Cardio-vascular DiseaseIMPACDNCT03604939
Improving Access to Control of Diseases for Women
A study testing Evaluation of social, cultural and behavioral factors and Evaluation of the feasibility and acceptability of delivery of early detections services in people with Cardio-vascular Disease and Stroke Cancer, run by International Agency for Research on Cancer at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardio-vascular Disease, Stroke Cancer, Breast Cancer
- What is being tested?
- Evaluation of social, cultural and behavioral factors and Evaluation of the feasibility and acceptability of delivery of early detections services
- How many people
- 1,200 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2017to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Women suffering from debilitating illnesses, pregnant women and women refusing to participate will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Evaluation of social, cultural and behavioral factors, Evaluation of the feasibility and acceptability of delivery of early detections services
- Keywords
- cardio-vascular disease, stroke cancer, breast cancer, oral cancer, cervical cancer
- Medical subject headings
- Breast Neoplasms, Mouth Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 year
Outcomes of the questionnaire survey 3/5
proportion of the participants with a diagnosis of hypertension who adhere to the treatment advised
Measured: 1 year
Outcomes of the questionnaire survey 4/5
proportion of the participants with a diagnosis of diabetes who adhere to the treatment advised
Measured: 1 year
Outcomes of the questionnaire survey 5/5
proportion of the participants with a diagnosis of cancer who adhere to the treatment advised
Measured: 1 year
NCD Screening study 1/11
screen positivity - proportion of the screened participants detected to have high blood pressure
Measured: 1 year
NCD Screening study 2/11
screen positivity - proportion of the screened participants detected to have high BMI
Measured: 1 year
NCD Screening study 3/11
screen positivity - proportion of the screened participants detected to have abnormal HPV detection test
Measured: 1 year
NCD Screening study 4/11
screen positivity - proportion of the screened participants detected to have abnormal oral examination test
Measured: 1 year
NCD Screening study 5/11
screen positivity - proportion of the screened participants detected to have abnormal visual examination test
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Jan 2017
- Primary completion1 Aug 2018
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardio-vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- GBH Cancer Memorial Hospital Udaipur, India
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604939
- Sponsor's protocol ID
- DCA/SCR/2016/01
- Acronym
- IMPACD
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2017
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30998427Basu 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.
PubMed 30606132
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access to Control of Diseases for Women
- ClinicalTrials.gov ID
- NCT03604939
- Acronym / sponsor ID
- IMPACD / DCA/SCR/2016/01
- Keywords
- cardio-vascular disease, stroke cancer, breast cancer, oral cancer, cervical cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Collaborators
- GBH Cancer Memorial Hospital Udaipur, India
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Women suffering from debilitating illnesses, pregnant women and women refusing to participate will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of social, cultural and behavioral factorsEvaluation of the social, cultural and behavioral factors that impact the uptake of the NCD prevention and control services among women, using the RARE methodology | Diagnostic test | – |
| Evaluation of the feasibility and acceptability of delivery of early detections servicesEvaluation of the feasibility and acceptability of delivery of the NCD early detections services by the trained community health workers at home settings | Diagnostic test | – |
Primary outcome
Outcomes of the questionnaire survey 1/5
Time frame: 1 year
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
Time frame: 1 year
proportion of the participants who know about the common NCDs including cancers and their early symptoms
Outcomes of the questionnaire survey 3/5
Time frame: 1 year
proportion of the participants with a diagnosis of hypertension who adhere to the treatment advised
Outcomes of the questionnaire survey 4/5
Time frame: 1 year
proportion of the participants with a diagnosis of diabetes who adhere to the treatment advised
Outcomes of the questionnaire survey 5/5
Time frame: 1 year
proportion of the participants with a diagnosis of cancer who adhere to the treatment advised
NCD Screening study 1/11
Time frame: 1 year
screen positivity - proportion of the screened participants detected to have high blood pressure
NCD Screening study 2/11
Time frame: 1 year
screen positivity - proportion of the screened participants detected to have high BMI
NCD Screening study 3/11
Time frame: 1 year
screen positivity - proportion of the screened participants detected to have abnormal HPV detection test
NCD Screening study 4/11
Time frame: 1 year
screen positivity - proportion of the screened participants detected to have abnormal oral examination test
NCD Screening study 5/11
Time frame: 1 year
screen positivity - proportion of the screened participants detected to have abnormal visual examination test
NCD Screening study 6/11
Time frame: 1 year
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
Time frame: 1 year
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
Time frame: 1 year
positive predictive values of further assessment - proportion of participants with confirmed diabetes among those assessed for high sugar
NCD Screening study 9/11
Time frame: 1 year
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
Time frame: 1 year
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
Time frame: 1 year
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 secondary outcome
effect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Background: PubMed 30998427Mahajan 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.
- Background: PubMed 30606132Basu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of social, cultural and behavioral factors and Evaluation of the feasibility and acceptability of delivery of early detections services in people with Cardio-vascular Disease and Stroke Cancer, run by International Agency for Research on Cancer at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcomes of the questionnaire survey 1/5 (time frame: 1 year). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03604939, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.