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Heart DiseasesNCT03159325

The Healing Circles Project

A study testing Healing Circles in people with Heart Diseases and Cardiovascular Diseases, run by Simon Fraser University at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 110 years
Conditions the study is for
Heart Diseases, Cardiovascular Diseases
What is being tested?
Healing Circles
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
4 sitesCanada
Study dates
20 Aug 2017to 15 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Canada4 sites
  • Kelowna General Hospital

    Kelowna, British Columbia

  • Northern Health Authority

    Prince George, British Columbia

  • St. Paul's Hospital

    Vancouver, British Columbia

  • Vancouver General Hospital

    Vancouver, British Columbia

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Healing Circles
Keywords
internet, chronic disease management, technology, telehealth, application
Medical subject headings
Heart Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healing CirclesBehavioural

    See description in the arm description.

Study groups in NCT03159325
Study groupRoleWhat they receive
Usual CareNo interventionThe usual care group will receive all standard treatment, instructions and information for patients with cardiovascular disease, but no Healing Circles program.
Healing CirclesExperimentalHealing 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.
Receives: Behavioral: Healing Circles

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject

Secondary outcomes (3)
  1. 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.

    Measured: At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject

  2. 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.

    Measured: At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject

  3. 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).

    Measured: At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2017
  2. Study start20 Aug 2017
  3. Primary completion15 Sep 2023
  4. Study completion15 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03159325
Sponsor's protocol ID
H16-03203
Status last verified
Apr 2024
First submitted
3 May 2017
Last updated
26 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 30635261

Questions about this trial

What is this clinical trial studying?

A study testing Healing Circles in people with Heart Diseases and Cardiovascular Diseases, run by Simon Fraser University at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline in patient self-management (Health Education Impact Questionnaire v3.0) every 6 months until study end. (time frame: At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03159325, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.

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