Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000834459
Ethics application status
Approved
Date submitted
8/06/2025
Date registered
4/08/2025
Date last updated
4/08/2025
Date data sharing statement initially provided
4/08/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Training For Increasing Awareness on Prevention and Control of Dengue Among Female Community Health Volunteers in Pokhara Metropolitan,Kaski, Nepal
Scientific title
Effects of Training For Increasing Awareness on Prevention and Control of Dengue Among Female Community Health Volunteers in Pokhara Metropolitan,Kaski, Nepal
Secondary ID [1] 314610 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dengue 337745 0
Condition category
Condition code
Infection 334074 334074 0 0
Other infectious diseases
Public Health 334716 334716 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to evaluate the effectiveness of a structured educational program grounded in the Health Belief Model (HBM) in improving awareness, attitudes, and health beliefs related to dengue prevention and control among Female Community Health Volunteers (FCHVs) in Pokhara Metropolitan, Kaski, Nepal.
Materials and Resources:
Training Booklet: Developed by researcher specifically for this study, based on HBM constructs and reviewed by research supervisor and public health experts from technical working group of National Health Education Information and communication centre.
Intervention Toolkit: Printed handouts and presentation slides created for this study to support the three hour training session.
Approval: Educational booklet content was approved by the National Health Education, Information and Communication Centre (NHEICC), Ministry of Health and Population, Nepal.
Procedures & Timeline:
Pre Test (Week –1): One week before training, a structured questionnaire assessed baseline knowledge, attitudes, and HBM constructs of FCHVs in the intervention group.
Training Session (Week 0):
Duration: Single, three hour, face to face group session delivered in Nepali.
Content: Mini lecture on dengue transmission, symptoms, prevention, home based care, and control; facilitated group discussion; distribution of the study’s educational booklet.
Facilitators: Principal investigator and trained public health professionals.
Post Test (Week 6): Forty two days after training, the same questionnaire was re administered to measure changes in knowledge, attitudes, and health beliefs.
Total intervention period: six weeks (one phase, one session).
Delivery Details:
Mode: In person, group setting
Language: Nepali
Location: Wards 33, 17, and 22 of Pokhara Metropolitan City
Adaptations: Flexible scheduling and reminder calls were used to maximize FCHV attendance.
Comparator / Control Treatment
Population: FCHVs from Wards 13, 20, and 25 of Pokhara Metropolitan City.
Assessments:
Pre Test: Administered at the same time as the intervention group’s pre test (one week before Week 0).
Post Test: Administered 42 days after baseline assessment (Week 6).
No Training: Control participants did not receive any educational session during the six week period.
Ethical Fairness: After completion of the post test, the same educational booklet (approved by NHEICC) was provided to all control group FCHVs.
Intervention code [1] 331237 0
Prevention
Intervention code [2] 331381 0
Lifestyle
Comparator / control treatment
The control group consisted of Female Community Health Volunteers (FCHVs) from Ward Nos. 13, 20, and 25 of Pokhara Metropolitan City. No intervention or training was provided to them during the study period. They only participated in the pre- and post-test assessments.
Control group
Active

Outcomes
Primary outcome [1] 341736 0
The primary outcome of this study will be the change in dengue-related knowledge among Female Community Health Volunteers (FCHVs) in the intervention group, measured by comparing pre-test and post-test scores.
Timepoint [1] 341736 0
baseline and 6 week following end of trainning education session.
Secondary outcome [1] 448565 0
Change in attitudes toward dengue prevention and control.
Timepoint [1] 448565 0
Outcomes were assessed at two timepoints: baseline (pre-intervention) and 6 weeks following the intervention (post-intervention).
Secondary outcome [2] 448566 0
Change in perceived susceptibility
Timepoint [2] 448566 0
Changes in perceived susceptibility constructs were assessed at baseline and six weeks after the intervention.
Secondary outcome [3] 449249 0
Change in perceived severity
Timepoint [3] 449249 0
Changes in perceived severity constructs were assessed at baseline and six weeks after the intervention
Secondary outcome [4] 449250 0
Change in perceived benefits.
Timepoint [4] 449250 0
Changes in perceived benefits constructs were assessed at baseline and six weeks after the intervention
Secondary outcome [5] 449251 0
Change in perceived barriers.
Timepoint [5] 449251 0
Changes in perceived barriers constructs were assessed at baseline and six weeks after the intervention
Secondary outcome [6] 449252 0
Change in self-efficacy.
Timepoint [6] 449252 0
Changes in self-efficacy constructs were assessed at baseline and six weeks after the intervention

Eligibility
Key inclusion criteria
The inclusion criteria for this study are Female Community Health Volunteers (FCHVs) who are working under the governmental health institutions of Pokhara Metropolitan City. Participants must provide informed consent to participate in the study, demonstrating their understanding and agreement to be involved.
Minimum age
20 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2025
Date of last participant enrolment
Anticipated
Actual
2/04/2025
Date of last data collection
Anticipated
Actual
30/05/2025
Sample size
Target
154
Accrual to date
Final
140
Recruitment outside Australia
Country [1] 27113 0
Nepal
State/province [1] 27113 0
GANDAKI

Funding & Sponsors
Funding source category [1] 319170 0
Self funded/Unfunded
Name [1] 319170 0
Gyanu Poudel
Country [1] 319170 0
Nepal
Primary sponsor type
Individual
Name
Gyanu Poude (School of Health and Allied Sciences, Pokhara University)
Address
Country
Nepal
Secondary sponsor category [1] 321630 0
None
Name [1] 321630 0
Address [1] 321630 0
Country [1] 321630 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317752 0
Institutional review committee, Pokhara University
Ethics committee address [1] 317752 0
Ethics committee country [1] 317752 0
Nepal
Date submitted for ethics approval [1] 317752 0
16/02/2025
Approval date [1] 317752 0
07/03/2025
Ethics approval number [1] 317752 0
171/208182

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142026 0
Mr Gyanu Poudel
Address 142026 0
Pokhara University,ward no 30, Dhungepatan, Khudi
Country 142026 0
Nepal
Phone 142026 0
+9779856003053
Fax 142026 0
Email 142026 0
[email protected]
Contact person for public queries
Name 142027 0
Gyanu Poudel
Address 142027 0
Pokhara University,ward no 30, Dhungepatan, Khudi
Country 142027 0
Nepal
Phone 142027 0
+9779856003053
Fax 142027 0
Email 142027 0
[email protected]
Contact person for scientific queries
Name 142028 0
Gyanu Poudel
Address 142028 0
Pokhara University,ward no 30, Dhungepatan, Khudi
Country 142028 0
Nepal
Phone 142028 0
+9779856003053
Fax 142028 0
Email 142028 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Postal address: pokhara metropolitan, 21,Nirmalpokhari,Kaski,Nepal

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.