Effects of a Health Belief Model-Based Community Educational Program to Increase the Awareness of Atrial Fibrillation Among Older Adults: a Randomized Controlled Trial
NCT Number: NCT06582823
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation (AF)
Sponsor: The University of Hong Kong
Sex: ALL
Age: OLDER_ADULT
Enrollment: 390
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SCREENING
Start Date: 2023-08-12
Completion Date: 2024-12

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 .

Primary Outcome Measures: 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., \&amp; 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 Outcome Measures: 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., 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., 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 \&gt; 0.8).

Fong, T. C. T., Ho, R. T. H., \&amp; 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, 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., \&amp; 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, From enrollment to the end of treatment at 3 months