Clinical trial NCT03512483: VCH -- vAFC Phase 3
Official title: The Virtual Atrial Fibrillation Clinic: Improving Specialty Care Delivery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Cardiac
Telehealth
Older Adults
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Interior Health
First posted: 2018-04-30
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this third phase of a three-phase study is to pilot a virtual AF clinic (vAFC) compared to usual onsite care provided by a specialty AF clinic. Older adults with AF will be recruited and randomized into either the vAFC (videoconference appointments with specialists at the Vancouver AF clinic, supplemented with educational content on an AF website developed from phase one results) or the usual care group (onsite appointments with specialists at the Vancouver AF clinic). This pilot will generate evidence to determine the feasibility of scaling up the vAFC model to other sites.

Detailed description: Background: Specialty atrial fibrillation (AF) clinics have been shown to reduce AF-related hospitalizations, emergency department readmissions, and overall healthcare costs, while at the same time improving health behaviours and quality of life for patients. An AF clinic delivered virtually may offer a viable approach to remove barriers to accessing specialty care, but currently, no virtual AF models exist. However, virtual clinics that use new and emerging digital and communications technologies have been used in managing patients with a variety of chronic diseases: inflammatory bowel disease, diabetes, kidney disease, ophthalmology problems, and for post-operative follow-up (e.g., orthopedic surgery). They have been found to facilitate rapid referral, improve communication with providers, improve clinical indicators, improve self-efficacy, and achieve knowledge comparable to usual care. Purpose: The primary purpose of phase 3 of the project is to implement and evaluate an alternative model of care, a Virtual AF Clinic (vAFC) to referred patients with AF living in communities outside the Greater Vancouver area.

Methodology:

Design: We will test two modes of AF care: 1) virtual AF care (intervention group) and 2) in person AF clinic care (control group). The intervention group will receive the vAFC. The vAFC will include up to four scheduled encounters with the NPs/cardiologist: an initial encounter following baseline work-up (e.g., Holter, echo) and at 4 to 6 weeks, 3 months, and 6 months. For the duration of the intervention, the vAFC group will also receive access to a website with specific AF educational content and resources. The control group will receive usual onsite AF care provided by the Vancouver AF clinic. Recruitment: A total of 60-80 patients with AF, 30-40 allocated to each group, will be recruited from the Vancouver AF clinic. This sample size is consistent with recommendations for pilot/feasibility studies. AF clinic staff will identify eligible patients, and will send them a "letter of initial contact" letter. Patients will contact or be contacted by the research team who will provide additional study details, answer questions, conduct screening for eligibility, and obtain consent. Data Collection: Intervention and control groups will complete the same repeated measures during the study period. Demographics will be obtained at baseline. The primary outcomes: AF

Knowledge and AF Quality of Life, and secondary outcomes:

Healthcare Utilization, and Perceived Stress, will be obtained at three time points: baseline (t1) (following consent, prior to randomization), 3 months (t2), and 6 months (t3).The secondary outcomes: Lifestyle Behaviors, Physical Activity, and Patient Satisfaction will be obtained at t1 and t3. Questionnaire data will be collected using the online survey program Qualtrics. Each participant will be assigned a unique identifier code and emailed a link to the survey and consent form once they have completed eligibility screening. Patient health history, stroke risk, bleeding risk, and medications will be extracted from the consult letter sent to the AF clinic during patient referral. Website usage will be measured for each participant using Google Analytics. Following the study, approximately eight participants from each study arm will be invited to participate in an hour-long interview. Data Analysis: The focus of the pilot will be on effect sizes, as a

guide for determining the number of cases required for a full- scale study and the feasibility for such a study. The data will be

evaluated both graphically and statistically, with an emphasis on the effect sizes of the changes across time and on the effect sizes for the group differences.

Eligibility criteria: Inclusion Criteria:

* 65 years or older;
* Patients with a diagnosis of atrial fibrillation confirmed through an ECG;
* first time patient at the AF Vancouver clinic;
* live outside Vancouver city;
* have no problems with memory and recall;
* will be English speaking or have a family member who can assist with reading, understanding and completing the consent and survey documents;
* able to give own consent to participate in this study;
* have access to a computer/tablet/laptop with reliable internet;
* participate voluntarily and freely.

Exclusion Criteria:

* if the participant seems like a poor candidate for virtual care based on the discretion of the AF clinic staff;
* cognitive impairment;
* uncompensated hearing impairment.

Primary outcomes:
measure: Change from baseline Atrial Fibrillation Effect on Quality of Life (AFEQT)
timeFrame: baseline, 3 months and 6 months
measure: Change from baseline Atrial Fibrillation Knowledge
timeFrame: baseline, 3 months and 6 months
Secondary outcomes:
measure: Healthcare Utilization
timeFrame: baseline, 3 months and 6 months
measure: Perceived Stress
timeFrame: baseline, 3 months and 6 months
measure: Smoking behaviour
timeFrame: baseline and 6 months
measure: Alcohol consumption
timeFrame: baseline and 6 months
measure: Nutrition
timeFrame: baseline and 6 months
measure: Physical Activity
timeFrame: baseline and 6 months
measure: Waist Circumference
timeFrame: baseline and 6 months
measure: Weight
timeFrame: baseline and 6 months
measure: Height
timeFrame: baseline and 6 months
measure: Bleeding Risk
timeFrame: baseline and 6 months
measure: Stroke Risk
timeFrame: baseline and 6 months
measure: Website Usage
timeFrame: baseline to 6 months
measure: Demographics and health history
timeFrame: baseline
measure: Patient satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Kathy L Rush, PhD
role: PRINCIPAL_INVESTIGATOR
References: