The Healing Circles Project

Delivery of Self-management Through a Peer-support Telehealth Intervention in Patients With Cardiovascular Disease: The Healing Circles Project

Heart disease is a leading cause of death and disability in Canada. Providing social and peer supports has been proven to help patients manage their health and stay out of the hospital. The use of telehealth has opened up a wider possibility of patients receiving peer support while staying in their homes and communities. The investigators plan to study a new application for supporting patients through peer support. The application can be accessed by smartphone, tablet and desktop/laptop computer. Over two years, the investigators anticipate that the application (Healing Circles) will improve patient self care and reduce hospitalizations.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases; Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Healing Circles

Detailed Description

Cardiovascular disease (CVD) is a leading cause of death and disability in Canada costing $22.2 billion annually in health care costs and lost productivity. Cardiovascular diseases are complex conditions that afflict older adults more so than any other population. As CVD is a chronic condition, many patients live with their disease and are affected by it on a daily basis in their homes and communities. Unfortunately, many patients 'suffer' in isolation. It is well-accepted that patient self-management plays a key role in improving patient health and reducing hospital admissions. Social and peer support, as well as timely access to credible information on managing CVD are essential for patient self-management.

While there is a growing understanding that patients with CVD benefit from being actively engaged in their own care, questions remain as to where and how self management support should be delivered. Integration of self-management programs within the health care system has been a challenge due to the system emphasis on the management of acute and episodic conditions rather than the less intense and more drawn-out patient interactions characteristic of chronic conditions. Clearly alternatives are needed to support patient self-management and reduce needless hospital admissions.

The rise in technology and telecommunications has opened up an array of possibilities for patients to be connected to their health while remaining in their homes and community. Outside of the health care sector, peer support and social networking have seen tremendous growth through the use of telecommunications. The value of these networks to improving health and self-management, however, has not been robustly studied.

Through an existing partnership between university-based researchers, industry (Curatio), decision-makers (Vancouver Coastal Health), clinicians and patients the investigators have developed a peer support and self-management platform called Healing Circles. The investigator's 10-week pilot study of Healing Circles in patients with ischemic heart disease demonstrated the feasibility and acceptability, and resulted in key improvements to social support and self-management, as well as demonstrated ease of use of the application itself. The current proposal represents the next phase in our program to scale-up and spread the use of Healing Circles.

The primary hypothesis is that patients with CVD using the Healing Circles platform will have improved self-management skills compared to patients receiving usual care. Secondary hypotheses are that participation in Healing Circles application will improve quality of life and health service use (and associated costs). Outcomes of end-user perceptions, attitudes and satisfaction with the platform will also be assessed.

Participants (n=250) will be recruited through cardiology and cardiac outpatient clinics in Greater Vancouver, as well as through community presentations and mailouts. Patients with documented CVD, who have regular access to a device that supports Healing Circles (computer, tablet or smartphone) will be randomized to either the Healing Circles application or usual care and followed for up to a 2.5 year period.

Healing Circles participants will form 'Circles' with 8 to 10 other participants to connect with and support one another as they learn to live day-to-day with their CVD. Patients also have the ability to connect and engage all members of the wider Healing Circles community. The investigators anticipate that participation in Healing Circles will support patient self-management for patients in their homes resulting in reduced need for health care and hospital use.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Scott Lear, PhD; Phone Number: 604-682-2344 ext. 62278; Email: slear@providencehealth.bc.ca
• Study Contact Backup: Name: Rochelle Nocos; Phone Number: 604-806-8242; Email: rochelle_nocos@sfu.ca

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada
      • Recruiting
      • Kelowna General Hospital
      • Contact: Rochelle Nocos; Phone Number: 604-806-8242; Email: rochelle_nocos@sfu.ca
    • Prince George, British Columbia, Canada
      • Not yet recruiting
      • Northern Health Authority
      • Contact: Rochelle Nocos; Phone Number: 604-806-8242; Email: rochelle_nocos@sfu.ca
    • Vancouver, British Columbia, Canada
      • Not yet recruiting
      • Vancouver General Hospital
      • Contact: Rochelle Nocos; Phone Number: 604-806-8242; Email: rochelle_nocos@sfu.ca
    • Vancouver, British Columbia, Canada
      • Recruiting
      • St. Paul's Hospital
      • Contact: Rochelle Nocos; Phone Number: 604-806-8242; Email: rochelle_nocos@sfu.ca
      • Contact: Brodie Sakakibara; Phone Number: 250-807-8505; Email: brodie@mail.ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

(i) men and women with CVD (ischemic heart disease, atrial fibrillation, heart failure and patients with implantable cardioverter-defibrillator); (ii) at least 18 years of age; (iii) own, or have regular access to, either a smartphone (Android or iOS operating system), tablet or laptop/desktop computer; and (iv) able to understand English.

Exclusion Criteria:

(i) patients with planned surgical intervention (will be approached after surgery); (ii) another household member in the study; and (iii) unable to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; The usual care group will receive all standard treatment, instructions and information for patients with cardiovascular disease, but no Healing Circles program.
Experimental: Healing Circles; Healing Circles is an evidence-based and patient-informed novel self-management platform designed to support patients with CVD. It uses a private, secure social network that helps connect patients to one another, to personalized, disease management information , and provides functions to assist patients in self-management via evidence-based principles of behaviour change.	Behavioral: Healing Circles; See description in the arm description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in patient self-management (Health Education Impact Questionnaire v3.0) every 6 months until study end.	In this 40 item questionnaire, participants will be asked to answer questions related to life engagement, health behaviours, skill acquisition, constructive attitudes, self-monitoring, health service navigation, social support, and emotional well-being.	At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related Quality of Life (EuroQol 5D5L)	In this 5-item questionnaire, participants will be asked to answer questions related to mobility, self-care, your usual activities, pain/discomfort, anxiety/depression.	At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject
Subjective Quality of Life (ICECAP-A)	In this 5-item questionnaire, participants will be asked to answer questions related to feeling settled and secure, love and friendship, independence, achievements, enjoyment and pleasure.	At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject
Health Resource Use (study specific questionnaire)	In this questionnaire, participants will be asked to answer questions about the heath services you have used in the past six months (e.g., health professional visits, hospitalizations, medication use, as well as work and time off of work due to health issues).	At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject

Collaborators and Investigators

• Sponsor: Simon Fraser University
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Scott Lear, PhD, Simon Fraser University; Study Director: Brodie Sakakibara, PhD, University of British Columbia

Publications and helpful links

General Publications

• Sakakibara BM, Chakrabarti S, Krahn A, Mackay MH, Sedlak T, Singer J, Whitehurst DG, Lear SA. Delivery of Peer Support Through a Self-Management mHealth Intervention (Healing Circles) in Patients With Cardiovascular Disease: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 11;8(1):e12322. doi: 10.2196/12322.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2017
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: internet; technology; telehealth; chronic disease management; application
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases
• Other Study ID Numbers: H16-03203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No