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Improving Atrial Fibrillation Specialty Care Delivery in Rural Communities (vAFC)

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ClinicalTrials.gov Identifier: NCT03512483
Recruitment Status : Not yet recruiting
First Posted : April 30, 2018
Last Update Posted : May 11, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Interior Health
Information provided by (Responsible Party):
Kathy Rush, University of British Columbia

Brief Summary:
This study evaluates a new model of specialty care for older adults in rural communities with Atrial Fibrillation (AF) compared to usual rural physician care. Half the participants will receive the new model of specialty care, the Virtual AF Clinic (vAFC), while the other half will receive usual care. The vAFC will combine usual care, telehealth appointments with AF specialized nurse practitioners/cardiologist, and an educational website. Participants will be recruited from rural physician offices and will be followed for 12 months collecting data at four time points on AF quality of life, AF knowledge, healthcare utilization (e.g., hospital/emergency department/physician visits), lifestyle behaviors (e.g., physical activity), and stroke/bleeding risk. This will generate evidence to determine the feasibility of scaling up the vAFC model to other sites.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Behavioral: Virtual Atrial Fibrillation Clinic Not Applicable

Detailed Description:

Chronic diseases and unhealthy behaviors are more prevalent in older adults in rural communities yet they have less access to healthcare, especially specialist care. This is problematic for the rising population of older adults with atrial fibrillation (AF) who have rapid disease progression, and increased risk of stroke, heart failure, and death. In rural communities with specialty care gaps, a virtually delivered AFC offers a viable cost effective option for older adults with AF compared to general practitioner (GP) care, given the complexity of AF patients with multiple co-morbidities and poor symptom control.

The purpose of phase 3 of this multi-phase study is to conduct a randomized controlled trial to test a newly developed virtual AF clinic in comparison to usual rural GP care.

Participants in the control group (usual care) will receive usual GP care in their rural communities. Usual care will include some combination of treatment, education, and support as per each GPs individual practice. Participants will also have contact with the research team during the four data collection time points (baseline, 3 months, 6 months, and 12 months).

Participants in the intervention group (vAFC) 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 up to a maximum of four scheduled telehealth appointments: an initial appointment following randomization, at 4-6 weeks, 3 months, and 6 months. Participants will attend appointments at their local hospital. Appointments will follow the usual protocol of the onsite AF clinic in Kelowna including, but not limited to, reviewing with patients their vital signs, tests (e.g., Echo, Holter, stress test), symptom management, concerns, and medications.

In addition to the telehealth appointments participants in the intervention group will also have access to an educational AF website. Following randomization participants will be given an orientation on how to access the website, its purpose, and a tour of the content. The website content is inclusive of topics specific to AF, such as; (1) What is AF, (2) Risk Factors, (3) Lifestyle, (4) Symptom Management, (5) Complications, (6) Frequently Asked Questions, and (7) Patient Stories. Content was developed and vetted by researchers and clinicians to ensure information is relevant, up to date, and evidence based. To promote and encourage website interaction, emails will be sent to participants once a month for the duration of the intervention with highlights and important messages from the website


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Virtual Atrial Fibrillation Clinic: Improving Specialty Care Delivery in Rural Communities
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care
Participants in the control arm will receive usual GP care in their rural communities. Usual care will include some combination of treatment, education, and support as per each GPs individual practice. Participants will also have contact with the research team during the four data collection time points (baseline, 3 months, 6 months, and 12 months).
Experimental: Virtual Atrial Fibrillation Clinic
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. Participants will attend appointments at their local hospital. Appointments will follow the usual protocol of the onsite AF clinic in Kelowna including, but not limited to, reviewing with patients their vials, tests (e.g., Echo, Holter, stress test), symptom management, concerns, and medications.
Behavioral: Virtual Atrial Fibrillation Clinic
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 Measures :
  1. Change from baseline Atrial Fibrillation Effect on Quality of Life (AFEQT) at 3, 6, and 12 months [ Time Frame: baseline, 3 months, 6 months, and 12 months ]
    A 7 point likert scale measuring how much their atrial fibrillation has bothered them over the past 4 weeks, where 1= "not at all" and 7 = "extremely". Subscales include symptoms, daily life, treatment concerns, and treatment satisfaction. Overall scores or subscale scores range from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered).

  2. Change from baseline Atrial Fibrillation Knowledge at 3, 6, and 12 months [ Time Frame: baseline, 3 months, 6 months, and 12 months ]
    Multiple choice survey with three response options, asking questions about atrial fibrillation, including questions regarding symptoms, heart structure, complications, lifestyle, medication, and treatment options


Secondary Outcome Measures :
  1. Healthcare Utilization [ Time Frame: every 3 months from baseline to 12 months ]
    Tracking sheet where participants are asked to record all health encounters related to their atrial fibrillation, who initiated the encounter, date, and result of encounter.

  2. Perceived Stress [ Time Frame: baseline, 3 months, 6 months, and 12 months ]
    A 14 questions 5 point likert scale measuring feelings and thoughts during the last month. In each case participants are asked to indicate how often they felt or thought a certain way. Total perceived stress ranges from 0 to 56. A total score of 0 corresponds to no perceived stress (responding "never" to all negative items and "very often" to all positive items). A total score of 56 corresponds to high perceived stress (responding "very often" to all negative items and "never" to all positive items

  3. Smoking behaviour [ Time Frame: baseline, 6 months, and 12 months ]
    Two questions determining whether the participant uses tobacco products, and if yes, how often in the past month they use those tobacco products

  4. Alcohol consumption [ Time Frame: baseline, 6 months, and 12 months ]
    Three questions determining whether participants drink alcohol, how often they drink alcohol, and how much alcohol they drink

  5. Nutrition [ Time Frame: baseline, 6 months, and 12 months ]
    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

  6. Physical Activity [ Time Frame: baseline, 6 months, and 12 months ]
    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

  7. Waist Circumference [ Time Frame: baseline and 12 months ]
    Waist circumference in centimeters recorded at the top of the Iliac crest.

  8. Weight [ Time Frame: baseline and 12 months ]
    Weight in kilograms or pounds. Used in the calculation of Body Mass Index

  9. Height [ Time Frame: baseline and 12 months ]
    Height in meters or feet. Used in the calculation of Body Mass Index

  10. Bleeding Risk [ Time Frame: baseline and 12 months ]
    HAS-BLED tool to assess bleeding risk includes 9 parameters with 1 point assigned to each parameter for a total score of 0-9; a score of 3 or greater indicates high risk of bleeding

  11. Stroke Risk [ Time Frame: baseline and 12 months ]
    CHADS2-VASc to assess risk of stroke includes 8 parameters assigned 1-2 points for a total score of 10; scores reflect need for anticoagulation

  12. Website Usage [ Time Frame: baseline to 12 months ]
    Using Google Tag Manager, participant website usage will include time spent on the website, number of visits, pages visited, videos watched, content downloaded, external links clicked, as well as dates and times of website visits.

  13. Telehealth Appointment Dates [ Time Frame: 1-4 appointments as deemed by the Nurse Practitioners/Cardiologist: 1-2 weeks, 4-6 weeks, 3 months, and 6 months ]
    GP notification of intervention allocation, the date of referral, dates of all vAFC appointments for the intervention group



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 65 years or older;
  • Patients with a diagnosis of atrial fibrillation confirmed through an ECG;
  • living in one of the three targeted communities;
  • 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:

  • unstable or poorly controlled comorbidities (e.g., hypertension, New York Heart Association class IV heart failure or required hospital admission within past 3 months, hyperthyroidism);
  • current or anticipated pacemaker, internal cardioverter defibrillator or cardio resynchronization therapy;
  • cardiac surgery within past 3 months;
  • cognitive impairment;
  • uncompensated hearing impairment;
  • have problems with memory and recall;
  • do not have fluency in English and without a family member who can assist with reading, understanding and completing the consent and survey documents;
  • unable to give own consent to participate in this study;
  • do not have access to a computer/tablet/laptop with reliable internet

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512483


Contacts
Contact: Kathy L Rush, PhD 250-807-9561 kathy.rush@ubc.ca
Contact: Lindsay Burton, MSc 250-8078652 lindsay.burton@ubc.ca

Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Interior Health
Investigators
Principal Investigator: Kathy L Rush, PhD University of British Columbia

Responsible Party: Kathy Rush, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT03512483     History of Changes
Other Study ID Numbers: H17-03540
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kathy Rush, University of British Columbia:
Atrial Fibrillation
Rural
Virtual
Older Adults

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes