None listed
Conditions
Brief summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia affecting one in four people in the adult population. AF is a major cause of admission to hospital and represents a major public health burden. AF is an independent risk factor for stroke, with a near five fold excess of stroke observed in patients with AF. It is of even greater concern that patients living with AF experience a range of physical and psychological symptoms which are distressing and impact negatively on their quality of life. In addition, those with AF have a high prevalence of known cardiovascular risk factors such as being physically inactive, overweight and having hypertension. Despite the evidence that cardiovascular risk factors are poorly controlled in patients with AF, they are typically not included in risk factor reduction programmes. Therefore, in this study, we aim to determine if a simple patient-centred, home-based risk factor management program can improve cardiovascular risk and quality of life in patients with clinically diagnosed AF. The study will be a pilot trial using a pre-post design with 3 month follow-up of clinical outcomes involving 20 people with AF. A mixed methods design comprising both quantitative and qualitative methods will be utilised. Study volunteers will have a baseline assessment and an initial in-person module selection and goal-setting session of approximately one hour. All participants will take part in a 3-month patient-centred intervention with tailored risk factor management and an individually tailored community-based exercise program. This program is based on health coaching and motivational interviewing principles and the extensive experience the researchers have with modular secondary prevention of cardiovascular disease and behaviour modification in high risk patients. Simultaneous, ongoing consultation with their general practitioner and specialist physician will be encouraged as part of standard medical care. Outcome assessments for all participants in the pilot study will be made at three months after baseline assessment.
Interventions
A pilot study is proposed with 20 participants, using a prepost design, to determine the format required for a risk
factor management program. Participants will receive a patient-centred intervention targeting individualised risk factor management of 3 months duration with 3 month followup, including a community-based physical activity program, in addition to standard medical care. The program is based on health coaching principles.
The patient-centred intervention targeting individualised ris
A pilot study is proposed with 20 participants, using a prepost design, to determine the format required for a risk factor management program. Participants will receive a patient-centred intervention targeting individualised risk factor management of 3 months duration with 3 month followup, including a community-based physical activity program, in addition to standard medical care. The program is based on health coaching principles. The patient-centred intervention targeting individualised risk factor management involves a 1 hour face-to-face goal setting meeting at baseline. Ongoing support is provided throughout the trial by regular telephone calls from the intervention nurse. Patients will receive a mean of 4 calls (for about 10-20 minutes each) throughout the 3 month intervention period, depending on need. Motivational interviewing techniques will be used. Motivational interviewing, as described by Miller and Rollnick, is a method that works on facilitating and engaging intrinsic motivation within the client in order to change behaviour. The approach is non-judgmental, non-confrontational and non-adversarial. The community-based physical activity program depends on what is available in a participant's local community, e.g. could be a walking group. The number of sessions involved will depend on the goals set by each individual participant, e.g. they may select to walk for 20 minutes 5 times per week. Standard medical care involves a consultations with a GP, cardiologist or consultant. This is not determined by the study, and participants will continue to be treated by their doctors. Strategies used to improve adherence to the intervention protocols include the validated Morisky self-report; community pharmacy dispensed history print-out; and INR time in therapeutic range.
Sponsors
Concord Repatriation General Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients will be eligible to participate if they have presented to hospital with atrial fibrillation within the previous six months.
Exclusion criteria
Exclusion criteria are: clinical diagnosis of uncompensated cardiac failure (Class III or IV); uncontrolled arrhythmia or angina; severe or symptomatic aortic stenosis; uncontrolled hypotension/hypertension; diagnosis of a severe coexisting medical condition that would prevent participation (eg, dementia, terminal illness).
Outcome results
None listed