Atrial Fibrillation (AF)NCT06582823
Effects of a Health Belief Model-Based Community Educational Program to Increase the Awareness of Atrial Fibrillation Among Older Adults: a Randomized Controlled Trial
A study testing Health belief model-based community educational program in people with Atrial Fibrillation (AF), run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this study is to evaluate the effects of a theory-based community educational program among older adults in the community on atrial fibrillation (AF) knowledge. It will also learn about their competency to detect irregular pulses and compliance to regular pulse check. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Health belief model-based community educational program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Aug 2023to Dec 2024
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- adults aged 65 or older
- without a confirmed diagnosis of AF
Who cannot join
- cannot read Chinese
- with cognitive impairment (Abbreviated Mental Test ≤ 6)
- physical limitations in performing pulse palpation
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Nursing, LKS Faculty of Medicine, The University of Hong Kong
Hong Kong
About this study
The goal of this study is to evaluate the effects of a theory-based community educational program among older adults in the community on atrial fibrillation (AF) knowledge. It will also learn about their competency to detect irregular pulses and compliance to regular pulse check. The main questions it aims to answer are:
Do older adults in the community who received the Health Belief Model-based educational program have higher AF awareness?
Read more
Researchers will compare the educational program with the control, who receive an information leaflet about AF to see the effect on improving AF awareness.
Participants will:
Receive a 5-week Health Belief Model-based educational program or receive an information leaflet about AF.
Be reassessed immediately post-intervention and 3 month afterwards. Keep a logbook on their compliance to the advice of regular pulse palpation to detect AF pulse .
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Health belief model-based community educational program, Control
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health belief model-based community educational programOther
The 5-week intervention includes two weekly 60-minute face-to-face sessions for 8-10 participants, two weekly telephone follow-ups, and a booster session.
Week 1: Focuses on increasing knowledge about atrial fibrillation (AF), its risks, complications, and treatment benefits. The principal investigator (PI) provides education using interactive methods and colored visuals.
Week 2: Emphasizes skill building for pulse palpation to detect irregular pulses. Participants learn through demonstrations and practice using a simulated arm.
Weeks 3-4:Telephone follow-ups monitor adherence to pulse checking and address barriers. Support and advice are provided by the PI.
Week 5: A booster session reinforces knowledge and skills with scenario-based practice and use of a simulated arm.
ControlOther
The control group will receive an information leaflet presenting information about AF, health risks and complications associated with AF, common methods to screen for AF, and follow-up actions if positive screening results are suspected.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention integrate behavioral modeling to promote knowledge and skill retention and uptake. The content of the education sessions is consistent with the clinical management guidelines published by the E Receives: Other: Health belief model-based community educational program |
| Control | Active comparator | The control group Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Fibrillation Knowledge Scale
Atrial Fibrillation Knowledge Scale (AFKS-C, Chinese version) is a validated tool that includes 11 items concerning AF knowledge in general (3 items), symptom recognition (3 items), and treatment (5 items). Respondents can choose 1 of 3 options as an answer to each item. Marks will be given for correct answers and no deduction for incorrect answers, and higher marks indicate a higher AF knowledge level. The content validity index of the AFKS-C was 0.94, and the Kuder-Richardson formula 20 value was 0.60, indicating acceptable psychometric properties.
Li, P. W. C., Yu, D. S. F., Yan, B. P., Hendriks, J. M., Wong, C. W. Y., \& Chan, B. S. (2021). Psychometric Validation of the Chinese Version of the Atrial Fibrillation Knowledge Scale in Chinese Patients With Atrial Fibrillation. The Journal of cardiovascular nursing, 38(1), 92-100. https://doi.org/10.1097/JCN.0000000000000881
Measured: From enrollment to the end of study at 3 months
Secondary outcomes (4)
Competency in differentiating regular and irregular pulses
Competency in differentiating regular and irregular pulses will be evaluated by a simulated arm. Participants will be instructed to perform radial pulse palpation on the simulated arm in order to differentiate regular and irregular pulses. A total of four scenarios, with two regular and two irregular pulses, will be set up and randomly presented to evaluate the competency of participants in differentiating the regularity of pulses.
Measured: From enrollment to the end of study at 3 months
Compliance to performing self-screening of pulses
Compliance to performing self-screening of pulses is measured by using a logbook. Participants will be instructed to perform twice-daily radial pulse palpation. The regularity and pulse rate will be documented in the logbook. The compliance to the advice of pulse palpation will be evaluated by the frequency of performing pulse palpation and the percentage of completion of the logbook.
Measured: From enrollment to the end of treatment at 3 months
Patient Health Questionanire-4 (PHQ-4)
Patient Health Questionanire-4 (PHQ-4)will be used for measuring anxiety and depression symptoms in the past 14 days. It has 4 items to be rated on a 4-point scale ranging from 0 to 3, with higher sum scores indicating greater psychological distress. The Chinese version of PHQ-4 have good composite reliability (McDonald Omega \> 0.8).
Fong, T. C. T., Ho, R. T. H., \& Yip, P. S. F. (2023). Psychometric properties of the Patient Health Questionnaire-4 among Hong Kong young adults in 2021: Associations with meaning in life and suicidal ideation. Frontiers in psychiatry, 14, 1138755. https://doi.org/10.3389/fpsyt.2023.1138755
Measured: From enrollment to the end of treatment at 3 months
EuroQol Five Dimensions Five Levels (EQ-5D-5L)
EuroQol Five Dimensions Five Levels (EQ-5D-5L) will be used to measure health-related quality of life (HRQoL). It consists of two parts: EQ-5D descriptive system and EQ visual analogue scale. The first part uses 5 levels to indicate a participant's health state on 5 dimensions - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression - and the second part is an additional self-rated health item rated on a visual analogue scale ranging from 0-100. The Chinese version of EQ-5D-5L was validated with Cronbach's alpha coefficient 0.78.
Cheung, P. W. H., Wong, C. K. H., Samartzis, D., Luk, K. D. K., Lam, C. L. K., Cheung, K. M. C., \& Cheung, J. P. Y. (2016). Psychometric validation of the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) in Chinese patients with adolescent idiopathic scoliosis. Scoliosis and spinal disorders, 11, 19. https://doi.org/10.1186/s13013-016-0083-x
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start12 Aug 2023
- Primary completion29 Nov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Kin Ho Hui, The University of Hong Kong
- Investigators
- Ryan Kin Ho HUI, Principal investigator, School of Nursing, LKS Faculty of Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582823
- Sponsor's protocol ID
- UW 23-344
- Status last verified
- Aug 2024
- First submitted
- 30 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Health Belief Model-Based Community Educational Program to Increase the Awareness of Atrial Fibrillation Among Older Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06582823
- Acronym / sponsor ID
- UW 23-344
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 12 Aug 2023 (actual)
- Primary completion
- 29 Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Sep 2024 (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 study is to evaluate the effects of a theory-based community educational program among older adults in the community on atrial fibrillation (AF) knowledge. It will also learn about their competency to detect irregular pulses and compliance to regular pulse check. The main questions it aims to answer are:
Do older adults in the community who received the Health Belief Model-based educational program have higher AF awareness?
Researchers will compare the educational program with the control, who receive an information leaflet about AF to see the effect on improving AF awareness.
Participants will:
Receive a 5-week Health Belief Model-based educational program or receive an information leaflet about AF.
Be reassessed immediately post-intervention and 3 month afterwards. Keep a logbook on their compliance to the advice of regular pulse palpation to detect AF pulse .
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Health belief model-based community educational programThe intervention integrate behavioral modeling to promote knowledge and skill retention and uptake. The content of the education sessions is consistent with the clinical management guidelines published by the E |
| Control | Active comparator | Other: ControlThe control group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- adults aged 65 or older
- without a confirmed diagnosis of AF
Key exclusion criteria (3 listed)
- cannot read Chinese
- with cognitive impairment (Abbreviated Mental Test ≤ 6)
- physical limitations in performing pulse palpation
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 |
|---|---|---|
| Health belief model-based community educational programThe 5-week intervention includes two weekly 60-minute face-to-face sessions for 8-10 participants, two weekly telephone follow-ups, and a booster session. Week 1: Focuses on increasing knowledge about atrial fibrillation (AF), its risks, complications, and treatment benefits. The principal investigator (PI) provides education using interactive methods and colored visuals. Week 2: Emphasizes skill building for pulse palpation to detect irregular pulses. Participants learn through demonstrations and practice using a simulated arm. Weeks 3-4:Telephone follow-ups monitor adherence to pulse checking and address barriers. Support and advice are provided by the PI. Week 5: A booster session reinforces knowledge and skills with scenario-based practice and use of a simulated arm. | Other | Intervention |
| ControlThe control group will receive an information leaflet presenting information about AF, health risks and complications associated with AF, common methods to screen for AF, and follow-up actions if positive screening results are suspected. | Other | Control |
Primary outcome
Atrial Fibrillation Knowledge Scale
Time frame: From enrollment to the end of study at 3 months
Atrial Fibrillation Knowledge Scale (AFKS-C, Chinese version) is a validated tool that includes 11 items concerning AF knowledge in general (3 items), symptom recognition (3 items), and treatment (5 items). Respondents can choose 1 of 3 options as an answer to each item. Marks will be given for correct answers and no deduction for incorrect answers, and higher marks indicate a higher AF knowledge level. The content validity index of the AFKS-C was 0.94, and the Kuder-Richardson formula 20 value was 0.60, indicating acceptable psychometric properties. Li, P. W. C., Yu, D. S. F., Yan, B. P., Hendriks, J. M., Wong, C. W. Y., \& Chan, B. S. (2021). Psychometric Validation of the Chinese Version of the Atrial Fibrillation Knowledge Scale in Chinese Patients With Atrial Fibrillation. The Journal of cardiovascular nursing, 38(1), 92-100. https://doi.org/10.1097/JCN.0000000000000881
4 secondary outcomes
Competency in differentiating regular and irregular pulses
Time frame: From enrollment to the end of study at 3 months
Compliance to performing self-screening of pulses
Time frame: From enrollment to the end of treatment at 3 months
Patient Health Questionanire-4 (PHQ-4)
Time frame: From enrollment to the end of treatment at 3 months
EuroQol Five Dimensions Five Levels (EQ-5D-5L)
Time frame: From enrollment to the end of treatment at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- 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.
Ryan Kin Ho HUI principal investigator
School of Nursing, LKS Faculty of Medicine, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health belief model-based community educational program in people with Atrial Fibrillation (AF), run by The University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Sep 2024. 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 Hong Kong. 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?
Results are not available in the source record.
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?
Atrial Fibrillation Knowledge Scale (time frame: From enrollment to the end of study at 3 months). 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 3 Sep 2024.