for positive oral examination

    1 year

  • NCD Screening study 11/11

    positive predictive values of further assessment - proportion of participants with confirmed visual premalignant and malignant lesions on examination and/or biopsy among those assessed for positive visual examination

    1 year

Secondary Outcomes (1)

  • effect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis

    1 year

Interventions

Evaluation of social, cultural and behavioral factorsDIAGNOSTIC_TEST

Evaluation of the social, cultural and behavioral factors that impact the uptake of the NCD prevention and control services among women, using the RARE methodology

Evaluation of the feasibility and acceptability of delivery of early detections servicesDIAGNOSTIC_TEST

Evaluation of the feasibility and acceptability of delivery of the NCD early detections services by the trained community health workers at home settings

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen between 30 to 60 years residing in the villages of the Gogunda block in the district of Udaipur in Rajasthan, India, will be eligible to participate.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women between 30 to 60 years residing in the villages of the Gogunda block in the district of Udaipur in Rajasthan, India, will be eligible to participate.

You may not qualify if:

  • Women suffering from debilitating illnesses, pregnant women and women refusing to participate will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GBH Cancer Memorial Hospital

Udaipur, Rajasthan, 313001, India

Location

Related Publications (2)

  • Mahajan M, Naik N, Jain K, Patira N, Prasad S, Mogri S, Muwonge R, Lucas E, Faruq F, Sankaranarayanan R, Iyer S, Basu P. Study of Knowledge, Attitudes, and Practices Toward Risk Factors and Early Detection of Noncommunicable Diseases Among Rural Women in India. J Glob Oncol. 2019 Apr;5:1-10. doi: 10.1200/JGO.18.00181.

    PMID: 30998427BACKGROUND

  • Basu P, Mahajan M, Patira N, Prasad S, Mogri S, Muwonge R, Lucas E, Sankaranarayanan R, Iyer S, Naik N, Jain K. A pilot study to evaluate home-based screening for the common non-communicable diseases by a dedicated cadre of community health workers in a rural setting in India. BMC Public Health. 2019 Jan 3;19(1):14. doi: 10.1186/s12889-018-6350-4.

    PMID: 30606132BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsMouth NeoplasmsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHead and Neck NeoplasmsMouth DiseasesStomatognathic DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: 35,000 households in 228 villages, among which women between 30 to 60 years residing in the villages of the block are eligible to participate
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2017

First Posted

July 30, 2018

Study Start

January 1, 2017

Primary Completion

August 1, 2018

Study Completion

July 1, 2019

Last Updated

September 5, 2021

Record last verified: 2021-08

Locations

IN(1)