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NCT Number: 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

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 .

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, LKS Faculty of Medicine, The University of Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults aged 65 or older
  • without a confirmed diagnosis of AF

Exclusion criteria

  • cannot read Chinese
  • with cognitive impairment (Abbreviated Mental Test ≤ 6)
  • physical limitations in performing pulse palpation

Treatment and study plan

Health belief model-based community educational program

Other

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.

Control

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Competency in differentiating regular and irregular pulses

    Time frame: From enrollment to the end of study at 3 months

    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.

  2. Compliance to performing self-screening of pulses

    Time frame: From enrollment to the end of treatment at 3 months

    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.

  3. Patient Health Questionanire-4 (PHQ-4)

    Time frame: From enrollment to the end of treatment at 3 months

    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

  4. EuroQol Five Dimensions Five Levels (EQ-5D-5L)

    Time frame: From enrollment to the end of treatment at 3 months

    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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 3, 2024
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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