VCH -- vAFC Phase 3

NCT03512483 | Withdrawn

• 1 other identifier: H19-03601
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Cardiac; Telehealth; Older Adults

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline, 3 months and 6 months

• 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.

  baseline, 3 months and 6 months

Secondary Outcomes (14)

• Healthcare Utilization

  baseline, 3 months and 6 months

• Perceived Stress

  baseline, 3 months and 6 months

• Smoking behaviour

  baseline and 6 months

• Alcohol consumption

  baseline and 6 months

• Nutrition

  baseline and 6 months

Study Arms (2)

Usual Care

NO INTERVENTION

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)

Virtual Atrial Fibrillation Clinic

EXPERIMENTAL

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.

Behavioral: Virtual Atrial Fibrillation Clinic

Interventions

Virtual Atrial Fibrillation Clinic BEHAVIORAL

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.

Virtual Atrial Fibrillation Clinic

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Interior Health: collaborator

Study Sites (1)

University of British Columbia

Kelowna, British Columbia, V1V 1V7, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathy L Rush, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 30, 2018
• Study Start: March 12, 2020
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

CA (1)