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

NCT03924739 | Completed

• 1 other identifier: RGC14604418
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief 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

Atrial Fibrillation

Keywords

Atrial fibrillation; Self-care; Model of care; Nurse-led; Disease management; Empowerment

Outcome Measures

Primary Outcomes (1)

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

  The 20-item AFEQT measures disease-specific HRQoL in AF patients using 4 subscales: symptoms, daily activities, treatment concerns, and treatment satisfaction. All subscales are rated on a 7-point Likert scale, with higher scores indicating a poorer HRQoL.

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

Secondary Outcomes (4)

• Use of oral anticoagulants

  At 6 months (follow up)

• Morisky, Green and Levine Adherence Scale (MGLS)

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

• Hospital Anxiety and Depression Scale (HADS)

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

• Decision concordance on oral anticoagulant between patients and physicians

  At 6 months (follow up)

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in the intervention group will participate in a 13-week, nurse-coordinated integrated care model.

Behavioral: Nurse-coordinated integrated care model for AF

Control group

NO INTERVENTION

The control group will receive the conventional care provided by the study hospital.

Interventions

Nurse-coordinated integrated care model for AF BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The School of Nursing

Hong Kong, Hong Kong

Location

Related Publications (2)

• Li PWC, Yu DSF, Yan BP. Nurse-led multi-component behavioural activation programme to improve health outcomes in patients with atrial fibrillation: a mixed-methods study and feasibility analysis. Eur J Cardiovasc Nurs. 2023 Sep 5;22(6):655-663. doi: 10.1093/eurjcn/zvac104.

  PMID: 36394495 DERIVED

• Li PWC, Yu DSF, Yan BBY. A nurse-coordinated integrated care model to support decision-making and self-care in patients with atrial fibrillation: A study protocol. J Adv Nurs. 2019 Dec;75(12):3749-3757. doi: 10.1111/jan.14164. Epub 2019 Aug 27.

  PMID: 31350778 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Empowerment

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Study Officials

• Polly Li, Dr

  The University of Hong Kong, School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 23, 2019
• Study Start: July 3, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)