The Healing Circles Project

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159325
• Other study ID #: H16-03203
• Status: Completed
• Phase: N/A
• Start date: August 20, 2017
• Est. completion date: September 15, 2023

Study information

• Verified date: April 2024
• Source: Simon Fraser University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: September 15, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases

Intervention

Behavioral:
• Healing Circles
See description in the arm description.

Locations

Country	Name	City	State
Canada	Kelowna General Hospital	Kelowna	British Columbia
Canada	Northern Health Authority	Prince George	British Columbia
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Simon Fraser University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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