NCT04609202

Brief Summary

The aim of the study is to evaluate the effect of a person-centred nurse-led outpatient clinic on health related quality of life, for persons with AF. Secondary outcomes are effects on anxiety, depression, illness perception, symtom burden, life style and health economics.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

October 19, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2025

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

4.7 years

First QC Date

October 9, 2020

Last Update Submit

March 27, 2025

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationperson centred carehealth related quality of lifenurse led

Outcome Measures

Primary Outcomes (2)

  • Health related quality of life measured by EuroQol-5D (EQ-5D) questionnaire

    Change from baseline in health related quality of life, measured by EuroQol-5D (EQ-5D) questionnaire at six month and one year. EQ-5D measure Health related quality of life with scores (5 items) and a scale (0-100).

    Baseline, 6 month and 1 year

  • Arrhythmia related quality of life measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA)

    Change from baseline in arrhythmia related quality of life, measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA), at six month and one year. ASTA is a validated questionnaire with a 13-item arrhythmia related quality of life scale. The scores for the total scale range between 0 and 39, with higher scores reflecting more negative effects on HRQoL.

    Baseline, 6 month and 1 year

Secondary Outcomes (9)

  • Anxiety measured by Hospital Anxiety and Depression Scale (HADS)

    Baseline, 6 month and 1 year

  • Depression measured by Hospital Anxiety and Depression Scale (HADS)

    Baseline, 6 month and 1 year

  • Symptom burden measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA)

    Baseline, 6 month and 1 year

  • Lifestyle habits-smoking, measured by questionnaire,

    Baseline, 6 month and 1 year

  • Lifestyle habits-diet by questionnaire

    Baseline, 6 month and 1 year

  • +4 more secondary outcomes

Study Arms (2)

Nurse led person centred care

EXPERIMENTAL

Participants in the nurse led, person centred care arm will receive person centred follow up after hospitalization for atrial fibrillation. The person centred care and usual care routines are provided by nurses.

Behavioral: Nurse led person centred care

Usual care

ACTIVE COMPARATOR

Participants in the usual care arm will receive care as usual, ie follow up by doctors after hospitalization for atrial fibrillation.

Other: Usual care

Interventions

Nurse led person centred careBEHAVIORAL

Person centred care include patiens narratives, partnership and documentation of a health plan.

Nurse led person centred care
Usual careOTHER

Usual care provided by doctors

Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients aged \> 18 years with diagnosis of atrial fibrillation, referred for follow up after atrial fibrillation, able to provide informed consent and able and willing to fill in questionnaires.

You may not qualify if:

  • Atrial flutter diagnosis, Severe heart failure (corresponding to NYHA IIIB and NYHA IV), Cardiac surgery \< 3 month prior to hospitalization for atrial fibrillation, planned surgical procedures (catheter ablation, cardiac surgery), Atrial fibrillation in connection with acute coronary syndrome or infection, not able to fill in questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norrlands Universitetssjukhus

Umeå, Region Västerbotten, 90185, Sweden

Location

Related Publications (1)

  • Holmlund L, Hornsten C, Valham F, Olsson K, Hornsten A, Katsoularis I, Salonen L, Angerud KH. The effects of a nurse-led, person-centred outpatient clinic on patient-reported outcomes in patients with atrial fibrillation - a randomised controlled trial. Eur J Cardiovasc Nurs. 2026 Jan 29:zvag028. doi: 10.1093/eurjcn/zvag028. Online ahead of print.

    PMID: 41610156DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Karin H Ängerud

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 30, 2020

Study Start

October 19, 2020

Primary Completion

July 10, 2025

Study Completion

July 10, 2025

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)