Back to resultsPerson Centered Nurse Led Atrial Fibrillation Care
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Nurse led person centred care
Usual care
Sponsored by
About this trial
This is an interventional supportive care trial for Atrial Fibrillation focused on measuring atrial fibrillation, person centred care, health related quality of life, nurse led
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Norrlands UniversitetssjukhusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nurse led person centred care
Usual care
Arm Description
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.
Participants in the usual care arm will receive care as usual, ie follow up by doctors after hospitalization for atrial fibrillation.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04609202
Brief Title
Person Centered Nurse Led Atrial Fibrillation Care
Official Title
Measuring the Effect of Person Centered, Nurse Led Care on Health-related Quality of Life in Patients With Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
October 20, 2022 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, person centred care, health related quality of life, nurse led
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nurse led person centred care
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Participants in the usual care arm will receive care as usual, ie follow up by doctors after hospitalization for atrial fibrillation.
Intervention Type
Behavioral
Intervention Name(s)
Nurse led person centred care
Intervention Description
Person centred care include patiens narratives, partnership and documentation of a health plan.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care provided by doctors
Primary Outcome Measure Information:
Title
Health related quality of life measured by EuroQol-5D (EQ-5D) questionnaire
Description
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).
Time Frame
Baseline, 6 month and 1 year
Title
Arrhythmia related quality of life measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA)
Description
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.
Time Frame
Baseline, 6 month and 1 year
Secondary Outcome Measure Information:
Title
Anxiety measured by Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Baseline, 6 month and 1 year
Title
Depression measured by Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Baseline, 6 month and 1 year
Title
Symptom burden measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA)
Description
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.
Time Frame
Baseline, 6 month and 1 year
Title
Lifestyle habits-smoking, measured by questionnaire,
Description
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.
Time Frame
Baseline, 6 month and 1 year
Title
Lifestyle habits-diet by questionnaire
Description
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.
Time Frame
Baseline, 6 month and 1 year
Title
Lifestyle habits-physical activity by questionnaire
Description
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.
Time Frame
Baseline, 6 month and 1 year
Title
Lifestyle habits-alcohol use by questionnaire
Description
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.
Time Frame
Baseline, 6 month and 1 year
Title
Illness perception measured by Brief Illness Perception Questionnaire (B-IPQ)
Description
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.
Time Frame
Baseline, 6 month and 1 year
Title
Quality-adjusted life years,(QALYs) gathered with EuroQol-5D (EQ-5D) questionnaire.
Description
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.
Time Frame
Baseline to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karin H Ängerud, PhD
Phone
+46907869263
Email
karin.hellstrom.angerud@umu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Lena Holmlund, PhD student
Phone
+46907865198
Email
lena.holmlund@umu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin H Ängerud
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norrlands Universitetssjukhus
City
Umeå
State/Province
Region Västerbotten
ZIP/Postal Code
90185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin H Ängerud
Email
karin.hellstrom.angerud@regionvasterbotten.se
12. IPD Sharing Statement
Plan to Share IPD
No
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Person Centered Nurse Led Atrial Fibrillation Care
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