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A Nurse-coordinated Integrated Care Model for Patients With Atrial Fibrillation

NCT03924739 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2023-06-18

No results posted yet for this study

Summary

This study aims to evaluate the effects of a nurse-coordinated, empowerment-based integrated care model on self-care behaviors and psychosocial outcomes in patients with atrial fibrillation (AF), and to explore how this intervention affects the self-care behaviors and quality of life from the patients' perspective.

Stroke prevention by oral anticoagulants (OAC) and control of arrhythmia and risk factors remain the cornerstones of AF management. However, under-prescription, non-adherence to treatment, and suboptimal anticoagulation control limit the efficacy of OACs. The poor abilities of patients regarding the self-control of arrhythmia and risk factors further contributes to worse outcomes. According to the World Health Organization, the best approach to chronic disease management involves the empowerment of patients to become active self-care agents. The literature indicates that a multifaceted, nurse-coordinated care model integrating all important care components with an empowerment approach could most effectively and actively engage patients in self-care.

This mixed-methods study comprises a randomized controlled trial and an exploratory qualitative study. A total of 392 community-dwelling patients aged ≥65 years with a confirmed diagnosis of AF, a high stroke risk, and no OAC treatment will be recruited from the medical outpatient clinics of a university-affiliated teaching hospital. The patients will be randomly allocated to intervention or control groups, which will receive treatment via the nurse-coordinated integrated care model or standard care, respectively. We hypothesize that compared to patients receiving standard care, AF patients exposed to the nurse-coordinated care model will be more likely to achieve compatible patient and physician decisions regarding the use of OAC, as well as better changes in medication adherence, anxiety, depression and health-related quality of life both immediately and 6 months post intervention.

This study will uniquely adopt an empowerment-based approach to equip patients as active agents in AF management through a nurse-coordinated integrated care model that comprehensively addresses their needs. The findings will advance our knowledge of patients' self-care behaviors in the context of AF and will provide a new model of care to improve health outcomes in this population.

Conditions

Interventions

BEHAVIORAL

Nurse-coordinated integrated care model for AF

Participants in the intervention group will participate in a 13-week, nurse-coordinated integrated care model comprising the following care components intended to comprehensively address the needs of AF patients: 1) a risk profile assessment and shared decision-making regarding OAC use; 2) an empowerment-based educational module on AF self-care; 3) nurse-initiated telephone support; and 4) patient-initiated contact for professional advice.

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Polly Li, Dr · The University of Hong Kong, School of Nursing

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-03
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

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 NCT03924739 on ClinicalTrials.gov