NCT06582823

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
390

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

1.3 years

First QC Date

August 30, 2024

Last Update Submit

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

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

Other: Health belief model-based community educational program

Control

ACTIVE COMPARATOR

The control group

Other: Control

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.

Intervention
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.

Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

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

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ryan Kin Ho HUI

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

    PRINCIPAL INVESTIGATOR

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

Locations