NCT06761508

Brief Summary

The goal of this observational study is to assess different level of enhanced awareness and behavioral change of adults over the age of 35 who will be educated using video,infographic and pamphlet for the interval of one month

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

December 15, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

January 5, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2025

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

1 month

First QC Date

December 15, 2024

Last Update Submit

January 5, 2025

Conditions

Keywords

Behavioural change in hypertension prevention

Outcome Measures

Primary Outcomes (1)

  • Behavioural change in hypertension prevetion

    Behaviour changes within 1 month related to education \- Asking what kind of behaviour change occurred during 1 month Percentage caculation of participants who had behaviour change Each arm: Number of person who changed their behaviour/total number of participants in the arm

    One month

Secondary Outcomes (1)

  • Change in the awareness level of participants from baseline after 4 week

    4 weeks

Study Arms (3)

intervention group using video

OTHER

Administration of video to the first intervention group

Behavioral: Intervention study for Arm one using video

intervention group using infographics

OTHER

Administration of infographics to the second arm of the intervention group

Behavioral: intervention 2:using infographics

control group using pamphlet

OTHER

Administration of pamphlet to the control groups

Behavioral: intervention 3: use of pamphlet

Interventions

A 3 Arm randomized control trial, using video as the first Arm of intervention to assess the behaviour change of the community in hypertension prevention.

intervention group using video

A 3 Arm randomized control trial,that involves the use of infographics in Arm to assess the behaviour change of the community in hypertension prevention.

intervention group using infographics

A 3 Arm randomized control trial,that contains the use of pamphlet for the 3rd Arm which is the control group to assess the behaviour change of the community in hypertension prevention.

control group using pamphlet

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults age over 35 years old
  • Who does not know his/her blood pressure status within the last 6 months (The person who does not know he or she has a hypertension or not.)
  • Who agree to participate

You may not qualify if:

  • Who cannot come to the church 4 weeks later after the intervention.
  • Known hypertensive patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graduate School of Biomedical and Health Sciences Hiroshima University

Kasumi 1-2-3 Minami-ku, Japan, Nigeria

Location

MeSH Terms

Conditions

Hypertension

Interventions

Clinical Trials as Topic

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Studies as TopicEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Perpetua C Ottiwu, Masters

CONTACT

Moriyama Michiko, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is 3-arm, prospective, parallel (1:1:1), randomized controlled trial. A convenience sampling of registered persons who visit Basilica of the Most Holy Trinity in Onitsha, Anambra State, southeastern Nigeria for regular mass and forums on Sunday. Based on G Power, the total estimated sample size is 81. With proportionate stratification, the number of members required for each stratum of 90 catholic men, 450 catholic women, and 100 catholic youth is 12, 57, and 12, respectively. The participants will be randomly assigned from each stratum to the 3-arms (video, cartoon, pamphlet) based on balloting (draw lots).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 15, 2024

First Posted

January 7, 2025

Study Start

January 5, 2025

Primary Completion

February 5, 2025

Study Completion

April 5, 2025

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

To ensure confidentiality

Locations