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Atrial FibrillationvAFCNCT03512483

VCH -- vAFC Phase 3

A study testing Virtual Atrial Fibrillation Clinic in people with Atrial Fibrillation, run by University of British Columbia at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Virtual Atrial Fibrillation Clinic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
12 Mar 2020to Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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;
Show all 9Show fewer
  • able to give own consent to participate in this study;
  • have access to a computer/tablet/laptop with reliable internet;
  • participate voluntarily and freely.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of British Columbia

    Kelowna, British Columbia, V1V 1V7

Other trials in Canada

About this study

Official title: The Virtual Atrial Fibrillation Clinic: Improving Specialty Care Delivery

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.

Read the 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.

Being tested
Virtual Atrial Fibrillation Clinic
Keywords
Atrial Fibrillation, Cardiac, Telehealth, Older Adults
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Atrial Fibrillation ClinicBehavioural

    Participants in the intervention group will receive usual GP care plus the vAFC which consists of telehealth appointments with Nurse Practitioner/Cardiologist and access to an AF specific educational website. It is anticipated the vAFC, as with the onsite clinic, will include a maximum of four scheduled telehealth appointments: an initial appointment following randomization, at 4-6 weeks, 3 months, and 6 months.

Study groups in NCT03512483
Study groupRoleWhat they receive
Usual CareNo interventionControl group participants will be notified of their assignment and will continue their usual care with the AF clinic receiving onsite care. Participants will be contacted at 3 time points (baseline, 3 months, and 6 months)
Virtual Atrial Fibrillation ClinicExperimentalParticipants in the intervention group can expect to receive between 1 and 4 telehealth appointments over a 6 month period, as well as being contacted by the research team at 3 time points for data collection (baseline, 3 months, and 6 months). Telehealth appointments will consist of remote interactions with clinicians. Telehealth appointments will take place in participants' homes, using their personal computer/tablet/smartphone. Participants will also receive an orientation to the website and will be encouraged to visit often and utilize the resources. To promote and encourage website interaction, emails will be sent to participants once semi-monthly for the duration of the intervention with highlights and important messages from the website.
Receives: Behavioral: Virtual Atrial Fibrillation Clinic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline Atrial Fibrillation Effect on Quality of Life (AFEQT)

    Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire (AFEQT), a 20 item, 7-point scale, with four domains: Symptoms, Daily Activities, Treatment Concerns, and Satisfaction.

    Measured: baseline, 3 months and 6 months

  2. Change from baseline Atrial Fibrillation Knowledge

    Multiple choice survey with three response options, asking questions about atrial fibrillation, including questions regarding symptoms, treatment, medications, risk factors, and lifestyle.

    Measured: baseline, 3 months and 6 months

Secondary outcomes (14)
  1. Healthcare Utilization

    patient documentation of all health encounters related to their atrial fibrillation, who initiated the encounter, date, and result of encounter, as well as any indirect costs.

    Measured: baseline, 3 months and 6 months

  2. Perceived Stress

    The Perceived Stress Scale (PSS-14), a 14-item, 5-point scale, will measure the degree to which situations in ones life are considered stressful, ability to control aspects of life, confidence in handling problems, or being unable to cope with demands.

    Measured: baseline, 3 months and 6 months

  3. Smoking behaviour

    Two questions determining whether the participant uses tobacco products, and if yes, how often in the past month they use those tobacco products.

    Measured: baseline and 6 months

  4. Alcohol consumption

    Three questions determining whether participants drink alcohol, how often they drink alcohol, and how much alcohol they drink.

    Measured: baseline and 6 months

  5. Nutrition

    Five questions determining in a "typical week" how many days participants eat fruit and vegetables, how many servings of fruit and vegetables they eat, and what type of fat or oil is used in food preparation.

    Measured: baseline and 6 months

  6. Physical Activity

    Phone Frequency Intensity Time Type (FITT) Questionnaire - measuring often, how long, how out of breath, and what kinds of physical activity have been performed in a typical week.

    Measured: baseline and 6 months

  7. Waist Circumference

    Waist circumference in centimeters recorded at the top of the Iliac crest.

    Measured: baseline and 6 months

  8. Weight

    Weight in kilograms or pounds. Used in the calculation of Body Mass Index.

    Measured: baseline and 6 months

  9. Height

    Height in meters or feet. Used in the calculation of Body Mass Index.

    Measured: baseline and 6 months

  10. Bleeding Risk

    HAS-BLED tool to assess bleeding risk includes 7 risk factors, and a score equal to or greater than 3 indicates high risk of bleeding.

    Measured: baseline and 6 months

  11. Stroke Risk

    CHA2DS2-VASc to assess risk of stroke includes 8 parameters assigned 1-2 points for a total score of 10; scores reflect need for anticoagulation.

    Measured: baseline and 6 months

  12. Website Usage

    Using Google Analytics, participant website usage will include time spent on the website, number of visits, pages visited, page scroll depth, videos watched, content downloaded, external links clicked, as well as dates and times of website visits.

    Measured: baseline to 6 months

  13. Demographics and health history

    Patient demographics and health history including Age, sex, date of AF diagnosis, treatments since diagnosis, AF type, cardiac risk factors, co-morbidities, medication profile and history.

    Measured: baseline

  14. Patient satisfaction

    A modified version of the EUPS-AF will collect patient access to information; ease of health care, general assessment of healthcare provision, use of prescription medications, and relationship with care providers

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2018
  2. Study start12 Mar 2020 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionJun 2022 (estimated)

Why it stopped: COVID-19

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03512483
Sponsor's protocol ID
H19-03601
Acronym
vAFC
Status last verified
Nov 2020
First submitted
28 Mar 2018
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Atrial Fibrillation Clinic in people with Atrial Fibrillation, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Atrial Fibrillation Effect on Quality of Life (AFEQT) (time frame: baseline, 3 months and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.

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