CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
The medication adherence interventionbehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03864900
NCT03864900N/ACompleted

Efficacy of a Health Belief Model Based Intervention for Anticoagulation Adherence in Patients With Atrial Fibrillation: A Randomized Controlled Trial

National Taipei University of Nursing and Health Sciences·interventional·Posted Mar 6, 2019·Updated Sep 22, 2021

In Brief

A clinical study evaluating The medication adherence intervention for Anticoagulants. Completed, enrolled 72 participants across 2 sites.

Detailed Summary

Inconsistent anticoagulation therapy in AF patients is associated with a higher risk of stroke and abnormal bleeding. The purpose of the study is to investigate the efficacy of a health belief model based self-management of oral anticoagulant therapy intervention on the outcome of medication adherence and the mediators of knowledge, professional support, health belief, and self-efficacy in patients treated with oral anticoagulants for atrial fibrillation. A randomized clinical trial with repeated measurements was conducted. A convenient sample of 110 adults who were treated with anticoagulants for atrial fibrillation was recruited from two teaching hospitals in northern Taiwan. Participants were randomly assigned 1:1 to either the control group (n = 36) or the intervention group (n = 36) after completion of baseline questionnaires. Patients in the experimental group received the health belief model based anticoagulation adherence intervention, including one 60-minute individual instructions and six 15-minute telephone follow-ups. Participants in the control group received regular medication education, 10-minute individual instruction for health knowledge and six follow-up telephone calls for concerning health. Patients in both groups answered the study questionnaires at three and six months. The generalized estimating equations were used to analyze the efficacy of the intervention for enhancing knowledge, knowledge, perceived benefits, perceived barriers, self-efficacy, and adherence to anticoagulant therapies in patients treated with oral anticoagulants for atrial fibrillation. The results of the study will contribute to the knowledge for improving adherence to oral anticoagulation therapies in patients with atrial fibrillation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnticoagulants
CountriesTaiwan

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 6, 2019
Enrollment StartOct 13, 2015
Primary CompletionApr 20, 2017
Study CompletionOct 20, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.3 years ago

Interventions

The medication adherence interventionbehavioral

The health belief model based medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls.