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VCH -- vAFC Phase 3 (vAFC)

Primary Purpose

Atrial Fibrillation

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Atrial Fibrillation Clinic
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Cardiac, Telehealth, Older Adults

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Virtual Atrial Fibrillation Clinic

Arm Description

Control 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)

Participants 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
Alcohol consumption
Three questions determining whether participants drink alcohol, how often they drink alcohol, and how much alcohol they drink.
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.
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.
Waist Circumference
Waist circumference in centimeters recorded at the top of the Iliac crest.
Weight
Weight in kilograms or pounds. Used in the calculation of Body Mass Index.
Height
Height in meters or feet. Used in the calculation of Body Mass Index.
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.
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.
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.
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.
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

Full Information

First Posted
March 28, 2018
Last Updated
November 2, 2020
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), Interior Health
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1. Study Identification

Unique Protocol Identification Number
NCT03512483
Brief Title
VCH -- vAFC Phase 3
Acronym
vAFC
Official Title
The Virtual Atrial Fibrillation Clinic: Improving Specialty Care Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
COVID-19
Study Start Date
March 12, 2020 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), Interior Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Cardiac, Telehealth, Older Adults

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Control 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)
Arm Title
Virtual Atrial Fibrillation Clinic
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Atrial Fibrillation Clinic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Atrial Fibrillation Effect on Quality of Life (AFEQT)
Description
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.
Time Frame
baseline, 3 months and 6 months
Title
Change from baseline Atrial Fibrillation Knowledge
Description
Multiple choice survey with three response options, asking questions about atrial fibrillation, including questions regarding symptoms, treatment, medications, risk factors, and lifestyle.
Time Frame
baseline, 3 months and 6 months
Secondary Outcome Measure Information:
Title
Healthcare Utilization
Description
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.
Time Frame
baseline, 3 months and 6 months
Title
Perceived Stress
Description
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.
Time Frame
baseline, 3 months and 6 months
Title
Smoking behaviour
Description
Two questions determining whether the participant uses tobacco products, and if yes, how often in the past month they use those tobacco products.
Time Frame
baseline and 6 months
Title
Alcohol consumption
Description
Three questions determining whether participants drink alcohol, how often they drink alcohol, and how much alcohol they drink.
Time Frame
baseline and 6 months
Title
Nutrition
Description
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.
Time Frame
baseline and 6 months
Title
Physical Activity
Description
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.
Time Frame
baseline and 6 months
Title
Waist Circumference
Description
Waist circumference in centimeters recorded at the top of the Iliac crest.
Time Frame
baseline and 6 months
Title
Weight
Description
Weight in kilograms or pounds. Used in the calculation of Body Mass Index.
Time Frame
baseline and 6 months
Title
Height
Description
Height in meters or feet. Used in the calculation of Body Mass Index.
Time Frame
baseline and 6 months
Title
Bleeding Risk
Description
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.
Time Frame
baseline and 6 months
Title
Stroke Risk
Description
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.
Time Frame
baseline and 6 months
Title
Website Usage
Description
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.
Time Frame
baseline to 6 months
Title
Demographics and health history
Description
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.
Time Frame
baseline
Title
Patient satisfaction
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathy L Rush, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1V 1V7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

VCH -- vAFC Phase 3

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