Improving Access to Control of Diseases for Women (IMPACD)
Primary Purpose
Cardio-vascular Disease, Stroke Cancer, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Evaluation of social, cultural and behavioral factors
Evaluation of the feasibility and acceptability of delivery of early detections services
Sponsored by
About this trial
This is an interventional screening trial for Cardio-vascular Disease focused on measuring cardio-vascular disease, stroke cancer, breast cancer, oral cancer, cervical cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Women suffering from debilitating illnesses, pregnant women and women refusing to participate will be excluded.
Sites / Locations
- GBH Cancer Memorial Hospital
Outcomes
Primary Outcome Measures
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
Outcomes of the questionnaire survey 2/5
proportion of the participants who know about the common NCDs including cancers and their early symptoms
Outcomes of the questionnaire survey 3/5
proportion of the participants with a diagnosis of hypertension who adhere to the treatment advised
Outcomes of the questionnaire survey 4/5
proportion of the participants with a diagnosis of diabetes who adhere to the treatment advised
Outcomes of the questionnaire survey 5/5
proportion of the participants with a diagnosis of cancer who adhere to the treatment advised
NCD Screening study 1/11
screen positivity - proportion of the screened participants detected to have high blood pressure
NCD Screening study 2/11
screen positivity - proportion of the screened participants detected to have high BMI
NCD Screening study 3/11
screen positivity - proportion of the screened participants detected to have abnormal HPV detection test
NCD Screening study 4/11
screen positivity - proportion of the screened participants detected to have abnormal oral examination test
NCD Screening study 5/11
screen positivity - proportion of the screened participants detected to have abnormal visual examination test
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
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
NCD Screening study 8/11
positive predictive values of further assessment - proportion of participants with confirmed diabetes among those assessed for high sugar
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
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
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
Secondary Outcome Measures
effect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis
effect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis
Full Information
NCT ID
NCT03604939
First Posted
August 17, 2017
Last Updated
August 31, 2021
Sponsor
International Agency for Research on Cancer
Collaborators
GBH Cancer Memorial Hospital Udaipur, India
1. Study Identification
Unique Protocol Identification Number
NCT03604939
Brief Title
Improving Access to Control of Diseases for Women
Acronym
IMPACD
Official Title
Improving Access to Control of Diseases for Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Agency for Research on Cancer
Collaborators
GBH Cancer Memorial Hospital Udaipur, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Specific objectives of this study are the evaluation of:
The social, cultural and behavioral factors that impact the uptake of the NCD control services among rural women using the Rapid Assessment, Response and Evaluation (RARE) approach;
The feasibility and acceptability of the strategy to deliver the following NCD control services to the rural women at their homes by the trained CHWs:
Counselling of the tobacco habitués to give up the practice
Early detection of hypertension and diabetes to ensure prompt and regular treatment
Creating breast awareness and ensuring access to prompt diagnosis and treatment of the women with symptoms suggestive of breast cancer
Screening for cervical cancer by self-collected HPV test and ensuring prompt treatment of screen detected precancers and cancers
Screening of the habitual tobacco/alcohol users for oral cancer by OVE and ensuring prompt treatment of screen detected precancers and cancers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardio-vascular Disease, Stroke Cancer, Breast Cancer, Oral Cancer, Cervical Cancer
Keywords
cardio-vascular disease, stroke cancer, breast cancer, oral cancer, cervical cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
1200 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Evaluation of social, cultural and behavioral factors
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Evaluation of the feasibility and acceptability of delivery of early detections services
Intervention Description
Evaluation of the feasibility and acceptability of delivery of the NCD early detections services by the trained community health workers at home settings
Primary Outcome Measure Information:
Title
Outcomes of the questionnaire survey 1/5
Description
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
Time Frame
1 year
Title
Outcomes of the questionnaire survey 2/5
Description
proportion of the participants who know about the common NCDs including cancers and their early symptoms
Time Frame
1 year
Title
Outcomes of the questionnaire survey 3/5
Description
proportion of the participants with a diagnosis of hypertension who adhere to the treatment advised
Time Frame
1 year
Title
Outcomes of the questionnaire survey 4/5
Description
proportion of the participants with a diagnosis of diabetes who adhere to the treatment advised
Time Frame
1 year
Title
Outcomes of the questionnaire survey 5/5
Description
proportion of the participants with a diagnosis of cancer who adhere to the treatment advised
Time Frame
1 year
Title
NCD Screening study 1/11
Description
screen positivity - proportion of the screened participants detected to have high blood pressure
Time Frame
1 year
Title
NCD Screening study 2/11
Description
screen positivity - proportion of the screened participants detected to have high BMI
Time Frame
1 year
Title
NCD Screening study 3/11
Description
screen positivity - proportion of the screened participants detected to have abnormal HPV detection test
Time Frame
1 year
Title
NCD Screening study 4/11
Description
screen positivity - proportion of the screened participants detected to have abnormal oral examination test
Time Frame
1 year
Title
NCD Screening study 5/11
Description
screen positivity - proportion of the screened participants detected to have abnormal visual examination test
Time Frame
1 year
Title
NCD Screening study 6/11
Description
compliance to further assessment - proportion of screen positive participants undergoing further assessment at the primary health center or at the hospital
Time Frame
1 year
Title
NCD Screening study 7/11
Description
positive predictive values of further assessment - proportion of participants with confirmed diagnosis of hypertension among those assessed for high BP
Time Frame
1 year
Title
NCD Screening study 8/11
Description
positive predictive values of further assessment - proportion of participants with confirmed diabetes among those assessed for high sugar
Time Frame
1 year
Title
NCD Screening study 9/11
Description
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
Time Frame
1 year
Title
NCD Screening study 10/11
Description
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
Time Frame
1 year
Title
NCD Screening study 11/11
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
effect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis
Description
effect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis
Time Frame
1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Women suffering from debilitating illnesses, pregnant women and women refusing to participate will be excluded.
Facility Information:
Facility Name
GBH Cancer Memorial Hospital
City
Udaipur
State/Province
Rajasthan
ZIP/Postal Code
313001
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30998427
Citation
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.
Results Reference
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PubMed Identifier
30606132
Citation
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.
Results Reference
background
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Improving Access to Control of Diseases for Women
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