CompletedNot Applicable

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

Hong Kong392 participantsStarted 2018-07-03

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age ≥65 years * community-dwelling * confirmed diagnosis of AF * a CHA2DS2-VASc score of ≥1 in men and ≥2 in women * no use of OAC therapy Exclusion Criteria: * impaired communication or cognitive abilities (i.e., an Abbreviated Mental Test score ≤6) * or severe co-existing medical conditions (e.g., terminal illness) that would hinder participation in research activities

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire

Timeframe: Change from Baseline AFEQT at the 13th week (after the intervention) and 6 months (follow up)

Trial details

NCT IDNCT03924739

SponsorThe University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Atrial Fibrillation trials