MedTrace Logo

Efficacy of a Health Belief Model Based Intervention for Anticoagulation Adherence

NCT03864900 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-09-22

Study results available
· View outcomes & findings →

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.

Conditions

  • Anticoagulants

Interventions

BEHAVIORAL

The medication adherence intervention

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.

Sponsors & Collaborators

  • Taipei Medical University WanFang Hospital

    collaborator OTHER

  • Taipei Medical University Shuang Ho Hospital

    collaborator OTHER

  • National Taipei University of Nursing and Health Sciences

    lead OTHER

Principal Investigators

  • Tsae Jyy Wang, PhD · National Taipei University of Nursing and Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-13
Primary Completion
2017-04-20
Completion
2017-10-20

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03864900 on ClinicalTrials.gov