None listed
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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.
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)