Atrial FibrillationNCT04609202
Person Centered Nurse Led Atrial Fibrillation Care
A study testing Nurse led person centred care in people with Atrial Fibrillation, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Nurse led person centred care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 19 Oct 2020to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring the Effect of Person Centered, Nurse Led Care on Health-related Quality of Life in Patients With Atrial Fibrillation
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.
Read the detailed description
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.
We plan a randomized controlled trial comparing person centred nurse led care vs. standard care. A sample size of 100 persons per group will be recruited.
Data will be collected through questionnaires, medical records, interviews.
- Conditions
- Atrial Fibrillation
- Being tested
- Nurse led person centred care, Usual care
- Keywords
- atrial fibrillation, person centred care, health related quality of life, nurse led
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse led person centred careBehavioural
Person centred care include patiens narratives, partnership and documentation of a health plan.
Usual careOther
Usual care provided by doctors
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline, 6 month and 1 year
Secondary outcomes (9)
Anxiety measured by Hospital Anxiety and Depression Scale (HADS)
Change from baseline in anxiety, measured by Hospital Anxiety and Depression Scale (HADS) at six month and one year. HADS-anxiety ranges from 0 to 21; higher scores indicate higher anxiety complains.
Measured: Baseline, 6 month and 1 year
Depression measured by Hospital Anxiety and Depression Scale (HADS)
Change from baseline in depression, measured by Hospital Anxiety and Depression Scale (HADS), at six month and one year. HADS-depression ranges from 0 to 21; higher scores indicate higher depression complains.
Measured: Baseline, 6 month and 1 year
Symptom burden measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA)
Change from baseline in symptom burden, measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA), at six month and one year. ASTA is a validated questionnaire with a 9-item symptom scale, each with a score of 0-4, The scores for the total scale range between 0 and 27, with higher scores reflecting higher symptom burden.
Measured: Baseline, 6 month and 1 year
Lifestyle habits-smoking, measured by questionnaire,
Change from baseline in lifestyle habits-smoking, measured by questionnaire (developed by The Swedish National Board of Health and Welfare), whether the patient is non smoker, prior smoker or current smoker (self-report), at six month and one year.
Measured: Baseline, 6 month and 1 year
Lifestyle habits-diet by questionnaire
Change from baseline in lifestyle habits-diet, measured by a questionnaire (developed by The Swedish National Board of Health and Welfare) with 5 items about eating habits, at six month and one year.
Measured: Baseline, 6 month and 1 year
Lifestyle habits-physical activity by questionnaire
Change from baseline in lifestyle habits-physical activity, measured by a questionnaire (developed by The Swedish National Board of Health and Welfare) with 2 items about physical activity habits, at six month and one year.
Measured: Baseline, 6 month and 1 year
Lifestyle habits-alcohol use by questionnaire
Change from baseline in lifestyle habits-alcohol use, measured by a questionnaire (developed by The Swedish National Board of Health and Welfare) with 3 items about alcohol use, at six month and one year.
Measured: Baseline, 6 month and 1 year
Illness perception measured by Brief Illness Perception Questionnaire (B-IPQ)
Change from baseline in illness perception, measured by Brief Illness Perception Questionnaire (B-IPQ) at six month and one year. B-IPQ measures illness perception and is a 9-item validated questionnaire. 8 items are scored 0-10, the 9th item is a question of cause and answering in text.
Measured: Baseline, 6 month and 1 year
Quality-adjusted life years,(QALYs) gathered with EuroQol-5D (EQ-5D) questionnaire.
Change from baseline in quality-adjusted life years (QALYs) at one year. The EuroQoL-5D-3L (EQ-5D) will be used for the quality of life dimension, while the time elapsed between each EQ-5D measurement will be considered for the time dimension.
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start19 Oct 2020
- Primary completion10 Jul 2025 (estimated)
- Study completion10 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karin H Ängerud, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609202
- Sponsor's protocol ID
- Flimmerstudie2020
- Status last verified
- Mar 2025
- First submitted
- 9 Oct 2020
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 randomized controlled trial. Eur J Cardiovasc Nurs. 2026 Jul 28;25(5):954-964. doi: 10.1093/eurjcn/zvag028.
PubMed 41610156
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effect of Person Centered, Nurse Led Care on Health-related Quality of Life in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04609202
- Acronym / sponsor ID
- Flimmerstudie2020
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, person centred care, health related quality of life, nurse led
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 10 Jul 2025 (estimated)
- Study completion
- 10 Jul 2025 (estimated)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
We plan a randomized controlled trial comparing person centred nurse led care vs. standard care. A sample size of 100 persons per group will be recruited.
Data will be collected through questionnaires, medical records, interviews.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse led person centred care | Experimental | Behavioral: Nurse led person centred careParticipants 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. |
| Usual care | Active comparator | Other: Usual careParticipants in the usual care arm will receive care as usual, ie follow up by doctors after hospitalization for atrial fibrillation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse led person centred carePerson centred care include patiens narratives, partnership and documentation of a health plan. | Behavioural | Nurse led person centred care |
| Usual careUsual care provided by doctors | Other | Usual care |
Primary outcome
Health related quality of life measured by EuroQol-5D (EQ-5D) questionnaire
Time frame: Baseline, 6 month and 1 year
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).
Arrhythmia related quality of life measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA)
Time frame: Baseline, 6 month and 1 year
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.
9 secondary outcomes
Anxiety measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 6 month and 1 year
Depression measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 6 month and 1 year
Symptom burden measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA)
Time frame: Baseline, 6 month and 1 year
Lifestyle habits-smoking, measured by questionnaire,
Time frame: Baseline, 6 month and 1 year
Lifestyle habits-diet by questionnaire
Time frame: Baseline, 6 month and 1 year
Lifestyle habits-physical activity by questionnaire
Time frame: Baseline, 6 month and 1 year
Lifestyle habits-alcohol use by questionnaire
Time frame: Baseline, 6 month and 1 year
Illness perception measured by Brief Illness Perception Questionnaire (B-IPQ)
Time frame: Baseline, 6 month and 1 year
Quality-adjusted life years,(QALYs) gathered with EuroQol-5D (EQ-5D) questionnaire.
Time frame: Baseline to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 41610156Holmlund 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 randomized controlled trial. Eur J Cardiovasc Nurs. 2026 Jul 28;25(5):954-964. doi: 10.1093/eurjcn/zvag028.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin H Ängerud principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse led person centred care in people with Atrial Fibrillation, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life measured by EuroQol-5D (EQ-5D) questionnaire (time frame: Baseline, 6 month and 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04609202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.