HypertensionNCT06761508
Comparing of Different Visual Aids Like Video,info-graphics and Pamphlets in Enhancing Community Awareness and Promoting Behavioral Change Towards the Prevention of Hypertension in Basilica of the Most Holy Trinity Onitsha Anambra State,Nigeria
A study testing Intervention study for Arm one using video, intervention 2:using infographics and intervention 3: use of pamphlet in people with Hypertension, run by Hiroshima University at 1 site in Nigeria.
Trial 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 Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Intervention study for Arm one using video, intervention 2:using infographics and intervention 3: use of pamphlet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteNigeria
- Study dates
- 5 Jan 2025to 5 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Who cannot come to the church 4 weeks later after the intervention.
- Known hypertensive patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nigeria1 site
Graduate School of Biomedical and Health Sciences Hiroshima University
Kasumi 1-2-3 Minami-ku, Japan
Moriyama Michiko, PHD, +81-82-257-5365, morimich@hiroshima-u.ac.jp
Clementina Nwankwo, PHD
About this study
Official title: Comparison of Different Visual Aids in Enhancing Community Awareness and Promoting Behavioral Change in the Prevention of Hypertension in Anambra State,Nigeria
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
- Conditions
- Hypertension
- Being tested
- Intervention study for Arm one using video, intervention 2:using infographics, intervention 3: use of pamphlet
- Keywords
- Behavioural change in hypertension prevention
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention study for Arm one using videoBehavioural
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 2:using infographicsBehavioural
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 3: use of pamphletBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group using video | Other | Administration of video to the first intervention group Receives: Behavioral: Intervention study for Arm one using video |
| intervention group using infographics | Other | Administration of infographics to the second arm of the intervention group Receives: Behavioral: intervention 2:using infographics |
| control group using pamphlet | Other | Administration of pamphlet to the control groups Receives: Behavioral: intervention 3: use of pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One month
Secondary outcomes (1)
Change in the awareness level of participants from baseline after 4 week
- Awareness check: Using the Health belief model-The researchers-developed questionnaire:How much they are motivated (pre and post comparison)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start5 Jan 2025 (estimated)
- Primary completion5 Feb 2025 (estimated)
- Study completion5 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ottiwu Perpetua Chidiogor, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761508
- Sponsor's protocol ID
- MH/COMM/523/VOL.111
- Status last verified
- Jan 2025
- First submitted
- 15 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To ensure confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Visual Aids in Enhancing Community Awareness and Promoting Behavioral Change in the Prevention of Hypertension in Anambra State,Nigeria
- ClinicalTrials.gov ID
- NCT06761508
- Acronym / sponsor ID
- MH/COMM/523/VOL.111
- Conditions
- Hypertension
- Keywords
- Behavioural change in hypertension prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Study start
- 5 Jan 2025 (estimated)
- Primary completion
- 5 Feb 2025 (estimated)
- Study completion
- 5 Apr 2025 (estimated)
- First posted
- 7 Jan 2025 (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 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| intervention group using video | Other | Behavioral: Intervention study for Arm one using videoAdministration of video to the first intervention group |
| intervention group using infographics | Other | Behavioral: intervention 2:using infographicsAdministration of infographics to the second arm of the intervention group |
| control group using pamphlet | Other | Behavioral: intervention 3: use of pamphletAdministration of pamphlet to the control groups |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Who cannot come to the church 4 weeks later after the intervention.
- Known hypertensive patients
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 |
|---|---|---|
| Intervention study for Arm one using videoA 3 Arm randomized control trial, using video as the first Arm of intervention to assess the behaviour change of the community in hypertension prevention. | Behavioural | intervention group using video |
| intervention 2:using infographicsA 3 Arm randomized control trial,that involves the use of infographics in Arm to assess the behaviour change of the community in hypertension prevention. | Behavioural | intervention group using infographics |
| intervention 3: use of pamphletA 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. | Behavioural | control group using pamphlet |
Primary outcome
Behavioural change in hypertension prevetion
Time frame: One month
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
1 secondary outcome
Change in the awareness level of participants from baseline after 4 week
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No. To ensure confidentiality
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention study for Arm one using video, intervention 2:using infographics and intervention 3: use of pamphlet in people with Hypertension, run by Hiroshima University at 1 site in Nigeria.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 7 Jan 2025. 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 Nigeria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Perpetua C Ottiwu, Masters (+2340832605330, m232417@hiroshima-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioural change in hypertension prevetion (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2025.