Effects of a Health Belief Model-Based Community Educational Program to Increase the Awareness of Atrial Fibrillation Among Older Adults: a Randomized Controlled Trial
1 other identifier
interventional
390
1 country
1
Brief 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. 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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 12, 2023
CompletedFirst Submitted
Initial submission to the registry
August 30, 2024
CompletedFirst Posted
Study publicly available on registry
September 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedSeptember 3, 2024
August 1, 2024
1.3 years
August 30, 2024
August 30, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
From enrollment to the end of study at 3 months
Secondary Outcomes (4)
Competency in differentiating regular and irregular pulses
From enrollment to the end of study at 3 months
Compliance to performing self-screening of pulses
From enrollment to the end of treatment at 3 months
Patient Health Questionanire-4 (PHQ-4)
From enrollment to the end of treatment at 3 months
EuroQol Five Dimensions Five Levels (EQ-5D-5L)
From enrollment to the end of treatment at 3 months
Study Arms (2)
Intervention
EXPERIMENTALThe 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 COMPARATORThe control group
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- adults aged 65 or older
- without a confirmed diagnosis of AF
You may not qualify if:
- cannot read Chinese
- with cognitive impairment (Abbreviated Mental Test ≤ 6)
- physical limitations in performing pulse palpation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Nursing, LKS Faculty of Medicine, The University of Hong Kong
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ryan Kin Ho HUI
School of Nursing, LKS Faculty of Medicine, The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor of Nursing Student
Study Record Dates
First Submitted
August 30, 2024
First Posted
September 3, 2024
Study Start
August 12, 2023
Primary Completion
November 29, 2024
Study Completion
December 1, 2024
Last Updated
September 3, 2024
Record last verified: 2024-08