- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06388473
Implementation of a Web-based App for Screening in Men in a Malaysian Primary Care Setting (iScreenMen)
April 24, 2024 updated by: University of Malaya
The purpose of this study is to determine how to successfully implement ScreenMen in the primary care setting.
ScreenMen is a mobile web-based app that has been developed to increase the uptake of screening in men.
ScreenMen undertook a vigorous and systematic approach in its development.
It was developed based on theories, evidence and needs of men.
ScreenMen particularly target men in the age group of 20 to 50 years as this group of men usually do not attend any health screening.
This research is necessary because ScreenMen has yet to be implemented in the primary care setting.
The study will last about five months and your participation will be about five months.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kuala Lumpur, Malaysia, 56100
- Klinik Kesihatan Cheras Baru
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthcare providers that were involved in the clinic health screening program.
- Patients who were aged 18 years and above were eligible to participate.
Exclusion Criteria:
- Temporary healthcare providers (working in the clinic less than six months during the study period) and those who were away on leave.
- Patients who did not understand Bahasa Malaysia, English or Mandarin, cognitively impaired, had an active psychiatric illness or were too ill.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tailored implementation intervention
The tailored implementation intervention comprised of six implementation strategies: 1) Involve executive boards, 2) Mandate change, 3) Provide education and training, 4) Identify and prepare champions, 5) The use of information and communication technology and 6) Audit and provide feedback.
|
The tailored implementation intervention comprised of six implementation strategies: 1) Involve executive boards, 2) Mandate change, 3) Provide education and training, 4) Identify and prepare champions, 5) The use of information and communication technology and 6) Audit and provide feedback.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reach
Time Frame: Beginning of intervention
|
Number of healthcare providers who attended the workshop / Number of healthcare providers who were invited to the workshop.
|
Beginning of intervention
|
Reach
Time Frame: Through study completion, 5 months.
|
The number of patients who accessed ScreenMen.
|
Through study completion, 5 months.
|
Adoption of ScreenMen using qualitative methods
Time Frame: 5 months into study
|
Factors affecting the participation of healthcare providers in adopting ScreenMen in daily practice using qualitative interviews.
|
5 months into study
|
Implementation of ScreenMen using qualitative methods
Time Frame: 5 months into study
|
Factors affecting the implementation of ScreenMen daily practice using qualitative interviews.
|
5 months into study
|
Maintenance of ScreenMen using qualitative methods
Time Frame: 5 months into study
|
Intention to implement ScreenMen and factors influencing the decision using qualitative methods.
|
5 months into study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of COVID-19 on the clinic using qualitative methods
Time Frame: 5 months into study
|
The clinic situation during the COVID-19 pandemic and how it affected daily practice using qualitative methods.
|
5 months into study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chirk Jenn Ng, PhD, University of Malaya
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 14, 2021
Primary Completion (Actual)
June 6, 2021
Study Completion (Actual)
June 6, 2021
Study Registration Dates
First Submitted
April 7, 2024
First Submitted That Met QC Criteria
April 24, 2024
First Posted (Actual)
April 29, 2024
Study Record Updates
Last Update Posted (Actual)
April 29, 2024
Last Update Submitted That Met QC Criteria
April 24, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NMRR-20-2188-56086 IIR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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