Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000928516
Ethics application status
Approved
Date submitted
18/08/2015
Date registered
7/09/2015
Date last updated
27/02/2020
Date data sharing statement initially provided
27/02/2020
Date results information initially provided
27/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nurse-led atrial fibrillation management- the NEAT study.
Scientific title
For patients with atrial fibrillation, will a nurse-led clinic facilitated by the use of a guidelines-based EDS system and compared to standard treatment, improve lifestyle risk factors and health related quality of life.
Secondary ID [1] 286424 0
nil
Universal Trial Number (UTN)
Trial acronym
NEAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 294593 0
Condition category
Condition code
Cardiovascular 294893 294893 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is 3 months in duration for each study participant. There will be 2 face-to-face visits at the beginning and completion of the intervention, with 4 phone consultations in between. It is expected that the face-to-face visits will take approximately 30 minutes in duration.

The intervention is a nurse-led support package which contains the following components:

1. An electronic decision support (EDS) tool

A mobile enabled web app designed to facilitate a discussion between the nurse and study participant and to build an individual patient profile. The app will be used by the nurse to take the participant through potential risk factors, lifestyle factors and medication options. The profile is based on the their stroke risk (using the CHAD2S2-VASc score), their medication adherence (using Morisky medication adherence score) and their cardiovascular risk factors and lifestyle choices. The app will be used at baseline and at the 3 month face-to-face follow up visit.

2. Health counselling and goal setting

At the baseline visit, the nurse will provide education and the pathophysiology of AF, its symptoms and possible complications. The nurse will discuss rate and rhythm control as well as prophylactic vascular therapy (including strict anti-coagulation monitoring) and information about knowing when to report to hospital. Each study participant randomised to the intervention arm will also receive a booklet entitled “Living with Atrial Fibrillation”.

At the baseline visit the nurse will provide behaviour change support, through motivational interviewing principles (Miller & Rollnick, 2012) and use the EDS tool to facilitate the discussion about HR-QoL encouraging patients to set realistic goals in line with their priority and motivation.

3. Three-month telephone-based support and follow up

The study participant will receive regular telephone support (minimum of four phone calls in the intervention period) and the nurse will continue to provide psychosocial support and educational interventions as offered at the baseline visit. The length of each phone call will be recorded in the Case Report Form (CRF).

The final face-to-face visit (3 months after the baseline visit) will collect the same individual patient data as collected as baseline including but not limited to vital sign measures, quality of life measures, and medication adherence.
Intervention code [1] 291500 0
Lifestyle
Intervention code [2] 291501 0
Prevention
Intervention code [3] 292678 0
Treatment: Other
Comparator / control treatment
Standard care for their cardiovascular health, comprising in-patient treatment including diagnostic and interventional procedures, pharmacotherapy, and lifestyle counselling, as determined by their usual doctors.
Control group
Active

Outcomes
Primary outcome [1] 294649 0
- health related quality of life as measured by the SF-12 questionnaire.
Timepoint [1] 294649 0
- measured at baseline and at three months after randomisation
Secondary outcome [1] 313793 0
- Resting systolic blood pressure, using Microlife BP A200 Afib blood pressure monitor.
Timepoint [1] 313793 0
- measured 3 months after randomisation
Secondary outcome [2] 316952 0
Medication adherence - measured using the Morisky Medication Adherence Scale (MMAS).
Timepoint [2] 316952 0
- measured at baseline and at 3 months after randomisation.
Secondary outcome [3] 316953 0
Health literacy - measured using the Rapid Estimate of Adult Literacy in Medicine - short form (REALM- SF).
Timepoint [3] 316953 0
- measured at baseline and at three months after randomisation.
Secondary outcome [4] 316955 0
Cognition - measured using the Montreal Cognitive Assessment (MoCA).
Timepoint [4] 316955 0
- measured at baseline and at 3 months after randomisation.
Secondary outcome [5] 316956 0
Physical Activity level - measured using the Global Physical Activity Questionnaire (GPAC).
Timepoint [5] 316956 0
- measured at baseline and at 3 months after randomisation .
Secondary outcome [6] 316957 0
Alcohol consumption - measured using the Alcohol Use Disorders Identification Test (AUDIT).
Timepoint [6] 316957 0
- measured at baseline and at 3 months after randomisation.
Secondary outcome [7] 317158 0
Smoking status - self reported measure.
Timepoint [7] 317158 0
measured at baseline and at 3 months after randomisation.
Secondary outcome [8] 317159 0
Body Mass Index (BMI) assessed according to international standards by measuring weight on calibrated scales, and height with a stadiometer
Timepoint [8] 317159 0
- measured at baseline and at 3 months after randomisation.

Eligibility
Key inclusion criteria
Inclusion criteria are as follows:
- Participants must be over the age of 18 years,
- living independently,
- have a primary and secondary diagnosis of AF, confirmed by a 12-lead ECG.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Age < 30 years;
2) Home address outside the catchment area of the hospitals;
3) Inability to provide informed consent;
3) Absence of ECG documentation of AF during index presentation;
4) Patients with end stage heart failure (NYHA class IV, LVEF < 35%);
5) Cardiac surgery < 2 months prior to index presentation;
6) Terminal (life expectancy < 1 year and/or palliative care) and/or active malignancy (undergoing current chemo or radiotherapy; secondary diagnosis or via patient self-report; or via interrogation of notes after patient consent)
7) Documented thyrotoxicosis or acute pneumonia at the time of index presentation;
8) poor English literacy;
9) non-independent living.
10) End-stage renal dysfunction (Hx of dialysis; secondary diagnosis coding of renal failure or via patient self-report; or via interrogation of notes after patient consent)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants identified by medical physicians will be invited by the study team to attend a study visit. At the baseline visit participants will receive detailed information about the study and sign informed consent if willing to proceed. All consented participants will have the following information collected: review against inclusion/exclusion criteria, documented diagnosis of AF, relevant vital sign measures (heart rate, blood pressure) and cardiovascular risk factor measure (BMI, smoking status, alcohol consumption, physical activity level). All participants will be randomised via a central computer generated randomisation process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to either control or intervention group with a 1:1 allocation as per a computer generated randomisation schedule using permuted blocks of random sizes. The block sizes will not be disclosed, to ensure concealment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary analyses will be conducted using SPSS for Windows. Continuous variables will be reported as mean plus/minus standard deviation (SD), and categorical variables as numbers and percentages. Within subject differences between baseline and follow-up will be analysed using Wilcoxon signed ranks tests for non-parametric variables. Between group comparisons will be analysed using Student's t-test, the Mann Whitney U test (for non-normally distributed continuous data) and the chi-squared test (with calculation of odds ratios and 95% CIs) where appropriate. SF12 data will be analysed using software by OptumInsight.
Process evaluation interviews will be analysed using an inductive approach.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/08/2015
Actual
20/08/2015
Date of last participant enrolment
Anticipated
30/04/2017
Actual
29/06/2018
Date of last data collection
Anticipated
30/07/2017
Actual
28/12/2018
Sample size
Target
72
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 3613 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 3614 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 7034 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 10185 0
2050 - Camperdown
Recruitment postcode(s) [2] 10186 0
2139 - Concord Repatriation Hospital
Recruitment postcode(s) [3] 14766 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 290994 0
Charities/Societies/Foundations
Name [1] 290994 0
Vanguard Grant - Heart Foundation
Country [1] 290994 0
Australia
Funding source category [2] 295089 0
Commercial sector/Industry
Name [2] 295089 0
Bayer Australia
Country [2] 295089 0
Australia
Primary sponsor type
University
Name
Charles Perkins Centre, Sydney Nursing School, University of Sydney
Address
Building D17, Johns Hopkins Drive, University of Sydney,
Camperdown 2006 NSW
Country
Australia
Secondary sponsor category [1] 289674 0
None
Name [1] 289674 0
Address [1] 289674 0
Country [1] 289674 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293379 0
SLHD - Concord Repatriation General Hospital Ethics Committee
Ethics committee address [1] 293379 0
Hospital Rd, Concord NSW 2139
Ethics committee country [1] 293379 0
Australia
Date submitted for ethics approval [1] 293379 0
Approval date [1] 293379 0
11/06/2015
Ethics approval number [1] 293379 0
HREC/15/CRGH/57

Summary
Brief summary
The study is a single blind randomised controlled trial to determine whether a nurse-led clinic which uses a mobile enable web app (a computer program that also works on a smartphone or tablet) to guide discussion between the nurse and patient, can improve lifestyle risk factors and health related quality of life (HR-QoL) in participants with AF. The study aims to provide evidence of feasibility with the intention to seek funding for a larger study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56086 0
Prof Lis Neubeck
Address 56086 0
Room 4.B.29, Sighthill Campus,
Edinburgh Napier University
Sighthill Court, Sighthill
Edinburgh EH11 4BN
Country 56086 0
United Kingdom
Phone 56086 0
+44 7491 522 050
Fax 56086 0
Email 56086 0
[email protected]
Contact person for public queries
Name 56087 0
Prof Lis Neubeck
Address 56087 0
Room 4.B.29, Sighthill Campus,
Edinburgh Napier University
Sighthill Court, Sighthill
Edinburgh EH11 4BN
Country 56087 0
United Kingdom
Phone 56087 0
+44 7491 522 050
Fax 56087 0
Email 56087 0
[email protected]
Contact person for scientific queries
Name 56088 0
Prof Lis Neubeck
Address 56088 0
Room 4.B.29, Sighthill Campus,
Edinburgh Napier University
Sighthill Court, Sighthill
Edinburgh EH11 4BN
Country 56088 0
United Kingdom
Phone 56088 0
+44 7491 522 050
Fax 56088 0
Email 56088 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7123Study protocol  [email protected]
7124Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Gallagher C, Orchard J, Sanders P, et al. NursE le... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNursE led Atrial Fibrillation Management: The NEAT Study: A Randomized Controlled Trial.2020https://dx.doi.org/10.1097/JCN.0000000000000680
N.B. These documents automatically identified may not have been verified by the study sponsor.